PRO1184 for Advanced Solid Tumors
Purpose
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.
Conditions
- 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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Patients will receive PRO1184 in ascending dose levels to establish a maximum tolerated dose, if reached, and the recommended Phase 2 dose, followed by dose expansion at selected dose and schedule.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental PRO1184 |
PRO1184 monotherapy in escalating doses in Part A and at the recommended dose in Part B. |
|
Recruiting Locations
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- ProfoundBio US Co.
Detailed Description
This is a Phase 1/2 study of PRO1184, a folate receptor alpha (FRĪ±) 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.