Description:
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.
Title
- Brief Title: Study to Evaluate CCS1477 in Haematological Malignancies
- Official Title: An Open-label Phase I/IIa Study to Evaluate the Safety and Efficacy of CCS1477 as Monotherapy in Patients With Advanced Haematological Malignancies.
Clinical Trial IDs
- ORG STUDY ID:
CCS1477-02
- NCT ID:
NCT04068597
Conditions
- Haematological Malignancy
- Acute Myeloid Leukemia
- Non Hodgkin Lymphoma
- Multiple Myeloma
Interventions
| Drug | Synonyms | Arms |
|---|
| CCS1477 | | CCS1477 dose escalation AML/High risk MDS |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| CCS1477 dose escalation NHL/MM | Experimental | | |
| CCS1477 dose escalation AML/High risk MDS | Experimental | | |
| CCS1477 expansion phase NHL | Experimental | | |
| CCS1477 expansion phase MM | Experimental | | |
| CCS1477 expansion phase AML/High risk MDS | Experimental | | |
Eligibility Criteria
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)
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Incidence of treatment-related adverse events |
| Time Frame: | Up to 12 months |
| Safety Issue: | |
| Description: | Treatment-related adverse events and serious adverse events |
Secondary Outcome Measures
| Measure: | Response rate |
| Time Frame: | Up to 12 months |
| Safety Issue: | |
| Description: | Defined as number of patients who have a response according to
RECIL criteria (NHL)
IMWG criteria (Multiple myeloma)
ELN recommendations 2017 (AML) |
| Measure: | Duration of Response |
| Time Frame: | Up to 12 months |
| Safety Issue: | |
| Description: | Defined as the time from start of treatment until disease progression |
| Measure: | AUC of CCS1477 |
| Time Frame: | 35 days |
| Safety Issue: | |
| Description: | Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration of CCS1477 |
| Measure: | Cmax of CCS1477 |
| Time Frame: | 35 days |
| Safety Issue: | |
| Description: | Maximum observed plasma concentration (Cmax) of CCS1477 |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | CellCentric Ltd. |
Last Updated
August 3, 2021
