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CPI-006

Phase 1

COVID-19 | Small molecule | Infectious Disease |Corvus Pharmaceuticals, Inc.|Last Updated: Dec 21, 2023

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

CPI-006 · 2 trials · 14 indications

Phase 1 2
NCT04464395Study of CPI-006 as Immunotherapy for Hospitalized COVID-19 PatientsCOVID-19
COMPLETED30 Analytics
NCT03454451CPI-006 Alone and in Combination With Ciforadenant and With Pembrolizumab for Patients With Advanced CancersNon-Small Cell Lung Cancer
COMPLETED117 Analytics
PHASE1COMPLETED
Study of CPI-006 as Immunotherapy for Hospitalized COVID-19 Patients
COVID-19Unlock trial analytics
PHASE1COMPLETED
CPI-006 Alone and in Combination With Ciforadenant and With Pembrolizumab for Patients With Advanced Cancers
Non-Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Treatment-Emergent Adverse Events to Determine Single Dose of CPI-006 That is Safe in Patients with COVID-19
Up to 30 days after dose of CPI-006.

Incidence of adverse events (including serious adverse events and dose limiting toxicities).

Immunoglobulin Anti-SARS CoV-2 Levels
Baseline and Day 28.

Measure changes in serum or plasma immunoglobulin anti-SARS CoV-2 levels.

Incidence of dose-limiting toxicities (DLTs) of CPI-006 as a single agent and in combination with ciforadenant and with pembrolizumab.
From start of treatment to end of treatment, up to 36 months
Incidence of treatment-emergent adverse events as assessed by NCI CTCAE v.4.03, of CPI-006 as single agent and in combination with ciforadenant and with pembrolizumab.
From start of treatment to end of treatment, up to 36 months
Identify the MDL(maximum dose level) of single agent CPI-006
From start of treatment to end of treatment, up to 36 months

Secondary Endpoints

Negative Nasal Swab Polymerase Chain Reaction (PCR) SARS CoV-2 Viral Tests
Baseline to two consecutive negative nasal swab PCR SARS CoV-2 viral tests (separated by at least 48 hours).
Duration of symptoms
Up to 24 weeks after dose of CPI-006.
Time to discharge
Up to 24 weeks after dose of CPI-006.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CPI-006 Dose EscalationEXPERIMENTALCPI-006 + Standard of Care
Control ArmOTHERStandard of Care Only
Cohort 1aEXPERIMENTALCPI-006
Cohort1bEXPERIMENTALCPI-006 + ciforadenant
Cohort 1cEXPERIMENTALCPI-006 + pembrolizumab
Cohort 2aEXPERIMENTALCPI-006
Cohort 2bEXPERIMENTALCPI-006 + ciforadenant
Cohort 2cEXPERIMENTALCPI-006 + pembrolizumab

Interventions

NameTypeDescription
CPI-006DRUGParticipants will receive a single dose of CPI-006 at one of four dose levels (0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg, or 5.0 mg/kg) along with standard of care.
Standard of CareOTHERParticipants will receive standard of care treatment only.
CPI-006 + ciforadenantDRUGSubjects will receive escalating doses of CPI-006 administered intravenously once every 21 days in combination with CPI-444 orally twice daily until MTD is reached for CPI-006 or until disease progression.
CPI-006 + pembrolizumabDRUGSubjects will receive escalating doses of CPI-006 in combination with pembrolizumab administered intravenously once every 21 days until MTD is reached for CPI-006 or until disease progression.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Nasal swab test positive by reverse transcriptase PCR for SARS CoV-2 within past 7 days, and onset of COVID-19 symptoms no more than 10 days prior to the positive test * Hospitalized and have stable mild to moderate symptoms of COVID-19 * Blood oxygen saturation of a minimum o...

Countries:United StatesAustralia
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Frequently asked questions about CPI-006

What is CPI-006 used for?

CPI-006 is an investigational small molecule being studied for COVID-19 and Non-Small Cell Lung Cancer. It is developed by Corvus Pharmaceuticals, Inc. (CRVS) and is currently in Phase 1 clinical development. CPI-006 has been evaluated in clinical trials for these indications, though it remains investigational and is not yet approved.

Who makes CPI-006?

CPI-006 is being developed by Corvus Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker CRVS. The company is conducting clinical trials to evaluate CPI-006 as a potential treatment for COVID-19 and Non-Small Cell Lung Cancer.

What phase is CPI-006 in?

CPI-006 is in Phase 1 clinical development. It has completed two Phase 1 trials, one in advanced cancers including Non-Small Cell Lung Cancer and another in hospitalized COVID-19 patients. CPI-006 is investigational and has not been approved by regulatory authorities.

What clinical trials is CPI-006 in?

CPI-006 has been studied in two completed Phase 1 clinical trials. NCT03454451 evaluated CPI-006 alone and in combination with ciforadenant and pembrolizumab in patients with advanced cancers, including Non-Small Cell Lung Cancer. NCT04464395 studied CPI-006 as immunotherapy for hospitalized COVID-19 patients.

Is CPI-006 the same as ciforadenant or pembrolizumab?

No, CPI-006 is a distinct investigational small molecule. In clinical trial NCT03454451, CPI-006 was studied alone and in combination with ciforadenant and with pembrolizumab, which are separate drugs. CPI-006 is not the same as either of these agents.