Actively Recruiting
HTL0039732 in Participants With Advanced Solid Tumours
Led by Cancer Research UK · Updated on 2025-06-08
150
Participants Needed
5
Research Sites
202 weeks
Total Duration
On this page
Sponsors
C
Cancer Research UK
Lead Sponsor
N
Nxera Pharma UK Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
HTL0039732 in Participants With Advanced Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and ability to cooperate with treatment and follow-up
- For Phase 1 Part A: Histologically or cytologically confirmed advanced solid tumor refractory to standard treatment or no further standard therapy appropriate
- At least one measurable or assessable tumor lesion with progression after last therapy
- Consent for fresh tumor biopsy samples if accessible and eligible for atezolizumab; optional at disease progression
- Consent to access and analyze archival or fresh tumor tissue if archival unavailable
- For Phase 1 Part B: Histologically proven advanced solid tumor with significant PGE2/EP4 signaling, including specified cancer types or mutations
- For Phase 2a: Histologically proven advanced solid tumors refractory to treatment or no appropriate standard therapy, including specific indications like MSS CRC with mutations, gastric adenocarcinoma, clear cell renal carcinoma, and mCRPC
- Consent for archival tissue access and fresh biopsies at baseline and on treatment with some exceptions
- Disease progression by RECIST v1.1 or PCWG3 criteria for mCRPC
- Life expectancy of at least 12 weeks
- ECOG performance status 0 or 1
- Hematological and biochemical values within protocol-defined ranges
- Stable thyroid function; stable thyroxine doses allowed
- Age 18 years or older at consent
You will not qualify if you...
- Radiotherapy (except palliative), chemotherapy, systemic anti-cancer therapy, or investigational drugs within 4 weeks prior to enrollment; immunotherapy within 12 weeks before first dose
- Ongoing toxic effects from prior treatments greater than Grade 1
- Central nervous system metastases unless treated, stable, asymptomatic, and off steroids for 4 weeks
- Women who are pregnant, lactating, or of childbearing potential (exceptions apply)
- Men with partners of childbearing potential (exceptions apply)
- Recent major thoracic or abdominal surgery without recovery
- High medical risk from uncontrolled systemic disease or active infection
- Known current or latent tuberculosis, HIV, hepatitis B or C
- Prior treatment with EP4 inhibitors
- Use of selective cyclooxygenase-2 inhibitors within 8 weeks
- Allergies to hydroxypropyl methylcellulose
- Use of systemic immunosuppressive agents within 2 weeks (exceptions apply)
- Significant cardiovascular disease
- Active peptic ulcer disease or frequent gastritis, dyspepsia, or reflux symptoms
- Participation in another interventional clinical trial during this study
- Difficulty swallowing or absorbing oral medications
- Any condition judged by the investigator as unsuitable for study participation
- For Phase 1 Part B and Phase 2a: live vaccines within 4 weeks, immunodeficiency, autoimmune disease requiring systemic treatment within 2 years, history or suspicion of interstitial lung disease or pneumonitis, hypersensitivity to atezolizumab, or prior severe immunotherapy reactions
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
2
Velindre Cancer Centre
Cardiff, United Kingdom, CF14 2TL
Actively Recruiting
3
Clatterbridge Cancer Centre
Liverpool, United Kingdom, CH63 4JY
Actively Recruiting
4
Guy's Hospital
London, United Kingdom, SE1 9RT
Actively Recruiting
5
The Christie Hospital
Manchester, United Kingdom, M20 4BX
Actively Recruiting
Research Team
B
Bristi Basu, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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