Clinical Trials /

A Study of CPI-0209 in Patients With Advanced Solid Tumors

NCT04104776

Description:

First-in-human, open-label, sequential dose escalation and expansion study of CPI-0209 in patients with advanced solid tumors alone and in combination with other therapies. CPI-0209 is a small molecule inhibitor of EZH2.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of CPI-0209 in Patients With Advanced Solid Tumors
  • Official Title: A Phase 1/2 Study of CPI-0209 Monotherapy and in Combination With Other Therapy in Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: 0209-01
  • NCT ID: NCT04104776

Conditions

  • Advanced Solid Tumor

Interventions

DrugSynonymsArms
CPI-0209Monotherapy
IrinotecanCombination Therapy

Purpose

First-in-human, open-label, sequential dose escalation and expansion study of CPI-0209 in patients with advanced solid tumors alone and in combination with other therapies. CPI-0209 is a small molecule inhibitor of EZH2.

Trial Arms

NameTypeDescriptionInterventions
MonotherapyExperimentalCPI-0209 will be dosed once per day orally in 28 day cycles
  • CPI-0209
Combination TherapyExperimentalCPI-0209 will be dosed once per day orally in 21 day cycles. Irinotecan iv will be dosed on day 1 of every cycle.
  • CPI-0209
  • Irinotecan

Eligibility Criteria

        Inclusion Criteria:

          -  18 years or older

          -  Life expectancy of ≥ 12 weeks

          -  Recovered to baseline or Grade ≤ 1 severity from toxicity related to prior treatments,
             unless AEs are clinically non-significant and/or stable on supportive therapy

          -  ECOG 0-1

          -  Adequate bone marrow function

          -  Adequate renal function

          -  Adequate liver function

        Exclusion Criteria:

          -  Previous solid organ or hematopoietic cell transplant

          -  Known brain metatstases

          -  Known Gilbert's disease

          -  Prior EZH2 inhibitor

          -  Concomitant medication(s) or food or beverage that are moderate or strong CYP3A
             inducers or inhibitors within 2 weeks prior to the first dose of study drug

          -  Clinically significant cardiovascular disease

          -  Major surgery within 4 weeks

          -  GI disorders affecting absorption

          -  Uncontrolled infection

          -  Suspected pneumonitis or interstitial lung disease

          -  Known additional malignancy that is active and/or progressive requiring treatment

          -  Known HIV or active hepatitis

          -  Chronic liver disease

          -  Women of child bearing potential and men with reproductive potential, if they are -
             unwilling to use adequate contraception while on study therapy and for 3 months
             thereafter

          -  Patients unwilling or unable to comply with this study protocol
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Phase 1: Frequency of Dose-limiting toxicities (DLTs)
Time Frame:DLTs assessed during Cycle 1 (first 28 days on study for monotherapy and first 21 days for combination therapy)
Safety Issue:
Description:The maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of CPI-0209 as monotherapy and in combination with irinotecan in patients with advanced solid tumors

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Constellation Pharmaceuticals

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