A Phase I/Ib/II Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Anvumetostat Alone and in Combination With Docetaxel in Subjects With Advanced MTAP-null Solid Tumors

Study Identifier:
20210023
CT.gov Identifier:
NCT05094336
EudraCT Identifier:
202350000000
EU Trial (CTIS) Number:
2023-504363-17-00
Study Contact Information:
N/A
Recruitment Complete

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Study Summary

To evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 193 Alone and in Combination With Docetaxel in Subjects With Advanced MTAP-null Solid Tumors.

To report the initial clinical results from dose-escalation in the ongoing first-in-human (FIH) study.

Methods: AMG193 was orally administered in continuous 28-day cycles to patients (pts) with advanced MTAP-null solid tumors. Dose escalation proceeded via a BLRM method.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18 - 100 Years
    Study Drug
  • Drug: Experimental: Part 1a, Phase 1: Anvumetostat Monotherapy Dose Exploration
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    Inclusion criteria
    • Participant has provided informed consent/assent before initiation of any study specific activities/procedures.
    • Age> or = 18 years.
    • Evidence of homozygous loss of cyclin dependent kinase inhibitor 2A (CDKN2A) (null) (Parts 1a, 1j, 1k, and 2a only) and/or methylthioadenosine phosphorylase (MTAP) (null) in the tumor tissue or blood (Parts 1a to 1k, Parts 2a and 2b) or lost MTAP expression in the tumor tissue (Parts 1a to 1k, Parts 2a and 2b).
    • Histologically confirmed metastatic or locally advanced solid tumor not amenable to curative treatment with surgery and/or radiation.
    • Able to swallow and retain orally (PO) administered study treatment and willing to record daily adherence to investigational product.
    • Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Note: except participants enrolling to Part 1m.
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
    • Adequate hematopoietic function per local laboratory
    • Adequate renal function per local laboratory
    • Adequate glucose control per local laboratory (Part 1 only)
    • Adequate liver function per local laboratory
    • Adequate coagulation parameters
    • Adequate pulmonary function
    • Adequate cardiac function
    • Minimum life expectancy of 12 weeks as per investigator judgement.
    • A total of 25 slides of archived tumor tissue (formalin-fixed, paraffin-embedded [FFPE] sample collected within 5 years) or an archival block must be available.
    • For Part 1f (MTAP-null or lost MTAP expression HNSCC): Must be willing to undergo tumor biopsy.
    • For Parts 1a and 1b backfill: Must be willing to undergo tumor biopsy, before start of treatment (archival sample acceptable if obtained with 6 months of enrollment and subject has not received any other treatment since sample was obtained) and while on treatment.
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
    • Adequate hematopoietic function per local laboratory
    • Adequate renal function per local laboratory
    • Adequate glucose control per local laboratory (Part 1 only)
    • Adequate liver function per local laboratory
    • Adequate coagulation parameters
    • Adequate pulmonary function
    • Adequate cardiac function
    • Minimum life expectancy of 12 weeks as per investigator judgement.
    • A total of 25 slides of archived tumor tissue (formalin-fixed, paraffin-embedded [FFPE] sample collected within 5 years) or an archival block must be available.
    • For Part 1f (MTAP-null or lost MTAP expression HNSCC): Must be willing to undergo tumor biopsy.
    • For Part 1a: Must be willing to undergo tumor biopsy, before start of treatment (archival sample acceptable if obtained with 6 months of enrollment and subject has not received any other treatment since sample was obtained) and while on treatment.
    • For DSPS study (Part 1j): Must be willing to participate in DSPS substudy (US sites only).
    • Food Effect Substudy (Part 1k): Specific Inclusion Criteria
    • Subject able and willing to eat a standardized high-fat, high-caloric meal
    • Subject able and willing to fast for ≥ 6 hours
    • Taiwan Registry:
    • Inclusion Conditions
    • Subjects must meet all of the following conditions to be eligible for inclusion in this trial:
    • 101 Subjects have provided subject consent before commencing any trial activities or procedures.
    • 102 Age ≥18 years old.
    • 103 There is evidence that tumor tissue loses homozygous CDKN2A (deletion) (parts 1a, 1j, 1k and 2a only) and/or tumor tissue or blood MTAP (deleted) (parts 1a to 1k, 2a and 2b) or tumor tissue does not Performance MTAP (Parts 1a to 1k, Parts 2a and 2b).
    • 104 Histologically confirmed metastatic or locally advanced solid tumors that cannot be curatively treated with surgery and/or radiotherapy.
    • • Parts 1a, 1j, and 1k: Solid tumors that are MTAP-deficient and/or CDKN2A-deficient or do not express MTAP, for which standard therapy is not available, has failed, or is unavailable/tolerable; or, in the judgment of the trial sponsor, standard therapy fails to produce meaningful results clinical benefit.
    • • Part 1c: MTAP-deficient or non-expressing NSCLC
    • • Non-actionable mutation (i.e. EGFR, ALK, MET, RET, ROS1, KRASG12C): Prior 1 to 3 lines of systemic therapy for metastatic/localized Advanced disease, must have received platinum-containing chemotherapy, and should have received anti-programmed cell death ligand 1 (PD-L1) therapy, unless there are contraindications (such as autoimmune diseases) or the PD-L1 expression level has been tested below 1%.
    • • Have actionable mutations (i.e., EGFR, ALK, MET, RET, ROS1, KRASG12C): Subjects with actionable tumor gene abnormalities should have disease progression after receiving approved treatment for the abnormality. In addition, prior 1 to 3 lines of systemic therapy (excluding treatments targeting actionable mutations) must have included platinum-containing chemotherapy.
    • Note: Subjects who have previously received only first-line therapy can only be included in the trial if they are unable to receive standard second-line therapy due to intolerance or other medically sufficient reasons.
    • • Part 1e: MTAP-deficient or MTAP-deficient biliary tract cancer (BTC), previously treated with 1 to 2 lines of systemic therapy for metastatic/locally advanced disease, if fibroblast growth factor receptor fusion/rearrangement is confirmed, This includes platinum-based chemotherapy and targeted therapy.
    • • Part 1f: Head and neck squamous cell carcinoma (HNSCC) with missing or MTAP-deficient MTAP and previously treated with 1 to 2 lines of systemic therapy for metastatic/locally advanced disease, including platinum-based chemotherapy and PD-1 or PD-L1 inhibitors.
    • • Part 1g: Pancreatic adenocarcinoma with missing or non-MTAP expression, previously treated with 1 to 2 lines of systemic therapy, including standard chemotherapy regimens such as mFOLFIRINOX, gemcitabine/abraxane.
    • • Part 1h: Solid tumors that lack MTAP or do not express MTAP (except lymphoma or primary brain tumors) for which there is no standard therapy; or standard therapy has failed or is unavailable/tolerable; or, in the judgment of the trial sponsor, Standard therapies fail to produce meaningful clinical benefit.
    • Note: If ≥5 subjects are recruited from any single tumor type, Amgen may further restrict recruitment from that tumor type in Part 1h to ensure inclusion of a heterogeneous solid tumor population.
    • • Part 1i: Part 1i qualifications are for the purpose of qualifying for the specific expansion group from which the indication is selected.
    • • Parts 2a and 2b: NSCLC with MTAP deletion and/or CDKN2A deletion (part 2a only), or non-MTAP expression, who have previously received 1 to 2 lines of systemic therapy for locally advanced/metastatic disease, must include PD1 or PD-L1 inhibitors and platinum-based chemotherapy, including targets if confirmed to have a treatable oncogenic driver mutation (i.e., EGFR, ALK, MET, RET, ROS1, KRASG12C), if there is an approved therapy for this indication treat.
    • 105 Ability to swallow and maintain oral investigational treatment and willingness to record daily dosing of investigational drug.
    • 106 Have measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1).
    • 107 East Coast Cancer Collaborative (ECOG) performance status is 0 or 1.
    • 108 Adequate hematopoiesis, as determined by local laboratory testing, is defined as:
    • • Absolute neutrophil count ≥ 1.5 x 109/L within 7 days (granular growth hormone [G-CSF]) or within 14 days (polymer Glycolated G-CSF) without growth factor supplementation;
    • • Platelet count ≥ 100 x 109/L (no platelet transfusions within 7 days of screening assessment);
    • • Heme >9 g/dL (no platelet transfusions within 7 days of screening assessment) red blood cell transfusion),
    • 109 Adequate renal function as determined by local laboratory testing, defined as:
    • • Creatinine clearance ≥ 60 mL/min based on the Cockcroft-Gault estimated glomerular filtration rate or the Modification of Diet in Renal Disease formula.
    • 110 Adequate glycemic control as determined by local laboratory (Part 1a only), defined as:
    • • Fasting blood glucose ≤ 160 mg/dL.
    • 111 Adequate liver function as determined by local laboratory testing, defined as:
    • • Part 1: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times the upper limit of normal (ULN) (if < 5 times ULN in subjects with liver metastases);
    • • Part 1: Total bilirubin < 1.5 times ULN (< 2.0 times ULN in subjects with liver metastases and Guibert syndrome documented in medical records ).
    • • Part 2: AST and ALT ≤ 1.5 times ULN;
    • • Part 2: Total bilirubin ≤≦ ULN (< 1.5 times ULN if the subject has liver metastases and Guibert syndrome documented in the medical record).
    • 112 Appropriate coagulation parameters, defined as:
    • • Prothrombin time or activated partial thromboplastin time < 1.5 times ULN and international normalized ratio (INR) < 1.5 times ULN or outside the target range (when receiving anticoagulant prophylaxis ).
    • 113 Adequate pulmonary function, defined as:
    • • Clinically insignificant pleural hydrops (postoperative [s/p] indwelling catheters for non-small cell lung cancer and malignant pleural mesothelioma are allowed if the subject requires drainage less frequently than every Every 2 weeks)
    • • Baseline oxygen saturation > 90% on room air at rest.
    • 114 Adequate cardiac function is defined as:
    • • Cardiac ejection fraction ≥ 50% as measured by cardiac ultrasound or multi-channel ventricular function photography
    • • No evidence of clinically significant pericardial effusion
    • • 350 msec < reference point QTc ≤ 470 msec (based on the average of three replicates at screening).
    • 115 The trial administrator judged the subjects' life expectancy to be at least 12 weeks.
    • 116 A total of 25 sealed tumor tissue slides (formalin-fixed paraffin-embedded [FFPE] specimens collected within 5 years) or sealed tumor tissue blocks must be provided. The tumor component of the sealed specimen shall be pre-examined and must contain at least 20% tumor material. Subjects who are unable to provide sealed tumor tissue and who undergo tumor tissue biopsy before AMG 193 administration (day 1 of cycle 1) will be allowed to be included in the trial. Subjects who are unable to provide sufficient sealed tumor tissue, and if it is medically impossible to obtain new tumor tissue sections, may be included in the trial (only parts 1a, 1j, and 1k) with the consent of the trial sponsor and Amgen's medical monitor.
    • 117 Part 1f (Head and neck squamous cell carcinoma with missing MTAP or no expression of MTAP): Must be willing to undergo tumor tissue biopsy before starting treatment (if collected within 6 months before inclusion and the subject has not undergone After other treatments, sealed specimens may be accepted) and tissue sections will be re-sectioned approximately 4 weeks after the start of treatment.
    • 118 Backfill for Part 1a: Must be willing to undergo tumor tissue biopsy before starting treatment (sealed specimens are acceptable if obtained within 6 months before inclusion and the subject has not received other treatments since the specimen was collected), and Tissue sections were again taken approximately 4 weeks after the start of treatment (part 1 was day 1 of cycle 2). Note: Treatment of PD tissue sections for designated dose groups may be discontinued after Amgen confirms completion of PD exploration. Subjects who are unable to provide sufficient sealed tumor tissue, and if it is medically impossible to obtain new tumor tissue sections, may be allowed to be included in the trial (only part 1a) with the consent of the trial sponsor and Amgen's medical monitor.
    • 119 DSPS Trial (Part 1j): Must be willing to participate in this DSPS subtrial (US testing facilities only). Food Effects Subtrial (Part 1k): Specific Inclusion Criteria120
    • Subjects are able and willing to consume a standardized high-fat, high-calorie diet121
    • Subjects are able and willing to fast for more than 6 hours
    • Specific Inclusion Criteria for subjects with glioma (Part 1m only)
    • -Disease measurable as defined per Modified Response Assessment in Neuro-Oncology Criteria 2.0 (mRANO 2.0)
    • Key eligibility criteria for patients with NSCLC (Part 1c) include adult patients (≥ 18 years of age) with MTAP-deleted advanced tumors (determined by NGS or evidence of MTAP depletion determined by IHC); treatment with 1-3 prior lines of systemic therapy in the advanced/metastatic setting including platinum-based chemotherapy. Additionally, patients without actionable mutations must have received treatment with a PD(L)-1 inhibitor (unless contraindicated or PD-L1 < 1%), and patients whose tumors harbor actionable genomic aberrations (i.e. EGFR, ALK, MET, RET, ROS1, KRASG12C) should have disease progression on approved systemic therapies for these aberrations
    Exclusion criteria
    • Spinal cord compression or untreated brain metastases or leptomeningeal disease.
    • History of other malignancy within the past 2 years
    • Any evidence of current interstitial lung disease
    • Active infection
    • Evidence of active severe acute respiratory syndrome coronavirus 2 (SARS-COV2) infection.
    • History of arterial thrombosis
    • Myocardial infarction and/or symptomatic congestive heart failure.
    • Gastrointestinal tract disease
    • History of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
    • History of solid organ transplant.
    • Diagnosis of Congenital Short QT Syndrome.
    • Major surgery
    • Anti-tumor therapy within 28 days of study day 1,
    • Prior treatment with an methionine adenosyltransferase 2 (MAT2A) inhibitor or a protein arginine methyltransferase 5 (PRMT5) inhibitor.
    • Prior treatment with docetaxel (Part 2 only)
    • Prior irradiation to 25% of the bone marrow.
    • Therapeutic or palliative radiation therapy within 2 weeks of study day 1.
    • Live vaccine therapy within 4 weeks before study drug administration.
    • Use of therapeutic anti-coagulation for treatment of active thromboembolic events.
    • Use of prescription medications that are known strong inducers of cytochrome P450 3A4 (CYP3A4) within 14 days or 5 half-lives (whichever is longer) before study day 1
    • Unresolved toxicity from prior anti-cancer therapy
    • Currently receiving treatment in another investigational device or drug study
    • Known positive test for Human Immunodeficiency Virus (HIV).
    • Positive hepatitis B surface antigen
    • positive hepatitis C virus ribonucleic acid (RNA) by polymerase chain reaction (PCR)
    • Female participants of childbearing potential unwilling to use protocol specified method of contraception
    • Taiwan Registry:
    • Exclusion Conditions
    • Subjects meet any of the following criteria , i.e. excluded from the trial:
    • disease-related
    • 201 spinal cord compression or untreated brain metastases or leptomeningeal disease. Subjects who have had brain metastases and have completed appropriate treatment with radiotherapy or surgery at least 4 weeks before day 1 of the trial are still eligible to participate in the trial if they meet all of the following conditions: a) Stable or improved residual Neurological symptoms ≤ grade 2; b) Maintain a stable dose of dexamethasone (if applicable).
    • Other medical conditions
    • 204 Have suffered from other malignant tumors in the past 2 years, except for the following situations:
    • The malignant tumor has received curative treatment, there is no known active disease ≥ 2 years before inclusion, and the treating physician determines that the risk of recurrence is low.
    • Non-melanotic skin cancer or malignant nevus that has been appropriately treated and has no evidence of disease.
    • Carcinoma in situ of the cervix, appropriately treated and with no evidence of disease.
    • Ductal carcinoma in situ of the breast, appropriately treated and with no evidence of disease.
    • Prostatic intraepithelial hyperplasia without evidence of prostate cancer.
    • Non-invasive urothelial papillary carcinoma or carcinoma in situ with appropriate treatment.
    • 205 Evidence of current or previous interstitial lung disease or non-infectious pneumonia.
    • 206 Active infection requiring systemic therapy.
    • 207 There is evidence of active SARS-COV2 infection. If recent SARS-COV2 infection is known or suspected, at least 10 days must elapse after the onset of symptoms (if any).
    • 208 History of arterial thrombosis (eg, stroke or transient cerebral ischemia) within 6 months of the first dose of AMG 193.
    • 209 Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > Class II), unstable angina, or cardiac arrhythmia requiring treatment within 12 months of the first dose of AMG 193.
    • 210 Gastrointestinal disease resulting in inability to take oral medications, malabsorption syndromes requiring intravenous nutrition, gastric/jejunal tube feeding, and poorly controlled inflammatory gastrointestinal disease (eg, Crohn's disease and ulcerative colitis).
    • 211 History of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to trial entry, unless approved by the program sponsor and Amgen Medical Monitor, or gastrointestinal procedure resulting in malabsorption medical history.
    • 212 had received solid organ transplantation.
    • 213 was diagnosed with congenital short QT syndrome.
    • Previous/current concurrent treatments
    • 214 Major surgery within 28 days of first dose of AMG 193 .
    • 215 Receive anti-tumor therapy (chemotherapy, antibody therapy, molecular target therapy, hormonal therapy, or use of investigational drug) within 28 days of trial day 1, unless the 5-fold half-life of the anti-tumor therapy is less than 28 days (in which case, In consultation with the Amgen Medical Monitor, inclusion is allowed if washout occurs <28 days after prior therapy).
    • NOTE: The use of bisphosphonates or denosumab for skeletal-related events is permitted per institutional guidelines.
    • 216 had previously received MAT2A inhibitor or PRMT5 inhibitor treatment.
    • 217 Previous treatment with docetaxel (Part 2 only).
    • 218 >25% of bone marrow had previously received radiotherapy.
    • 219 Received therapeutic or palliative radiation therapy within 2 weeks before trial day 1. Subjects must have recovered from all radiation therapy-related toxicities.
    • 220 Administer live vaccines within 4 weeks before starting investigational drug administration.
    • 221 Use of therapeutic anticoagulants to treat active thromboembolic events.
    • NOTE: Subject to discussion and approval by the trial moderator and medical monitor, subjects may be eligible if they receive a stable dose of anticoagulant therapy for thromboembolic events for ≥ 3 months.
    • Note: For subjects who are receiving anticoagulant therapy and undergoing biopsy, safety precautions, such as suspending medication, may be considered if deemed necessary and safe by the trial moderator.
    • 222 Use of known potent CYP3A4 inducers (including rifampin, mitotane , avasimibe, rifapentine, apalutamide, ivosidenib, phenytoin, carbamazepine, enzalutamide, hypericum extract, lumacaftor, phenobarbital) or inhibitors (including VIEKIRA PAK, indinavir/ritonavir, tipranavir/ritonavir, ritonavir, cobicistat, ketoconazole, troleandomycin, telaprevir , danoprevir/ritonavir, elvitegravir/ritonavir, saquinavir/ritonavir, lopinavir/ritonavir, itraconazole, indinavir, voriconazole, mifepristone, mibefradil, LCL161, clarithromycin, josamycin, lonafarnib, posaconazole, telithromycin, grapefruit juice, conivaptan, tucatinib, nefazodone, ceritinib , Prescription medicines such as nelfinavir, saquinavir, ribociclib, idelalisib, boceprevir).
    • 223 Failure to resolve toxicities from prior cancer therapy, defined as failure to resolve to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 0 or 1, or to a grade described in the eligibility criteria, with the exception of alopecia.
    • Irreversible grade 2 or 3 toxicity of previous cancer treatment (defined as: existing and stable for ≥ 5 months before inclusion in the trial), such as endocrine abnormalities controlled with hormone replacement therapy; if not explicitly listed in the exclusion criteria and approved by the trial host If the person and the trial sponsor agree unanimously, inclusion in the trial may be allowed.
    • Previous/current concurrent clinical trial experience
    • 224 Currently receiving treatment with other experimental devices or experimental drugs, or ending treatment with other experimental devices or experimental drugs for less than 28 days. No other test procedures are allowed while participating in this trial.
    • Diagnostic Assessment
    • 225 Known positive test for human immunodeficiency virus.
    • 226 There is evidence of infection with hepatitis B or hepatitis C, based on more than one of the following results and/or criteria:
    • Hepatitis B surface antigen (HepBsAg) positive
    • HepBsAg negative plus hepatitis B core antibody (HepBcAb) and/or Hepatitis B surface antibody (HepBsAb) is positive, and hepatitis B virus (HBV) DNA is detectable using polymerase chain reaction (PCR). (Please note that HepBsAg and/or HepBsAb negativity coupled with HepBcAb positivity will trigger the requirement for PCR detection of HBV DNA). Subjects who are HBV DNA negative can be included in the trial, but HBV DNA needs to be monitored every 2 months
    • PCR test positive for hepatitis C virus RNA. Note: Subjects who receive antiviral treatment and have negative hepatitis C virus RNA results can be included in the trial, but they need to monitor hepatitis C virus RNA every 2 months.
    • Other Exclusions
    • 227 Female subjects of childbearing potential who are unwilling to participate in the trial schedule during treatment, for an additional 21 days after the last dose of AMG 193 and for an additional 6 months after the last dose of chemotherapy as specified in the trial protocol. Drawing book specifies contraceptive methods.
    • 228 Female subjects who breastfed or planned to breastfeed during the trial up to an additional 21 days after the last dose of AMG 193 and an additional 6 months after the last dose of chemotherapy as specified in the trial protocol.
    • 229 Female subjects planned to become pregnant during the trial for an additional 21 days after the last dose of AMG 193 and for an additional 6 months after the last dose of chemotherapy as specified in the trial protocol.
    • 230 Female subjects of childbearing potential with a positive highly sensitive urine pregnancy test or serum pregnancy test on day 1 at screening.
    • 231 The male subject's female partner is of childbearing potential and is unwilling to practice abstinence (avoidance of the opposite sex) for an additional 21 days after the last dose of AMG 193 and an additional 6 months after the last dose of chemotherapy as specified in the trial protocol. sexual intercourse) or use contraceptive methods.
    • 232 Male subject whose partner is pregnant and unwilling to abstain from sex or use condoms for an additional 21 days after the last dose of AMG 193 and an additional 6 months after the last dose of protocol-specified chemotherapy.
    • 233 Male subjects who were unwilling to refrain from donating sperm during treatment, for an additional 21 days after the last dose of AMG 193, and for an additional 6 months after the last dose of chemotherapy as specified in the trial protocol.
    • 234 Subject is known to be allergic to any intended medication. For part 2, allergic to docetaxel or polysorbate 80.
    • 235 For Parts 1c to 1h and Part 2, subjects are unable to undergo computed tomography (CT) scans with iodinated contrast agents or magnetic resonance imaging (MRI) with gium contrast agents.
    • 236 To the best of the knowledge of the subject and the trial moderator, the subject may not be able to complete all follow-up visits and procedures specified in the trial protocol, and/or cooperate with all necessary trial procedures (e.g., clinical outcome assessment).
    • 237 Other clinically significant abnormalities, conditions, disease records or evidence (other than the conditions listed above) that, in the opinion of the trial moderator or Amgen physician, may endanger the safety of the subjects, or affect trial evaluation, procedures or completion.

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Amita Patnaik
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Solid Tumor