Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSD
Dates
study started
estimated completion

Description

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.

Official Title

Phase 1/2 Study of PRO1184 in Patients With Locally Advanced and/or Metastatic Solid Tumors

Details

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.

Keywords

Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer, Endometrial Cancer, Non-small Cell Lung Cancer, Mesothelioma, Triple Negative Breast Cancer, HER2-negative Breast Cancer, Hormone Receptor-positive Breast Cancer, antibody-drug conjugate, folate receptor alpha, folate receptor, solid tumor, breast cancer, HR+/HER2- breast cancer, topoisomerase I inhibitor, phase 1, ProfoundBio, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Ovarian Neoplasms, Endometrial Neoplasms, Triple Negative Breast Neoplasms, Mesothelioma, Malignant, Fallopian Tube Neoplasms, PRO1184

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California Los Angeles Medical Center not yet accepting patients
    Los Angeles California 90095 United States
  • University of California, San Diego; Moores Cancer Center not yet accepting patients
    San Diego California 92093 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
ProfoundBio US Co.
ID
NCT05579366
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 134 study participants
Last Updated