RecruitingPhase 1NCT02998567

Combination Study of Guadecitabine/ASTX727 and Pembrolizumab

HyPeR: A Phase 1, Dose Escalation Study of Guadecitabine /ASTX727 in Combination With Pembrolizumab (MK3475) in Patients With Refractory Solid Tumours


Sponsor

Royal Marsden NHS Foundation Trust

Enrollment

60 participants

Start Date

Jan 26, 2017

Study Type

INTERVENTIONAL

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — guadecitabine (or ASTX727) and pembrolizumab (an immunotherapy) — in patients with advanced solid tumors (cancers that form solid masses, like lung, bowel, or bladder cancer) that have stopped responding to standard treatments. **You may be eligible if...** - You have an advanced solid tumor that no longer responds to standard treatments, or for which no standard treatment is available or appropriate - You may be eligible for a specific part of the study if your tumor previously responded to a checkpoint inhibitor (a type of immunotherapy like pembrolizumab) but later stopped working - You are in generally good enough health to participate **You may NOT be eligible if...** - You have active autoimmune disease that requires treatment - You are on high-dose steroids or other immune-suppressing medications - You have untreated brain metastases (cancer spread to the brain) - You are pregnant or breastfeeding - You have had prior serious reactions to immunotherapy drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGuadecitabine

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

DRUGPembrolizumab

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

DRUGASTX727

In arm B2 (lung expansion) replacing guadecitabine


Locations(2)

Royal Marsden Hospital

Sutton, Surrey, United Kingdom

UCLH

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT02998567