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

  • STATUS
    Recruiting
  • End date
    May 31, 2023
  • participants needed
    268
  • sponsor
    Innovent Biologics (Suzhou) Co. Ltd.
Updated on 24 January 2021
lymphoma
measurable disease
solid tumor

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.

Details
Condition Advanced Malignancies
Treatment IBI110, IBI110+ Sintilimab
Clinical Study IdentifierNCT04085185
SponsorInnovent Biologics (Suzhou) Co. Ltd.
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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
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

Exclusion Criteria

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
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
Hydrothorax, ascites, and pericardial effusion with clinical symptoms
requiring drainage
Known history of hypersensitivity to any components of the IBI110 or
Sintilimab
Uncontrolled complications of disease
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
History of other primary malignancies. 22. Pregnant or nursing females
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