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NCT Number: NCT04068597

Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies

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.

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Key information

Conditions

Haematological Malignancy Acute Myeloid Leukemia Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Higher-risk Myelodysplastic Syndrome Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Peripheral Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Non Hodgkin Lymphoma Paraproteinemias Peripheral T Cell Lymphoma Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Institute Bergonie, Bordeaux, France

Loading trial locations.

About this study

This includes patients with Peripheral T-cell lymphoma.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CCS1477

Drug

Oral capsule

Pomalidomide

Drug

oral capsule

Dexamethasone

Drug

oral tablet

Azacitidine

Drug

Powder suspension for Injection

Venetoclax

Drug

Oral tablet

bortezomib

Drug

Powder for solution for injection

Ixazomib

Drug

Oral capsule

Elranatamab

Drug

Solution for injection

Other names: Elrexfio

Teclistamab

Drug

Solution for injection

Other names: Tecvayli

Lenalidomide

Drug

Oral capsule

Daratumumab

Drug

Solution for injection, concentrate for solution for infusion

Primary outcomes

  1. Incidence of treatment-related adverse events

    Time frame: Up to 12 months

    Treatment-related adverse events and serious adverse events

  2. Incidence of laboratory abnormalities

    Time frame: Up to 12 months

    Laboratory abnormalities characterised by type, frequency, severity and timing

Secondary outcomes

  1. Response rate

    Time frame: Up to 12 months

    Defined as number of patients who have a response according to

    • RECIL criteria (NHL)
    • IMWG criteria (Multiple myeloma)
    • ELN recommendations 2017 (AML)

  2. Duration of Response

    Time frame: Up to 12 months

    Defined as the time from start of treatment until disease progression

  3. AUC of CCS1477

    Time frame: 35 days

    Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration of CCS1477

  4. Cmax of CCS1477

    Time frame: 35 days

    Maximum observed plasma concentration (Cmax) of CCS1477

Study contacts

Contact information is provided by the study sponsor or research team.

Karen Clegg, MD, MFPM

CONTACT

[email protected]

Tomasz Knurowski, PhD

CONTACT

[email protected]

07882871299

Sponsors and collaborators

Lead sponsor

CellCentric Ltd.

Industry

Registry information

Official study title

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.

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Aug 28, 2019
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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