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Trial Title:
Study of ACE-86225106 to Treat Patients With Advanced Solid Tumors
NCT ID:
NCT06380660
Condition:
Solid Tumor, Adult
BRCA1 Mutation
BRCA2 Mutation
Ovarian Cancer
Breast Cancer
Prostate Cancer
Conditions: Official terms:
Ovarian Neoplasms
Conditions: Keywords:
ACE-86225106
advanced solid tumors
PARP inhibitor
BRCA mutation
breast cancer
ovarian cancer
CRPC
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ACE-86225106 tablet
Description:
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.
Arm group label:
ACE-86225106 tablet
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.
Detailed description:
This study is a Phase I/II, open-label, multicentre study of ACE-86225106 administered
orally in patients with advanced solid tumors.
Criteria for 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)/(Breast Cancer gene) BRCA 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.
Gender:
All
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Facility:
Name:
Sun Yat-Sen University Cancer Center
Address:
City:
Guangzhou
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Facility:
Name:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Start date:
March 22, 2024
Completion date:
March 21, 2029
Lead sponsor:
Agency:
Acerand Therapeutics (Shanghai) Limited
Agency class:
Industry
Source:
Acerand Therapeutics Limited
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06380660
