Study to Evaluate CCS1477 in Advanced Tumours

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
CellCentric Ltd.
Study ID
NCT03568656
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • CCS1477 — DRUG
    Capsules, oral
  • Abiraterone acetate — DRUG
    Abiraterone acetate 500mg tablets plus prednisone/prednisolone
  • Enzalutamide — DRUG
    Enzalutamide 40mg capsules/tablets
  • Darolutamide — DRUG
    300mg tablets
  • Olaparib — DRUG
    150mg tablets
  • Atezolizumab — DRUG
    840mg/14ml concentrate for solution for infusion vials

Study Details

A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 in patients with metastatic castration resistant prostate cancer, metastatic breast cancer, non-small cell lung cancer or advanced solid tumours.

Key Dates

Start date
Jul 23, 2018
Status verified
Aug 2025
Primary completion
Jul 6, 2025
Completion
Jul 6, 2025

Study Design

Enrollment
220 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: CCS1477 dose escalation - mCRPC
    CCS1477 monotherapy in patients with mCRPC
  • Experimental: CCS1477 expansion phase - mCRPC
    CCS1477 monotherapy in patients with mCRPC
  • Experimental: CCS1477 and abiraterone acetate, combination dose finding and expansion - mCRPC
    CCS1477 plus abiraterone acetate in patients with mCRPC
  • Experimental: CCS1477 and enzalutamide, combination dose finding and expansion - mCRPC
    CCS1477 plus enzalutamide in patients with mCRPC
  • Experimental: CCS1477 Monotherapy - Solid tumours
    CCS1477 expansion phase in patients with advanced solid tumours with molecular markers which may indicate potential for response to p300/CBP inhibition
  • Experimental: CCS1477 and darolutamide, combination dose finding and expansion - mCRPC
    CCS1477 plus darolutamide in patients with mCRPC
  • Experimental: CCS1477 and olaparib, combination dose finding and expansion - mCRPC and metastatic breast cancer
    CCS1477 plus olaparib in patients with mCRPC or metastatic breast cancer.
  • Experimental: CCS1477 and atezolizumab, combination dose finding and expansion - non-small cell lung cancer
    CCS1477 plus atezolizumab in patients with non-small cell lung cancer

Primary Outcome Measure

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

Locations (2)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Thomas Jefferson University, Sidney Kimmel Cancer CenterPhiladelphiaPennsylvania19107-

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