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

  • STATUS
    Recruiting
  • End date
    Mar 31, 2024
  • participants needed
    250
  • sponsor
    CellCentric Ltd.
Updated on 28 October 2022
cancer
myeloid leukemia
lymphoma
multiple myeloma
hodgkin's disease
leukemia
dexamethasone
azacitidine
venetoclax

Summary

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.

Details
Condition Haematological Malignancy, Acute Myeloid Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma, Higher-risk Myelodysplastic Syndrome
Treatment Pomalidomide, Dexamethasone, Azacitidine, venetoclax, CCS1477
Clinical Study IdentifierNCT04068597
SponsorCellCentric Ltd.
Last Modified on28 October 2022

Eligibility

Yes No Not Sure

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)
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