The Primary Objective of This Study to Evaluate the Safety and Tolerability of IBI334 and Determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D)and Anti Tumor Activity of IBI334.

A Phase I/II Study of IBI334 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

This is open-label, multicenter, Phase I/II study is designed to evaluate the Safety and tolerability and Efficacy of IBI334 Monotherapy in participants with advanced solid tumors.

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: IBI334

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250117
      • Affiliated Cancer Hospital of Shandong First Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria：

1. Subjects with 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 ≥ 12 weeks;
5. At least 1 evaluable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1with Phase Ia ;At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 with Phase Ib+II；

Exclusion Criteria：

1. Participate in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of the interventional study;
2. Received live vaccines within 4 weeks prior to first dose of the study drug or plan on receiving any live vaccine during the study;
3. History of immunodeficiency disease, including congenital or acquired immunodeficiency diseases;
4. Severe allergic or hypersensitive to other EGFR or B7H3 antibodies or any ingredients of IBI334;
5. Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief, which must not affect tumor assessment throughout the study;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBI334 in advanced solid tumors	Drug: IBI334; There are six dose of IBI334 ,QW IV in first cycle and Q2W IV behind the first cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with treatment-related adverse events	Up to 60 days post last dose
Percentage of subjects woth Dose-Limitine toxicities(DLTs)	Up to 28 days following first dose

Secondary Outcome Measures

Outcome Measure	Time Frame
PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: area under the curve (AUC)	Day 1 up to treatment duration reaches 24 months
PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to:maximum concentration (Cmax)	Day 1 up to treatment duration reaches 24 months
PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: clearance (CL)	Day 1 up to treatment duration reaches 24 months
PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: apparent volume of distribution (V)	Day 1 up to treatment duration reaches 24 months
PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: half-life (t1/2).	Day 1 up to treatment duration reaches 24 months
Prevalence and incidence of anti-IBI334 antibodies.	Day 1 up to treatment duration reaches 24 months
Preliminary efficacy ： objective response rate (ORR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria	Day 1 up to treatment duration reaches 24 months
Preliminary efficacy : duration of response (DoR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria	Day 1 up to treatment duration reaches 24 months
Preliminary efficacy : disease control rate (DCR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria	Day 1 up to treatment duration reaches 24 months
Preliminary efficacy :time to response (TTR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria	Day 1 up to treatment duration reaches 24 months
Preliminary efficacy :progression-free survival (PFS) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria	Day 1 up to treatment duration reaches 24 months
Preliminary efficacy :overall survival (OS)	Day 1 up to treatment duration reaches 24 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2023
• Primary Completion (Actual): March 20, 2025
• Study Completion (Actual): March 20, 2025

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 31, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CIBI334A101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No