Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies

CellCentric

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Multiple Myeloma; Higher-risk Myelodysplastic Syndrome; Non Hodgkin Lymphoma; Peripheral T Cell Lymphoma; Haematological Malignancy; Acute Myeloid Leukemia

Treatments: Drug: CCS1477; Drug: Venetoclax; Drug: Dexamethasone; Drug: Pomalidomide; Drug: Azacitidine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04068597

CCS1477-02

Details and patient eligibility

About

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.

Full description

This includes patients with Peripheral T-cell lymphoma.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 (> 480 msec)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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250 participants in 6 patient groups

CCS1477 dose escalation NHL/MM

Experimental group

Description:

CCS1477 monotherapy

Treatment:

Drug: CCS1477

CCS1477 dose escalation AML/Higher risk MDS

Experimental group

Description:

CCS1477 monotherapy

Treatment:

Drug: CCS1477

CCS1477 expansion phase NHL/Peripheral T-cell lymphoma

Experimental group

Description:

CCS1477 monotherapy

Treatment:

Drug: CCS1477

CCS1477 monotherapy expansion and combination dose finding and expansion - MM

Experimental group

Description:

CCS1477 monotherapy, CCS1477 combination with pomalidomide-dexamethasone

Treatment:

Drug: Pomalidomide

Drug: Dexamethasone

Drug: CCS1477

CCS1477 monotherapy expansion and combination dose finding and expansion - AML

Experimental group

Description:

CCS1477 monotherapy, CCS1477 combination with azacitidine, CCS1477 combination with azacitidine and venetoclax

Treatment:

Drug: Azacitidine

Drug: Venetoclax

Drug: CCS1477

CCS1477 monotherapy expansion and combination dose finding and expansion - Higher risk MDS

Experimental group

Description:

CCS1477 monotherapy, CCS1477 combination with azacitidine, CCS1477 combination with azacitidine and venetoclax

Treatment:

Drug: Azacitidine

Drug: Venetoclax

Drug: CCS1477