At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- HTL0039732 Capsules (drug), HTL0039732 Capsules or HTL0039732 tablets and atezolizumab infusion (drug)
- How long the study runs
- Study runs about 64 months (dates as stated)
- About the drug or intervention
- HTL0039732 Capsules — drug: 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. · HTL0039732 Capsules or HTL0039732 tablets and atezolizumab infusion — drug: HTL0039732 Capsules or HTL0039732 tablets will be administered orally on a QD schedule to participants starting on Cycle 1 Day 1.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 150
- Started
- 2023-08-02
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for neoplasms
- • Phase1/Phase2 - 150 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with neoplasms
Where?
- • Cambridge - Addenbrooke's Hospital
- • Cardiff - Velindre Cancer Centre
- • Dundee - Ninewells Hospital
- • Liverpool - Clatterbridge Cancer Centre
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
The trial will investigate HTL0039732, a novel specific E-type prostanoid receptor 4 (EP4) antagonist, as a monotherapy and in combination with atezolizumab, a monoclonal antibody that binds to the programmed death ligand 1 (PD-L1). The trial may be expanded in future to also evaluate HTL0039732 in combination with other approved anti-cancer therapies. HTL0039732 is a small molecule drug that blocks activation of EP4 receptors by prostaglandin E2 (PGE2), a naturally occurring substance in the body. Prostaglandin E2 may be elevated in cancer and signalling via the EP4 receptor can lead to suppression of immune activity, allowing the cancer to escape from the immune system. Blocking the EP4 receptor may relieve that immunosuppression, allowing the immune system to be active against the cancer again. Atezolizumab is an established immune checkpoint inhibitor that overcomes a key immunosuppressive signal and improves the magnitude and quality of tumour-specific T-cell responses, resulting in improved anti-cancer activity. Atezolizumab, and other similar agents, are approved for the treatment of several different types of cancer. As a common mechanism of immune suppression, immune checkpoint inhibitors also have a role in combination immunotherapies and combining EP4 inhibition by HTL0039732 with PD-L1 blockade by atezolizumab, is expected to have increased activity. The trial will investigate HTL0039732 as a monotherapy and in combination with atezolizumab, and potentially with other approved anti-cancer therapies, in participants with advanced solid tumours (Phase 1 Part A) and in participants with advanced solid tumours where PGE2/EP4 signalling is believed to be more prevalent or significant (Phase 1 Part B and Phase 2a). This is a first-in-human clinical trial and is split as follows: * Phase 1 is the 'dose escalation' phase, where two groups (known as Part A and Part B) of participants with solid tumours will receive increasing doses of HTL0039732 to find the safest dose. * Part A participants will receive HTL0039732 as a single agent. * Part B participants will receive HTL0039732 in combination with atezolizumab. * More parts may be added in future for participants to receive HTL0039732 in combination with other approved anti-cancer therapies. * Phase 2a is the 'dose expansion' phase, where participants grouped according to the type of cancer they have will receive the recommended Phase 2 dose (RP2D) of HTL0039732 in combination with atezolizumab, and potentially in combination with other approved anti-cancer therapies. Phase 2a will follow a response enrichment approach; activity of the investigational medicinal products will be assessed in each group and ongoing recruitment will focus on tumour types with promising signals. The main aims of the clinical trial are to find out: * The most appropriate dose of HTL0039732 administered on its own, and the most appropriate dose/s of HTL0039732 to take forward for further investigation in combination with atezolizumab and with other approved anti-cancer therapies. * More about any potential side effects of HTL0039732 when given alone and in combination with atezolizumab and other approved anti-cancer therapies.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ at least one target lesion that is not intended to be biopsied)
What the study is looking for
- ✓Written (signed and dated) agreement to take part and capable of co-operating with investigational medicinal product...
- ✓Phase 1, testing different doses phase
- ✓Part A (HTL0039732 monotherapy):
- ✓Consent to access and analysis of any available archival tissue or a fresh tumour sample at baseline, if archival...
- ✓Consent for fresh tumour biopsy sample(s) at time of PD, if the participant has accessible disease and is eligible...
Who cannot take part
- ✗Ongoing toxic manifestations of previous treatments that are Grade \>1 per CTCAE v5.0.
- ✗Any central nervous system metastases (unless potential participants have had local therapy and are not causing symptoms,...
- ✗Women of child-bearing potential (or who are already pregnant or lactating). Exceptions apply.
- ✗Men with partners of childbearing potential. Exceptions apply.
- ✗Major thoracic or abdominal surgery from which the potential participant has not yet recovered.
See the full criteria
Where Is This Study? (6 UK sites)
Addenbrooke's Hospital
Cambridge CB2 0QQ, United Kingdom
Velindre Cancer Centre
Cardiff CF14 2TL, United Kingdom
Ninewells Hospital
Dundee DD1 9SY, United Kingdom
Clatterbridge Cancer Centre
Liverpool CH63 4JY, United Kingdom
Guy's Hospital
London SE1 9RT, United Kingdom
The Christie Hospital
Manchester M20 4BX, United Kingdom
How to Get in Touch
Bristi Basu, Dr
Sponsor contactCONTACT
