PRO1184 for Advanced Solid Tumors

About

Brief 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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 1/Phase 2

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

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

Join this Trial

Contact our clinical trial navigators for opportunities that may be suitable for you