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

Program Status

Recruiting

Phase

Phase 1

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

No

Drugs

IBI110, IBI110+ Sintilimab, IBI110, Sintilinab

Tags

MSI-H/ MMRd, MSS/ MMRp

Comments

CD223 is thought to be an indication of cell exhaustion. By blocking binding to LAG-3 site, it can allow immune cells to stay actived. CD223 is expressed in numerous immune cells and can allow multiple immune cell types to attack the tumor. Additonally, an anti-PD-1 drug is used to block binding to bind PD-1, which is also expressed during cell exhaustion. This could allow the cells to attack more effectively.

anti-PD-1 drugs are pretty common in clinical trial, but CD-223 drugs are not commonly found. These targets could make the cancer more susceptible in certain patient types.

Certain patients that have received anti-PD-1 or anti-CTLA-4 are not eligible.

Location Location Status
China
Shanghai Pulmonary Hospital
Shanghai
Recruiting

Contacts

Qian Qu, Bachelor
Contact
86-18501735865 qian.wu@innoventbio.com
Caicun Zhou, M.D
Contact
+86 21 65115006 caicunzhoudr@163.com

Inclusion Criteria

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

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.

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.

NCT ID

NCT04085185

Date Trial Added

2019-09-11

Updated Date

2022-09-14