Study of TY-302 Capsules Combined With Abiraterone in Patients With Metastatic Castration-resistant Prostate Cancer（mCRPC）

NCT07104617 | Not Yet Recruiting Phase 1

• 1 other identifier: TYKM1602301
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the safety, and preliminary antitumor activity of TY-302 combined with Abiraterone tablets in patients with metastatic castration-resistant prostate cancer (mCRPC) that have failed novel endocrine therapy

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Outcome Measures

Primary Outcomes (5)

• (Escalation stage) Dose Limiting Toxicity (DLT)

  Numbers of participants experiencing AEs which are defined as DLTs classfied by CTCAE v5.0.

  Up to approximately 28 days

• Maximum tolerated dose（MTD）

  To determine the maximum tolerated dose for combination-agent escalation.

  Within 28 days of the first dose

• (Escalation stage) Recommended Phase 2 Dose（RP2D）

  The RP2D is defined as the dose level chosen for the dose expansion arms, based on safety, tolerability, efficacy collected during the dose escalation portion of the study

  Within 28 days of the last patient dosed in escalation stage

• Adverse events (AEs)

  Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.

  From Baseline up to 28 days after the end of the treatment

• （Expansion stage) Progression-free survival (rPFS）

  rPFS is defined as the time from randomization to occurrence of: radiological tumor progression using RECIST 1.1 as assessed by BICR; progression of bone lesions using PCWG criteria; or death due to any cause. Progression as per modified RECIST 1.1 is ≥20% increase in the sum of diameters of target lesions and progression of existing non-target lesions. Progression of bone lesions by PCWG criteria is the appearance of ≥2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and are persistent for ≥6 weeks.

  Up to approximately 21 months

Secondary Outcomes (4)

• Prostate-specific antigen (PSA) response rate

  Up to approximately 21 months

• Overall survival (OS)

  Up to approximately 21 months

• Duration of response (DOR)

  Up to approximately 21 months

• Objective response rate (ORR)

  Up to approximately 21 months

Study Arms (1)

TY-302+Abiraptor

EXPERIMENTAL

Find the maximum tolerated dose(MTD) and the recommended phase 2 dose (RP2D) of TY-302, given orally. • Increased dose cohorts from low dose to MTD, starting at 75mg Once a day. Abiraterone, 1000mg each time, once a day.

Drug: TY-302; Drug: Abiraptor

Interventions

TY-302 DRUG

Take the specified dose (75mg or 100mg) orally once a day. Take it on an empty stomach in the morning with about 200 mL of warm water.

TY-302+Abiraptor

Abiraptor DRUG

Take orally, 1000mg each time, once a day. Take it on an empty stomach in the morning with warm water, or take it orally at least two hours after fasting.

TY-302+Abiraptor

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years.
• Metastatic castration-resistant prostate adenocarcinoma confirmed by pathology (with no neuroendocrine or small cell features indicated by the initial pathological examination), if pathological examination is performed in the subsequent CRPC stage, the accompanying other pathological types should not exceed 10%. Those with only pelvic lymph node metastasis or local recurrent metastasis (such as in the bladder, rectum, etc.) cannot be included.
• Testosterone levels ≤50ng/dL (≤1.75nmol/L) within 28 days prior to the first administration. If the patient has not undergone bilateral orchiectomy in the past, they must be undergoing and voluntarily continue to receive LHRH agonists/antagonists for androgen deprivation therapy throughout the study treatment period
• During screening, if the disease progresses, that is, the subject experiences one or more of the following three conditions; PSA progression is defined as no PSA \> 1ng/ml and at least two elevated PSA levels with an interval of ≥1 week. ② Disease progression as defined in RECIST 1.1; ③ Bone disease progression as defined by the PCWG3 standard refers to the discovery of ≥2 new lesions on bone scans.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and life expectancy \> 3 months.
• Have good organ functions, including:
• Liver function: Total bilirubin (TBIL) ≤ 1.5×ULN (except for documented Gilbert syndrome), alanine aminotransferase (ALT) ≤ 2.5×ULN, and aspartate aminotransferase (AST) ≤ 2.5×ULN (for patients with liver metastasis, ALT/AST≤5×ULN), albumin ≥3.0g/L; Renal function: Serum creatinine (Cr) ≤ 1.5×ULN, or creatinine clearance rate ≥50 mL/min (calculated according to the Cockcroft and Gault formula); Blood routine: PLT ≥ 100×109/L, ANC ≥ 1.5×109/L, WBC≥ 3.5×109/L and Hb ≥ 90g/L; The international normalized ratio (INR) is ≤1.5, and the activated partial prothrombin time (APTT) is ≤1.5×ULN (in the absence of anticoagulation therapy).
• agrees to maintain abstinence (control heterosexual sexual intercourse) or take contraceptive measures, and agrees not to donate sperm
• Be able to provide written informed consent approved by institutional review board (IRB) or independent ethics committee (IEC).

You may not qualify if:

• Patients with the following treatment:
• Received CDK4/6 inhibitors (e.g., Palbociclib, Ribociclib, Abemaciclib, Trilaciclib/G1T38, SHR6390, pirociclib) ;
• Received abirone acetate tablets and their analogues (CYP17 inhibitors, such as ketoconazole, etc.) or two or more novel endocrine therapies for prostate cancer;
• Received with strontium-89, samarium or radium-223 within 12 weeks prior to the first administration;
• Received systemic treatment for prostate cancer (anti-androgen therapy, chemotherapy, targeted therapy, immunotherapy, or other interventional clinical trial drugs, except castration therapy drugs) within 4 weeks prior to the first medication;
• Received traditional Chinese medicine preparations with anti-tumor therapeutic effects within one week before the first administration, or those who have received nitrourea or mitomycin treatment within six weeks before the first administration;
• Received blood transfusion, albumin infusion or used hematopoietic growth factor within 2 weeks before the first administration;
• Within two weeks prior to the first administration, the patient has received treatment with drugs prohibited by the protocol \[such as CYP3A strong suppressors, CYP3A strong inducers, and CYP3A-sensitive substrates with a narrow therapeutic index, etc.\];
• Major surgery was performed within 28 days before the first administration of the drug , or surgery was performed when the surgical effect had not yet recovered at the time of screening or during the planned enrollment for treatment;
• Has received allogeneic transplants such as stem cell transplantation, bone marrow transplantation or liver transplantation in the past;
• Palliative radiotherapy was received within 2 weeks before the first administration;
• The first administration was within no more than five half-lives from the implantation of radioactive particles.
• In addition to prostate cancer, there are other malignant tumors at the same time (excluding basal cell carcinoma or squamous cell carcinoma of the skin that can be treated locally and have been cured, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma of the breast and papillary thyroid carcinoma, etc.); Excluding other malignant tumors that have been cured by radical treatment for at least 5 years;
• There is previous evidence indicating the existence of homologous recombination gene mutations (such as BRCA1, BRCA2, etc.)
• Known to be allergic to any excipients of TY-302 Capsules, or to Abiraterone acetate tablets and their excipients;

Sponsors & Collaborators

• TYK Medicines, Inc: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Location

Study Officials

• Study Director

  TYK Medicines, Inc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhu Ji, Doctor of Medicine

CONTACT

0571-88122222; zhuji@zjcc.org.cn

Sun yan, Doctor of Medicine

CONTACT

13735818864; sunyan592@zjcc.org.cn

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: July 29, 2025
• First Posted: August 5, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)