A Phase Ib Study of Primary Efficacy and Safety of IBI321 Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors

Innovent Biologics

Status and phase: Not yet enrolling; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: IBI321

Study type: Interventional

Funder types: Industry

Identifiers

NCT05172856

CIBI321A103

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
2. Male or female subjects ≥18 years and ≤75 years.
3. At least one measurable lesion per RECIST version 1.1
4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
5. Life expectancy of ≥ 12 weeks.
6. Adequate hematologic and end organ function

Exclusion criteria

1. Failure to recover from adverse events from the most recent anti-tumor treatments
2. Acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
3. 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.
4. Any other serious underlying medical (e.g., uncontrolled hypertension, active uncontrolled infection, active gastric ulcer,uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, other serious cardiac conditions not listed in exclusion criteria), psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
5. Pregnancy, lactation, breastfeeding.
6. Previous exposure to any anti-TIGIT antibody, or recombinant protein.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

IBI321 in advanced solid tumors

Experimental group

Treatment:

Drug: IBI321