A Study of IBI363 in Subjects with Advanced Solid Malignancies

Phase 2

Recruiting

• Conditions: Melanoma; Non-small Cell Lung Cancer; Colorectal Cancer; Renal Cell Cancer
• Interventions: Drug: IBI363

• Registration Number: NCT06281678
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2024-02-04
• Study First Submitted QC: 2024-02-25
• Study First Posted: 2024-02-28
• Study Start: 2024-04-08
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19
• Primary Completion: 2026-03-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 178

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	up to 2 years

Secondary Outcome Measures

Name	Time	Method
Adverse Event （AE）	Up to 90 days post last dose
Dose-limiting Toxicity （DLT）	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.

Trial Locations

Locations (9)

University of California, San Francisco (UCSF); 🇺🇸 San Francisco, California, United States

Ocala Oncology Center; 🇺🇸 Ocala, Florida, United States

BRCR Medical Center; 🇺🇸 Plantation, Florida, United States

University of Kansas Medical Center (KUMC); 🇺🇸 Fairway, Kansas, United States

Michigan Hematology & Oncology Consultants - MedOnc Dearborn; 🇺🇸 Dearborn, Michigan, United States

Michigan Hematology & Oncology Consultants - MedOnc Troy; 🇺🇸 Troy, Michigan, United States

MD Anderson Cancer Center-University of Texas; 🇺🇸 Houston, Texas, United States

Oncology Consultants P.A.; 🇺🇸 Houston, Texas, United States

Fred Hutchinson Cancer Center; 🇺🇸 Seattle, Washington, United States