RightFit
RecruitingPhase 1 / Phase 2

Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies

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.

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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 (\> 470 msec)

Study sites (6)

GA

IN

MD

NE

PA