Study to Evaluate CCS1477 in Haematological Malignancies

Multiple Myeloma Clinical Trial

Official 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04068597
• Other study ID #: CCS1477-02
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 9, 2019
• Est. completion date: June 30, 2025

Study information

• Verified date: October 2023
• Source: CellCentric Ltd.
• Contact: Tomasz Knurowski, PhD
• Phone: 07882871299
• Email: Tomasz.Knurowski[@]cellcentric.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 in patients with Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukaemia or High Risk Myelodysplastic syndrome.

Description:

This includes patients with Peripheral T-cell lymphoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Haematological Malignancy
• Hematologic Neoplasms
• Higher-risk Myelodysplastic Syndrome
• Lymphoma
• Lymphoma, T-Cell, Peripheral
• Multiple Myeloma
• Myelodysplastic Syndromes
• Neoplasms
• Non Hodgkin Lymphoma
• Peripheral T Cell Lymphoma

Intervention

Drug:
• CCS1477
Oral capsule
• Pomalidomide
oral capsule
• Dexamethasone
oral tablet
• Azacitidine
Powder suspension for Injection
• Venetoclax
Oral tablet

Locations

Country	Name	City	State
France	Institute Bergonie	Bordeaux
France	Institute Gustave Roussy	Villejuif
Spain	University Hospital Vall D'Hebron	Barcelona
Spain	CIOCC Hospital Universitario HM Sanchinarro	Madrid
Sweden	Karolinska Institute	Stockholm
United Kingdom	University Hospital of Wales	Cardiff
United Kingdom	Western General Hospital	Edinburgh
United Kingdom	Gartnavel General Hospital	Glasgow
United Kingdom	Leicester Royal Infirmary	Leicester
United Kingdom	NIHR University College London Clinical Research Facility	London
United Kingdom	The Christie Hospital	Manchester
United Kingdom	Cancer and Haematology Centre	Oxford
United Kingdom	University Hospital of Southampton	Southampton
United Kingdom	The Royal Marsden	Sutton	Surrey
United States	Mayo Clinic	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
CellCentric Ltd.

Countries where clinical trial is conducted

United States,  France,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-related adverse events	Treatment-related adverse events and serious adverse events	Up to 12 months
Primary	Incidence of laboratory abnormalities	Laboratory abnormalities characterised by type, frequency, severity and timing	Up to 12 months
Secondary	Response rate	Defined as number of patients who have a response according to; RECIL criteria (NHL); IMWG criteria (Multiple myeloma); ELN recommendations 2017 (AML)	Up to 12 months
Secondary	Duration of Response	Defined as the time from start of treatment until disease progression	Up to 12 months
Secondary	AUC of CCS1477	Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration of CCS1477	35 days
Secondary	Cmax of CCS1477	Maximum observed plasma concentration (Cmax) of CCS1477	35 days