Study of Ciforadenant in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma

NCT04280328 | Completed Phase 1 FDA Drug

• 1 other identifier: CPI-444-003
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1b open-label study of ciforadenant, an oral, small molecule inhibitor targeting adenosine-2A receptors (A2AR), on safety/tolerability and efficacy in combination with daratumumab, a monoclonal antibody targeting CD38, in relapsed or refractory multiple myeloma.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability of ciforadenant in combination with daratumumab relapsed / refractory multiple myeloma.

  Incidence of treatment-emergent adverse events, as assessed by NCI CTCAE v.5

  From start of treatment to end of treatment, up to 24 months

• Safety and tolerability of ciforadenant in combination with daratumumab relapsed / refractory multiple myeloma.

  Incidence of dose-limiting toxicities (DLTs) of CPI-444 in combination with daratumumab

  28 days following first administration of ciforadnenat in combination with daratumumab

Secondary Outcomes (6)

• Overall response rate.

  From start of treatment to end of treatment, up to 24 months

• Duration of response.

  From start of treatment to end of treatment, up to 24 months

• Disease control rate.

  From start of treatment to end of treatment, up to 24 months

• Time to next therapy.

  Up to 2 years after end of treatment.

• Progression free survival.

  Up to 2 years after end of treatment.

Study Arms (1)

Ciforadenant in combination with daratumumab

EXPERIMENTAL

Ciforadenant 100 mg orally twice daily in combination with daratumumab IV 16 mg/kg.

Drug: Ciforadenant; Drug: daratumumab

Interventions

Ciforadenant DRUG

100 mg orally twice daily for 28-day cycles

Also known as: CPI-444

Ciforadenant in combination with daratumumab

daratumumab DRUG

16 mg/kg administered intravenously as follows based on 28-day cycles: * Cycles 1 - 2: Days 1, 8, 15, and 22 * Cycles 3 - 6: Days 1 and 15 * Cycles 7 - 24: Day 1

Ciforadenant in combination with daratumumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Relapsed or refractory myeloma.
• Must have been exposed to at least 2 cycles of an IMiD containing regimen and PI containing regimen and must be refractory to at least one of the two.
• Must have completed and tolerated 2 cycles of daratumumab or other anti-CD38 targeting antibodies.
• Active myeloma requiring systemic treatment.
• Measurable disease per protocol.
• ECOG performance status of 0 - 2.
• Life expectancy of at least 3 months.

You may not qualify if:

• POEMS syndrome; non-secretory myeloma (no measurable protein on sFLC assay); amyloidosis.
• History of select prior malignancies.
• Previous intolerance to daratumumab or any study drug.
• Received an allogeneic stem cell transplant within 12 months, or an autologous stem cell transplant within 6 months, or have ongoing toxicity related to transplant.
• Have an active infection or serious comorbid medical condition.
• Any live attenuated vaccination against infectious diseases (e.g., influenza, varicella) within 4 weeks of initiation of study treatment; uncontrolled human immunodeficiency virus, or positive tests for hepatitis B or hepatitis C.
• Female participants pregnant or breast-feeding.
• Screening chemistry and blood counts within protocol limits
• Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressant medication during study treatment.

Sponsors & Collaborators

• Corvus Pharmaceuticals, Inc.: lead

Study Sites (1)

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

ciforadenant; daratumumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Deborah Strahs

  Corvus Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 21, 2020
• Study Start: February 20, 2020
• Primary Completion: September 21, 2021
• Study Completion: March 1, 2022
• Last Updated: March 11, 2022

Record last verified: 2022-03

Locations

US (1)