Advanced Solid TumorPhase 1NCT07885267
Safety and Tolerability of AT-0174 in Adults With Advanced Solid Tumors
A Phase 1 study testing AT-0174 in people with Advanced Solid Tumor, run by Antido Therapeutics (Australia) Pty Ltd at 7 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- AT-0174
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 7 sitesAustralia
- Study dates
- 15 Nov 2023to 28 Aug 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Australia7 sites
The Queen Elizabeth Hospital
Adelaide, South Australia, SA 5011
Grampians Health
Ballarat, Victoria, VIC 3350
Sunshine Coast University Private Hospital
Birtinya, Queensland, QLD 4575
St Vincent's Hospital Melbourne
Fitzroy, Victoria, VIC 3065
Southside Cancer Care Centre
Miranda, New South Wales, NSW 2228
Royal North Shore Hospital
St Leonards, New South Wales, NSW 2065
Wollongong Hospital
Wollongong, New South Wales, NSW 2500
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacology, and Preliminary Efficacy of AT-0174 in Subjects With Advanced Solid Malignancies
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
- Being tested
- AT-0174
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT-0174Drug
Oral capsules taken once daily.
| Study group | Role | What they receive |
|---|---|---|
| AT-0174 | Experimental | Participants receive AT-0174 orally once daily in 28-day cycles at assigned dose levels. Receives: Drug: AT-0174 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose-limiting toxicities (DLTs)
DLTs graded per NCI CTCAE v5.0.
Measured: Cycle 1 (28 days)
Number of participants with treatment-emergent adverse events
Adverse events graded per NCI CTCAE v5.0.
Measured: From first dose through 30 days after last dose
Recommended Phase 2 dose (RP2D) of AT-0174
Determined from safety and tolerability data.
Measured: Through study completion, approximately 33 months
Secondary outcomes (1)
Percent change from baseline in plasma kynurenine (KYN) and tryptophan (TRP) concentrations
Plasma KYN and TRP measured before and after AT-0174 dosing, as a pharmacodynamic measure of TDO2/IDO1 pathway inhibition.
Measured: Baseline (pre-dose) through Cycle 4 (28-day cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start15 Nov 2023
- Primary completion29 Jul 2026
- Study completion28 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antido Therapeutics (Australia) Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885267
- Sponsor's protocol ID
- AT-0174-001
- Other IDs
- ACTRN12623000956606
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability, Pharmacology, and Preliminary Efficacy of AT-0174 in Subjects With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT07885267
- Acronym / sponsor ID
- AT-0174-001
- Conditions
- Advanced Solid Tumor
- Keywords
- AT-0174, TDO2/IDO1 dual inhibitor, TDO2 inhibitor, IDO1 inhibitor, Kynurenine pathway, Tryptophan metabolism, Immuno-oncology, First-in-human
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Antido Therapeutics (Australia) Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 29 Jul 2026 (actual)
- Study completion
- 28 Aug 2026 (actual)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AT-0174 | Experimental | Drug: AT-0174Participants receive AT-0174 orally once daily in 28-day cycles at assigned dose levels. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AT-0174Oral capsules taken once daily. | Drug | AT-0174 |
Primary outcome
Number of participants with dose-limiting toxicities (DLTs)
Time frame: Cycle 1 (28 days)
DLTs graded per NCI CTCAE v5.0.
Number of participants with treatment-emergent adverse events
Time frame: 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
Time frame: Through study completion, approximately 33 months
Determined from safety and tolerability data.
1 secondary outcome
Percent change from baseline in plasma kynurenine (KYN) and tryptophan (TRP) concentrations
Time frame: Baseline (pre-dose) through Cycle 4 (28-day cycles)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AT-0174 in people with Advanced Solid Tumor, run by Antido Therapeutics (Australia) Pty Ltd at 7 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with dose-limiting toxicities (DLTs) (time frame: Cycle 1 (28 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.