Clinical trial · Interventional
Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies
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.
NCT04068597CI-TRIAL-00115764recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Haematological Malignancy | — | UNRESOLVED | — |
| Higher-risk Myelodysplastic Syndrome | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Non Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Peripheral T Cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine | Drug | Azacitidine | ALIAS |
| Bortezomib | Drug | Bortezomib | ALIAS |
| CCS1477 | Drug | — | UNRESOLVED |
| Daratumumab | Drug | Daratumumab | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Elranatamab | Drug | Elranatamab | ALIAS |
| Ixazomib | Drug | Ixazomib | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Pomalidomide |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- CCS1477 dose escalation NHL/MM
- description
- CCS1477 monotherapy
- interventionNames
- Drug: CCS1477
- type
- EXPERIMENTAL
- label
- CCS1477 dose escalation AML/Higher risk MDS
- description
- CCS1477 monotherapy
- interventionNames
- Drug: CCS1477
- type
- EXPERIMENTAL
- label
- CCS1477 monotherapy expansion and combination dose finding and expansion NHL
- description
- CCS1477 monotherapy, CCS1477 combination with lenalidomide
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.