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SHR-1701；BP102

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Co-Diagnostics, Inc.|Last Updated: Jun 27, 2024

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment81
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04856774Trial of SHR-1701 Plus BP102 in Subjects With Selected Solid TumorsPHASE1 COMPLETED 81 — — Jun 1, 2021Mar 30, 2024Jun 27, 20241 China
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Study Endpoints
Primary Endpoints
recommended phase 2 dose (Phase Ib)
At the end of Cycle 2 (each cycle is 21 days)
Objective response rate (ORR)
2 years
Secondary Endpoints
Dose Limiting Toxicity (DLT) (Phase 1b)
At the end of Cycle 2 (each cycle is 21 days)
Number of participants with treatment emergent adverse events (TEAEs)
For each participant, from the first dose till 90 days after the last dose
Number of participants with treatment emergent serious adverse events (SAEs)
For each participant, from the first dose till 90 days after the last dose
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SHR -1701 + BP102EXPERIMENTAL -
Interventions
NameTypeDescription
SHR-1701；BP102DRUGDrug: SHR-1701 IV infusion Drug: BP102 IV infusion Phase Ib: SHR-1701 30mg/kg + BP102 15mg/kg Q3w as starting dose, until recommended phase 2 dose is determined.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Histologically or cytologically confirmed solid malignancy that is metastatic or unresectable for which standard curative or palliative measures do not exist or are no longer effective (phase Ib) 2. Histologically or cytologically confirmed metastatic or locally advanced soli...

Countries:China
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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