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.

View Full Description

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.

View Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

134

Study ID:

NCT05579366

Recruitment Status:

Recruiting

Sponsor:

ProfoundBio US Co.

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There are 10 Locations for this study

See Locations Near You

HonorHealth
Scottsdale Arizona, 85258, United States More Info
Muhammad R. Khawaja, MD, MPH
Contact
480-323-4637
[email protected]
University of California Los Angeles Medical Center
Los Angeles California, 90095, United States More Info
Gottfried Konecny, MD
Contact
310-500-8384
[email protected]
University of California, San Diego; Moores Cancer Center
San Diego California, 92093, United States More Info
Sandip Patel, MD
Contact
858-822-5182
[email protected]
Providence Medical Foundation
Santa Rosa California, 95403, United States More Info
Ian Anderson, MD
Contact
707-528-1050
[email protected]
University of Kansas Medical Center (KUMC)
Westwood Kansas, 66205, United States More Info
Jun Zhang, MD, PhD
Contact
913-588-8150
[email protected]
Karmanos Cancer Institute
Detroit Michigan, 48085, United States More Info
Ira Winer, MD. PhD
Contact
313-576-9435
[email protected]
University of Oklahoma - Health Sciences Center
Oklahoma City Oklahoma, 73104, United States More Info
Debra Richardson, MD
Contact
214-645-4673
[email protected]
Sarah Cannon Research Institute at Tennessee Oncology
Nashville Tennessee, 37203, United States More Info
Erika Hamilton, MD
Contact
615-320-5090
[email protected]
Mary Crowley Cancer Research
Dallas Texas, 75521, United States More Info
Douglas Orr, MD
Contact
972-566-3000
[email protected]
START Mountain Region
West Valley City Utah, 84119, United States More Info
Justin Call, MD
Contact
801-907-4750
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

134

Study ID:

NCT05579366

Recruitment Status:

Recruiting

Sponsor:


ProfoundBio US Co.

How clear is this clinincal trial information?

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