Safety and Tolerability of AT-0174 in Adults With Advanced Solid Tumors

NCT07885267 | Completed Phase 1

• 2 other identifiers: AT-0174-001ACTRN12623000956606
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 7

Brief Summary

This is a first-in-human, open-label, multicenter Phase 1 study of AT-0174, an investigational oral dual TDO2/IDO1 inhibitor. It is being conducted in adults with advanced solid tumors that have progressed on, or are not suitable for, standard therapy. The main goals are to evaluate the safety and tolerability of AT-0174 and to identify a recommended dose for further study.

Conditions

Advanced Solid Tumor

Keywords

AT-0174; TDO2/IDO1 dual inhibitor; TDO2 inhibitor; IDO1 inhibitor; Kynurenine pathway; Tryptophan metabolism; Immuno-oncology; First-in-human; Dose escalation; Advanced solid tumor

Outcome Measures

Primary Outcomes (3)

• Number of participants with dose-limiting toxicities (DLTs)

  DLTs graded per NCI CTCAE v5.0.

  Cycle 1 (28 days)

• Number of participants with treatment-emergent adverse events

  Adverse events graded per NCI CTCAE v5.0.

  From first dose through 30 days after last dose

• Recommended Phase 2 dose (RP2D) of AT-0174

  Determined from safety and tolerability data.

  Through study completion, approximately 33 months

Secondary Outcomes (1)

• Percent change from baseline in plasma kynurenine (KYN) and tryptophan (TRP) concentrations

  Baseline (pre-dose) through Cycle 4 (28-day cycles)

Study Arms (1)

AT-0174

EXPERIMENTAL

Participants receive AT-0174 orally once daily in 28-day cycles at assigned dose levels.

Drug: AT-0174

Interventions

AT-0174 DRUG

Oral capsules taken once daily.

AT-0174

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Histologically or cytologically confirmed unresectable, locally advanced or metastatic solid tumor that is refractory to, or not suitable for, standard therapy
• Measurable or evaluable disease
• ECOG performance status 0-1
• Life expectancy of at least 3 months
• Adequate bone marrow, liver and kidney function

You may not qualify if:

• \- Recent anticancer therapy, radiotherapy, major surgery or investigational agent before the first dose
• Active or untreated central nervous system metastases
• Clinically significant cardiovascular disease
• Active hepatitis B, hepatitis C or known HIV infection
• Need for medicines that increase serotonin levels
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Antido Therapeutics (Australia) Pty Ltd: lead

Study Sites (7)

Southside Cancer Care Centre

Miranda, New South Wales, NSW 2228, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, NSW 2065, Australia

Location

Wollongong Hospital

Wollongong, New South Wales, NSW 2500, Australia

Location

Sunshine Coast University Private Hospital

Birtinya, Queensland, QLD 4575, Australia

Location

The Queen Elizabeth Hospital

Adelaide, South Australia, SA 5011, Australia

Location

Grampians Health

Ballarat, Victoria, VIC 3350, Australia

Location

St Vincent's Hospital Melbourne

Fitzroy, Victoria, VIC 3065, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2026
• First Posted: October 21, 2026
• Study Start: November 15, 2023
• Primary Completion: July 29, 2026
• Study Completion: August 28, 2026
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (7)