PRO1160 for Advanced Solid and Liquid Tumors (PRO1160-001)

February 29, 2024 updated by: ProfoundBio US Co.

Phase 1/2 Study of PRO1160 in Patients With Renal Cell Carcinoma (RCC), Nasopharyngeal Carcinoma (NPC), or Non-Hodgkin Lymphoma (NHL)

Brief Summary:

This study will test the safety, including side effects, and determine the characteristics of a drug called PRO1160 in participants with solid tumors.

Participants will have solid tumor or liquid cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).

This Phase 1/2 study will have two parts. Part A of the study will find out how much and how frequently PRO1160 should be given to participants. Part B will use the dose and schedule found in Part A to find out how safe PRO1160 is and if it works to treat the diseases under study. The diseases under study will be Renal Cell Carcinoma (RCC),Nasopharyngeal Carcinoma (NPC) and Non-Hodgkin Lymphoma (NHL).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 1/2 study of PRO1160, a CD70 targeted antibody-drug conjugate, to evaluate the safety, tolerability, PK, and antitumor activity of PRO1160 in patients with selected locally advanced /or metastatic solid and liquid tumors, including renal cell carcinoma, nasopharyngeal carcinoma and non-hodgkin lymphoma. 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 PRO1160 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 of Chinese Academy of Medical Sciences
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
      • Shanghai, Shanghai, China
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Comprehensive Cancer Center - Duarte
      • Irvine, California, United States, 92618
        • Recruiting
        • The City of Hope Orange County Lennar Foundation Cancer Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Karmanos Cancer Institute
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine in St. Louis
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center - Montefiore Hospital
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Levine Cancer Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic - Euclid Hospital
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute - Nashville
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
    • Utah
      • West Valley City, Utah, United States, 84119
        • Recruiting
        • START Mountain Cancer Center

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:

  • Pathologically confirmed metastatic or unresectable solid malignancy including Renal Cell carcinoma, Nasopharyngeal carcinoma or Stage III or IV Non Hodgkin Lymphoma
  • Relapsed or refractory disease following prior systemic therapies known to confer medical 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 RCC and NPC and per Lugano for NHL

Exclusion Criteria:

  • Prior treatment with anti-CD70 directed therapy
  • 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: PRO1160
PRO1160 monotherapy in escalating doses in Part A and at the recommended phase 2 dose in Part B
Drug: PRO1160
Intravenous infusion of PRO1160

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events
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: Through end of treatment, up to approximately 1 year
The proportion of patients experiencing dose limiting toxicities
Through end of treatment, up to approximately 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: Through end of treatment, up to approximately 1 year
Patients who achieve partial or complete response per RECIST v1.1 criteria (RCC and NPC) and Lugano Classification 2014 (NHL)
Through end of treatment, up to approximately 1 year
Disease Control Rate
Time Frame: Through end of treatment, up to approximately 1 year
Patients who achieve stable disease, partial or complete response per RECIST v1.1 criteria (RCC and NPC) and Lugano Classification 2014 (NHL)
Through end of treatment, 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
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 PRO1160
Time Frame: Through end of treatment, up to approximately 1 year
Measurement of maximum plasma concentration after the administration of PRO1160
Through end of treatment, up to approximately 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenic potential of PRO1160
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)

March 15, 2023

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

January 31, 2023

First Submitted That Met QC Criteria

January 31, 2023

First Posted (Actual)

February 9, 2023

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO1160-001

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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