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Completed

NCT Number: NCT04353830

A Study Evaluating the Safety, Tolerability, and Initial Efficacy of Recombinant Human Anti-T-cell Immunoreceptor With Ig and ITIM Domains (TIGIT) Monoclonal Antibody Injection (IBI939) in Subjects With Advanced Malignant Tumors

This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of IBI939 in subjects with advanced malignancies

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking University Cancer Hospital & Institute

Beijing, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Able to understand and willing to sign the ICF.
  • Adults 18 years of age or older.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy at least 12 weeks.
  • Adequate organ and bone marrow function.

Eligibility Criteria:

  • Previous exposure to any anti-TIGIT antibody.
  • Participate in another interventional clinical study, except for the observational (non-interventional) clinical study or the survival follow-up phase of the interventional study.
  • Any investigational drugs received within 4 weeks prior to the first study treatment.
  • Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy.
  • Immunosuppressive drugs were used within 4 weeks prior to the first administration of the study drug.
  • Medication requiring long-term systemic hormones or any other immunosuppression therapy.
  • Major surgical procedures (craniotomy, thoracotomy, or laparotomy) or unhealed wounds, ulcers, or fractures were performed within 4 weeks prior to the first dose of study therapy.
  • Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases, or leptomeningeal disease.
  • History of autoimmune disease , present active autoimmune disease or inflammatory diseases
  • Positive human immunodeficiency virus (HIV) test.
  • Active hepatitis B or C, or tuberculosis.
  • History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
  • Known history of hypersensitivity to any components of the IBI939 or Sintilimab.
  • Pregnant or nursing females.

Treatment and study plan

IBI939

Drug

Several dose levels will be evaluated for IBI939 administered as a single agent and in combination with Sintilimab. IBI939 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit. Those who discontinue treatment with single-agent IBI939 may receive combination treatment with Sintilimab or IBI939+ Sintilimab. Combination treatment may continue until disease progression or loss of clinical benefit.

IBI939+ Sintilimab

Drug

IBI939: Several dose levels will be evaluated for IBI939 in combination with Sintilimab. IBI939 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit.

Sintilimab: Sintilimab will be given as 200 mg via IV infusion on Day 1 of each 21-day cycle in combination with IBI939. Combination treatment may continue until disease progression or loss of clinical benefit.

Primary outcomes

  1. Number of subjects with AEs and SAEs

    Time frame: up to 2 years after enrollment

    To evaluate the safety and tolerability of IBI939 alone or in combination with Sintilimab [Adverse events (AEs), Serious Adverse Events (SAEs) ]

  2. Percentage of Participants with Dose-Limiting Toxicities (DLTs)

    Time frame: From Baseline to the end of Cycle 1

    To evaluate the safety and tolerability of IBI939 alone or in combination with Sintilimab.

Secondary outcomes

  1. Pharmacokinetics: AUC

    Time frame: up to 2 years after enrollment

    The area under the curve (AUC) of serum concentration of the drug after the administration.

  2. Pharmacokinetics: Cmax

    Time frame: up to 2 years after enrollment

    Maximum concentration (Cmax) of the drug after administration

  3. Immunogenicity: Percentage of ADA positive subjects

    Time frame: up to 2 years after enrollment

    Immunogenicity: Number of Anti-Drug Antibodies (ADA) positive subjects will be counted and percentage of ADA positive subjects will be calculated to evaluate immunogenicity of IBI939.

  4. Preliminary anti-tumor activity (Objective Response Rate)

    Time frame: up to 2 years after enrollment

    Objective Response Rate (ORR) is the percentage of Complete Response (CR) plus partial response (PR) assessed by RECIST v1.1 criteria for solid tumors.

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

A Phase 1a, Open-label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Initial Efficacy of Recombinant Human Anti-T-cell Immunoreceptor With Ig and ITIM Domains (TIGIT) Monoclonal Antibody Injection (IBI939) in Subjects With Advanced Malignant Tumors

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 20, 2020
Registry last updated
Mar 1, 2023

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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