A Study of Dose Escalation of IBI321 in Patients With Advanced Solid Tumors

NCT04911894 | Completed Phase 1

• 1 other identifier: CIBI321A102
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This first-in-human open-label, multicenter, dose-escalation and expansion study is designed to evaluate the safety, tolerability, and primary efficacy of IBI321 in participants with locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has proven to be ineffective or intolerable.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants with Dose-Limiting Toxicities (DLTs)

  From Day 1 of Cycle 1 to Day 28

• Percentage of Participants with Adverse Events (AEs), treatment-related AE (TRAE), immune-related AEs (irAE) and serious adverse event (SAE) per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0

  From Day 1 to up to 2 years

Secondary Outcomes (9)

• Objective Response Rate (ORR)per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

  From Baseline until disease progression (up to 2 years)

• Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

  From Baseline until disease progression (up to 2 years)

• Duration of Response (DoR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

  From Baseline until disease progression (up to 2 years)

• Overall Survival (OS)

  From Baseline until disease progression (up to 2 years)

• Area Under the Concentration-Time Curve (AUC) of IBI321

  From Day 1 up to 2 years

Study Arms (1)

Phase Ia Dose-Escalation Stage: IBI321

EXPERIMENTAL

Drug: IBI321

Interventions

IBI321 DRUG

Several dose levels will be evaluated for IBI321 administered as a single agent. IBI321 will be given via IV infusion on Day 1 of each cycle until disease progression or loss of clinical benefit.

Phase Ia Dose-Escalation Stage: IBI321

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
• Patients with advanced solid tumors who had failed standard treatment.
• Male or female subjects ≥18 years and ≤75 years.
• At least one measurable lesion per RECIST version 1.1
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
• Life expectancy of ≥ 12 weeks.
• Adequate hematologic and end organ function

You may not qualify if:

• Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, targeted therapy, or immunotherapy.
• Failure to recover from adverse events from the most recent anti-tumor
• Acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
• Subjects with CNS metastasis unless they are asymptomatic or adequately treated with radiotherapy and/or surgery and subjects are neurologically stable with minimal residual symptoms/signs.
• Pregnancy, lactation, breastfeeding.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: June 3, 2021
• Study Start: June 21, 2021
• Primary Completion: January 30, 2023
• Study Completion: February 17, 2023
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

CN (1)