HTL0039732 in Participants With Advanced Solid Tumours (NCT05944237) | Clinical Trial Compass
RecruitingPhase 1/2
HTL0039732 in Participants With Advanced Solid Tumours
United Kingdom150 participantsStarted 2023-07-13
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Written (signed and dated) informed consent and capable of co-operating with investigational medicinal product administration and follow-up.
✓. Phase 1, dose escalation phase
✓. 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 either tumour tissue or circulating tumour DNA \[ctDNA\]);
✓. Gastric or gastroesophageal junction (GOJ) adenocarcinoma;
✓. Clear cell renal cell carcinoma;
✓. mCRPC
✓. 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 accessible lesion, to permit their inclusion in the study. This will continually be assessed through the study.
Exclusion criteria
✕. 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 mCRPC) or investigational medicinal products during the 4 weeks prior to enrolment; or first dose of an immunotherapy during the previous 12 weeks before first dose of HTL0039732.
What they're measuring
1
Maximum tolerated dose (MTD; Dose Escalation Phase)
Timeframe: From first dose of HTL0039732 up to the end of Cycle 1, a time frame of up to 30 days.
2
RP2D (Dose Escalation Phase)
Timeframe: From first dose of HTL0039732 up to the off-study visit (maximum 115 weeks).
3
Number of Adverse Events (AEs) Related to HTL0039732 (Dose Escalation and Expansion Phase)
Timeframe: Safety data will be collected from the time of informed consent until 28 days after the last dose of HTL0039732. The average time from consent to the end of follow-up will be presented.
4
Number of AEs Related to Atezolizumab (Dose Escalation and Expansion Phase)
Timeframe: Safety data will be collected from the time of informed consent until 90 days after the last dose of atezolizumab. The average time from consent to the end of follow-up will be presented.
. 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.