NCT05774873

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

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

February 8, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 20, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

August 9, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2025

Completed
Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

1.6 years

First QC Date

February 8, 2023

Last Update Submit

December 31, 2025

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (12)

  • 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

  • +7 more secondary outcomes

Study Arms (1)

IBI334 in advanced solid tumors

EXPERIMENTAL
Drug: IBI334

Interventions

IBI334DRUG

There are six dose of IBI334 ,QW IV in first cycle and Q2W IV behind the first cycle

IBI334 in advanced solid tumors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • Male or female subjects ≥ 18 years old;
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
  • Anticipated life expectancy of ≥ 12 weeks;
  • 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；

You may not qualify if:

  • Participate in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of the interventional study;
  • Received live vaccines within 4 weeks prior to first dose of the study drug or plan on receiving any live vaccine during the study;
  • History of immunodeficiency disease, including congenital or acquired immunodeficiency diseases;
  • Severe allergic or hypersensitive to other EGFR or B7H3 antibodies or any ingredients of IBI334;
  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Cancer Hospital of Shandong First Medical university

Jinan, Shandong, 250117, China

Location

Related Publications (1)

  • Guan J, Chia T, Li B, Zhu T, Liao Z, Deng J, Fu F, Wu W, Liu C, Liu Y, Li N, Yue L, Cao L, Lu J, Zhu M, Ling X, Zheng H, Lin S, Li L, Zhou S, He K. B7-H3-mediated cis-inhibition of EGFR by a tumor-selective bispecific antibody enhances anti-tumor efficacy and minimizes toxicities. Nat Commun. 2026 Feb 24. doi: 10.1038/s41467-026-69703-7. Online ahead of print.

    PMID: 41735305DERIVED

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

February 8, 2023

First Posted

March 20, 2023

Study Start

August 9, 2023

Primary Completion

March 20, 2025

Study Completion

March 20, 2025

Last Updated

January 6, 2026

Record last verified: 2025-12

Locations

CN(1)