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

A Phase I/II, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of ACE-86225106 as Monotherapy in Patients With Advanced Solid Tumors

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer; Ovarian Cancer; Prostate Cancer; BRCA1 Mutation; BRCA2 Mutation; Solid Tumor, Adult
• Intervention / Treatment: Drug: ACE-86225106 tablet

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 Type: Interventional
• Enrollment (Estimated): 298
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China
      • Chongqing Cancer Hospital
  • Fujian
    • Fuzhou, Fujian, China
      • Fujian Cancer Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • Sun Yat-sen University Cancer Center
  • Henan
    • Anyang, Henan, China
      • Anyang Cancer Hospital
    • Zhengzhou, Henan, China
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China
      • Hubei Cancer Hospital
    • Wuhan, Hubei, China
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China
      • Hunan Cancer Hospital
  • Shandong
    • Jinan, Shandong, China
      • Jinan Central Hospital
    • Jinan, Shandong, China
      • Qilu Hospital Shangdong University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Fudan University Shanghai Cancer Center
  • Shanxi
    • Taiyuan, Shanxi, China
      • Second Hospital Affiliated to Shanxi Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Zhejiang Cancer Hospital
    • Wenzhou, Zhejiang, China
      • First Hospital Affiliated to Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACE-86225106 tablet; ACE-86225106 tablet monotherapy	Drug: ACE-86225106 tablet; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	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.	Up to 3 years
Duration of Response (DoR) and Time to Response (TTR)	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.	Up to 3 years
Progression Free Survival (PFS)	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.	Up to 3 years
Overall Survival (OS)	OS is defined as the time from the first study treatment to the date of death due to any cause	Up to 3 years
Pharmacokinetic (PK) parameters and Pharmacodynamic (PD) marker change	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.	Up to 3 years
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)	The tests for the above serum tumor markers will support the tumor response evaluation.	Up to 3 years

Collaborators and Investigators

• Sponsor: Acerand Therapeutics (Shanghai) Limited
• Investigators: Study Director: Derek Yang, MD, Acerand Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2024
• Primary Completion (Estimated): December 21, 2028
• Study Completion (Estimated): March 21, 2029

Study Registration Dates

• First Submitted: April 16, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): August 4, 2026
• Last Update Submitted That Met QC Criteria: August 3, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: breast cancer; PARP inhibitor; ovarian cancer; advanced solid tumors; BRCA mutation; CRPC; ACE-86225106
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Prostatic Neoplasms; Ovarian Neoplasms; Breast Neoplasms
• Other Study ID Numbers: ACE-106-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No