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New hope for Hard-to-Treat cancers: experimental PARP inhibitor enters human trials

NCT ID NCT06380660

Disease control Sponsor: Acerand Therapeutics (Shanghai) Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 2 times

Summary

This study is testing an experimental drug called ACE-86225106 in adults with advanced solid tumors that are difficult to treat or have stopped responding to standard therapies. The drug works by blocking a protein that helps cancer cells repair themselves, potentially slowing or stopping tumor growth. The main goals are to check the drug's safety, find the best dose, and see if it shrinks tumors in people with cancers like ovarian, breast, or prostate cancer linked to BRCA gene mutations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 298 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Provide written informed consent; 2. Advanced solid tumors, difficult to treat or intolerant to standard treatment, suitable for investigational treatment; 3. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 4. Has a life expectancy of at least 3 months; 5. Has measurable disease per RECIST 1.1, castration-resistant prostate Ccancer (CRPC) patients can be assessed according to PCWG3; 6. Adequate organ function and bone marrow function; 7. Can provide tumor specimens and blood samples for Homologous Recombination Deficiency (HRD)/ Homologous Recombination Repair (HRR) related gene testing. Exclusion Criteria: 1. Receiving any anti-cancer drugs, major surgery, extensive radiation therapy, or local radiation therapy within protocol-defined wash-out period; 2. Concomitant use of medications or herbal supplements known to be strong or moderate inhibitors or inducers of cytochrome P450 3A4 (CYP3A4); 3. Receiving continuous corticosteroid treatment with a dose of prednisone greater than 10 mg/day or an equivalent dose. 4. Receiving continuous treatment with prednisone at a dose of \>10 mg/d or other corticosteroids at an equivalent dose for any reason. 5. Any previous treatment-related toxicities have not recovered, i.e., to ≤ Grade 1 (as evaluated by NCI-CTCAE v5), except alopecia and other Grade 2 toxicities that are deemed not to affect the conduct of the study, as assessed by the sponsor and the clinical investigator. 6. Spinal cord compression or brain metastases unless asymptomatic, treated and stable. 7. Severe cardiovascular disorders. 8. Myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with evidence suggesting possible MDS/AML. 9. Concomitant diseases or conditions that would preclude the absorption of the investigational product. 10. Active infections, or a known history of HIV infection, or a known active hepatitis B or C, or a known active tuberculosis. 11. Other malignancies that require treatment within 3 years prior to first dose of study investigational product. 12. Conditions with rapid deterioration during the screening period. 13. Known allergy or hypersensitivity to the investigational product or any of the excipients of the investigational product. 14. Has other medical conditions that at the discretion of investigator interfere with safety or efficacy evaluation, or affect treatment compliance.

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Conditions

The condition(s) this trial relates to.

BRCA1-related cancer predisposition BRCA2-related cancer predisposition breast cancer breast neoplasm neoplasm ovarian cancer prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BRCA1 mutation BRCA2 mutation Breast cancer Ovarian cancer Prostate cancer Solid tumor, adult

Contacts and locations

Locations

  • Anyang Cancer Hospital

    Anyang, Henan, China

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality, China

  • First Hospital Affiliated to Wenzhou Medical University

    Wenzhou, Zhejiang, China

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, China

  • Fujian Cancer Hospital

    Fuzhou, Fujian, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, China

  • Hubei Cancer Hospital

    Wuhan, Hubei, China

  • Hunan Cancer Hospital

    Changsha, Hunan, China

  • Jinan Central Hospital

    Jinan, Shandong, China

  • Qilu Hospital Shangdong University

    Jinan, Shandong, China

  • Second Hospital Affiliated to Shanxi Medical University

    Taiyuan, Shanxi, China

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, China

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.