Study to Evaluate CCS1477 (inobrodib) in Haematological Malignancies
Sponsor: CellCentric Ltd.
ClinicalTrials ID:NCT04068597
This Phase 1/2a study evaluates CCS1477's safety and biological activity in patients with relapsed or refractory haematological malignancies, including Peripheral T-cell lymphoma. Eligible participants must have an ECOG status of 0-2, confirmed diagnosis, prior standard therapy, and adequate organ function. Interventions include CCS1477, Pomalidomide, Dexamethasone, Azacitidine, and Venetoclax.
Patient Parameters
| Parameter | Options |
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Program Overview
A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 (inobrodib) in patients with Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukaemia or High Risk Myelodysplastic syndrome.
Description
This includes patients with Peripheral T-cell lymphoma.
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)
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| The Center for Cancer and Blood Disorders (CCBD) | 20817 | Bethesda | Maryland |
| Nebraska Cancer Specialists | 68130 | Omaha | Nebraska |
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