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CPI-818

Phase 1

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

Target and mechanism

Molecular targetITK
Target classEnzyme
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment151

FDA Designations

No designations recorded

Clinical trial landscape

CPI-818 · 1 trial · 1 indication

Phase 1 1
NCT03952078A Dose Escalation Study Evaluating CPI-818 in Relapsed/Refractory T-Cell LymphomaT-cell Lymphoma
ACTIVE NOT_RECRUITING151 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Dose Escalation Study Evaluating CPI-818 in Relapsed/Refractory T-Cell Lymphoma
T-cell LymphomaUnlock trial analytics

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 to 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 3 trials (matched to "T-cell Lymphoma")

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Frequently asked questions about CPI-818

What is CPI-818 used for?

CPI-818 is an investigational small molecule being developed for the treatment of T-cell lymphoma. It is currently in Phase 1 clinical development for this indication.

What does CPI-818 target?

CPI-818 targets ITK, an enzyme involved in T-cell signaling. By inhibiting ITK, CPI-818 is designed to interfere with pathways relevant to T-cell lymphoma.

Who is developing CPI-818?

CPI-818 is being developed by Corvus Pharmaceuticals, Inc., a biopharmaceutical company. The company is listed on the NASDAQ under the ticker symbol CRVS.

What phase is CPI-818 in?

CPI-818 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities.

What clinical trials is CPI-818 in?

CPI-818 is being studied in a Phase 1 dose escalation trial (NCT03952078) for relapsed or refractory T-cell lymphoma. The trial is active but not recruiting, with an enrollment of 151 participants across the United States, Australia, China, and South Korea.

Is CPI-818 the same as any other drug?

CPI-818 is the primary name for this investigational compound. No alternative names have been reported for CPI-818 in its clinical development.