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New treatment option for Solid Tumor, Adult
Official title Study of ACE-86225106 to Treat Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06380660
What this study is testing
What is ACE-86225106 tablet?
ACE-86225106 tablet is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for solid tumor, adult.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provide written informed consent;
- Advanced solid tumors, difficult to treat or intolerant to standard treatment, suitable for investigational treatment;
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Has a life expectancy of at least 3 months;
- Has measurable disease per RECIST 1.1, castration-resistant prostate Ccancer (CRPC) patients can be assessed according to PCWG3;
You likely can't join if
- Receiving any anti-cancer drugs, major surgery, extensive radiation therapy, or local radiation therapy within protocol-defined wash-out period;
- Concomitant use of medications or herbal supplements known to be strong or moderate inhibitors or inducers of cytochrome P450 3A4 (CYP3A4);
- Receiving continuous corticosteroid treatment with a dose of prednisone greater than 10 mg/day or an equivalent dose.
- Receiving continuous treatment with prednisone at a dose of \>10 mg/d or other corticosteroids at an equivalent dose for any reason.
- 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...
- Spinal cord compression or brain metastases unless asymptomatic, treated and stable.
See the full eligibility criteria
- Provide written informed consent;
- Advanced solid tumors, difficult to treat or intolerant to standard treatment, suitable for investigational treatment;
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Has a life expectancy of at least 3 months;
- Has measurable disease per RECIST 1.1, castration-resistant prostate Ccancer (CRPC) patients can be assessed according to PCWG3;
- Adequate organ function and bone marrow function;
- Can provide tumor specimens and blood samples for Homologous Recombination Deficiency (HRD)/ Homologous Recombination Repair (HRR) related gene testing.
- Receiving any anti-cancer drugs, major surgery, extensive radiation therapy, or local radiation therapy within protocol-defined wash-out period;
- Concomitant use of medications or herbal supplements known to be strong or moderate inhibitors or inducers of cytochrome P450 3A4 (CYP3A4);
- Receiving continuous corticosteroid treatment with a dose of prednisone greater than 10 mg/day or an equivalent dose.
- Receiving continuous treatment with prednisone at a dose of \>10 mg/d or other corticosteroids at an equivalent dose for any reason.
- 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...
- Spinal cord compression or brain metastases unless asymptomatic, treated and stable.
- Severe cardiovascular disorders.
- Myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with evidence suggesting possible MDS/AML.
- Concomitant diseases or conditions that would preclude the absorption of the investigational product.
- Active infections, or a known history of HIV infection, or a known active hepatitis B or C, or a known active tuberculosis.
- Other malignancies that require treatment within 3 years prior to first dose of study investigational product.
- Conditions with rapid deterioration during the screening period.
- Known allergy or hypersensitivity to the investigational product or any of the excipients of the investigational product.
- Has other medical conditions that at the discretion of investigator interfere with safety or how well it works evaluation, or affect treatment compliance.
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Anyang, Henan, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Jinan, Shandong, China
- Shanghai, Shanghai Municipality, China
- Taiyuan, Shanxi, China
- Hangzhou, Zhejiang, China
- Wenzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Anyang, Henan, China; Zhengzhou, Henan, China; Wuhan, Hubei, China and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.