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New treatment option for Neoplasms
Official title HTL0039732 in Participants With Advanced Solid Tumours
ClinicalTrials.gov ID: NCT05944237
What this study is testing
What is HTL0039732 Capsules?
HTL0039732 Capsules is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for neoplasms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Written (signed and dated) informed consent and capable of co-operating with investigational medicinal product administration and follow-up.
- Phase 1, dose escalation phase Part A (HTL0039732 monotherapy):
- Histologically or cytologically proven advanced solid tumour, refractory to conventional treatment, or for which no further conventional therapy is...
- At least 1 measurable lesion according to RECIST v1.1, which (in the Investigator's opinion) has had objective radiological progression on or after...
- Consent to access and analysis of any available archival tissue or a fresh tumour sample at baseline, if archival tissue is unavailable.
You likely can't join if
- Radiotherapy (except for palliative reasons), chemotherapy, non chemotherapy systemic anti-cancer therapy (apart from life-long hormone suppression...
- 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 asymptomatic, radiologically stable and have been...
- 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 eligibility criteria
Who can join
- Written (signed and dated) informed consent and capable of co-operating with investigational medicinal product administration and follow-up.
- Phase 1, dose escalation phase Part A (HTL0039732 monotherapy):
- Histologically or cytologically proven advanced solid tumour, refractory to conventional treatment, or for which no further conventional therapy is considered appropriate by the Investigator or is declined by the...
- At least 1 measurable lesion according to RECIST v1.1, which (in the Investigator's opinion) has had objective radiological progression on or after the last therapy, or at least one assessable lesion e.g. pleural or...
- Consent to access and analysis of any available archival tissue or a fresh tumour sample at baseline, if archival tissue is unavailable.
- Consent for fresh tumour biopsy sample(s) at time of PD, if the participant has accessible disease and is eligible to receive atezolizumab. Optional at time of disease progression. Phase 1 Part B: \- Histologically...
- MSS CRC with PIK3CA or HER2 mutation, and/or other driver mutation as agreed with the Sponsor (genomic alteration to have been previously identified using a validated next-generation sequencing method performed on...
- Gastric or gastroesophageal junction (GOJ) adenocarcinoma;
- Clear cell renal cell carcinoma;
- mCRPC Phase 1 Part B and Phase 2a:
- Consent to access and analysis of any available archival tissue.
- Consent for fresh tumour biopsy samples at baseline and on treatment. However, the following exceptions will be permitted if archival tissue is available at the recruiting site:
- Patients with mCRPC: biopsies are not required for those whose only safely accessible lesions are bone metastases that lack an accessible soft tissue component.
- For the first 12 participants in each indication: the on-trial biopsy is optional; and the baseline biopsy is mandatory if there is a safely accessible lesion but may be omitted for patients who have no safely...
- Disease refractory to conventional treatment, or for which no further conventional therapy is considered appropriate by the Investigator or is declined by the participant.
- Except for mCRPC, at least 1 measurable lesion according to RECIST v1.1, which (in the Investigator's opinion) has had objective radiological progression on or after the last therapy. Potential participants with mCRPC...
- Previously irradiated lesions cannot be counted as target lesions unless clearly progressed after the radiotherapy.
- Lesions that are intended to be biopsied should not be counted as target lesions (those undergoing biopsy must have at least one target lesion that is not intended to be biopsied).
- For indications where anti-PD-1/PD-L1 therapy is standard of care (such as clear cell renal cell carcinoma, or gastric or GOJ adenocarcinoma with elevated PD-L1 expression), patients must have received that therapy and...
- Life expectancy of at least 12 weeks.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Haematological and biochemical indices within the protocol specified ranges.
- Stable thyroid function tests. Stable doses of thyroxine replacement are permitted.
- Aged 18 years or over at the time consent is given.
What rules you out
- Radiotherapy (except for palliative reasons), chemotherapy, non chemotherapy systemic anti-cancer therapy (apart from life-long hormone suppression such as luteinising hormone-releasing agents in participants with...
- 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 asymptomatic, radiologically stable and have been off steroids for ≥4 weeks prior to enrolment).
- 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.
- At high medical risk because of non-malignant systemic disease, including active uncontrolled infection.
- Known history of current or latent tuberculosis, HIV or Hepatitis B or C infection.
- Prior treatment with EP4 inhibitor.
- Treatment with selective cyclooxygenase-2 inhibitor in the 8 weeks prior to enrolment.
- Known hypersensitivity or intolerance to hydroxypropyl methylcellulose.
- Use of systemic immunosuppressive agent in the 2 weeks prior to enrolment. Exceptions apply.
- Significant cardiovascular disease.
- Known active peptic ulcer disease, or symptoms of gastritis, dyspepsia or gastro-esophageal reflux disease (one or more episodes per week).
- Current or planned participation in another treatment clinical trial, whilst taking part in this trial of HTL0039732.
- Limited ability to swallow or absorb oral medications.
- Any other condition that, in the Investigator's opinion, would mean that the trial is not in the best interests of the potential participant. Phase 1 Part B and Phase 2a:
- Any live vaccines in the 4 weeks prior to enrolment.
- Diagnosis of immunodeficiency.
- Active autoimmune disease requiring systemic treatment in the 2 years prior to enrolment.
- History or clinical suspicion of interstitial lung disease, history of (non-infectious) pneumonitis that required steroids, or current pneumonitis.
- Hypersensitivity to atezolizumab or any of its excipients.
- Prior adverse reaction to cancer immunotherapy that required steroid or other immunosuppressive treatment or led to discontinuation of that treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Cambridge, United Kingdom
- Cardiff, United Kingdom
- Liverpool, United Kingdom
- London, United Kingdom
- Manchester, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cambridge, United Kingdom; Cardiff, United Kingdom; Liverpool, United Kingdom; London, United Kingdom; Manchester, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.