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RecruitingInterventionalPhase 1/Phase 2

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.

NCT ID: NCT04068597Sponsor: CellCentric Ltd.Last updated: 2025-12-18

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.

Detailed description

This includes patients with Peripheral T-cell lymphoma.

Arms & interventions

  • DrugCCS1477

    Oral capsule

  • DrugPomalidomide

    oral capsule

  • DrugDexamethasone

    oral tablet

  • DrugAzacitidine

    Powder suspension for Injection

  • DrugVenetoclax

    Oral tablet

  • DrugBortezomib

    Powder for solution for injection

  • DrugIxazomib

    Oral capsule

  • DrugElranatamab

    Solution for injection

  • DrugTeclistamab

    Solution for injection

  • DrugLenalidomide

    Oral capsule

  • DrugDaratumumab

    Solution for injection, concentrate for solution for infusion

Outcome measures

Primary

  • Incidence of treatment-related adverse events

    Treatment-related adverse events and serious adverse events

    Time frame: Up to 12 months

  • Incidence of laboratory abnormalities

    Laboratory abnormalities characterised by type, frequency, severity and timing

    Time frame: Up to 12 months

Secondary

  • Response rate

    Time frame: Up to 12 months

  • Duration of Response

    Time frame: Up to 12 months

  • AUC of CCS1477

    Time frame: 35 days

  • Cmax of CCS1477

    Time frame: 35 days

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (6)

Emory Winship Cancer Institute

Atlanta, Georgia, 30322

Recruiting
Dr Nisha Joseph, MD · Principal Investigator

Community Health Network

Indianapolis, Indiana, 46227

Recruiting
Pablo M Bedano, MD · Contact
Pablo M Bedano, MD · Principal Investigator

The Center for Cancer and Blood Disorders (CCBD)

Bethesda, Maryland, 20817

Recruiting
Victor Priego, MD · Principal Investigator

Nebraska Cancer Specialists

Omaha, Nebraska, 68130

Recruiting
Stefano Tarantolo, MD · Principal Investigator

University of Nebraska Medical Center

Omaha, Nebraska, 68198-6846

Recruiting
Marnee Strege, RN BSN · Contact
Sarah Holstein, MD · Principal Investigator

Penn Medicine - Abramson Cancer Center Perelman

Philadelphia, Pennsylvania, 19104

Recruiting
Dan Vogl, MD · Principal Investigator