RECRUITING

A Study of IBI363 in Subjects With Advanced Solid Malignancies

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Conditions

Solid Tumors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-08
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06281678

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Male or female subjects ≥ 18 years old;
  3. 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
  4. 4. Anticipated life expectancy of ≥ 3 months;
  1. 1. Inadequate bone marrow and organ function;
  2. 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. 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. 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. 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.

Contacts and Locations

Study Contact

Amanda Guo
CONTACT
1-832-207-5244
amanda.guo@innoventbio.com
William Liu
CONTACT
1-917-436-6817
william.liu01@innoventbio.com

Study Locations (Sites)

Oncology Consultants P.A.
Houston, Texas, 77030
United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2024-04-08
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-04-08
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Solid Tumors