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CPI-818

Phase 1

T-cell Lymphoma | Small molecule | Oncology |Corvus Pharmaceuticals, Inc.|Last Updated: Apr 16, 2025

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
CONTROLLEDDMC
Total Trials1
Total Enrollment151
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03952078A Dose Escalation Study Evaluating CPI-818 in Relapsed/Refractory T-Cell LymphomaPHASE1 ACTIVE NOT_RECRUITING 151 — — May 3, 2019Apr 30, 2026Apr 16, 202522 United States, Australia +2
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Study Endpoints
Primary Endpoints
Incidence, nature, and severity of adverse events following treatment with CPI 818 to establish the safety and tolerability with increasing dose
First dose until 30 days after treatment stop
Incidence and nature of dose limiting toxicities (DLTs) of CPI 818 to establish either the maximum tolerated dose (MTD) or the maximum administered dose (MAD) of CPI 818
Up to approximately 21 days after first dose
Secondary Endpoints
Area under the curve (AUC) of CPI-818 in blood samples to evaluate the pharmacokinetic profile of CPI 818
Day 1, 2, 8, 15 of Cycle 1, Day 1 and 2 of Cycle 3, and Day 1 for all even number Cycles. Each Cycle is 21 days.
Maximum serum concentration (Cmax) of CPI-818 in blood samples to evaluate the pharmacokinetic profile of CPI 818
Day 1, 2, 8, 15 of Cycle 1, Day 1 and 2 of Cycle 3, and Day 1 for all even number Cycles. Each Cycle is 21 days.
Objective response rate per Laguno Classification for CTCL and Consensus Statement for Response for CTCL to assess the anti-tumor activity of CPI 818 in subjects with R/R T cell lymphoma
From start of treatment through end of study treatment, up to approximately 24 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CPI-818 Dose EscalationEXPERIMENTALParticipants will receive CPI-818 capsule, orally, twice per day at an assigned dose, till disease progression, complete response or remission (CR) for \>2 months or if dose determined to be unsafe.
CPI-818 Dose Expansion phaseEXPERIMENTALParticipants with different T-cell lymphoma sub-types will receive CPI-818 capsules at the specific dose selected from the Dose escalation phase of the study. CPI-818 capsules at the selected dose will be taken orally, twice per day until disease progression or CR for \> 2 months.
Interventions
NameTypeDescription
CPI-818DRUGInterleukin-2 inducible T-cell Kinase Inhibitor
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: * Adult subjects age ≥18 years * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Histologically confirmed evidence of T-cell lymphoma * Measurable disease. * Adequate organ function. * At least 2 standard therapies for advanced or recurrent disease or ha...

Countries:United StatesAustraliaChinaSouth Korea
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Competitive Landscape -Cutaneous T-Cell Lymphoma 4 trials
CompanyTickerTrialsLead PhaseDrugs
Soligenix, Inc.SNGX1PHASE3Hypericin
Incyte CorporationINCY2PHASE2Ruxolitinib, Pembrolizumab
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK1 — Undisclosed
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT03952078primaryCompletionDate: changed
LOWMay 24, 2026NCT03952078studyFirstPostDate: changed