Study of ACE-86225106 to Treat Patients With Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Solid Tumor, Adult; BRCA1 Mutation; BRCA2 Mutation; Ovarian Cancer; Breast Cancer; Prostate Cancer
• Interventions: Drug: ACE-86225106 tablet

• Registration Number: NCT06380660
• Lead Sponsor: Acerand Therapeutics (Shanghai) Limited

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.

Detailed Description

This study is a Phase I/II, open-label, multicentre study of ACE-86225106 administered orally in patients with advanced solid tumors.

Study Timeline

• Study Start: 2024-03-22
• Study First Submitted: 2024-04-16
• Study First Submitted QC: 2024-04-18
• Study First Posted: 2024-04-24
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Primary Completion: 2028-12-21
• Study Completion: 2029-03-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 298

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ACE-86225106 tablet	ACE-86225106 tablet	ACE-86225106 tablet monotherapy

Primary Outcome Measures

Name	Time	Method
Number of participants experiencing adverse events (AEs)/serious adverse events (SAEs)	From time of information consent to 30 days post last dose, up to 3 years	Number of participants with incidence of adverse events and with serious adverse events including changes from baseline in laboratory parameters, vital signs, ECGs, and physical examination, etc.
The number of patients experiencing dose limiting toxicity (DLT), as defined in the protocol	From the first dose of ACE-86225106 on Cycle 1 Day 1 up to and including the planned end of Cycle 1 (at the end of 28 days)	A DLT is defined as any toxicity events related to ACE-86225106 that occur from the first dose of study treatment until the planned end date of Cycle 1 (DLT assessment period), meeting the criteria specified in protocol.
Recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD)	Up to 3 years	RP2D will be finally determined by the Safety Monitoring Committee (SMC) and sponsor based on all data from the dose escalation module and backfill module, as well as the exposure-response relationship evaluated (if available). MTD is defined as the maximum dose level at which ≤1 patient have DLTs during the DLT observation period, and it should be determined with 6 evaluable patients.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Up to 3 years	ORR is defined as proportion of patients who achieved complete response (CR) or partial response (PR) according to RECIST 1.1 recorded from first investigational product treatment until disease progression or death due to any cause. The confirmation of response for patients who has PR or CR at first time should be performed by at least 4 weeks. For castration-resistant prostate cancer (CRPC) patients, bone lesion will be assessed according to PCWG3 criteria.
Duration of Response (DoR) and Time to Response (TTR)	Up to 3 years	DOR is defined, for patients with an objective response, as the time from first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or death due to any cause.
Progression Free Survival (PFS)	Up to 3 years	PFS is defined as the time from the first study treatment to the date of the first documentation of objective progression of disease (PD) or death due to any cause.
Overall Survival (OS)	Up to 3 years	OS is defined as the time from the first study treatment to the date of death due to any cause
Pharmacokinetic (PK) parameters and Pharmacodynamic (PD) marker change	Up to 3 years	Blood drug concentrations at each scheduled time point will be summarized descriptively, and individual and mean concentration-time curves will be plotted by dose group.
Serum tumor marker change: CA125, etc. (OC), prostatic specific antigen (PSA, prostate cancer) decreased, and specific tumor markers for other tumor types may also be included (to be assessed by clinical investigators)	Up to 3 years	The tests for the above serum tumor markers will support the tumor response evaluation.

Trial Locations

Locations (13)

First Hospital Affiliated to Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China

Chongqing Cancer Hospital; 🇨🇳 Chongqing, Chongqing, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

Jinan Central Hospital; 🇨🇳 Jinan, Shandong, China

Qilu Hospital Shangdong University; 🇨🇳 Jinan, Shandong, China

Second Hospital Affiliated to Shanxi Medical University; 🇨🇳 Taiyuan, Shanxi, China

Fujian Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China

Sun Yat-Sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, 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

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China