A Study Evaluating the Safety, Tolerability, and Initial Efficacy of IBI110 in Subjects With Advanced Malignant Tumors

NCT04085185 | Unknown Phase 1 DMC

• 1 other identifier: CIBI110A101
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of IBI110 in subjects with advanced malignancies.

Conditions

Advanced Malignancies

Outcome Measures

Primary Outcomes (2)

• Number of subjects with AEs and SAEs

  To evaluate the safety and tolerability of IBI110 alone or in combination with Sintilimab \[Adverse events (AEs), Serious Adverse Events (SAEs) \]

  up to 2 years after enrollment

• Percentage of Participants with Dose-Limiting Toxicities (DLTs)

  To evaluate the safety and tolerability of IBI110 alone or in combination with Sintilimab.

  From Baseline to the end of Cycle 1

Secondary Outcomes (4)

• Pharmacokinetics: AUC

  up to 2 years after enrollment

• Pharmacokinetics: Cmax

  up to 2 years after enrollment

• Immunogenicity: Percentage of ADA positive subjects

  up to 2 years after enrollment

• Preliminary anti-tumor activity of IBI110 (Objective Response Rate)

  up to 2 years after enrollment

Study Arms (4)

Phase Ia Dose-Escalation Stage:IBI110

EXPERIMENTAL

Participants will be treated with escalating doses of IBI110 to determine the MTD.

Drug: IBI110

Phase Ia Expansion Stage:IBI110

EXPERIMENTAL

Participants will be enrolled in the expansion stage to better characterize the safety, tolerability, PK variability, and preliminary efficacy of IBI110 in different cancer types.

Drug: IBI110

Phase Ib Dose-Escalation Stage:IBI110+ Sintilimab

EXPERIMENTAL

Participants will be treated with escalating doses of IBI110 in combination with a fixed dose of Sintilimab to determine the MTD.

Drug: IBI110+ Sintilimab

Phase Ib Expansion Stage:IBI110+ Sintilimab

EXPERIMENTAL

Participants will be enrolled in the expansion stage to better characterize the safety, tolerability, PK variability, and preliminary efficacy of IBI110 in combination with Sintilimab in different cancer types.

Drug: IBI110+ Sintilimab

Interventions

IBI110 DRUG

Several dose levels will be evaluated for IBI110 administered as a single agent and in combination with Sintilimab. IBI110 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 IBI110 may receive combination treatment with IBI110 plus Sintilimab. Combination treatment may continue until disease progression or loss of clinical benefit.

Phase Ia Dose-Escalation Stage:IBI110

IBI110+ Sintilimab DRUG

IBI110: Several dose levels will be evaluated for IBI110 in combination with Sintilimab. IBI110 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 IBI110. Combination treatment may continue until disease progression or loss of clinical benefit.

Phase Ib Dose-Escalation Stage:IBI110+ 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:

• 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.
• Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumors and lymphomas that are refractory to standard therapy, or for which no standard therapy exists.
• Measurable disease according to RECIST Version 1.1 in solid tumor.
• Subjects (women of child-bearing potential and males) must be willing to use viable contraception method that is deemed effective by the investigator throughout the treatment period and for at least three months following the last dose of study drug. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential.

You may not qualify if:

• Previous exposure to any anti-lag-3 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.
• There were unrecovered toxicity (excluding hair loss or fatigue) according to NCI CTCAE v5.0 induced by previous antitumor therapy (24 weeks before the first dose of study), and there were unrecovered immune-related adverse events (irAE) associated with immunotherapy.
• Previous immunotherapy, such as anti-PD-1 / anti-PD-L1 antibody or anti-CTLA4 antibody, was discontinued due to the presence of \> grade 3 irAE.
• 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
• Present or history of pulmonary diseases such as interstitial pneumonia, pneumoconiosis, drug-related pneumonia, pulmonary fibrosis, active pulmonary infection, severely impaired pulmonary function.
• Positive human immunodeficiency virus (HIV) test.
• Active hepatitis B or C, or tuberculosis.
• Hydrothorax, ascites, and pericardial effusion with clinical symptoms requiring drainage.

Sponsors & Collaborators

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

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, China

RECRUITING

Related Publications (2)

• Wang Q, Xiong A, Mao C, Wang W, Cui J, Fang J, Zhuang W, Yang K, Zuo W, Yang J, Ye L, Zhang Z, Sheng Z, Liu Z, Wang D, Du X, Yi T, Long S, Xu N, Zhou C. Efficacy and safety of anti-LAG-3 IBI110 in combination with sintilimab and chemotherapy for advanced squamous non-small cell lung cancer: a randomized phase II study. Cancer Immunol Immunother. 2026 Jan 27;75(2):56. doi: 10.1007/s00262-026-04299-x.

  PMID: 41591537 DERIVED

• Mao C, Xiong A, Qian J, Wang W, Liu Y, Zhang T, Wu Z, Ni H, Lu J, Long S, Zhao L, Chen Y, Zhou C, Xu N. Dual inhibition of LAG-3 and PD-1 with IBI110 and sintilimab in advanced solid tumors: the first-in-human phase Ia/Ib study. J Hematol Oncol. 2024 Dec 31;17(1):132. doi: 10.1186/s13045-024-01651-5.

  PMID: 39736787 DERIVED

Central Study Contacts

Qian Qu, Bachelor

CONTACT

86-18501735865; qian.wu@innoventbio.com

Caicun Zhou, M.D

CONTACT

+86 21 65115006; caicunzhoudr@163.com

Study Design

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

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 11, 2019
• Study Start: December 4, 2019
• Primary Completion: December 15, 2023
• Study Completion: June 30, 2024
• Last Updated: September 14, 2022

Record last verified: 2022-09

Locations

CN (1)