A Study to Evaluate the Safety , Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer

NCT04672356 | Completed Phase 1

• 1 other identifier: CIBI939A102(Ia)
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an open-label, phase I clinical study to evaluate the efficacy, tolerability and safety of recombinant fully human anti-TIGIT antibody (IBI939) in combination with recombinant fully human anti-programmed cell death receptor 1 (PD-1) antibody (sintilimab) in subjects with advanced lung cancer.

Conditions

Advanced Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  3 months

• Recommended Phase II Dose(RP2D)

  2 months

Secondary Outcomes (11)

• Objective response rate(ORR)

  6 months

• Disease Control Rate(DCR)

  6 months

• Time to Objective Response (TTR)

  6 months

• Duration of Response (DoR)

  6 months

• Progression-free survival(PFS)

  6 months

Study Arms (2)

Phase Ia: IBI939 in combination with Sintilimab

EXPERIMENTAL

IBI939 10mg/kg combination with Sintilimab

Biological: IBI939; Biological: Sintilimab

Phase Ia:IBI939 in combination with Sintilimab

EXPERIMENTAL

IBI939 20mg/kg combination with Sintilimab

Biological: IBI939; Biological: Sintilimab

Interventions

IBI939 BIOLOGICAL

IBI939 injection

Phase Ia: IBI939 in combination with Sintilimab; Phase Ia:IBI939 in combination with Sintilimab

Sintilimab BIOLOGICAL

Sintilimab injection

Phase Ia: IBI939 in combination with Sintilimab; Phase Ia:IBI939 in combination with Sintilimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed the Informed Consent Form;
• Male or female ≥ 18 and≤75 years of age;
• Life expectancy ≥ 12 weeks;
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) score is 0 or 1
• Have at least 1 lesion (not previously irradiated) with an accurately measured longest diameter ≥ 10 mm by computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast agent is preferred) at baseline (except lymph nodes which must have short axis ≥ 15 mm) according to RECIST V1.1 and lesions amenable to repeated accurate measurements.
• Histologically or cytologicallyconfirmed non-small cell lung or small cell lung cancer

You may not qualify if:

• Previous exposure to immune-mediated therapy; previous use of antitumor vaccine;
• Received the last anti-tumor therapy within 4 weeks prior to the first dose of study drug;
• Received any investigational agent within 4 weeks prior to the first dose of study drug;
• Received systemic treatment with Chinese herbal medicine indicated for cancer or drugs used for immunoregulation (including thymosin, interferon, interleukin, except for local use for pleural effusion) within 2 weeks before the first dose;
• Are participating in another interventional clinical study, or observational (non-interventional) clinical study or in the follow-up phase of an interventional study;

Sponsors & Collaborators

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

Study Sites (1)

Jilin Province Cancer Hospital

Jilin, China

Location

MeSH Terms

Interventions

sintilimab

Study Officials

• Ying Cheng

  Jilin Province Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2020
• First Posted: December 17, 2020
• Study Start: January 25, 2021
• Primary Completion: January 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

CN (1)