Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies
Recruiting now · Phase 1/Phase 2
Conditions studied: Haematological Malignancy, Acute Myeloid Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma, Higher-risk Myelodysplastic Syndrome, Peripheral T Cell Lymphoma
In brief
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.
Key facts
- Study ID
- NCT04068597
- Run by
- CellCentric Ltd.
- People needed
- 250
- Starts
- 2019-08-09
- Expected to finish
- 2027-03-31
- Last updated by the study team
- 2026-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Royal Stoke University Hospital — Stoke-on-Trent, United Kingdom (enrolling)
- Community Health Network — Indianapolis, Indiana, United States (enrolling)
- The Center for Cancer and Blood Disorders (CCBD) — Bethesda, Maryland, United States (enrolling)
- Nebraska Cancer Specialists — Omaha, Nebraska, United States (enrolling)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
- Penn Medicine - Abramson Cancer Center Perelman — Philadelphia, Pennsylvania, United States (enrolling)
- Newcastle upon Tyne Hospitals — Newcastle upon Tyne, United Kingdom (enrolling)
- Nottingham University Hospitals NHS Trust — Nottingham, United Kingdom (enrolling)
- Cancer and Haematology Centre — Oxford, United Kingdom (enrolling)
- University Hospital of Southampton — Southampton, United Kingdom (enrolling)
- Emory Winship Cancer Institute — Atlanta, Georgia, United States (enrolling)
- Hospital Germans Trias i Pujol/ ICO Badalona — Badalona, Spain (enrolling)
- Hospital Clínic de Barcelona — Barcelona, Spain (enrolling)
- ICO L'Hospitalet (Instituto Catalán de Oncología) — Barcelona, Spain (enrolling)
- Hospital Universitario de La Princesa — Madrid, Spain (enrolling)
- Hospital Universitario Gregorio Marañón — Madrid, Spain (enrolling)
- Hospital Infanta Leonor — Madrid, Spain (enrolling)
- Hospital Universitario Ramón y Cajal — Madrid, Spain (enrolling)
- Hospital Universitario 12 de Octubre — Madrid, Spain (enrolling)
- Universidad de Navarra — Pamplona, Spain (enrolling)
- Hospital Universitario y Politécnico La Fe de la Comunidad Valenciana — Valencia, Spain (enrolling)
- The Royal Marsden — Sutton, Surrey, United Kingdom (enrolling)
- The Clatterbridge Cancer Centre NHS Foundation Trust, — Bebington, United Kingdom (enrolling)
- University Hospitals Bristol — Bristol, United Kingdom (enrolling)
- University Hospital of Wales — Cardiff, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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