PRO1184 for Advanced Solid Tumors (PRO1184-001)

January 15, 2024 updated by: ProfoundBio US Co.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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. 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.

Study Type

Interventional

Enrollment (Estimated)

134

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Cancer Hospital, Chinese Academy of Medical Sciences
        • Contact:
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • Hunan Cancer Hospital - Phase 1
      • Changsha, Hunan, China
        • Recruiting
        • Hunan Cancer Hospital - Thoracic Medicine Dept II
    • Jilin
      • Chang chun, Jilin, China
        • Recruiting
        • Jilin cancer hospital
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Fudan University Shanghai Cancer Center- Phase 1
        • Contact:
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California Los Angeles Medical Center
      • San Diego, California, United States, 92093
        • Recruiting
        • University of California, San Diego; Moores Cancer Center
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Providence Medical Foundation
        • Contact:
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Medical Center (KUMC)
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48085
        • Recruiting
        • Karmanos Cancer Institute
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma - Health Sciences Center
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute at Tennessee Oncology
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75521
        • Recruiting
        • Mary Crowley Cancer Research
        • Contact:
    • Utah
      • West Valley City, Utah, United States, 84119

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRO1184
PRO1184 monotherapy in escalating doses in Part A and at the recommended dose in Part B.
Drug: PRO1184
Intravenous infusion of PRO1184

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: Through end of treatment, up to approximately 1 year.
Type, incidence, severity, and seriousness of adverse events
Through end of treatment, up to approximately 1 year.
Dose limiting toxicity
Time Frame: At the end of Cycle 1 (each cycle is 21 days)
The proportion of patients experiencing dose limiting toxicities
At the end of Cycle 1 (each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Overall Response
Time Frame: Up to approximately 1 year.
Best response per RECIST v1.1 criteria for all tumor types other than pleural mesothelioma which will use mRECIST v1.1
Up to approximately 1 year.
Objective response rate
Time Frame: Up to approximately 1 year.
Patients who achieve partial or complete response per RECIST v1.1 criteria
Up to approximately 1 year.
Disease control rate
Time Frame: Up to approximately 1 year.
Patients who achieve stable disease, partial or complete response per RECIST v1.1 criteria
Up to approximately 1 year.
Progression-free survival
Time Frame: Up to approximately 18 months.
Time from start of treatment to first documented disease progression or death
Up to approximately 18 months.
Overall survival
Time Frame: Up to approximately 2 years.
Time from the start of study treatment to the date of death from any cause
Up to approximately 2 years.
Duration of objective response
Time Frame: From date of enrollment until the date of first documented disease progression or date of study withdrawal, whichever came first, assessed up to 12 months.
Time from the first documentation of an objective tumor response (CR or PR) to the first documented tumor progression or death
From date of enrollment until the date of first documented disease progression or date of study withdrawal, whichever came first, assessed up to 12 months.
Peak Plasma Concentration (Cmax) for PRO1184
Time Frame: Through end of treatment, up to approximately 1 year.
Measurement of maximum plasma concentration after the administration of PRO1184.
Through end of treatment, up to approximately 1 year.
Area under the plasma concentration versus time curve (AUC) for PRO1184
Time Frame: Through end of treatment, up to approximately 1 year.
Measurement of AUC after the administration of PRO1184.
Through end of treatment, up to approximately 1 year.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenic potential of PRO1184
Time Frame: Through end of treatment, up to approximately 1 year.
Assessment of anti-drug antibodies
Through end of treatment, up to approximately 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ProfoundBio US Co.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2022

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

October 4, 2022

First Submitted That Met QC Criteria

October 11, 2022

First Posted (Actual)

October 13, 2022

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 15, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO1184-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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