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HTL0039732 in Participants With Advanced Solid Tumours

NCT05944237 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-06-08

No results posted yet for this study

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.

Conditions

  • Neoplasms
  • Prostatic Neoplasms, Castration-Resistant
  • Stomach Neoplasms
  • Esophageal Neoplasms
  • Head and Neck Neoplasms
  • Colorectal Neoplasms
  • Pancreatic Neoplasms
  • Lung Neoplasms
  • Urinary Bladder Neoplasms
  • Mesothelioma, Malignant
  • Uterine Cervical Neoplasms
  • Kidney Neoplasms
  • Sarcoma
  • Pheochromocytomas

Interventions

DRUG

HTL0039732 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.

DRUG

HTL0039732 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.

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-13
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • United Kingdom

Study Locations

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Entities

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 NCT05944237 on ClinicalTrials.gov