Clinical Trials /

Study to Evaluate CCS1477 in Haematological Malignancies

NCT04068597

Description:

A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 in patients with Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukaemia or High Risk Myelodysplastic syndrome.

Related Conditions:
  • Acute Myeloid Leukemia
  • Multiple Myeloma
  • Myelodysplastic Syndromes
  • Non-Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study to Evaluate CCS1477 in Haematological Malignancies
  • Official Title: An Open-label Phase I/IIa Study to Evaluate the Safety and Efficacy of CCS1477 as Monotherapy in Patients With Advanced Haematological Malignancies.

Clinical Trial IDs

  • ORG STUDY ID: CCS1477-02
  • NCT ID: NCT04068597

Conditions

  • Haematological Malignancy
  • Acute Myeloid Leukemia
  • Non Hodgkin Lymphoma
  • Multiple Myeloma

Interventions

DrugSynonymsArms
CCS1477CCS1477 dose escalation NHL/MM

Purpose

A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 in patients with Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukaemia or High Risk Myelodysplastic syndrome.

Trial Arms

NameTypeDescriptionInterventions
CCS1477 dose escalation NHL/MMExperimental
  • CCS1477
CCS1477 dose escalation AML/High risk MDSExperimental
  • CCS1477
CCS1477 expansion phase NHLExperimental
  • CCS1477
CCS1477 expansion phase MMExperimental
  • CCS1477
CCS1477 expansion phase AML/High risk MDSExperimental
  • CCS1477

Eligibility Criteria

        Inclusion Criteria:

          -  Provision of consent

          -  ECOG performance status 0-2

          -  Patients with confirmed (per standard disease specific diagnostic criteria), relapsed
             or refractory haematological malignancies (NHL, MM and AML)

          -  Must have previously received standard therapy

          -  Adequate organ function

        Exclusion Criteria:

          -  Intervention with any chemotherapy, investigational agents or other anti-cancer drugs
             within 14 days or 5 half-lives of the first dose

          -  Major surgical procedure or significant traumatic injury within 4 weeks of the first
             dose of study treatment

          -  Strong inhibitors of CYP3A4 or CYP3A4 substrates with a narrow therapeutic range taken
             within 2 weeks of the first dose of study treatment

          -  Strong inducers of CYP3A4 within 4 weeks of the first dose of study treatment

          -  Patients should discontinue statins prior to starting study treatment

          -  CYP2C8 substrates with a narrow therapeutic range taken within 2 weeks of the first
             dose of study treatment

          -  Any unresolved reversible toxicities from prior therapy >CTCAE grade 1 at the time of
             starting study treatment (except alopecia and grade 2 neuropathy)

          -  Any evidence of severe or uncontrolled systemic diseases

          -  Any known uncontrolled inter-current illness

          -  QTcF prolongation (> 480 msec)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of treatment-related adverse events
Time Frame:Up to 12 months
Safety Issue:
Description:Treatment-related adverse events and serious adverse events

Secondary Outcome Measures

Measure:Response rate
Time Frame:Up to 12 months
Safety Issue:
Description:Defined as number of patients who have a response according to RECIL criteria (NHL) IMWG criteria (Multiple myeloma) ELN recommendations 2017 (AML)
Measure:Duration of Response
Time Frame:Up to 12 months
Safety Issue:
Description:Defined as the time from start of treatment until disease progression
Measure:AUC of CCS1477
Time Frame:35 days
Safety Issue:
Description:Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration of CCS1477
Measure:Cmax of CCS1477
Time Frame:35 days
Safety Issue:
Description:Maximum observed plasma concentration (Cmax) of CCS1477

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:CellCentric Ltd.

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