Study of IBI318 in Participants With Advanced Malignancies

Innovent Biologics

Status and phase

Completed

Phase 1

Conditions

Advanced Malignancy

Treatments

Biological: IBI318

Study type

Interventional

Funder types

Industry

Identifiers

NCT03875157

CIBI318A101

Details and patient eligibility

About

An open label, multicenter, phase Ia/Ib study to evaluate the safety, tolerability, and initial efficacy of IBI318 in the treatment of patients with advanced malignancies.

Full description

An open label, multicenter, phase Ia/Ib study to evaluate the safety, tolerability, and initial efficacy of IBI318 in the treatment of patients with advanced malignancies.

Enrollment

103 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Sign the informed consent form
Men or women 18 years or older
Expected survival time ≥ 12 weeks
Tumor assessment according to RECIST v1.1, at least one measurable lesion
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Have adequate organ and bone marrow function
Male participants and female participants must agree to use contraception during the treatment period and within 180 days after the treatment period
Female subjects must not be pregnant or breastfeeding. If premenopausal, negative urine or serum pregnancy tests are required
Ia: Subjects with locally advanced, recurrent or metastatic histologically or cytologically confirmed solid tumors or hematologic tumors and are refractory or intolerant to existing standard treatments
Ib: Metastatic non-small cell lung cancer, advanced liver cancer, advanced esophageal squamous cell cancer, advanced gastric cancer, or other tumors that have been proved by histology or cytology with initial therapeutic effect in Phase Ia

Exclusion criteria

Previous exposure to immunotherapy including but not limited to, anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anti-tumor vaccine
Participation in another interventional clinical study, an observational (non-interventional) clinical study, or a follow-up phase of an interventional study
Receive last anti-tumor treatment within 4 weeks prior to the first dose of study drug
Use of immunosuppressive drugs within 4 weeks prior to the first dose of study drug
Require long-term steroid therapy or any other form of immunosuppressive therapy not including inhaled steroids
Toxicity (excluding hair loss or fatigue) caused by previous antitumor therapy that did not recover to NCI CTCAE v 5.0 level 0-1 within 4 weeks prior to the first dose of study drug
Received major surgery or has unhealed wounds, ulcers, or fractures within 4 weeks prior to the first dose of study drug
Expect to receive other anti-tumor treatments during study (allowing palliative radiotherapy)
History of infectious pneumonitis that required steroids or has current pneumonitis
Known active untreated CNS metastases and/or spinal cord compression and/or cancerous meningitis, or with a history of soft meningeal cancer
Active autoimmune disease that has required systemic treatment in past 2 years
Known active Hepatitis B or Hepatitis C virus
Uncontrolled concomitant diseases or neurological, psychiatric/social conditions that could affect study compliance, significantly increase the risk of adverse events, or affect the participant's ability to provide written informed consent
Known history of human immunodeficiency virus (HIV) infection
Known history of active tuberculosis (TB) or active syphilis
History of allogeneic organ transplantation or hematopoietic stem cell transplantation
Accompanied by uncontrolled third interstitial fluids requiring repeated drainage, such as pleural effusion, ascites, pericardial effusion, etc.
Known severe allergic reactions to other monoclonal antibodies or are allergic to any IBI318 formulation component
Female subjects who are pregnant or lactating

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

103 participants in 11 patient groups

IBI318 DL1

Experimental group

Treatment:

Biological: IBI318

IBI318 DL2

Experimental group

Treatment:

Biological: IBI318

IBI318 DL3

Experimental group

Treatment:

Biological: IBI318

IBI318 DL4

Experimental group

Treatment:

Biological: IBI318

IBI318 DL5

Experimental group

Treatment:

Biological: IBI318

IBI318 DL6

Experimental group

Treatment:

Biological: IBI318

IBI318 DL7

Experimental group

Treatment:

Biological: IBI318

IBI318 DL8

Experimental group

Treatment:

Biological: IBI318

IBI318 DL7b

Experimental group

Treatment:

Biological: IBI318

IBI318 DL8b

Experimental group

Treatment:

Biological: IBI318

IBI318 RP2D

Experimental group

Treatment:

Biological: IBI318

Trial contacts and locations

Data sourced from clinicaltrials.gov

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