A Phase Ia/b Study of ADRX-0706 in Subjects With Select Advanced Solid Tumors

Study Identifier:
ADRX-0706-001
CT.gov Identifier:
NCT06036121
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruitment Complete

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Study Summary

The primary purpose of this study is to assess the safety, tolerability, and pharmacokinetics, and to identify the optimal dose of ADRX-0706 in patients with select advanced solid tumors.

The Phase 1a part consisted of a dose escalation of ADRX-0706 to evaluate initial safety and tolerability in patients with select advanced solid tumors, and to identify the recommended dose to be used in the Phase 1b part. This second portion of the study will continue to assess the safety and tolerability of ADRX-0706, as well as evaluate preliminary efficacy and determine the optimal dose in urothelial cancer, triple-negative breast cancer, and cervical cancer expansion cohorts.

To evaluate ADRX-0706 in selected subjects with advanced solid tumors.

Nectin-4 expression evaluated retrospectively by immunohistochemistry using an internal assay (IHC).

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.
  • Bladder
  • Breast Cancers
  • Non-Small Cell Lung Cancer
  • Ovarian
  • Pancreas
  • Renal
  • Head & Neck
  • Solid Tumor
  • Cervical cancer
    • 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
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Phase 1a Dose Escalation
    • Read More
  • Drug: Experimental: Phase 1b Dose Expansion
  • Drug: Intervention/treatment:
  • Drug: Drug: ADRX-0706
  • Drug: Experimental Drugs
  • Drug: Specifications of ADRX-0706 injection: 30 mg (3 ml)/bottle; Dosage and administration: one-time intravenous injection; Dosage schedule: one cycle every 3 weeks.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    Inclusion criteria
    • Phase 1a Dose Escalation: Subjects with histologically confirmed select advanced solid tumors, including urothelial carcinoma (UC), head and neck squamous cell carcinoma (HNSCC), breast cancer, cervical cancer, ovarian cancer, non-small cell lung cancer (NSCLC), and pancreatic cancer. Subjects must have received at least one prior systemic regimen and have no other therapy available known to provide meaningful clinical benefit in the opinion of the investigator.
    • Measurable disease according to RECIST version 1.1
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    • Adequate hematologic, liver, and renal function
    • 1. Phase Ia dose escalation: Subjects with selected advanced solid tumors confirmed by histology , including urothelial carcinoma, head and neck squamous cell carcinoma, breast cancer, cervical cancer, ovarian cancer, non-small cell lung cancer and pancreatic cancer. Subjects must have previously received at least one systemic treatment regimen for their cancer , and the investigator believes that there is no other known treatment that can provide them with meaningful clinical benefit.
    • 2. Subjects must have measurable lesions according to RECIST version 1.1.
    • 3. Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1.
    • 4. Adequate hematologic, hepatic, and renal function.
    Exclusion criteria
    • Active and uncontrolled central nervous system metastases
    • Significant cardiovascular disease
    • History of another malignancy other than the one for which the subject is being treated on this study within 3 years
    • Receipt of any anticancer or investigational therapy within 5 elimination half-lives or 14 days (whichever is less)
    • Any P-gp inducers/inhibitors or strong CYP3A inhibitors received within 14 days prior to the first dose of study drug
    • Receiving systemic antimicrobial treatment for active infection; routine antimicrobial prophylaxis is permitted
    • 1. Active and uncontrolled central nervous system metastases .
    • 2. Severe cardiovascular disease .
    • 3. A history of other malignant tumors other than the malignant tumor that the subject is being treated for in this study within 3 years before the first administration of the study drug.
    • 4. Received any anticancer or investigational treatment within 5 elimination half-lives (t1/2) or 14 days (whichever is shorter) before the first dose of study drug.
    • 5. Received any P-gp inducer/inhibitor or strong CYP3A inhibitor within 14 days before the first dose of study drug.
    • 6. Patients are receiving systemic antimicrobial treatment for active infection (virus, bacteria or fungus) at the time of the first administration of study drug . Routine antimicrobial prophylaxis is allowed.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Bladder
    Breast Cancers
    Non-Small Cell Lung Cancer
    Ovarian
    Pancreas
    Renal
    Head & Neck
    Solid Tumor
    Cervical cancer
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Sreenivasa Chandana
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Bladder
    Breast Cancers
    Non-Small Cell Lung Cancer
    Ovarian
    Pancreas
    Renal
    Head & Neck
    Solid Tumor
    Cervical cancer