Study of ACE-86225106 to Treat Patients With Advanced Solid Tumors
NCT ID: NCT06380660
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
298 participants
INTERVENTIONAL
2024-03-22
2029-03-21
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ACE-86225106 tablet
ACE-86225106 tablet monotherapy
ACE-86225106 tablet
ACE-86225106 will be administered orally daily as a continuous regimen. Subjects will continue to receive study treatment until PD as judged by local investigator review, development of unacceptable toxicity, or withdrawal of consent.
Interventions
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ACE-86225106 tablet
ACE-86225106 will be administered orally daily as a continuous regimen. Subjects will continue to receive study treatment until PD as judged by local investigator review, development of unacceptable toxicity, or withdrawal of consent.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Acerand Therapeutics (Shanghai) Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Sherwin Cai, MD
Role: STUDY_DIRECTOR
Acerand Therapeutics
Locations
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Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Anyang Cancer Hospital
Anyang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jinan Central Hospital
Jinan, Shandong, China
Qilu Hospital Shangdong University
Jinan, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Second Hospital Affiliated to Shanxi Medical University
Taiyuan, Shanxi, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
First Hospital Affiliated to Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Other Identifiers
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ACE-106-001
Identifier Type: -
Identifier Source: org_study_id