Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruiting
Participants planned
125
Countries
1
Sites
3
Cancer
Determination of the maximum tolerated dose or maximum administered dose of DT-7012 as monotherapy (dose escalation cohort only) and assessment of the safety and tolerability of DT-7012 administered in combination with pembrolizumab (combination dose escalation cohort)
Key facts
- Sponsor
- Domain Therapeutics Australia Pty Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 11 Feb 2026 → ongoing
- Decision date (initial)
- 2026-01-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Domain Therapeutics
External identifiers
- EU CT number
- 2025-523758-15-00
- ClinicalTrials.gov
- NCT06819735
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacodynamic, Pharmacokinetic
Determination of the maximum tolerated dose or maximum administered dose of DT-7012 as monotherapy (dose escalation cohort only) and assessment of the safety and tolerability of DT-7012 administered in combination with pembrolizumab (combination dose escalation cohort)
Secondary objectives 3
- Assessment of the safety and tolerability of DT-7012 as monotherapy
- Determination of the pharmacokinetics of DT-7012
- Assessment of the anti-tumour activity of DT-7012
Conditions and MedDRA coding
Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065143 | Malignant solid tumour | 10029104 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Dose escalation Several dose escalation cohorts, each of them at a given dose level of the IMP
|
Not Applicable | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Participants must have a histologically or cytologically confirmed solid tumour among selected cancer types.
- Participants must be ≥ 18 years of age on the day of signing the informed consent form.
- 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.
- Participants must have an ECOG PS of 0 or 1.
Exclusion criteria 3
- 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.
- 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.
- 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Secondary endpoints 3
- Occurrence of DLTs, TEAEs, TRAEs, AESIs, SAEs, and AEs leading to treatment discontinuation.
- Measurement of pharmacokinetics parameters: maximum (peak) observed plasma concentration [Cmax] and time of maximum (peak) observed plasma concentration [Tmax].
- Measurement of anti-tumour activity parameters: overall response rate (ORR), disease control rate (DCR), duration of response (DOR), duration of stable disease (SD).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Domain Therapeutics Australia Pty Limited
- Sponsor organisation
- Domain Therapeutics Australia Pty Limited
- Address
- Suite 1 Level 3, 62 Lygon Street 62 Lygon Street
- City
- Carlton
- Postcode
- 3053
- Country
- Australia
Scientific contact point
- Organisation
- Domain Therapeutics Australia Pty Limited
- Contact name
- Clinical Development
Public contact point
- Organisation
- Domain Therapeutics Australia Pty Limited
- Contact name
- Clinical Development
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 18 | 3 |
| Rest of world
Australia
|
— | 107 | — |
Investigational sites
Hôpitaux Universitaires Strasbourg - Hôpital de Hautepierre
Medical Oncology, 1 Avenue Molière, Service d'oncologie médicale, STRASBOURG
Institut Gustave Roussy
DITEP, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Bergonié
Medical Oncology, 229 Cours de l'Argonne, 33000, BORDEAUX
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2026-02-11 | 2026-02-12 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Urgent safety measures 1 · Art. 54 CTR
Urgent safety measure US-118591
- Event date
- 2026-02-05
- Submission date
- 2026-02-10
- In response to
- SUSAR
- Member states affected
- France
- Event description
- The trial study participant dosed at 20 mg/kg experienced a severe Infusion-Related Reaction (IRR) around the half of the infusion of DT-7012.
This participant had received the following pre-medication:
- Paracetamol – taken orally at 07:50 am on day of infusion. Paracetamol was not administered in the clinic.
- Promethazine – administered 11:38 am intravenously.
- Hydrocortisone – administered 11:30 am intravenously.
The clinical presentation was dominated by a severe low back pain, rigor and restlessness preceding the appearance of chest pain. The pain subsided and the participant recovered/resolved approximately 70 minutes after the onset of the symptoms. The participant was hospitalized overnight and discharged within 24 hours of the start of the Infusion Related Reaction. - Measures taken
- DT-7012 infusion duration must be increased to 240 minutes (± 10 minutes) for the first and second infusions of participants receiving DT-7012 at the dose of 20 mg/kg.
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 16 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-523758-15-00_for_publication | 4.2 |
| Recruitment arrangements (for publication) | D1_Protocol_synopsis_FR_2025-523758-15_for_publication | 4.0 |
| Recruitment arrangements (for publication) | K1_Recruitment_procedure_FR_2025-523758-15-00 | 1 |
| Recruitment arrangements (for publication) | K2_Document_additionnel_FR_2025-523758-15-00 | 1 |
| Recruitment arrangements (for publication) | K3_GP_leter_FR_for_publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_Information_and_ICF_biopsies_1_FR_for_publication | 3.1 |
| Subject information and informed consent form (for publication) | L1_Information_and_ICF_biopsies_2_FR_for_publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_Information_and_ICF_biopsies_3_FR_for_publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_Information_and_ICF_future_use_of_bio_samples | 2 |
| Subject information and informed consent form (for publication) | L1_Information_and_ICF_Monotherapy_1_FR_for_publication | 1 |
| Subject information and informed consent form (for publication) | L1_Information_and_ICF_Monotherapy_2_FR_for_publication | 1 |
| Subject information and informed consent form (for publication) | L1_Information_and_ICF_Monotherapy_3_FR_for_publication | 1 |
| Subject information and informed consent form (for publication) | L1_Information_and_ICF_pregnancy_FR | 1 |
| Subject information and informed consent form (for publication) | L2_Participant_card_FR_2025-523758-15-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_EN_2025-523758-15-00_for_publication | 4.2 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_FR_2025-523758-15-00_for_publication | 4.2 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-03 | France | Acceptable 2025-12-23
|
2026-01-14 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-01-22 | France | Acceptable 2025-12-23
|
2026-01-22 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-02-05 | France | Acceptable 2025-12-23
|
2026-02-05 |