Evaluating CCS1477 for blood cancers
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.
PHASE1; PHASE2 · CellCentric Ltd. · NCT04068597
This study is testing a new drug called CCS1477 to see if it can help people with certain blood cancers who haven't responded to other treatments.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CellCentric Ltd. (industry) |
| Drugs / interventions | chemotherapy |
| Locations | 39 sites (Atlanta, Georgia and 38 other locations) |
| Trial ID | NCT04068597 on ClinicalTrials.gov |
What this trial studies
This study assesses the safety, tolerability, pharmacokinetics, and biological activity of CCS1477 (inobrodib) in patients with various hematological malignancies, including Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukemia, and higher-risk Myelodysplastic Syndrome. It involves patients who have relapsed or refractory conditions and have previously received standard therapies. The study will evaluate the effectiveness of CCS1477 in combination with other treatments such as Pomalidomide and Dexamethasone.
Who should consider this trial
Good fit: Ideal candidates include patients with confirmed relapsed or refractory hematological malignancies who have previously undergone standard therapy.
Not a fit: Patients currently receiving chemotherapy or other investigational agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with difficult-to-treat blood cancers.
How similar studies have performed: Other studies have shown promise in targeting similar hematological malignancies, suggesting potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Atlanta, Georgia and 38 other locations
- Emory Winship Cancer Institute — Atlanta, Georgia, United States (RECRUITING)
- Community Health Network — Indianapolis, Indiana, United States (RECRUITING)
- The Center for Cancer and Blood Disorders (CCBD) — Bethesda, Maryland, United States (RECRUITING)
- Nebraska Cancer Specialists — Omaha, Nebraska, United States (RECRUITING)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (RECRUITING)
- Penn Medicine - Abramson Cancer Center Perelman — Philadelphia, Pennsylvania, United States (RECRUITING)
- Institute Bergonie — Bordeaux, France (COMPLETED)
- Gustave Roussy — Villejuif, France (COMPLETED)
- Hospital Germans Trias i Pujol/ ICO Badalona — Badalona, Spain (RECRUITING)
- University Hospital Vall D'Hebron — Barcelona, Spain (COMPLETED)
- Hospital Clínic de Barcelona — Barcelona, Spain (RECRUITING)
- ICO L'Hospitalet (Instituto Catalán de Oncología) — Barcelona, Spain (RECRUITING)
- Hospital Universitario de La Princesa — Madrid, Spain (RECRUITING)
- Hospital Universitario Gregorio Marañón — Madrid, Spain (RECRUITING)
- Hospital Infanta Leonor — Madrid, Spain (RECRUITING)
- Hospital Universitario Ramón y Cajal — Madrid, Spain (RECRUITING)
- Hospital Universitario 12 de Octubre — Madrid, Spain (RECRUITING)
- CIOCC Hospital Universitario HM Sanchinarro — Madrid, Spain (COMPLETED)
- Universidad de Navarra — Pamplona, Spain (RECRUITING)
- Hospital Universitario y Politécnico La Fe de la Comunidad Valenciana — Valencia, Spain (RECRUITING)
- Karolinska Comprehensive Cancer Center — Stockholm, Sweden (COMPLETED)
- The Royal Marsden — Sutton, Surrey, United Kingdom (RECRUITING)
- The Clatterbridge Cancer Centre NHS Foundation Trust, — Bebington, United Kingdom (RECRUITING)
- University Hospitals Bristol — Bristol, United Kingdom (RECRUITING)
- University Hospital of Wales — Cardiff, United Kingdom (RECRUITING)
- Royal Derby Hospital — Derby, United Kingdom (RECRUITING)
- Western General Hospital — Edinburgh, United Kingdom (RECRUITING)
- Gartnavel General Hospital — Glasgow, United Kingdom (RECRUITING)
- Leicester Royal Infirmary — Leicester, United Kingdom (RECRUITING)
- St Bartholomew's Hospital — London, United Kingdom (RECRUITING)
- Sarah Cannon Research Institute UK — London, United Kingdom (RECRUITING)
- NIHR University College London Clinical Research Facility — London, United Kingdom (RECRUITING)
- Imperial College — London, United Kingdom (RECRUITING)
- The Christie Hospital — Manchester, United Kingdom (RECRUITING)
- Newcastle upon Tyne Hospitals — Newcastle upon Tyne, United Kingdom (RECRUITING)
- Nottingham University Hospitals NHS Trust — Nottingham, United Kingdom (RECRUITING)
- Cancer and Haematology Centre — Oxford, United Kingdom (RECRUITING)
- University Hospital of Southampton — Southampton, United Kingdom (RECRUITING)
- Royal Stoke University Hospital — Stoke-on-Trent, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Tim Somervaille — The Christie NHS Foundation Trust
- Study coordinator: Tomasz Knurowski, PhD
- Email: Tomasz.Knurowski@cellcentric.com
- Phone: 07882871299
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Haematological Malignancy, Acute Myeloid Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma, Higher-risk Myelodysplastic Syndrome, Peripheral T Cell Lymphoma