Actively Recruiting
A Cancer Research UK Phase I/IIa Trial of HTL0039732 Given Orally Alone or With Immunotherapy or Other Approved Therapies in Advanced Solid Tumors
Led by Cancer Research UK · Updated on 2025-06-08
150
Participants Needed
5
Research Sites
N/A
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
Researchers are evaluating a new drug called HTL0039732, a novel EP4 receptor antagonist, in people with advanced solid tumors. The trial aims to study HTL0039732 alone and combined with atezolizumab or other approved anti-cancer therapies. This first-in-human Phase 1/2a trial focuses on finding the best dose and understanding potential side effects of HTL0039732, while exploring its ability to help the immune system fight cancer by blocking a pathway that suppresses immune activity. Participants will receive HTL0039732 as oral capsules once daily in cycles of 21 days, either alone or combined with a fixed 1200 mg intravenous dose of atezolizumab given every three weeks. The trial is divided into dose escalation phases where doses of HTL0039732 are increased to find the safest and most effective dose, and a dose expansion phase where participants with specific cancer types receive the recommended dose. Additional future parts may study HTL0039732 combined with other therapies. Throughout the study, participants will be closely monitored with scans, biopsies, blood tests, and safety assessments. Researchers will track side effects, drug levels in the blood, tumor response, immune activity, and survival measures over up to 118 weeks. Safety data will be collected from consent until after treatment ends. Participants may receive up to 36 cycles of treatment if benefiting. The study will provide detailed information on dosing, safety, and anti-cancer effects of HTL0039732 in advanced solid tumors.
CONDITIONS
Brief Title
HTL0039732 in Participants With Advanced Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and able to follow treatment and follow-up
- Adults aged 18 years or older
- Histologically or cytologically confirmed advanced solid tumor, refractory to or without suitable conventional treatment
- At least one measurable or assessable lesion per RECIST v1.1 or PCWG3 criteria
- Consent to provide archival or fresh tumor biopsy samples when applicable
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group performance status 0 or 1
- Hematological and biochemical lab values within protocol specified ranges
- Stable thyroid function, with stable thyroxine allowed
You will not qualify if you...
- Recent radiotherapy, chemotherapy, systemic anti-cancer therapy within 4 weeks, or immunotherapy within 12 weeks
- Ongoing treatment-related toxicities above 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 unless exceptions apply
- Men with partners of childbearing potential unless exceptions apply
- Major surgery not yet recovered from
- High medical risk due to non-cancer diseases or uncontrolled infections
- Known active tuberculosis, HIV, or hepatitis B or C infection
- Prior treatment with EP4 inhibitors or recent use of selective COX-2 inhibitors
- Hypersensitivity to hydroxypropyl methylcellulose or atezolizumab
- Use of systemic immunosuppressants within 2 weeks unless excepted
- Significant cardiovascular disease
- Active peptic ulcer disease or frequent gastritis/GERD symptoms
- Current participation in another interventional clinical trial
- Limited ability to swallow or absorb oral medications
- Live vaccines within 4 weeks before enrollment
- Immunodeficiency or active autoimmune disease requiring recent systemic treatment
- History or suspicion of interstitial lung disease or pneumonitis
- Prior adverse reactions to cancer immunotherapy requiring steroids or discontinuation
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 cycles of 21 days each, with possible extension for up to 18 additional cycles
Participants receive HTL0039732 capsules orally once daily in 21-day cycles. Some participants also receive atezolizumab as an intravenous infusion on Day 1 of each cycle. Treatment may continue up to 18 cycles initially and may be extended if participants are benefiting.
Visits every 3 weeks corresponding to each treatment cycle
Duration - Up to 28 days after last HTL0039732 dose and up to 90 days after last atezolizumab dose
Participants are monitored for side effects and overall response after treatment ends to evaluate safety and efficacy.
Approximately 1 to 2 visits post-treatment
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
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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