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:
Terminated/Withdrawn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.
Endometrial
Ovarian
Breast Cancers
Gastroesophageal
Non-Small Cell Lung Cancer
Urinary tract
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.
Phase I/II
Sex
Female & Male
Age
18+ years
Study Drug
N/A
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Terminated/Withdrawn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
- 1Patients must be pathologically confirmed to have one of the following tumors: Ovarian cancer (must be high-grade ovarian epithelial carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma, including serous, endometrioid, and clear cell carcinomas, excluding mucinous, low-grade, and carcinomas with sarcomatous or neuroendocrine components); Endometrial cancer (including endometrioid, serous, and clear cell carcinomas, as well as carcinosarcomas, excluding gastrointestinal mucinous, low-grade, mixed, or undifferentiated carcinomas, and carcinomas with sarcomatous or mesonephric components); Triple-negative breast cancer (TNBC), i.e., estrogen receptor (ER) negative, progesterone receptor (PR) negative, and human epidermal growth factor receptor 2 (HER2) negative breast cancer; Non-small cell lung cancer (NSCLC) confirmed by a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory (or with local equivalent certification) according to the American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) guidelines; Esophageal, gastroesophageal junction (GEJ), or gastric adenocarcinoma; Esophageal squamous cell carcinoma (ESCC). Urothelial carcinoma (bladder cancer, ureteral cancer, or renal pelvis cancer)2The patient must have metastatic or unresectable locally advanced recurrent tumors and be unsuitable for further local treatment.3Disease can be measured at baseline as defined in RECIST version 1.1 (Eisenhauer et al., 2009).4The patient must agree to provide a pre-treatment tumor tissue sample (archived or fresh biopsy sample).5An Eastern Cooperative Oncology Group (ECOG) performance status score of 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.
- 1The patient had previously received targeted therapy against protein tyrosine kinase 7 (PTK7).2When receiving Auristatin-based antibody-drug conjugates (ADCs) as recent first-line treatment, the best response is disease progression.3The patient has a history of another malignant tumor within 3 years prior to the first administration of the study drug, or there is evidence of residual disease from a previously diagnosed malignant tumor.4Active central nervous system metastases are known, including carcinomatous meningitis.5Have any uncontrolled viral, bacterial, or fungal infection within 2 weeks prior to the first administration of the study drug. Routine antimicrobial prophylaxis is permitted.6A positive hepatitis B surface antigen (HBsAg) test is required. Additional testing (e.g., hepatitis B virus [HBV] core antibody and HBV surface antibody tests) should be performed on patients with increased risk factors to rule out recent or occult infections.7Patients with active hepatitis C (positive polymerase chain reaction [PCR] test, or who have received antiviral therapy for hepatitis C within the past 6 months) were eligible for enrollment. Patients who had received treatment for hepatitis C infection but had a record of at least 12 weeks of sustained virological response were also eligible for enrollment.8Human immunodeficiency virus (HIV) infection is known to exist.9The patient had used a potent cytochrome P450 3A (CYP3A) inhibitor within 2 weeks prior to the first administration of the 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