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

NCT06380660 | Recruiting Phase 1 DMC

• 1 other identifier: ACE-106-001
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 14

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.

Conditions

BRCA1 Mutation; BRCA2 Mutation; Ovarian Cancer; Breast Cancer; Prostate Cancer; Solid Tumor, Adult

Keywords

ACE-86225106; advanced solid tumors; PARP inhibitor; BRCA mutation; breast cancer; ovarian cancer; CRPC

Outcome Measures

Primary Outcomes (3)

• Number of participants experiencing adverse events (AEs)/serious adverse events (SAEs)

  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.

  From time of information consent to 30 days post last dose, up to 3 years

• The number of patients experiencing dose limiting toxicity (DLT), as defined in the protocol

  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.

  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)

• Recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD)

  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.

  Up to 3 years

Secondary Outcomes (6)

• Objective Response Rate (ORR)

  Up to 3 years

• Duration of Response (DoR) and Time to Response (TTR)

  Up to 3 years

• Progression Free Survival (PFS)

  Up to 3 years

• Overall Survival (OS)

  Up to 3 years

• Pharmacokinetic (PK) parameters and Pharmacodynamic (PD) marker change

  Up to 3 years

Study Arms (1)

ACE-86225106 tablet

EXPERIMENTAL

ACE-86225106 tablet monotherapy

Drug: ACE-86225106 tablet

Interventions

ACE-86225106 tablet DRUG

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.

ACE-86225106 tablet

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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;
• 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.

You may not qualify 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 toxicities that are deemed not to affect the conduct of the study, as assessed by the sponsor and the clinical investigator.
• 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 efficacy evaluation, or affect treatment compliance.

Sponsors & Collaborators

• Acerand Therapeutics (Shanghai) Limited: lead

Study Sites (14)

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, China

RECRUITING

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

Anyang Cancer Hospital

Anyang, Henan, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

Hubei Cancer Hospital

Wuhan, Hubei, China

RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

RECRUITING

Jinan Central Hospital

Jinan, Shandong, China

RECRUITING

Qilu Hospital Shangdong University

Jinan, Shandong, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

RECRUITING

Second Hospital Affiliated to Shanxi Medical University

Taiyuan, Shanxi, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

RECRUITING

First Hospital Affiliated to Wenzhou Medical University

Wenzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Breast Neoplasms; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Sherwin Cai, MD

  Acerand Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Teresa Shi

CONTACT

8613916513539; teresa.shi@acerand.com

Sherwin Cai, MD

CONTACT

sherwin.cai@acerand.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 24, 2024
• Study Start: March 22, 2024
• Primary Completion (Estimated): December 21, 2028
• Study Completion (Estimated): March 21, 2029
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (14)