Combination Study of Guadecitabine/ASTX727 and Pembrolizumab

Sponsor
Royal Marsden NHS Foundation Trust
Study ID
NCT02998567
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Guadecitabine — DRUG
    In arm 1 (escalation) and 2 (expansion).
  • Pembrolizumab — DRUG
    In arm 1 (escalation) and 2 (expansion).
  • ASTX727 — DRUG
    In arm B2 (lung expansion) replacing guadecitabine

Study Details

HyPeR is a multi-centre Phase 1 Dose Escalation Study of Guadecitabine (SGI-110)/ASTX727 a Second Generation Hypo-Methylating Agent in Combination with Pembrolizumab (MK3475) in Patients with Refractory Solid Tumours. The investigators will be investigating the safety and toxicity of the combination.

Key Dates

First listed
Dec 20, 2016
Start date
Jan 26, 2017
Status verified
Aug 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Escalation
    Fixed dose of Pembrolizumab with escalating dose of Guadecitabine to establish the phase 2 recommended dose.
  • Experimental: Expansion
    Continuation of the Guadecitabine and Pembrolizumab dose established in arm 1: expansion in the recommended patient population.
  • Experimental: B2: Lung Expansion
    To further explore the safety and activity of the combination of ASTX727 (replacement of guadecitabine to an oral dose tablet) with pembrolizumab in patients with NSCLC with primary or secondary resistance to PD-1/PD-L1 inhibitors.

Primary Outcome Measure

Establish maximum tolerated dose (MTD) [ Time Frame: 12 months ]

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