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. CCS1477

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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)

Additional Trial Information

Phase 1/2

Enrollment: 250 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Maryland

American Oncology Partners of Maryland (Bethesda) The Center for Cancer & Blood Disorders - Bethesda

Bethesda, MD

Open and Accepting

Nebraska

Nebraska Cancer Specialists - Midwest Cancer Center Legacy Nebraska Cancer Specialists

Omaha, NE

Open and Accepting
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