HTL0039732 in Participants With Advanced Solid Tumours

Required: PIK3CA activating mutation

cancers with PI3K/AKT/mTOR pathway activating mutations using a clinically-validated assay

Required: HER2 (ERBB2) mutation

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])

Must have received: conventional treatment

refractory to conventional treatment, or for which no further conventional therapy is considered appropriate by the Investigator or is declined by the potential participant

Must have received: anti-PD-1/PD-L1 therapy — indications where anti-PD-1/PD-L1 therapy is standard of care (e.g. clear cell renal cell carcinoma, or gastric or GOJ adenocarcinoma with elevated PD-L1 expression)

patients must have received that therapy and must be considered to have had progressive disease by the Investigator either on, or within 6 months after, that treatment

Cannot have received: EP4 inhibitor

Prior treatment with EP4 inhibitor

Cannot have received: selective cyclooxygenase-2 inhibitor

Treatment with selective cyclooxygenase-2 inhibitor in the 8 weeks prior to enrolment