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

NCT07885267 — Phase 1, Completed, 26 participants, Antido Therapeutics (Australia) Pty Ltd

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A Phase I Study to Evaluate the Safety, Tolerability, Pharmacology, and Preliminary Efficacy of AT-0174 in Subjects With Advanced Solid Malignancies

Registry	NCT07885267
Status	Completed
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	26 (Actual)
Sponsor	Antido Therapeutics (Australia) Pty Ltd (Industry)
Conditions	Advanced Solid Tumor
Interventions	AT-0174 (Drug)
Dates	start 2023-11-15, primary completion 2026-07-29, completion 2026-08-28, first posted 2026-10-21, last updated 2026-10-21
Locations	7 sites in Australia

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
AT-0174	Experimental	Drug: AT-0174	Participants receive AT-0174 orally once daily in 28-day cycles at assigned dose levels.

AT-0174 (Drug): Oral capsules taken once daily.

+Outcome measures

Primary outcomes

Number of participants with dose-limiting toxicities (DLTs) [Cycle 1 (28 days)]: DLTs graded per NCI CTCAE v5.0.
Number of participants with treatment-emergent adverse events [From first dose through 30 days after last dose]: Adverse events graded per NCI CTCAE v5.0.
Recommended Phase 2 dose (RP2D) of AT-0174 [Through study completion, approximately 33 months]: Determined from safety and tolerability data.

Secondary outcomes

Percent change from baseline in plasma kynurenine (KYN) and tryptophan (TRP) concentrations [Baseline (pre-dose) through Cycle 4 (28-day cycles)]: Plasma KYN and TRP measured before and after AT-0174 dosing, as a pharmacodynamic measure of TDO2/IDO1 pathway inhibition.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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

Exclusion Criteria:

* \- 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

+Locations (7)

Facility	City	Country
Southside Cancer Care Centre	Miranda, New South Wales	Australia
Royal North Shore Hospital	St Leonards, New South Wales	Australia
Wollongong Hospital	Wollongong, New South Wales	Australia
Sunshine Coast University Private Hospital	Birtinya, Queensland	Australia
The Queen Elizabeth Hospital	Adelaide, South Australia	Australia
Grampians Health	Ballarat, Victoria	Australia
St Vincent's Hospital Melbourne	Fitzroy, Victoria	Australia