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

Advanced Malignancies Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04353830
• Other study ID #: CIBI939A101
• Status: Completed
• Phase: Phase 1
• Start date: May 22, 2020
• Est. completion date: May 11, 2022

Study information

• Verified date: February 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 11, 2022
• Est. primary completion date: May 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Able to understand and willing to sign the ICF.

2. Adults 18 years of age or older.

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

4. Life expectancy at least 12 weeks.

5. Adequate organ and bone marrow function.

Eligibility Criteria:

1. Previous exposure to any anti-TIGIT antibody.

2. Participate in another interventional clinical study, except for the observational (non-interventional) clinical study or the survival follow-up phase of the interventional study.

3. Any investigational drugs received within 4 weeks prior to the first study treatment.

4. Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy.

5. Immunosuppressive drugs were used within 4 weeks prior to the first administration of the study drug.

6. Medication requiring long-term systemic hormones or any other immunosuppression therapy.

7. 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.

8. Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases, or leptomeningeal disease.

9. History of autoimmune disease , present active autoimmune disease or inflammatory diseases

10. Positive human immunodeficiency virus (HIV) test.

11. Active hepatitis B or C, or tuberculosis.

12. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.

13. Known history of hypersensitivity to any components of the IBI939 or Sintilimab.

14. Pregnant or nursing females.

Related Conditions & MeSH terms

• Advanced Malignancies
• Neoplasms

Intervention

Drug:
• IBI939
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
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.
• IBI939+ Sintilimab
IBI939: IBI939 in combination with Sintilimab will be given with RP2D. 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.

Locations

Country	Name	City	State
China	Peking University Cancer Hospital & Institute	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with AEs and SAEs	To evaluate the safety and tolerability of IBI939 alone or in combination with Sintilimab [Adverse events (AEs), Serious Adverse Events (SAEs) ]	up to 2 years after enrollment
Primary	Percentage of Participants with Dose-Limiting Toxicities (DLTs)	To evaluate the safety and tolerability of IBI939 alone or in combination with Sintilimab.	From Baseline to the end of Cycle 1
Secondary	Pharmacokinetics: AUC	The area under the curve (AUC) of serum concentration of the drug after the administration.	up to 2 years after enrollment
Secondary	Pharmacokinetics: Cmax	Maximum concentration (Cmax) of the drug after administration	up to 2 years after enrollment
Secondary	Immunogenicity: Percentage of ADA positive subjects	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.	up to 2 years after enrollment
Secondary	Preliminary anti-tumor activity (Objective Response Rate)	Objective Response Rate (ORR) is the percentage of Complete Response (CR) plus partial response (PR) assessed by RECIST v1.1 criteria for solid tumors.	up to 2 years after enrollment