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Solid Tumor MalignanciesPhase 1NCT06136884

A First-In-Human, Phase 1 Study Evaluating Oral TACC3 PPI Inhibitor, AO-252, in Advanced Solid Tumors With or Without Brain Metastases

A Phase 1 study testing AO-252 in people with Solid Tumor Malignancies and Brain Metastases From Solid Tumors, run by A2A Pharmaceuticals Inc. at 6 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to assess the safety, tolerability and efficacy of the study drug AO-252 and identify the best dose for use in future studies. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AO-252
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
6 sitesUnited States
Study dates
2 Nov 2023to 27 Jan 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • Adults ≥ 18 years of age.
  • Patient has histologically or cytologically confirmed metastatic or locally advanced unresectable solid tumors with TP53 mutation/loss and with/without brain metastasis. Patients must have relapsed/be refractory to at least 1 line of systemic therapy in the metastatic setting (excluding melanoma).
  • Prostate cancer:
  • mCRPC with histologic confirmation of adenocarcinoma. mCRPC with neuroendocrine features or mixed histology are excluded
  • Patients will be enrolled irrespective of the TP53 status
  • Participant must have prostate specific antigen (PSA) of ≥ 2 ng/mL
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  • Is surgically or medically castrated, with testosterone levels of less than 50 ng/dL
  • Patients who progressed on at least 1 prior novel androgen receptor AR-targeted therapy (that is, abiraterone acetate, apalutamide, enzalutamide, darolutamide), and or at least 1 prior systemic chemotherapy (e.g., docetaxel)
  • Solid tumors with brain metastasis:
  • Histologically or cytologically confirmed metastatic or locally advanced unresectable solid tumors excluding melanoma with TP53 mutation/loss and tumor must have relapsed/be refractory to at least 1 line of systemic therapy. Untreated brain metastases not requiring immediate local CNS therapy
  • Previously treated brain metastases with progression of previous lesions or new lesions, but not requiring immediate local CNS therapy
  • At least one measurable untreated brain lesion ≥0.5 cm and <3.0 cm in the longest axis
  • Prior SRS radiosurgery (must be completed within 7 days of study treatment initiation) is allowed as long as the previous treatment volume does not overlap with the current targets.
  • Measurable disease per RECIST v1.1 criteria. For mCRPC patients, tumor response will be evaluated using RECIST version 1.1 (soft tissue) and PCWG-3 criteria (bone) and efficacy endpoints will also include radiographic progression-free survival (rPFS), PSA50 response and PSA progression
  • Adequate bone marrow reserve, cardiac, liver, and renal function:
  • Absolute neutrophil count (ANC) ≥ 1,500/mm3
  • Platelet count ≥ 100,000/mm3
  • Hemoglobin ≥ 9 g/dL
  • Bilirubin ≤ 1.5 × upper limit of normal (ULN) or direct bilirubin ≤ ULN for patients with total bilirubin levels >1.5 × ULN
  • Alanine aminotransferase (ALT, SGPT) and aspartate aminotransferase (AST, SGOT) ≤ 2.5 × ULN (≤ 5 × ULN if liver metastases are present)
  • INR ≤ 1.5 × ULN unless patient is receiving anticoagulant therapy and PT or aPTT is within therapeutic range of intended use of anticoagulants
  • Creatinine clearance ≥ 60 mL/min (by Cockroft Gault formula).
  • Female patients of child-bearing potential must have a negative serum pregnancy test and use at least 1 form of acceptable birth control method listed below as approved by the Investigator before initiating study treatment and for 3 months after the last dose of study drug.
  • Sterilization
  • Any hormonal contraceptives (non-CYP 3A4 inhibitors) associated with inhibition of ovulation
  • IUD (intrauterine device) or intrauterine hormone releasing system
  • Male patients must be sterilized or use a form of barrier contraception, such as condoms with spermicide, during the study and for 3 months after the last dose of study drug.
  • Life expectancy of ≥ 3 months.
  • Ability to provide written informed consent.
  • An Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.

Who cannot join

  • Patients with symptomatic brain metastases requiring treatment and/or leptomeningeal disease
  • Patients with a previous history of another malignancy (other than cured basal cell or squamous cell carcinoma of the skin or cured in-situ carcinoma) within 3 years of study entry.
  • Patients with uncontrolled pleural effusions, pericardial effusion, or ascites that do not resolve.
  • Patients with gastrointestinal tract disease causing the inability to take oral medication (e.g., swallowing difficulties, malabsorption syndromes, extensive small bowel resection [> 100cm], gastric bypass surgery).
  • Pregnant or breast-feeding patients or any patient with child-bearing potential not using adequate contraception.
  • Known human immunodeficiency virus, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (excluding cured HBV and/or cured HCV infection).
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  • Presence of any serious concomitant systemic disorders incompatible with the study in the opinion of the Investigator (e.g., uncontrolled congestive heart failure, active infection).
  • Radiation therapy to > 30% of bone marrow within 3 months before study entry.
  • Patients with clinically significant autoimmune disease, either currently present of present within 2 years, including a current requirement for systemic immunosuppressive therapy equivalent to > 10 mg/prednisone daily (local immunosuppressive therapy such as inhaled or topical corticosteroids is allowed).
  • 11. Patients with abnormal or clinically significant electrocardiogram (ECG) abnormality, including but not limited to a confirmed corrected QT interval using Fridericia's formula (QTcF) > 470 msec.
  • 12. Patient has received systemic anticancer therapy within 3 weeks or 5 half-lives, whichever is shorter.
  • 13. Patients must have recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline.
  • 14. Any of the following conditions (on-study testing is not required):
  • Known HIV-infected patients unless on effective anti-retroviral therapy with an undetectable viral load within 6 months and no opportunistic infection within the past 12 months, or b. Known or suspected hepatitis B if active infection (patients with chronic hepatitis B infection must have an undetectable HBV viral load on suppressive therapy, if indicated; positive surface antibody alone is not an exclusion), or c. Known or suspected hepatitis C infection that has not been treated and cured unless currently on treatment with an undetectable viral load.
  • 15. Administration of strong or moderate cytochrome (CYP) 3A4 inhibitors and inducers within 14 days or 5 half-lives (whichever is shorter) prior to the administration of study drug.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Robbin Frnka, Chief ClinOps Officer contact

2142055746

rfrnka@coiledtx.com

6 sites in 1 country

United States6 sites, 6 recruiting

  • Hollings Cancer Center - MUSC

    Charleston, South Carolina, 29425

    Recruitment Coordinator, 843-792-9321, hcc-clinical-trials@musc.edu

    Brian Orr, MD

    Recruiting

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230

    Angela Hotchkiss, ahotchkiss@marycrowley.org

    Douglas Orr, MD

    Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Ira Winer, MD

    Recruiting

  • Next Oncology -Virginia

    Fairfax, Virginia, 22031

    Anthony Young, ayoung@nextoncology.com

    Mohamad Salkeni, MD

    Recruiting

  • The University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030

    Guoxin Feng, gfeng@mdanderson.org

    Amber Kennon, amkennon@mdanderson.org

    Recruiting

  • Oklahoma Univeristy

    Oklahoma City, Oklahoma, 73104

    Christina Caldwell, 405-271-8001 ext. 48171, Christina-Caldwell@ouhsc.edu

    Debra Richardson, MD

    Recruiting

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Dose-escalation and Dose-Expansion Study Evaluating AO-252, a Protein-Protein Interaction Inhibitor of TACC3, in Patients With Advanced Solid Tumors With or Without Brain Metastases

The purpose of this study is to assess the safety, tolerability and efficacy of the study drug AO-252 and identify the best dose for use in future studies.

Read the detailed description

The purpose of this study is to characterize the safety, tolerability including determination of maximum tolerated dose (MTD), and identify the recommended Phase 2 dose (RP2D). The study will also look at pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumor activity of AO-252 as a monotherapy in participants with advanced solid tumors with or without brain mestastases.

Being tested
AO-252
Keywords
brain metastases, solid tumors, AO-252
Medical subject headings
Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AO-252Drug

    AO-252 will be administered oral tablets or capsules daily

Study groups in NCT06136884
Study groupRoleWhat they receive
Part 1: Dose EscalationExperimentalParticipants will be assigned to dose levels.
Receives: Drug: AO-252
Part 2: Dose ExpansionExperimentalAfter doses are decided in Part 1, participants entering part 2 will be assigned to a dose level.
Receives: Drug: AO-252

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety Assessments [Dose escalation]

    Incidence of Dose Limiting Toxicities (DLTs) in DLT-evaluable subjects

    Measured: 12 months

  2. Safety Assessments [Dose escalation]

    Identify the maximum tolerated dose and the doses for expansion

    Measured: 12 months

  3. Safety Assessments [Dose escalation and Dose expansion]

    Number of participants with Serious Adverse Events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0

    Measured: 30 months

  4. Safety Assessments [Dose escalation and Dose expansion]

    Number of participants with Treatment-related Adverse Events (AEs) graded per NCI-CTCAE version 5.0

    Measured: 30 months

  5. Safety Assessments [Dose escalation and Dose expansion]

    Number of participants with Treatment-Emergent AEs (TEAEs) graded per NCI-CTCAE version 5.0

    Measured: 30 months

  6. Safety Assessments [Dose escalation and Dose expansion]

    Number of participants with Dose Interruptions and Permanent Treatment Discontinuations

    Measured: 30 months

Secondary outcomes (7)

  1. Antitumor Activity of AO-252 [Dose escalation and Dose expansion]

    Determine the objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Measured: 30 months

  2. Antitumor Activity of AO-252 [Dose escalation and Dose expansion]

    Determine the disease control rate (DCR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Measured: 30 months

  3. Antitumor Activity of AO-252 [Dose escalation and Dose expansion]

    Determine the time to response (TTR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

    Measured: 30 months

  4. Antitumor Activity of AO-252 [Dose escalation and Dose expansion]

    Determine the time to progression (TTP) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Measured: 30 months

  5. Pharmacokinetic Profile of AO-252 [Dose escalation and Dose expansion]

    Identity the maximum concentration (Cmax) on Day 1 of Cycle 1-3 and D14 and 28 of Cycle 1

    Measured: 30 months

  6. Pharmacokinetic Profile of AO-252 [Dose escalation and Dose expansion]

    Identify the area under the curve (AUC) on Day 1 of Cycle 1-3 and D14 of Cycle 1

    Measured: 30 months

  7. Pharmacokinetic Profile of AO-252 [Dose escalation and Dose expansion]

    Identify the time to maximum concentration (Tmax) on Day 1 of Cycle 1-3 and D14 of Cycle 1

    Measured: 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start2 Nov 2023
  3. Primary completion28 Jan 2027 (estimated)
  4. Study completion27 Jan 2028 (estimated)

Resources

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06136884
Sponsor's protocol ID
A2A-O-004
Status last verified
Aug 2026
First submitted
7 Nov 2023
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AO-252 in people with Solid Tumor Malignancies and Brain Metastases From Solid Tumors, run by A2A Pharmaceuticals Inc. at 6 sites in United States.

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 30 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Robbin Frnka, Chief ClinOps Officer (2142055746, rfrnka@coiledtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Assessments [Dose escalation] (time frame: 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06136884.

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 17 Aug 2026.

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