Ovarian Cancer Clinical Trial
PRO1184 for Advanced Solid Tumors
Summary
This study will test the safety, including side effects, and determine the characteristics of a drug called PRO1184 in participants with solid tumors.
Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).
This study will have two parts. Part A of the study will find out how much and how frequently PRO1184 should be given to participants. Part B will use the dose and schedule found in Part A to find out how safe PRO1184 is and if it works to treat solid tumor cancers.
Full Description
This is a Phase 1/2 study of PRO1184, a folate receptor alpha (FRα) targeted antibody-drug conjugate, to evaluate the safety, tolerability, PK, and antitumor activity of PRO1184 in patients with selected locally advanced and/or metastatic solid tumors, including epithelial ovarian cancer, endometrial cancer, breast cancer, non-small cell lung cancer, and mesothelioma. This study consists of 2 parts, Part A: Dose Escalation and Part B: Dose Expansion.
Part A may evaluate up to 7 dose levels of PRO1184 on Day 1 of a 21 day cycle by IV infusion.
Part B will be initiated at a dose level based on a comprehensive analysis of safety, tolerability, clinical PK, PD and activity data from Part A in up to 4 different cohorts of up to 20 patients per cohort.
Patients will continue to receive study treatment until the first instance of disease progression, unacceptable toxicity, investigator decision, consent withdrawal, study termination by the Sponsor, pregnancy, or death.
Eligibility Criteria
Inclusion Criteria:
histologically or cytologically confirmed metastatic or unresectable solid malignancy including ovarian cancer (must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer), endometrial cancer, non-small cell lung cancer, breast cancer (hormone receptor positive, HER2-negative and triple-negative), mesothelioma
previously received therapies known to confer clinical benefit
willing to provide a tumor sample (archive tissue or fresh biopsy)
ECOG performance status 0 or 1
measurable disease per RECIST v1.1 for all tumor types other than pleural mesothelioma which will use mRECIST v1.1 at baseline
adequate hematologic, hepatic, renal and cardiac function
for Part B, evidence of folate receptor alpha expression in tumor cells
Exclusion Criteria:
other malignancy within 3 years
active CNS metastases (treated, stable CNS metastases are allowed)
uncontrolled Grade 3 or greater infection within 2 weeks
positive for HBV, HCV or HIV
use of a strong P450 CYP3A inhibitor within 14 days (dose escalation only)
additional protocol defined inclusion/exclusion criteria may apply
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There are 11 Locations for this study
Los Angeles California, 90095, United States
San Diego California, 92093, United States
Santa Rosa California, 95403, United States
Westwood Kansas, 66205, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48085, United States
Oklahoma City Oklahoma, 73104, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75521, United States
West Valley City Utah, 84119, United States
Beijing Beijing, , China
Changsha Hunan, , China
Changsha Hunan, , China
Chang chun Jilin, , China
Shanghai Shanghai, , China
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