RecruitingPhase 1Phase 2NCT05944237

HTL0039732 in Participants With Advanced Solid Tumours

A Cancer Research UK Phase I/IIa Trial of HTL0039732, Given Orally as Monotherapy and in Combination With Immunotherapy or Other Approved Therapies in Participants With Advanced Solid Tumours


Sponsor

Cancer Research UK

Enrollment

150 participants

Start Date

Jul 13, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this trial is to evaluate a new drug, HTL0039732, that will be administered on its own (as a monotherapy) and in combination with atezolizumab or with other approved anti-cancer therapies, in participants with advanced solid tumours.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase study testing a new experimental drug called HTL0039732 in people with advanced solid tumors that have stopped responding to standard treatments. The study is primarily focused on finding a safe dose and understanding how the drug behaves in the body. **You may be eligible if...** - You are 18 or older with an advanced solid tumor that has progressed despite standard treatments - At least one measurable or assessable tumor area is visible on imaging - You are in good enough physical condition to participate (as assessed by your doctor) - You are willing to provide written informed consent **You may NOT be eligible if...** - Your organ function does not meet the required levels - You have had certain recent cancer treatments that conflict with the study timeline - You have active uncontrolled infections or other serious conditions - You are pregnant or breastfeeding 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

DRUGHTL0039732 Capsules

HTL0039732 Capsules will be administered orally to fasted participants, although an exploration of food effects may be performed as a single dose at Cycle 0. A single dose will be administered between 3 and 9 days prior to commencement of Cycle 1. From Cycle 1 Day 1, HTL0039732 will be administered on a once daily (QD) schedule. Each administration cycle will consist of 21 days with no break between cycles. Participants may initially receive up to 18 cycles but may continue for a further 18 cycles if they are deemed to be benefitting.

DRUGHTL0039732 Capsules and atezolizumab infusion

HTL0039732 Capsules will be administered orally on a QD schedule to participants starting on Cycle 1 Day 1. Each administration cycle will consist of 21 days with no break between cycles. Participants will also receive 1200 mg atezolizumab as an IV infusion on Day1 of each cycle (i.e. every 3 weeks). Participants may initially receive up to 18 cycles of HTL0039732 but may continue for a further 18 cycles if they are deemed to be benefitting, and they may receive up to 36 cycles of atezolizumab.


Locations(5)

Addenbrooke's Hospital

Cambridge, United Kingdom

Velindre Cancer Centre

Cardiff, United Kingdom

Clatterbridge Cancer Centre

Liverpool, United Kingdom

Guy's Hospital

London, United Kingdom

The Christie Hospital

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05944237


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