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Study of IBI318 in Participants With Advanced Malignancies

To Evaluate the Safety, Tolerability, and Initial Efficacy of IBI318 in Patients With Advanced Malignancy, Multicenter, IA/IB Study

NCT03875157•Innovent Biologics (Suzhou) Co. Ltd.

View on ClinicalTrials.gov

Summary

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.

Detailed 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Sign the informed consent form
•2. Men or women 18 years or older
•3. Expected survival time ≥ 12 weeks
•4. Tumor assessment according to RECIST v1.1, at least one measurable lesion
•5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•6. Have adequate organ and bone marrow function
•7. Male participants and female participants must agree to use contraception during the treatment period and within 180 days after the treatment period
•8. Female subjects must not be pregnant or breastfeeding. If premenopausal, negative urine or serum pregnancy tests are required
•9. 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
•10. 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

•1. 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
•2. Participation in another interventional clinical study, an observational (non-interventional) clinical study, or a follow-up phase of an interventional study
•3. Receive last anti-tumor treatment within 4 weeks prior to the first dose of study drug
•4. Use of immunosuppressive drugs within 4 weeks prior to the first dose of study drug
•5. Require long-term steroid therapy or any other form of immunosuppressive therapy not including inhaled steroids
•6. 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
•7. Received major surgery or has unhealed wounds, ulcers, or fractures within 4 weeks prior to the first dose of study drug
•8. Expect to receive other anti-tumor treatments during study (allowing palliative radiotherapy)
•9. History of infectious pneumonitis that required steroids or has current pneumonitis
•10. Known active untreated CNS metastases and/or spinal cord compression and/or cancerous meningitis, or with a history of soft meningeal cancer
+9 more criteria

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, China

Key Dates

Start Date

April 19, 2019

Primary Completion Date

February 16, 2023

Completion Date

February 16, 2023

Last Updated

February 27, 2023

Enrollment

103

ACTUAL participants

Conditions

Advanced Malignancy

Interventions

IBI318

BIOLOGICAL

IBI318

BIOLOGICAL

IBI318

BIOLOGICAL

IBI318

BIOLOGICAL

IBI318

BIOLOGICAL

IBI318

BIOLOGICAL

IBI318

BIOLOGICAL

IBI318

BIOLOGICAL

IBI318

BIOLOGICAL

IBI318

BIOLOGICAL

IBI318

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Inclusion Criteria

Exclusion Criteria

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