Study to Evaluate CCS1477 (inobrodib) in Haematological Malignancies

Description

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.

Conditions

Haematological Malignancy, Acute Myeloid Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma, Higher-risk Myelodysplastic Syndrome, Peripheral T Cell Lymphoma

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Study Overview

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Study Details

Study 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.

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.

Study to Evaluate CCS1477 (inobrodib) in Haematological Malignancies

Condition
Haematological Malignancy
Intervention / Treatment

-

Contacts and Locations

Bethesda

The Center for Cancer and Blood Disorders (CCBD), Bethesda, Maryland, United States, 20817

Omaha

Nebraska Cancer Specialists, Omaha, Nebraska, United States, 68130

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

CellCentric Ltd.,

Tim Somervaille, PRINCIPAL_INVESTIGATOR, The Christie NHS Foundation Trust

Study Record Dates

2027-03-31