DT-7012 for Cancer | Malignant solid tumour | Advanced solid tumour

Inclusion criteria

• {"criterion_text":"- Participants must have a histologically or cytologically confirmed solid tumour among selected cancer types.\n- Participants must be ≥ 18 years of age on the day of signing the informed consent form.\n- Participants must have radiological evidence of disease to be eligible for the Dose Escalation Cohort and for the Paired Biopsy Cohort (measurable disease is NOT required). Participants must have measurable disease to be eligible for the Safety/PK/PD Cohort and for the Phase 1b dose escalation with pembrolizumab.\n- Participants must have an ECOG PS of 0 or 1."}

Exclusion criteria

• {"criterion_text":"- Participants with unresolved AEs from previous anti-cancer therapies of grade ≥ 2 as per CTCAE v5.0, with the exception of alopecia. Participants with prior grade 3 or 4 irAE(s) leading to immunotherapy treatment discontinuation will not be eligible. Participants with a history of grade 2 myocarditis or grade 2 pneumonitis will be excluded regardless of the aetiology.\n- Participants who underwent major surgery or significant traumatic injury within 4 weeks prior to Cycle 1 Day 1 who have not recovered adequately from any AEs and/or complications from the intervention prior to Cycle 1 Day 1.\n- Participants who have received prior radiotherapy within the 4 weeks prior to Cycle 1 Day 1 or limited field palliative radiotherapy within 2 weeks prior to Cycle 1 Day 1."}

Primary endpoints

• {"endpoint_text":"- Occurrence of dose-limiting toxicities (DLTs) during the DLT observation period and occurrence of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), adverse events of special interest (AESIs), serious advers events (SAEs) and adverse events (AEs) leading to treatment discontinuation.","definition_or_measurement_approach":"Measured as occurrence/proportion of participants experiencing DLTs during the DLT observation period and occurrence/proportion of TEAEs, TRAEs, AESIs, SAEs and AEs leading to discontinuation (safety/tolerability assessment)."}

Secondary endpoints

• {"endpoint_text":"- Occurrence of DLTs, TEAEs, TRAEs, AESIs, SAEs, and AEs leading to treatment discontinuation.","definition_or_measurement_approach":"Measured as occurrence/proportion of participants with these events (safety assessment)."}
• {"endpoint_text":"- Measurement of pharmacokinetics parameters: maximum (peak) observed plasma concentration [Cmax] and time of maximum (peak) observed plasma concentration [Tmax].","definition_or_measurement_approach":"Standard PK sampling to determine Cmax and Tmax from plasma concentration-time profiles."}
• {"endpoint_text":"- Measurement of anti-tumour activity parameters: overall response rate (ORR), disease control rate (DCR), duration of response (DOR), duration of stable disease (SD).","definition_or_measurement_approach":"Tumour response assessed using standard radiological criteria to derive ORR, DCR, DOR and duration of stable disease."}

France

Earliest CTIS Part Ii Submission Date

09-12-2025

Latest Decision Or Authorization Date

14-01-2026

Processing Time Days

36

Number Of Sites

3

Number Of Participants

18

Primary sponsor

Full Name

Domain Therapeutics Australia Pty Limited

Organisation Type

Pharmaceutical company

Country Of Registered Address

Australia