A Phase Ib Study of Primary Efficacy and Safety of IBI321 Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors
A Phase Ib, Open-Label, Multi-Center, Study of Primary Efficacy and Safety of IBI321 Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors
1 other identifier
interventional
110
1 country
1
Brief Summary
This is open-label, multicenter, Phase Ib study is designed to evaluate the Primary Efficacy and Safety of IBI321 Monotherapy or Combination Therapy in participants with advanced solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2022
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2021
CompletedFirst Posted
Study publicly available on registry
December 29, 2021
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedDecember 29, 2021
December 1, 2021
1.3 years
December 23, 2021
December 23, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators.
From Baseline until disease progression (up to 2 years)
Secondary Outcomes (9)
Progression Free Survival (PFS), According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators.
From Baseline until disease progression (up to 2 years)
Overall Survival (OS)
From Day 1 to up to 2 years
Percentage of Participants with Adverse Events (AEs) per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0
From Day 1 to up to 2 years
Area Under the Concentration-Time Curve (AUC) of IBI321
From Day 1 up to 2 years
Maximum Serum Concentration (Cmax) of IBI321
From Day 1 up to 2 years
- +4 more secondary outcomes
Study Arms (1)
IBI321 in advanced solid tumors
EXPERIMENTALInterventions
Eligibility Criteria
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.
- 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:
- Failure to recover from adverse events from the most recent anti-tumor treatments
- 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.
- Previous exposure to any anti-TIGIT antibody, or recombinant protein.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2021
First Posted
December 29, 2021
Study Start
March 1, 2022
Primary Completion
June 30, 2023
Study Completion
December 31, 2024
Last Updated
December 29, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share