NCT04068597 Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies
| NCT ID | NCT04068597 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | CellCentric Ltd. |
| Condition | Haematological Malignancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2019-08-09 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 250 participants in total. It began in 2019-08-09 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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)
Contact & Investigator
Tim Somervaille
PRINCIPAL INVESTIGATOR
The Christie NHS Foundation Trust
Frequently Asked Questions
Who can join the NCT04068597 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Haematological Malignancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04068597 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04068597 currently recruiting?
Yes, NCT04068597 is actively recruiting participants. Contact the research team at Tomasz.Knurowski@cellcentric.com for enrollment information.
Where is the NCT04068597 trial being conducted?
This trial is being conducted at Atlanta, United States, Indianapolis, United States, Bethesda, United States, Omaha, United States and 11 additional locations.
Who is sponsoring the NCT04068597 clinical trial?
NCT04068597 is sponsored by CellCentric Ltd.. The principal investigator is Tim Somervaille at The Christie NHS Foundation Trust. The trial plans to enroll 250 participants.