Advanced Solid TumorPhase 1ACESOT-1051NCT06260514
Study of APR-1051 in Patients With Advanced Solid Tumors
A Phase 1 study testing APR-1051 in people with Advanced Solid Tumor, run by Aprea Therapeutics at 7 sites in United States.
Trial summary
The purpose of this study is to assess the safety and effectiveness of APR-1051 through the performance of a Phase 1, open-label, safety, PK, and preliminary efficacy study of oral APR-1051 in patients with advanced solid tumors. 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?
- APR-1051
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 7 sitesUnited States
- Study dates
- 13 Jun 2024to Jun 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
- Age ≥ 18 years
- Diagnosis of advanced/metastatic solid tumor
- Measurable or evaluable disease per RECIST version 1.1 (radiographic disease progression per PCWG3 criteria for patients with mCRPC)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 or Karnofsky Performance Status (KPS) ≥ 70%
- Patients must have recovered to Grade 1 or baseline levels from toxicity or adverse events related to prior treatment for their cancer, excluding Grade ≤ 2 neuropathy, alopecia, or skin pigmentation
- Adequate bone marrow and organ function
- Women of child-bearing potential (WOCBP) or men of child-fathering potential must agree to use adequate contraception prior to study entry
Who cannot join
- Patient has had prior systemic anti-cancer therapy (cytotoxic chemotherapy, immunotherapy, targeted therapy) within 3 weeks (6 weeks in cases of mitomycin C, nitrosourea, lomustine) or at least 5 half-lives (whichever is shorter, but no less than 2 weeks) prior to Day 1
- Prior radiation therapy at the target lesion unless there is evidence of disease progression. If patient has had prior radiation therapy for disease progression, see Exclusion Criterion 1 for allowed interval between radiotherapy and Day 1 and recovery of AEs
- Treatment with any investigational agent administered within 30 days or 5 half-lives, whichever is shorter, before the first dose of APR-1051
- Major surgery within 21 days prior to Day 1
- Concomitant treatment with other anti-cancer therapy, including chemotherapy, immunotherapy, biological therapy, radiation therapy (except palliative local radiation therapy), or other novel anti-cancer agents. Note: endocrine therapy for breast and prostate cancer is allowed along with agents to treat or prevent skeletal related events (zoledronic acid, pamidronate, denosumab)
- Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
University Hospitals, Cleveland Medical Center
Cleveland, Ohio, 44106
Amit Mahipal, MD, 216-844-6031, Amit.Mahipal@UHHospitals.org
Amit Mahipal, MD
- Recruiting
NEXT Oncology -Virginia
Fairfax, Virginia, 22031
Maybelle De La Rosa, 703-783-4518, mdelarosa@nextoncology.com
Mohamad Salkeni, MD, FRCPC
- Recruiting
MD Anderson Cancer Center (MDACC)
Houston, Texas, 77030
Jessica Rhudy
713-745-5474, jrhudy@mdanderson.org
- Recruiting
NEXT Oncology- Houston
Houston, Texas, 77054
Emma Morales, 832-384-7912, emorales@nextoncolgy.com
Jennifer Segar, MD
- Recruiting
NEXT Oncology -Dallas
Irving, Texas, 75039
Rebecca Popiel, 972-893-8800, rpopiel@nextoncology.com
Shiraj Sen, MD
- Recruiting
Rutgers Cancer Institute
New Brunswick, New Jersey, 08903
Mohammad Ghalib, mhg68@cinj.rutgers.edu
Kassie DiOrio, kassie.diorio@rutgers.edu
- Recruiting
NEXT Oncology -San Antonio
San Antonio, Texas, 78229
Jordan Georg, 210-580-9500, jgeorg@nextoncology.com
David Sommerhalder, MD
About this study
Official title: A Phase 1, Open-Label, Multicenter, First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of APR-1051 in Patients With Advanced Solid Tumors
The purpose of this study is to assess the safety and effectiveness of APR-1051 through the performance of a Phase 1, open-label, safety, PK, and preliminary efficacy study of oral APR-1051 in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumor
- Being tested
- APR-1051
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APR-1051Drug
WEE1 Inhibitor
| Study group | Role | What they receive |
|---|---|---|
| APR-1051 | Experimental | Dose Escalation based on BOIN Design Receives: Drug: APR-1051 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related adverse events
- Part 1 dose escalation: Incidence of adverse Events (AE), serious AEs (SAE), treatment-related AEs, AEs that would qualify as a dose-limiting toxicity (DLT), changes in clinical laboratory values, vital signs, ECG, ECHO
- Part 1 dose escalation: Severity of adverse Events (AE), serious AEs (SAE), treatment-related AEs, and changes in clinical laboratory values, vital signs, ECG, ECHO according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
Measured: Day 1 to 28, each cycle is 28 days
Recommended dose of APR-1051
•Part 1 dose escalation: Recommended Phase 2 Dose (RP2D) of APR-1051 monotherapy [Time frame: Day 1 through to start of dose expansion phase]. The RP2D of will be determined based on review of safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy data
Measured: Day 1 to 28, each cycle is 28 days
Secondary outcomes (4)
Pharmacokinetics: Cmax/Cmin of APR-1051
Plasma concentration of APR-1051: maximum (Cmax), minimum (Cmin)
Measured: Day 1 to 112
Pharmacokinetics: Tmax of APR-1051
Time to peak plasma concentration of APR-1051 (Tmax)
Measured: Day 1 to 112
Pharmacokinetics: AUC of APR-1051
Area under plasma versus time curve (AUC) of APR-1051 max)
Measured: Day 1 to 112
Pharmacokinetics: t1/2 of APR-1051
Half-life of APR-1051 (t1/2)
Measured: Day 1 to 112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start13 Jun 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aprea Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260514
- Sponsor's protocol ID
- APR-1051-001
- Acronym
- ACESOT-1051
- Status last verified
- Oct 2026
- First submitted
- 18 Jan 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Multicenter, First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of APR-1051 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06260514
- Acronym / sponsor ID
- ACESOT-1051 / APR-1051-001
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Aprea TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 15 Feb 2024 (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.
The purpose of this study is to assess the safety and effectiveness of APR-1051 through the performance of a Phase 1, open-label, safety, PK, and preliminary efficacy study of oral APR-1051 in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| APR-1051 | Experimental | Drug: APR-1051Dose Escalation based on BOIN Design |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Diagnosis of advanced/metastatic solid tumor
- Measurable or evaluable disease per RECIST version 1.1 (radiographic disease progression per PCWG3 criteria for patients with mCRPC)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 or Karnofsky Performance Status (KPS) ≥ 70%
- Patients must have recovered to Grade 1 or baseline levels from toxicity or adverse events related to prior treatment for their cancer, excluding Grade ≤ 2 neuropathy, alopecia, or skin pigmentation
Key exclusion criteria (6 listed)
- Patient has had prior systemic anti-cancer therapy (cytotoxic chemotherapy, immunotherapy, targeted therapy) within 3 weeks (6 weeks in cases of mitomycin C, nitrosourea, lomustine) or at least 5 half-lives (whichever is shorter, but no less than 2 weeks) prior to Day 1
- Prior radiation therapy at the target lesion unless there is evidence of disease progression. If patient has had prior radiation therapy for disease progression, see Exclusion Criterion 1 for allowed interval between radiotherapy and Day 1 and recovery of AEs
- Treatment with any investigational agent administered within 30 days or 5 half-lives, whichever is shorter, before the first dose of APR-1051
- Major surgery within 21 days prior to Day 1
- Concomitant treatment with other anti-cancer therapy, including chemotherapy, immunotherapy, biological therapy, radiation therapy (except palliative local radiation therapy), or other novel anti-cancer agents. Note: endocrine therapy for breast and prostate cancer is allowed along with agents to treat or prevent skeletal related events (zoledronic acid, pamidronate, denosumab)
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 |
|---|---|---|
| APR-1051WEE1 Inhibitor | Drug | APR-1051 |
Primary outcome
Treatment-related adverse events
Time frame: Day 1 to 28, each cycle is 28 days
* Part 1 dose escalation: Incidence of adverse Events (AE), serious AEs (SAE), treatment-related AEs, AEs that would qualify as a dose-limiting toxicity (DLT), changes in clinical laboratory values, vital signs, ECG, ECHO * Part 1 dose escalation: Severity of adverse Events (AE), serious AEs (SAE), treatment-related AEs, and changes in clinical laboratory values, vital signs, ECG, ECHO according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
Recommended dose of APR-1051
Time frame: Day 1 to 28, each cycle is 28 days
•Part 1 dose escalation: Recommended Phase 2 Dose (RP2D) of APR-1051 monotherapy [Time frame: Day 1 through to start of dose expansion phase]. The RP2D of will be determined based on review of safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy data
4 secondary outcomes
Pharmacokinetics: Cmax/Cmin of APR-1051
Time frame: Day 1 to 112
Pharmacokinetics: Tmax of APR-1051
Time frame: Day 1 to 112
Pharmacokinetics: AUC of APR-1051
Time frame: Day 1 to 112
Pharmacokinetics: t1/2 of APR-1051
Time frame: Day 1 to 112
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 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.
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 APR-1051 in people with Advanced Solid Tumor, run by Aprea Therapeutics at 7 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 7 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: looking for participants now, as of the sponsor's last update on 9 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 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 Senior Medical Advisor (215-948-4119, info@aprea.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-related adverse events (time frame: Day 1 to 28, each cycle is 28 days). The study lists 2 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 9 Oct 2026.