A Phase I/II Study of PRO1107 in Patients With Advanced Solid Tumors
Study Identifier:
GCT1107-01 (PRO1107-001)
CT.gov Identifier:
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Terminated/Withdrawn
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Study Summary
This is a global, open-label, multicenter Phase 1/2 study to evaluate the safety, tolerability, PK, and antitumor activity of PRO1107 in patients with advanced solid tumors. This study consists of 2 parts, Part A: dose escalation and dose level expansion, and Part B: tumor specific expansion.
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.
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+ years
Study Drug
Read More
Study Status
Indicates the current recruitment status or the expanded access status
Terminated/Withdrawn
Requirements information
Inclusion criteria
- Inclusion Criteria
- art A:
- Pathologically confirmed diagnosis of one of the following tumor types:
- Ovarian cancer (epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer)
- Endometrial cancer (any subtype excluding sarcoma)
- Triple negative breast cancer (TNBC)
- Non-small cell lung cancer (NSCLC)
- Metastatic or unresectable locally advanced, recurrent, disease not amenable to further local therapy following prior systemic therapies known to confer clinical benefit.
- Part B:
- Participants must have a histologically or cytologically confirmed metastatic or unresectable solid malignancy as specified below:
- Ovarian cancer
- TNBC
- Endometrial cancer
- NSCLC
- Measurable disease at baseline as defined per RECIST, Version 1.1
- 1 Patients must have a pathologically confirmed diagnosis of one of the following tumors: Ovarian cancer (must be high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer, including serous, endometrioid, and clear cell carcinomas, and excluding mucinous, low-grade, and carcinomas with sarcomatous or neuroendocrine components) Endometrial cancer (including endometrioid, serous, and clear cell carcinomas and carcinosarcoma, and excluding gastrointestinal mucinous, low-grade, mixed, or undifferentiated carcinomas, and carcinomas with sarcomatous or mesonephric components) Triple-negative breast cancer (TNBC), defined as estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epithelial growth factor receptor 2 (HER2)-negative breast cancer, as determined by a Clinical Laboratory Improvement Amendments (CLIA)-certified (or with local equivalent) laboratory according to the American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) guidelines Non-small cell lung cancer (NSCLC) Esophageal, gastroesophageal junction (GEJ), or gastric adenocarcinoma Esophageal squamous cell carcinoma (ESCC) Urothelial carcinoma (bladder, ureter, or renal pelvis cancer)
- 2 Patients must have metastatic or unresectable locally advanced recurrent disease and be ineligible for further local therapy.
- 3 Measurable disease at baseline was defined according to RECIST version 1.1 (Eisenhauer et al., 2009).
- 4 Patients must consent to provide a pre-treatment tumor tissue sample (archive or fresh biopsy).
- 5 Eastern Cooperative Oncology Group (ECOG) performance status score was 0 or 1.
Exclusion criteria
- Exclusion Criteria
- Prior treatment with anti-PTK7-directed therapy.
- Had progressive disease as best response while on treatment with an auristatin (eg, a vedotin or pelidotin)- based ADC as the most recent line of therapy.
- History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (eg, 5-year overall survival [OS] ≥90%)
- Known active central nervous system metastases, including carcinomatous meningitis. Participants with brain metastases may participate provided the metastases have been treated and are stable for at least 4 weeks prior to the first dose of study drug, they have no new or enlarging brain metastases and have discontinued corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug. Participants with a history of brain metastases, suspected new brain metastases, or a diagnosis of NSCLC or breast cancer should have a computed tomography (CT)/ magnetic resonance imaging (MRI) scan of the brain at screening.
- Participants with active or chronic corneal disorders, history of corneal transplantation, or any clinically significant corneal disease that prevents adequate monitoring of potential drug-induced keratopathy. Note: Participants with other active ocular conditions requiring ongoing therapy and/or monitoring must be discussed with the sponsor prior to enrollment.
- Additional protocol defined inclusion/exclusion criteria may apply.
- 1Previously received anti-protein tyrosine kinase 7 (PTK7) targeted therapy.
- 2The best response was disease progression when receiving an auristatin (eg, vedotin or pelidotin) antibody-drug conjugate (ADC) as the most recent first-line therapy.
- 3Patients had a history of another malignancy within 3 years before the first dose of study drug, or evidence of residual disease from a previously diagnosed malignancy.
- 4Active central nervous system metastases, including carcinomatous meningitis, are known to occur.
- 5Any uncontrolled viral, bacterial, or fungal infection within 2 weeks before the first dose of study drug. Routine antimicrobial prophylaxis is allowed.
- 6A positive hepatitis B virus surface antigen (HBsAg) test. Patients with increased risk factors should also undergo additional testing (eg, hepatitis B virus [HBV] core antibody test and HBV surface antibody test) to exclude recent or occult infection.
- 7Active hepatitis C (positive polymerase chain reaction [PCR] test or receipt of antiviral treatment for hepatitis C within the past 6 months). Patients who have received treatment for hepatitis C infection but have a documented sustained virologic response for at least 12 weeks are allowed to participate in this study.
- 8Known human immunodeficiency virus (HIV) infection.
- 9Use of a strong cytochrome P450 3A (CYP3A) inhibitor within 2 weeks before the first dose of study drug.
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
Justin Call
Status
Recruitment Complete
Condition(s) Treated at Site
Endometrial
Ovarian
Breast Cancers
Gastroesophageal
Non-Small Cell Lung Cancer
Urinary tract