About this trial
An open-label, multi-site, multi-cohort phase 1/2 trial to be conducted in 2 parts (dose escalation and dose expansion/optimisation)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female participants ≥18 years old.
Performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
Life expectancy of >12 weeks, in the opinion of the investigator.
Ability to take oral medications and willing to record daily adherence to investigational product.
Disqualifiers
Other malignancy active within the previous 2 years except for basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast, for which the participants has completed curative therapy.
Prior chemotherapy, immunotherapy (immune checkpoint inhibitor, tumour vaccine, cytokine or growth factor given to control the cancer) or other anti-cancer therapy within less than 2 weeks before trial treatment administration.
Any persistent unresolved toxicity from previous anti-cancer therapies of CTCAE Grade ≥ 2 (except for peripheral neuropathy, alopecia, endocrine disorders that are controlled with replacement hormone therapy and asymptomatic laboratory abnormalities). Ongoing adjuvant treatments for previous cancers are allowed as concomitant treatments if they do not have direct anti-tumour effect on the index tumour (e.g. hormone-suppressing agents).
Prior definitive radiation therapy within less than 4 weeks and prior palliative radiotherapy within less than 2 weeks before trial treatment administration. Radiopharmaceuticals should be expected to have cleared sufficiently from the participant's body before trial treatment administration.
Trial design
Sequential
Treatments tested in this trial
ODM-212
DrugODM-212 40mg tablet
Ipilimumab and nivolumab
DrugIpilimumab: 1 mg/kg administered intravenously over 30 minutes every 6 weeks. Nivolumab: 360 mg administered intravenously over 30 minutes every 3 weeks.
Gemcitabine and nab-paclitaxel
DrugNab-paclitaxel 125 mg/m2 administered intravenously over 30 minutes on Days 1, 8 and 15 of each 28-day cycle. Gemcitabine 1000 mg/m2 administered intravenously over 30 minutes immediately after the completion of nab-paclitaxel administration on days 1, 8 and 15 of each 28-day cycle
sotorasib
DrugSotorasib total daily dose of 960 mg taken orally q.d. every day of the 21-day cycle
Treatment groups
Trial outcomes
Primary outcomes
Incidence of Dose Limiting Toxicities and Adverse Events
Incidence and severity of adverse events and clinical laboratory abnormalities
Sponsors and contacts
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