HTL0039732 in Participants With Advanced Solid Tumours

Sponsor
Cancer Research UK
Study ID
NCT05944237
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Colorectal Neoplasms
  • Esophageal Neoplasms
  • Head and Neck Neoplasms
  • Kidney Neoplasms
  • Lung Neoplasms
  • Mesothelioma, Malignant
  • Neoplasms
  • Pancreatic Neoplasms
  • Pheochromocytomas
  • Prostatic Neoplasms, Castration-Resistant
  • Sarcoma
  • Stomach Neoplasms
  • Urinary Bladder Neoplasms
  • Uterine Cervical Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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. A single dose will be administered between 3 and 9 days prior to commencement of Cycle 1. From Cycle 1 Day 1, HTL0039732 will be administered on a once daily (QD) schedule. Each administration cycle will consist of 21 days with no break between cycles. Participants may initially receive up to 18 cycles but may continue for a further 18 cycles if they are deemed to be benefitting.
  • HTL0039732 Capsules and atezolizumab infusion — DRUG
    HTL0039732 Capsules will be administered orally on a QD schedule to participants starting on Cycle 1 Day 1. Each administration cycle will consist of 21 days with no break between cycles. Participants will also receive 1200 mg atezolizumab as an IV infusion on Day1 of each cycle (i.e. every 3 weeks). Participants may initially receive up to 18 cycles of HTL0039732 but may continue for a further 18 cycles if they are deemed to be benefitting, and they may receive up to 36 cycles of atezolizumab.

Study Details

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.

Key Dates

Start date
Jul 13, 2023
Status verified
Jun 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Part A HTL0039732 (Dose Escalation Monotherapy)
    Groups of participants will receive increasing doses of HTL0039732 Capsules as a single agent to find a safe dose and a dose that best targets cancer cells.
  • Experimental: Phase 1 Part B HTL0039732 and Atezolizumab (Dose Escalation Combination)
    Groups of participants will receive increasing doses of HTL0039732 Capsules in combination with a fixed 1200 mg dose of atezolizumab to find a RP2D for HTL0039732.
  • Experimental: Phase 2a HTL0039732 and Atezolizumab (Dose Expansion Combination)
    An expansion cohort will receive the RP2D of HTL0039732 Capsules in combination with a fixed 1200 mg dose of atezolizumab.

Primary Outcome Measure

Maximum tolerated dose (MTD; Dose Escalation Phase) [ Time Frame: From first dose of HTL0039732 up to the end of Cycle 1, a time frame of up to 30 days. ]

Central Contacts

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