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.

The study consists of 4 main parts:

Part A: dose-escalation cohorts

Part B: tumor-specific monotherapy dose-expansion cohorts

Part C: ovarian cancer extension cohort

Part D: combination therapy cohorts

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

Part C:

High grade ovarian cancer:

Patients must have platinum-resistant/refractory ovarian cancer
Patients must have received prior bevacizumab
Patients with known or suspected deleterious germline or somatic BRCA mutations must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor
Patients must have previously received mirvetuximab soravtansine, if indicated based on an FDA approved test for FRα expression (i.e., FRα PS2+ membrane expression in at least 75% of tumor cells), unless the patient has a documented medical exception
Prior induction plus maintenance is considered 1 line of therapy, even if parts of the treatment regimen (induction or maintenance) are interrupted and/or resumed at a later date, in the absence of disease progression while on active treatment
A switch/change in regimen due solely to toxicity or patient preference (and not disease progression) is not considered a separate line of therapy

Part D:

Cohort D1 (PRO1184+carboplatin):

Patients must have platinum-sensitive ovarian cancer
Patients must have received 1 to 3 prior lines of therapy

Cohort D2 (PRO1184+bevacizumab):

-Patients must have platinum-resistant/refractory ovarian cancer

Cohort D3 (PRO1184+pembrolizumab):

Endometrial cancer (any subtype excluding sarcoma)
Patients must have received prior platinum-based chemotherapy for recurrent or advanced disease

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 CYP3A inhibitor within 14 days (dose escalation only)
prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate
additional protocol defined inclusion/exclusion criteria may apply

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

374

Study ID:

NCT05579366

Recruitment Status:

Recruiting

Sponsor:

ProfoundBio US Co.

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There are 16 Locations for this study

See Locations Near You

University of California Los Angeles Medical Center
Los Angeles California, 90095, United States
University of California, San Diego; Moores Cancer Center
San Diego California, 92093, United States
USOR Sansum Clinic
Santa Barbara California, 93105, United States
Providence Medical Foundation
Santa Rosa California, 95403, United States
University of Kansas Medical Center (KUMC)
Westwood Kansas, 66205, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit Michigan, 48085, United States
START Midwest
Grand Rapids Michigan, 49503, United States
University of Oklahoma - Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
Sarah Cannon Research Institute at Tennessee Oncology
Nashville Tennessee, 37203, United States
USOR Texas Oncology
Abilene Texas, 79606, United States
Mary Crowley Cancer Research
Dallas Texas, 75521, United States
USOR Texas Oncology
Fort Worth Texas, 76104, United States
START Mountain Region
West Valley City Utah, 84119, United States
USOR Virginia Cancer Specialists
Fairfax Virginia, 22031, United States
Cancer hospital, Chinese Academy of Medical Sciences
Beijing Beijing, , China
Hunan Cancer Hospital - Phase 1
Changsha Hunan, , China
Hunan Cancer Hospital - Thoracic Medicine Dept II
Changsha Hunan, , China
Jilin Cancer Hospital
Chang chun Jilin, , China
Fudan University Shanghai Cancer Center - Gynecologic Oncology
Shanghai Shanghai, , China
Fudan University Shanghai Cancer Center- Phase 1
Shanghai Shanghai, , China

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

374

Study ID:

NCT05579366

Recruitment Status:

Recruiting

Sponsor:


ProfoundBio US Co.

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