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

Phase 1

Recruiting

• Conditions: Advanced Malignancies
• Interventions: Drug: IBI110+ Sintilimab; Drug: IBI110

• Registration Number: NCT04085185
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2019-09-09
• Study First Submitted QC: 2019-09-09
• Study First Posted: 2019-09-11
• Study Start: 2019-12-04
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-13
• Last Update Posted: 2022-09-14
• Primary Completion: 2023-12-15
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 268

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.
6. 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.
7. Measurable disease according to RECIST Version 1.1 in solid tumor.
8. 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.

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Exclusion Criteria

1. Previous exposure to any anti-lag-3 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. 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.
9. 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.
10. Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases, or leptomeningeal disease.
11. History of autoimmune disease , present active autoimmune disease or inflammatory diseases
12. Present or history of pulmonary diseases such as interstitial pneumonia, pneumoconiosis, drug-related pneumonia, pulmonary fibrosis, active pulmonary infection, severely impaired pulmonary function.
13. Positive human immunodeficiency virus (HIV) test.
14. Active hepatitis B or C, or tuberculosis.
15. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 16. History of gastrointestinal perforation and/or fistula at 6 months prior to study inclusion.

17.Hydrothorax, ascites, and pericardial effusion with clinical symptoms requiring drainage.

18.Known history of hypersensitivity to any components of the IBI110 or Sintilimab.

19.Uncontrolled complications of disease.

20.Other acute or chronic illness, mental illness, or abnormal laboratory test values that may increase the risk of study participation or administration of study drugs, or interfere with the interpretation of study results.

21.History of other primary malignancies. 22. Pregnant or nursing females.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase Ib Expansion Stage:IBI110+ Sintilimab	IBI110+ Sintilimab	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.
Phase Ia Expansion Stage:IBI110	IBI110	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.
Phase Ia Dose-Escalation Stage:IBI110	IBI110	Participants will be treated with escalating doses of IBI110 to determine the MTD.
Phase Ib Dose-Escalation Stage:IBI110+ Sintilimab	IBI110+ Sintilimab	Participants will be treated with escalating doses of IBI110 in combination with a fixed dose of Sintilimab to determine the MTD.

Primary Outcome Measures

Name	Time	Method
Number of subjects with AEs and SAEs	up to 2 years after enrollment	To evaluate the safety and tolerability of IBI110 alone or in combination with Sintilimab \[Adverse events (AEs), Serious Adverse Events (SAEs) \]
Percentage of Participants with Dose-Limiting Toxicities (DLTs)	From Baseline to the end of Cycle 1	To evaluate the safety and tolerability of IBI110 alone or in combination with Sintilimab.

Secondary Outcome Measures

Name	Time	Method
Immunogenicity: Percentage of ADA positive subjects	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 IBI110.
Preliminary anti-tumor activity of IBI110 (Objective Response Rate)	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 and Lugano2014 criteria for lymphoma.
Pharmacokinetics: Cmax	up to 2 years after enrollment	Maximum concentration (Cmax) of the drug after administration
Pharmacokinetics: AUC	up to 2 years after enrollment	The area under the curve (AUC) of serum concentration of the drug after the administration.

Trial Locations

Locations (1)

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, China