A Phase I/IIa trial of HTL0039732 in Participants with Advanced Solid Tumours
Research type
Research Study
Full title
A Cancer Research UK Phase I/IIa Trial of HTL0039732, given Orally as Monotherapy and in Combination with Immunotherapy or Other Approved Therapies in Participants with Advanced Solid Tumours
IRAS ID
1006164
Contact name
David Gervais
Contact email
Sponsor organisation
Cancer Research UK
Eudract number
2022-000775-39
Clinicaltrials.gov Identifier
Research summary
This clinical trial is looking at HTL0039732, a new drug which has been tested in the laboratory and looks promising in treating cancers.
HTL0039732 is expected to work in two ways: (i) by slowing the cancer growth and; (ii) by increasing immune system activity that will then destroy the cancer cells.
This clinical trial is split into two phases:
Phase I is the ‘dose escalation’ phase where two groups of participants will receive increasing doses of HTL0039732 to find the safest dose.
- Part A will receive HTL0039732 on its own.
- Part B will receive HTL0039732 with another cancer drug called atezolizumab (this is called ‘in combination’).
Note: if a participant's cancer progresses (gets worse) while they are receiving HTL0039732 in Part A, they may be eligible to receive atezolizumab in combination with HTL0039732. If this occurs, participants will have to consent to have a biopsy and meet certain eligibility criteria. These participants would not cross-over into Part B; their data will be analysed and presented separately.
Phase IIa is the ‘dose expansion’ phase of the trial. In this part of the trial HTL0039732 will be given in combination with atezolizumab and potentially with other cancer drugs. This will allow us to find out more about how the drug is working and whether HTL0039732 affects cancer, and how it does it.
The three main aims of the clinical trial are to find out:
- The highest dose of HTL0039732 that can be given either on its own or in combination with atezolizumab in Phase I, and with atezolizumab and other anti-cancer drugs in Phase IIa.
- More about any potential side effects of HTL0039732 when given alone and in combination with atezolizumab in Phase I, and with atezolizumab and other anti-cancer drugs in Phase IIa.
- What happens to HTL0039732 inside the body and how it affects cancer cells.REC name
London - Surrey Borders Research Ethics Committee
REC reference
22/LO/0713
Date of REC Opinion
5 Jan 2023
REC opinion
Further Information Favourable Opinion