NCT06380660 Study of ACE-86225106 to Treat Patients With Advanced Solid Tumors
| NCT ID | NCT06380660 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Acerand Therapeutics (Shanghai) Limited |
| Condition | Solid Tumor, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 298 participants |
| Start Date | 2024-03-22 |
| Primary Completion | 2028-12-21 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 298 participants in total. It began in 2024-03-22 with a primary completion date of 2028-12-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to determine if the experimental treatment with poly-ADP ribose polymerase (PARP) inhibitor, ACE-86225106 is safe, tolerable and has anti-cancer activity in adult patients with advanced solid tumors.
Eligibility Criteria
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.
Contact & Investigator
Sherwin Cai, MD
STUDY DIRECTOR
Acerand Therapeutics
Frequently Asked Questions
Who can join the NCT06380660 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06380660 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06380660 currently recruiting?
Yes, NCT06380660 is actively recruiting participants. Contact the research team at teresa.shi@acerand.com for enrollment information.
Where is the NCT06380660 trial being conducted?
This trial is being conducted at Chongqing, China, Fuzhou, China, Guangzhou, China, Anyang, China and 10 additional locations.
Who is sponsoring the NCT06380660 clinical trial?
NCT06380660 is sponsored by Acerand Therapeutics (Shanghai) Limited. The principal investigator is Sherwin Cai, MD at Acerand Therapeutics. The trial plans to enroll 298 participants.