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OpenTrials
Completed

NCT Number: NCT05774873

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.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Affiliated Cancer Hospital of Shandong First Medical university

Jinan, Shandong, 250117, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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;

Treatment and study plan

IBI334

Drug

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

Primary outcomes

  1. Number of patients with treatment-related adverse events

    Time frame: Up to 60 days post last dose

  2. Percentage of subjects woth Dose-Limitine toxicities(DLTs)

    Time frame: Up to 28 days following first dose

Secondary outcomes

  1. PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: area under the curve (AUC)

    Time frame: Day 1 up to treatment duration reaches 24 months

  2. PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to:maximum concentration (Cmax)

    Time frame: Day 1 up to treatment duration reaches 24 months

  3. PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: clearance (CL)

    Time frame: Day 1 up to treatment duration reaches 24 months

  4. PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: apparent volume of distribution (V)

    Time frame: Day 1 up to treatment duration reaches 24 months

  5. PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: half-life (t1/2).

    Time frame: Day 1 up to treatment duration reaches 24 months

  6. Prevalence and incidence of anti-IBI334 antibodies.

    Time frame: Day 1 up to treatment duration reaches 24 months

  7. Preliminary efficacy : objective response rate (ORR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria

    Time frame: Day 1 up to treatment duration reaches 24 months

  8. Preliminary efficacy : duration of response (DoR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria

    Time frame: Day 1 up to treatment duration reaches 24 months

  9. Preliminary efficacy : disease control rate (DCR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria

    Time frame: Day 1 up to treatment duration reaches 24 months

  10. Preliminary efficacy :time to response (TTR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria

    Time frame: Day 1 up to treatment duration reaches 24 months

  11. Preliminary efficacy :progression-free survival (PFS) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria

    Time frame: Day 1 up to treatment duration reaches 24 months

  12. Preliminary efficacy :overall survival (OS)

    Time frame: Day 1 up to treatment duration reaches 24 months

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2023
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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