Study to Evaluate CCS1477 in Haematological Malignancies

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CellCentric Ltd.

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)