ClinicalTrials.Veeva

Menu

PRO1184 for Advanced Solid Tumors (PRO1184-001)

P

ProfoundBio

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Endometrial Cancer
Primary Peritoneal Carcinoma
Non-small Cell Lung Cancer
Breast Adenocarcinoma
Hormone Receptor-positive/Her2 Negative Breast Cancer
High Grade Epithelial Ovarian Cancer
Mesothelioma
Fallopian Tube Cancer
Triple Negative Breast Cancer
Ovarian Cancer

Treatments

Drug: PRO1184 intravenous infusion of PRO1184
Drug: PRO1184

Study type

Interventional

Funder types

Industry

Identifiers

NCT05579366
PRO1184-001

Details and patient eligibility

About

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).

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.

Enrollment

374 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

374 participants in 4 patient groups

Part A, B, C
Experimental group
Description:
PRO1184 monotherapy in escalating doses in Part A and at the recommended dose in Part B and C.
Treatment:
Drug: PRO1184
Part D1
Experimental group
Description:
PRO1184 in combination with carboplatin
Treatment:
Drug: PRO1184 intravenous infusion of PRO1184
Part D2
Experimental group
Description:
PRO1184 in combination with bevacizumab
Treatment:
Drug: PRO1184 intravenous infusion of PRO1184
Part D3
Experimental group
Description:
PRO1184 in combination with pembrolizumab
Treatment:
Drug: PRO1184 intravenous infusion of PRO1184

Trial contacts and locations

22

Loading...

Central trial contact

ProfoundBio Trial Support

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems