Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
CellCentric Ltd.
Study ID
NCT04068597
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Aug 9, 2019
Status verified
Dec 2025
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
250 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: CCS1477 dose escalation NHL/MM
    CCS1477 monotherapy
  • Experimental: CCS1477 dose escalation AML/Higher risk MDS
    CCS1477 monotherapy
  • Experimental: CCS1477 monotherapy expansion and combination dose finding and expansion NHL
    CCS1477 monotherapy, CCS1477 combination with lenalidomide
  • Experimental: CCS1477 monotherapy expansion and combination dose finding and expansion - MM
    CCS1477 monotherapy, CCS1477 combination with pomalidomide-dexamethasone, CCS1477 combination with bortezomib-dexamethasone, CCS1477 combination with ixazomib-dexamethasone, CCS1477 combination with elranatamab, CCS1477 combination with teclistamab, CCS1477 combination with lenalidomide, CCS1477 combination with lenalidomide and daratumumab
  • Experimental: CCS1477 monotherapy expansion and combination dose finding and expansion - AML
    CCS1477 monotherapy, CCS1477 combination with azacitidine, CCS1477 combination with azacitidine and venetoclax
  • Experimental: CCS1477 monotherapy expansion and combination dose finding and expansion - Higher risk MDS
    CCS1477 monotherapy, CCS1477 combination with azacitidine

Primary Outcome Measure

Incidence of treatment-related adverse events [ Time Frame: Up to 12 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Emory Winship Cancer InstituteAtlantaGeorgia30322
Dr Nisha Joseph, MD
[email protected]
404-778-1900
Dr Nisha Joseph, MD (PRINCIPAL_INVESTIGATOR)
Community Health NetworkIndianapolisIndiana46227
Pablo M Bedano, MD
[email protected]
317-621-4300
Pablo M Bedano, MD (PRINCIPAL_INVESTIGATOR)
The Center for Cancer and Blood Disorders (CCBD)BethesdaMaryland20817
Nejma Louahlia
[email protected]
301-571-2016
Victor Priego, MD (PRINCIPAL_INVESTIGATOR)
Nebraska Cancer SpecialistsOmahaNebraska68130
Ashley Servais
[email protected]
402-955-2691
Stefano Tarantolo, MD (PRINCIPAL_INVESTIGATOR)
University of Nebraska Medical CenterOmahaNebraska68198-6846
Marnee Strege, RN BSN
[email protected]
402-559-8155
Sarah Holstein, MD (PRINCIPAL_INVESTIGATOR)
Penn Medicine - Abramson Cancer Center PerelmanPhiladelphiaPennsylvania19104
Dan Vogl, MD
[email protected]
215-662-7140
Dan Vogl, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By condition
Leukemia (other)Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Emory Winship Cancer Institute· Atlanta, GACommunity Health Network· Indianapolis, INThe Center for Cancer and Blood Disorders (CCBD)· Bethesda, MDNebraska Cancer Specialists· Omaha, NEUniversity of Nebraska Medical Center· Omaha, NEPenn Medicine - Abramson Cancer Center Perelman· Philadelphia, PA

Related Studies