Clinical trial NCT03875157: Study of IBI318 in Participants With Advanced Malignancies
Official title: To Evaluate the Safety, Tolerability, and Initial Efficacy of IBI318 in Patients With Advanced Malignancy, Multicenter, IA/IB Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Malignancy
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2019-03-14
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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
11. Active autoimmune disease that has required systemic treatment in past 2 years
12. Known active Hepatitis B or Hepatitis C virus
13. 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
14. Known history of human immunodeficiency virus (HIV) infection
15. Known history of active tuberculosis (TB) or active syphilis
16. History of allogeneic organ transplantation or hematopoietic stem cell transplantation
17. Accompanied by uncontrolled third interstitial fluids requiring repeated drainage, such as pleural effusion, ascites, pericardial effusion, etc.
18. Known severe allergic reactions to other monoclonal antibodies or are allergic to any IBI318 formulation component
19. Female subjects who are pregnant or lactating

Primary outcomes:
measure: Number of participants experiencing dose-limiting toxicities (DLTs)
timeFrame: 28 days within first dose in phase Ia
measure: Number of participants experiencing clinical and laboratory adverse events (AEs)
timeFrame: Up to 90 days post last dose
measure: Number of all study participants who demonstrate a tumor response
timeFrame: up to 24 months
Secondary outcomes:
measure: The area under the curve (AUC) of plasma concentration of drug against time after administration of IBI318
timeFrame: Up to 90 days post last dose
measure: Maximum concentration (Cmax) after first dose interval of IBI318
timeFrame: Up to 90 days post last dose
measure: Time at which maximum concentration (Tmax) occurs for IBI318
timeFrame: Up to 90 days post last dose
measure: The half-life (t1/2) of IBI318 in plasma
timeFrame: Up to 90 days post last dose
measure: Positive rate of ADA and Nab
timeFrame: Up to 90 days post last dose
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
Study officials:
References: