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Combination Study of Guadecitabine/ASTX727 and Pembrolizumab

NCT02998567 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-12

No results posted yet for this study

Summary

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.

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

Guadecitabine

In arm 1 (escalation) and 2 (expansion).

DRUG

Pembrolizumab

In arm 1 (escalation) and 2 (expansion).

DRUG

ASTX727

In arm B2 (lung expansion) replacing guadecitabine

Sponsors & Collaborators

  • Astex Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Institute of Cancer Research, United Kingdom

    collaborator OTHER

  • Royal Marsden NHS Foundation Trust

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-26
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • United Kingdom

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02998567 on ClinicalTrials.gov