Summary

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

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).

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.

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.

Keywords

Ovarian Cancer, High Grade Epithelial Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer, Endometrial Cancer, Non-small Cell Lung Cancer, Mesothelioma, Breast Adenocarcinoma, Triple Negative Breast Cancer, Hormone Receptor-positive/Her2 Negative 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, Non-Small-Cell Lung Carcinoma, Ovarian Neoplasms, Ovarian Epithelial Carcinoma, Endometrial Neoplasms, Triple Negative Breast Neoplasms, Malignant Mesothelioma, Fallopian Tube Neoplasms, PRO1184, PRO1184 intravenous infusion of 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

    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

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 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

Locations

  • University of California Los Angeles Medical Center accepting new patients
    Los Angeles California 90095 United States
  • University of California, San Diego; Moores Cancer Center accepting new patients
    San Diego California 92093 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
ProfoundBio US Co.
ID
NCT05579366
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 374 study participants
Last Updated