Study of DT-7012 as a Single Agent and in Combination With an Immune Checkpoint Inhibitor in Participants With Advanced Solid Tumors (DOMISOL)

Domain Therapeutics Australia Pty Ltd

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: DT-7012; Drug: Immune checkpoint inhibitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT06819735

DT-7012-CLI-001

Details and patient eligibility

About

This is a phase 1/2, dose-escalation, clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of DT-7012 (an anti-CCR8 monoclonal antibody) as a single agent and in combination with an immune checkpoint inhibitor in adult participants with selected advanced solid tumors.

Full description

This is a phase 1/2, first-in-human, multicenter, open-label clinical study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of DT-7012, administered as monotherapy and in combination with an immune checkpoint inhibitor (ICI), in participants with selected recurrent advanced/metastatic solid tumors.

This study includes:

• a phase 1 Monotherapy Dose Escalation
• a phase 1b Combination Dose Escalation (this part will be initiated upon recommendation from the Safety Review Committee based on Monotherapy Dose Escalation data and corresponds to a dose escalation of a combination of DT-7012 with an ICI)
• a subsequent phase 2 Indication-Specific Efficacy part

The phase 1 aims at determining the maximum tolerated dose or maximum administered dose of DT-7012 as single agent and in combination with an ICI, and the safety and tolerability of DT-7012 as single agent and in combination with an ICI in participants with selected recurrent advanced/metastatic solid tumors.

The phase 2 will assess the efficacy of DT-7012 as monotherapy and/or in combination with an ICI in indication-specific cohorts.

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed solid tumor, among selected cancer types, that is recurrent, locally advanced (i.e., not eligible for curative surgery or radiotherapy) or metastatic, has progressed after at least one line of systemic therapy and has no established curative option.
• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the local site investigator/radiologist.
• At least 1 tumour lesion accessible to biopsy per treating physician judgement.
• Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
• Adequate organ function.

Exclusion criteria

• Any unresolved AEs from previous anti-cancer therapies of grade ≥2, with the exception of alopecia.
• Prior severe immune-related AEs (irAEs) leading to immunotherapy treatment discontinuation.
• Major surgery or significant traumatic injury within 4 weeks prior to Cycle 1 Day 1 with unadequately recovered AEs and/or complications from the intervention prior to Cycle 1 Day 1.
• 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.
• Prior anti-CCR8 monoclonal antibody treatment received in an investigational trial

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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125 participants in 3 patient groups

Part 1A

Experimental group

Description:

Dose escalation of DT-7012 as a single agent

Treatment:

Drug: DT-7012

Part 1B

Experimental group

Description:

Dose escalation of DT-7012 in combination with an ICI

Treatment:

Drug: Immune checkpoint inhibitor

Drug: DT-7012

Phase 2

Experimental group

Description:

Evaluation of DT-7012 as a sinle agent and/or in combination with an immune checkpoint inhibitor in indication-specific cohorts.

Treatment:

Drug: Immune checkpoint inhibitor

Drug: DT-7012