Health TrialsbyHealthPanel

Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies

ConditionsHaematological MalignancyAcute Myeloid LeukemiaNon Hodgkin LymphomaMultiple MyelomaHigher-risk Myelodysplastic SyndromePeripheral T Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCellCentric Ltd.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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

  • Teclistamab

    Drug

    Solution for injection

  • Lenalidomide

    Drug

    Oral capsule

  • Daratumumab

    Drug

    Solution for injection, concentrate for solution for infusion

Treatment groups

250 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: CCS1477 dose escalation NHL/MMExperimental treatment 1 intervention
Group B: CCS1477 dose escalation AML/Higher risk MDSExperimental treatment 1 intervention
Group C: CCS1477 monotherapy expansion and combination dose finding and expansion NHLExperimental treatment 2 interventions
Group D: CCS1477 monotherapy expansion and combination dose finding and expansion - MMExperimental treatment 9 interventions
Group E: CCS1477 monotherapy expansion and combination dose finding and expansion - AMLExperimental treatment 3 interventions
Group F: CCS1477 monotherapy expansion and combination dose finding and expansion - Higher risk MDSExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of treatment-related adverse events

Treatment-related adverse events and serious adverse events

Time frame
Up to 12 months
2

Incidence of laboratory abnormalities

Laboratory abnormalities characterised by type, frequency, severity and timing

Time frame
Up to 12 months

Secondary outcomes

1

Response rate

Defined as number of patients who have a response according to * RECIL criteria (NHL) * IMWG criteria (Multiple myeloma) * ELN recommendations 2017 (AML)

Time frame
Up to 12 months
2

Duration of Response

Defined as the time from start of treatment until disease progression

Time frame
Up to 12 months
3

AUC of CCS1477

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

Time frame
35 days
4

Cmax of CCS1477

Maximum observed plasma concentration (Cmax) of CCS1477

Time frame
35 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CellCentric Ltd.

Lead sponsor

Source ClinicalTrials.gov
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