A Multicenter, Open-label Phase II Clinical Study of SHR-7787 Combined With Other Antitumor Drugs in Patients With Advanced Solid Tumors
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 400
- Locations
- 2
- Primary Endpoint
- The Recommended phase II dose of SHR-7787 injection monotherapy (stage I)
Study Overview
Brief Summary
This study aims to evaluate the safety, tolerability and efficacy of SHR-7787 in combination with other anti-tumor drugs in patients with malignant solid tumors.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
- •Patients with histologically or cytologically confirmed unresectable solid tumors;
- •At least one measurable lesion was identified per RECIST 1.1;
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
- •Adequate organ functions as defined per protocol;
- •Minimum life expectancy of 3 months.
Exclusion Criteria
- •Patients with known active central nervous system (CNS) metastases;
- •History of other malignancy within the past 5 years, with exceptions defined in the protocol;
- •Patients with uncontrolled cancer pain;
- •Patients with serious cardiovascular and/or cerebrovascular diseases;
- •Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;
- •Patients with Severe infections within 4 weeks prior to the first dose;
- •Active pulmonary tuberculosis infection;
- •History of immunodeficiency;
- •History of autoimmune diseases;
- •The adverse events of previous antineoplastic therapy did not recover to CTCAE≤ grade 1;
- •Pregnant or nursing women, or planned to become pregnant during the study period;
- •Known allergic to any component of investigational drugs.
Arms & Interventions
SHR-7787 combined with SHR-1316
SHR-7787 injection combined with SHR-1316 injection.
Intervention: SHR-7787 Injection (Drug)
SHR-7787 combined with SHR-1316
SHR-7787 injection combined with SHR-1316 injection.
Intervention: SHR-1316 Injection (Drug)
SHR-7787 combined with SHR-4849
SHR-7787 injection combined with SHR-4849 injection.
Intervention: SHR-7787 Injection (Drug)
SHR-7787 combined with SHR-4849
SHR-7787 injection combined with SHR-4849 injection.
Intervention: SHR-4849 Injection (Drug)
SHR-7787 combined with etoposide and carboplatin/cisplatin
SHR-7787 injection combined with etoposide and carboplatin/cisplatin injection.
Intervention: SHR-7787 Injection (Drug)
SHR-7787 combined with etoposide and carboplatin/cisplatin
SHR-7787 injection combined with etoposide and carboplatin/cisplatin injection.
Intervention: Etoposide injection (Drug)
SHR-7787 combined with etoposide and carboplatin/cisplatin
SHR-7787 injection combined with etoposide and carboplatin/cisplatin injection.
Intervention: Carboplatin injection (Drug)
SHR-7787 combined with etoposide and carboplatin/cisplatin
SHR-7787 injection combined with etoposide and carboplatin/cisplatin injection.
Intervention: Cisplatin injection (Drug)
SHR-7787 combined with SHR-1316, etoposide, carboplatin/cisplatin
SHR-7787 injection combined with SHR-1316, etoposide, carboplatin/cisplatin injection.
Intervention: SHR-7787 Injection (Drug)
SHR-7787 combined with SHR-1316, etoposide, carboplatin/cisplatin
SHR-7787 injection combined with SHR-1316, etoposide, carboplatin/cisplatin injection.
Intervention: SHR-1316 Injection (Drug)
SHR-7787 combined with SHR-1316, etoposide, carboplatin/cisplatin
SHR-7787 injection combined with SHR-1316, etoposide, carboplatin/cisplatin injection.
Intervention: Etoposide injection (Drug)
SHR-7787 combined with SHR-1316, etoposide, carboplatin/cisplatin
SHR-7787 injection combined with SHR-1316, etoposide, carboplatin/cisplatin injection.
Intervention: Carboplatin injection (Drug)
SHR-7787 combined with SHR-1316, etoposide, carboplatin/cisplatin
SHR-7787 injection combined with SHR-1316, etoposide, carboplatin/cisplatin injection.
Intervention: Cisplatin injection (Drug)
SHR-7787 combined with SHR-4849 and SHR-1316
SHR-7787 injection combined with SHR-4849 and SHR-1316 injection.
Intervention: SHR-7787 Injection (Drug)
SHR-7787 combined with SHR-4849 and SHR-1316
SHR-7787 injection combined with SHR-4849 and SHR-1316 injection.
Intervention: SHR-1316 Injection (Drug)
SHR-7787 combined with SHR-4849 and SHR-1316
SHR-7787 injection combined with SHR-4849 and SHR-1316 injection.
Intervention: SHR-4849 Injection (Drug)
SHR-7787 combined with SHR-1316 and BP102
SHR-7787 injection combined with SHR-1316 and BP102 injection.
Intervention: SHR-7787 Injection (Drug)
SHR-7787 combined with SHR-1316 and BP102
SHR-7787 injection combined with SHR-1316 and BP102 injection.
Intervention: SHR-1316 Injection (Drug)
SHR-7787 combined with SHR-1316 and BP102
SHR-7787 injection combined with SHR-1316 and BP102 injection.
Intervention: BP102 Injection (Drug)
SHR-7787 combined with SHR-4849 and BP102
SHR-7787 injection combined with SHR-4849 and BP102 injection.
Intervention: SHR-7787 Injection (Drug)
SHR-7787 combined with SHR-4849 and BP102
SHR-7787 injection combined with SHR-4849 and BP102 injection.
Intervention: SHR-4849 Injection (Drug)
SHR-7787 combined with SHR-4849 and BP102
SHR-7787 injection combined with SHR-4849 and BP102 injection.
Intervention: BP102 Injection (Drug)
SHR-7787 combined with SHR-4849, SHR-1316 and carboplatin/cisplatin
SHR-7787 injection combined with SHR-4849, SHR-1316 and carboplatin/cisplatin injection.
Intervention: SHR-7787 Injection (Drug)
SHR-7787 combined with SHR-4849, SHR-1316 and carboplatin/cisplatin
SHR-7787 injection combined with SHR-4849, SHR-1316 and carboplatin/cisplatin injection.
Intervention: SHR-1316 Injection (Drug)
SHR-7787 combined with SHR-4849, SHR-1316 and carboplatin/cisplatin
SHR-7787 injection combined with SHR-4849, SHR-1316 and carboplatin/cisplatin injection.
Intervention: SHR-4849 Injection (Drug)
SHR-7787 combined with SHR-4849, SHR-1316 and carboplatin/cisplatin
SHR-7787 injection combined with SHR-4849, SHR-1316 and carboplatin/cisplatin injection.
Intervention: Carboplatin injection (Drug)
SHR-7787 combined with SHR-4849, SHR-1316 and carboplatin/cisplatin
SHR-7787 injection combined with SHR-4849, SHR-1316 and carboplatin/cisplatin injection.
Intervention: Cisplatin injection (Drug)
Outcomes
Primary Outcomes
The Recommended phase II dose of SHR-7787 injection monotherapy (stage I)
Time Frame: Expected to be two years after the start of the study.
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (stage I)
Time Frame: About 1 year after study initiation.
Incidence and severity of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (stage I)
Time Frame: About 1 year after study initiation.
Incidence of Dose Limited Toxicity (DLT) described in the protocol (stage I)
Time Frame: About 1 year after study initiation.
Objective response rate (ORR) (stage II)
Time Frame: Expected to be two years after the start of the study.
Progress Free Survival (FPS) (stage II)
Time Frame: Expected to be two years after the start of the study.
Secondary Outcomes
- Objective response rate (ORR)(About 1 year.)
- Duration of Response (DoR)(About 1 year.)
- Disease Control Rate (DCR)(About 1 year.)
- Progress Free Survival (PFS)(About 1 year.)
- Overall Survival (OS)(About 1 year.)