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SHR-7787

Phase 2

Malignant Solid Tumors | Small molecule | Oncology |Co-Diagnostics, Inc.|Last Updated: Jan 12, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment400
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07268040A Trial of SHR-7787 Injection Combined With Other Anti-tumor Drugs in Patients With Malignant Solid TumorsPHASE2 RECRUITING 400 — — Dec 23, 2025Dec 1, 2028Jan 12, 20262 China
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Study Endpoints
Primary Endpoints
The Recommended phase II dose of SHR-7787 injection monotherapy (stage I)
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)
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)
About 1 year after study initiation.
Incidence of Dose Limited Toxicity (DLT) described in the protocol (stage I)
About 1 year after study initiation.
Objective response rate (ORR) (stage II)
Expected to be two years after the start of the study.
Progress Free Survival (FPS) (stage II)
Expected to be two years after the start of the study.
Secondary Endpoints
Objective response rate (ORR)
About 1 year.
Duration of Response (DoR)
About 1 year.
Disease Control Rate (DCR)
About 1 year.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SHR-7787 combined with SHR-1316EXPERIMENTALSHR-7787 injection combined with SHR-1316 injection.
SHR-7787 combined with SHR-4849EXPERIMENTALSHR-7787 injection combined with SHR-4849 injection.
SHR-7787 combined with etoposide and carboplatin/cisplatinEXPERIMENTALSHR-7787 injection combined with etoposide and carboplatin/cisplatin injection.
SHR-7787 combined with SHR-1316, etoposide, carboplatin/cisplatinEXPERIMENTALSHR-7787 injection combined with SHR-1316, etoposide, carboplatin/cisplatin injection.
SHR-7787 combined with SHR-4849 and SHR-1316EXPERIMENTALSHR-7787 injection combined with SHR-4849 and SHR-1316 injection.
SHR-7787 combined with SHR-1316 and BP102EXPERIMENTALSHR-7787 injection combined with SHR-1316 and BP102 injection.
SHR-7787 combined with SHR-4849 and BP102EXPERIMENTALSHR-7787 injection combined with SHR-4849 and BP102 injection.
SHR-7787 combined with SHR-4849, SHR-1316 and carboplatin/cisplatinEXPERIMENTALSHR-7787 injection combined with SHR-4849, SHR-1316 and carboplatin/cisplatin injection.
Interventions
NameTypeDescription
SHR-7787 InjectionDRUGSHR-7787 Injection.
SHR-1316 InjectionDRUGSHR-1316 Injection.
SHR-4849 InjectionDRUGSHR-4849 Injection.
Etoposide injectionDRUGEtoposide Injection.
Carboplatin injectionDRUGCarboplatin Injection.
Cisplatin injectionDRUGCisplatin Injection.
BP102 InjectionDRUGBP102 Injection.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study; 2. Patients with histologically or cytologically confirmed unresectable solid tumors; 3. At least one measurable lesion was identified per RECIST 1.1; 4. Eastern Coop...

Countries:China
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