A 2-part Phase 1/2 Open-label Trial on ODM-212

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOrion Corporation, Orion Pharma

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 volunteers

Qualifiers

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

Design model

Sequential

Treatments tested in this trial

  • ODM-212

    Drug

    ODM-212 40mg tablet

  • Ipilimumab and nivolumab

    Drug

    Ipilimumab: 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

    Drug

    Nab-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

    Drug

    Sotorasib total daily dose of 960 mg taken orally q.d. every day of the 21-day cycle

Treatment groups

229 Participants
are divided into 3 treatment groups
Group A: ODM-212 with ipilimumab/nivolumab in mesotheliomaExperimental treatment 2 interventions
Group B: ODM-212 with gemcitabine and nab-paclitaxel in PDACExperimental treatment 2 interventions
Group C: ODM-212 with sotorasib in NSCLCExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of Dose Limiting Toxicities and Adverse Events

Incidence and severity of adverse events and clinical laboratory abnormalities

Time frame
Through study completion, on average of 2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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