A Study of IBI363 in Subjects with Advanced Solid Malignancies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-08

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Melanoma Non-small Cell Lung Cancer Colorectal Cancer Renal Cell Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IBI363

IBI363 will be administered as an intravenous (IV) infusion every 2 weeks or every 3 weeks.

Group Type EXPERIMENTAL

IBI363

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

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United States

Central Contacts

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Amanda Guo

Role: CONTACT

Phone: 1-832-207-5244

Review additional registry numbers or institutional identifiers associated with this trial.

CIBI363A202

Identifier Type: -

Identifier Source: org_study_id

A Study of IBI363 in Subjects with Advanced Solid Malignancies

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

IBI363

IBI363

Interventions

IBI363

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

Responsible Party

Locations

University of California, San Francisco (UCSF)

Ocala Oncology Center

BRCR Medical Center

University of Kansas Medical Center (KUMC)

Michigan Hematology & Oncology Consultants - MedOnc Dearborn

Michigan Hematology & Oncology Consultants - MedOnc Troy

MD Anderson Cancer Center-University of Texas

Oncology Consultants P.A.

Fred Hutchinson Cancer Center

Countries

Central Contacts

Amanda Guo

William Liu

Facility Contacts

Katy Tsai, MD

Michael Wong

Katy Tsai, MD

Ketan Doshi, MD

Sanjit Nirmalanandhan, Ph.D.

Ketan Doshi, MD

Chintan Gandhi, MD

Diana Casaa

Chintan Gandhi, MD

Saqib Abbasi, MD

Laura Mitchell

Saqib Abbasi, MD

Faisal Musa, MD

Heather Austin

Faisal Musa, MD

Laura Nadeau, MD

Heather Austin

Laura Nadeau, MD

Sarina Piha-Paul, MD

Qian Peng

Sarina Piha-Paul, MD

Mahran Shoukier

Bryand Osorio

Diane Tseng, MD

Margaret Busey

Diane Tseng, MD

Other Identifiers

CIBI363A202