A Study of IBI363 in Subjects with Advanced Solid Malignancies

December 16, 2024 updated by: Innovent Biologics (Suzhou) Co. Ltd.

A Phase 2, Open-label, Multicenter Study of IBI363 (PD1-IL2m) in Subjects with Advanced Solid Malignancies

This is a Phase 2, open-label, multicenter study designed to evaluate the efficacy, safety and tolerability of IBI363 (study drug) in subjects with advanced, refractory solid malignancies.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

178

Phase

  • Phase 2

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 Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco (UCSF)
        • Contact:
        • Contact:
        • Contact:
          • Katy Tsai, MD
    • Florida
      • Ocala, Florida, United States, 34474
      • Plantation, Florida, United States, 33322
    • Kansas
      • Fairway, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Medical Center (KUMC)
        • Contact:
        • Contact:
        • Contact:
          • Saqib Abbasi, MD
    • Michigan
      • Dearborn, Michigan, United States, 48126
        • Recruiting
        • Michigan Hematology & Oncology Consultants - MedOnc Dearborn
        • Contact:
        • Contact:
        • Contact:
          • Faisal Musa, MD
      • Troy, Michigan, United States, 48098
    • Texas
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77025
        • Recruiting
        • MD Anderson Cancer Center-University of Texas
        • Contact:
        • Contact:
          • Sarina Piha-Paul, MD
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center
        • Contact:
        • Contact:
        • Contact:
          • Diane Tseng, MD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subjects have the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
  2. Male or female subjects ≥ 18 years old;
  3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
  4. Anticipated life expectancy of ≥ 3 months;

Exclusion Criteria:

  1. Inadequate bone marrow and organ function;
  2. Received previous anti-tumor therapy: Any chemotherapy or targeted small molecule therapy (standard or investigational) within 2 weeks or 5 plasma half-lives. Received Nitrosoureas and mitomycin C within 6 weeks prior to first dose of study drug and during study; Any anti-cancer monoclonal antibody (mAb) within 4 weeks prior to first dose
  3. Received live vaccines within 28 days prior to first administration of the study drug or plan on receiving any live vaccine during the study;
  4. Has adverse reactions resulting from previous antitumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI-CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to investigator' discretion) or baseline prior to the first dose of the study drug;
  5. Undergone major surgery (Craniotomy, thoracotomy or laparotomy, and other surgery according to investigator' discretion, excluding needle biopsy) within 4 weeks prior to the first dose of the study drug, or who are expected to undergo major surgery during the study period, or who have severe unhealed wounds, trauma, ulcers, etc.

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: IBI363
IBI363 will be administered as an intravenous (IV) infusion every 2 weeks or every 3 weeks.
Drug: IBI363
IBI363 will be administered as an intravenous (IV) infusion every 2 weeks or every 3 weeks. Subjects will receive study medication until disease progression, toxicity intolerance, withdrawal of consent, the duration of treatment reaches 24 months, or any other reason that requires discontinuation of the study treatment, whichever occurs first.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (ORR)
Time Frame: up to 2 years
up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse Event （AE）
Time Frame: Up to 90 days post last dose
Up to 90 days post last dose
Dose-limiting Toxicity （DLT）
Time Frame: The DLT observation period is 35 days starting from the first day of cycle 1 (C1D1) for subjects assigned to 1000 μg/kg Q2W, while 28 days starting from the C1D1 for subjects assigned to 2000/3000/4000 μg/kg Q3W.
The DLT observation period is 35 days starting from the first day of cycle 1 (C1D1) for subjects assigned to 1000 μg/kg Q2W, while 28 days starting from the C1D1 for subjects assigned to 2000/3000/4000 μg/kg Q3W.

Collaborators and Investigators

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

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

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)

April 8, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 4, 2024

First Submitted That Met QC Criteria

February 25, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 16, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIBI363A202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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