NCT03875157CompletedPhase 1

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

Innovent Biologics (Suzhou) Co. Ltd.1 site in 1 country103 target enrollmentStarted: April 19, 2019Last updated: February 27, 2023

Conditions

Interventions

Trial Snapshot

Phase: Phase 1
Status: Completed
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Enrollment: 103
Locations: 1
Primary Endpoint: Number of participants experiencing clinical and laboratory adverse events (AEs)

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief 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.

Study Design

Study Type: Interventional
Allocation: Non Randomized
Intervention Model: Single Group
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

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