Phase Ib Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of IBI363 Combination Therapy in Subjects With Advanced Malignancies
Overview
- Phase
- Phase 1
- Intervention
- IBI363 + chemotherapy
- Conditions
- Advanced Malignancies
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Enrollment
- 556
- Locations
- 1
- Primary Endpoint
- Objective response rate (ORR)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
This is an open-label, multicenter Phase Ib study to evaluate the safety, tolerability, and efficacy of IBI363 in advanced malignancies patients
Investigators
Eligibility Criteria
Inclusion Criteria
- •Sign written informed consent and be able to comply with the program's visit schedule and related procedures.
- •Male or female subjects, age 18\~75 years.
- •Histologically or cytologically confirmed advanced malignancy.
- •Subjects who have progressed on standard therapy, who are unsuitable for standard therapy, who do not have standard therapy, or who have refused standard therapy. For particular cohort, subjects who have not received prior systemic therapy for advanced disease.
- •At least one measurable lesion (target lesion) per RECIST v1.
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or
- •Life expectancy of 3 months or more.
- •Female subjects of childbearing age or male subjects whose partners are female subjects of childbearing age agree to strictly adopt effective contraceptive measures throughout the entire treatment period and 6 months after the treatment period.
Exclusion Criteria
- •Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug.
- •Active or untreated CNS metastases confirmed by imaging evaluation during screening or previous imaging evaluation. Patients with asymptomatic brain metastases may participate in this study.
- •History of active thrombosis or deep vein thrombosis or pulmonary embolism within 4 weeks prior to the first dose of study drug.
- •Clinically significant cardiovascular or cerebrovascular disease.
- •Interstitial pneumonia, pulmonary fibrosis, pneumoconiosis, drug-associated pneumonia, and radiation pneumonitis requiring steroid hormone or other therapy, as well as history of severe abnormal lung function or other forms of restrictive lung disease.
- •History of allergies, asthma, atopic dermatitis.
- •Concomitant pleural or pericardial effusion requiring repeated drainage or with significant symptoms.
- •Active autoimmune disease requiring systemic therapy within 2 years prior to first dose.
- •Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- •Subjects with known or suspected hypersensitivity to the study drug and any excipients.
Arms & Interventions
Cohort 1
IBI363 combined with chemotherapy in patients with advanced NSCLC who have failed at least one prior line of standard therapy (which needs to include immunotherapy)
Intervention: IBI363 + chemotherapy
Cohort 2A
IBI363 combined with chemotherapy as first-line in patients with advanced colorectal cancer, including a safety run-in phase and a randomized controlled phase
Intervention: IBI363 + chemotherapy
Cohort 2B
IBI363 combined with chemotherapy as first-line in patients with advanced colorectal cancer, including a safety run-in phase and a randomized controlled phase
Intervention: IBI363 + chemotherapy
Cohort 3
IBI363 combined with chemotherapy in patients with advanced biliary tract tumors that have failed or are intolerant to first-line standard therapy
Intervention: IBI363 + chemotherapy
Cohort 4
IBI363 combined with chemotherapy in second-line in patients with Advanced Esophageal Squamous Cell Carcinoma
Intervention: IBI363 + chemotherapy
Cohort 5
IBI363 combined with chemotherapy in second-line in patients with Advanced Gastric Cancer
Intervention: IBI363 + chemotherapy
Cohort 6
IBI363 combined with chemotherapy in patients with Advanced Triple-Negative Breast Cancer
Intervention: IBI363 + chemotherapy
Cohort 7
IBI363 combined with chemotherapy in patients with platinum-resistant ovarian cancer that has failed or is intolerant to standard therapy
Intervention: IBI363 + chemotherapy
Cohort 8
IBI363 Combined with Investigator's Choice Standard of Care(SOC) in Patients with Advanced Solid Tumors
Intervention: IBI363 + Investigator's Choice SOC
Outcomes
Primary Outcomes
Objective response rate (ORR)
Time Frame: Through out the study (up to 2 years)
ORR is defined as the proportion of participants with a complete response (CR) or partial response (PR).
Serious Adverse Event (SAE)
Time Frame: Up to 90 days after the last administration
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0
disease control rate (DCR)
Time Frame: Through out the study (up to 2 years)
DCR is defined as the proportion of participants with a complete response (CR) or partial response (PR) or stable disease(SD)
time to response (TTR)
Time Frame: Through out the study (up to 2 years)
TTR is defined as the time from the date of first dose of study drug to the date of first documented tumor response (CR/PR)
Adverse Enent (AE)
Time Frame: Up to 90 days after the last administration
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0
Adverse Event of Special Interest (AESI)
Time Frame: Up to 90 days after the last administration
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0
progression-free survival (PFS)
Time Frame: Through out the study (up to 2 years)
PFS is defined as the time from the date of first dose of study drug to the date of the first documented progression or death due to any cause, whichever occurs first
Treatment-Emergent AE (TEAE)
Time Frame: Up to 90 days after the last administration
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0
duration of response (DoR)
Time Frame: Through out the study (up to 2 years)
DoR is defined as the time from the date of first documented tumor response (CR/PR) until PD/death
Overall survival (OS)
Time Frame: Through out the study (an average of 2 years)
OS is defined as the time from the date of first dose of study drug until the date of death from any cause.
Secondary Outcomes
- Area under the curve (AUC) of IBI363(Up to 2 years)
- Half-life (T1/2) of IBI363(Up to 2 years)
- Volume of distribution (V) of IBI363(Up to 2 years)
- Plasma concentration (Cmax) of IBI363(Up to 2 years)
- Immunogenicity of IBI363(Up to 2 years)
- Clearance (CL) of IBI363(Up to 2 years)