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
1 other identifier
interventional
103
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2019
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2019
CompletedFirst Posted
Study publicly available on registry
March 14, 2019
CompletedStudy Start
First participant enrolled
April 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 16, 2023
CompletedFebruary 27, 2023
February 1, 2023
3.8 years
February 28, 2019
February 23, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Number of participants experiencing dose-limiting toxicities (DLTs)
28 days within first dose in phase Ia
Number of participants experiencing clinical and laboratory adverse events (AEs)
Up to 90 days post last dose
Number of all study participants who demonstrate a tumor response
up to 24 months
Secondary Outcomes (5)
The area under the curve (AUC) of plasma concentration of drug against time after administration of IBI318
Up to 90 days post last dose
Maximum concentration (Cmax) after first dose interval of IBI318
Up to 90 days post last dose
Time at which maximum concentration (Tmax) occurs for IBI318
Up to 90 days post last dose
The half-life (t1/2) of IBI318 in plasma
Up to 90 days post last dose
Positive rate of ADA and Nab
Up to 90 days post last dose
Study Arms (11)
IBI318 DL1
EXPERIMENTALIBI318 DL2
EXPERIMENTALIBI318 DL3
EXPERIMENTALIBI318 DL4
EXPERIMENTALIBI318 DL5
EXPERIMENTALIBI318 DL6
EXPERIMENTALIBI318 DL7
EXPERIMENTALIBI318 DL8
EXPERIMENTALIBI318 DL7b
EXPERIMENTALIBI318 DL8b
EXPERIMENTALIBI318 RP2D
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-sen University Cancer Center
Guangzhou, China
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2019
First Posted
March 14, 2019
Study Start
April 19, 2019
Primary Completion
February 16, 2023
Study Completion
February 16, 2023
Last Updated
February 27, 2023
Record last verified: 2023-02