Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06281678

A Study of IBI363 in Subjects with Advanced Solid Malignancies

Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2024-12-19

178

Participants Needed

9

Research Sites

142 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

A Study of IBI363 in Subjects with Advanced Solid Malignancies

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to understand and provide written informed consent
  • Male or female aged 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Expected life expectancy of at least 3 months
Not Eligible

You will not qualify if you...

  • Inadequate bone marrow or organ function
  • Received chemotherapy or targeted small molecule therapy within 2 weeks or 5 plasma half-lives
  • Received Nitrosoureas or mitomycin C within 6 weeks prior to study drug start and during study
  • Received anti-cancer monoclonal antibody within 4 weeks prior to study drug start
  • Received live vaccines within 28 days prior to the study drug or plan to receive live vaccines during the study
  • Have unresolved adverse reactions from previous antitumor treatments above Grade 1 toxicity (except alopecia, fatigue, pigmentation, or other conditions deemed safe by investigator)
  • Underwent major surgery (craniotomy, thoracotomy, laparotomy, or other significant surgery) within 4 weeks prior to study drug start
  • Expected to have major surgery during the study period
  • Have severe unhealed wounds, trauma, or ulcers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 9 locations

1

University of California, San Francisco (UCSF)

San Francisco, California, United States, 94143

Actively Recruiting

2

Ocala Oncology Center

Ocala, Florida, United States, 34474

Actively Recruiting

3

BRCR Medical Center

Plantation, Florida, United States, 33322

Actively Recruiting

4

University of Kansas Medical Center (KUMC)

Fairway, Kansas, United States, 66205

Actively Recruiting

5

Michigan Hematology & Oncology Consultants - MedOnc Dearborn

Dearborn, Michigan, United States, 48126

Actively Recruiting

6

Michigan Hematology & Oncology Consultants - MedOnc Troy

Troy, Michigan, United States, 48098

Actively Recruiting

7

MD Anderson Cancer Center-University of Texas

Houston, Texas, United States, 77025

Actively Recruiting

8

Oncology Consultants P.A.

Houston, Texas, United States, 77030

Actively Recruiting

9

Fred Hutchinson Cancer Center

Seattle, Washington, United States, 98109

Actively Recruiting

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Research Team

A

Amanda Guo

CONTACT

W

William Liu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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A Study of IBI363 in Subjects with Advanced Solid Malignancies | DecenTrialz