Study of QLH12016 in Combination With Novel Hormonal Agent in Subjects With Advanced Prostate Cancer

NCT ID: NCT07104110

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2028-10-31

Brief Summary

This study is designed to determine if experimental treatment with QLH12016 in combination with novel hormonal agent (NHA) is safe, tolerable, and has anti-cancer activity in patients with advanced prostate cancer.

Conditions

Prostatic Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

QLH12016+NHA

Group Type: EXPERIMENTAL

QLH12016

Intervention Type: DRUG

oral AR PROTAC

abiraterone acetate

Intervention Type: DRUG

oral CYP17 inhibitor

enzalutamide

Intervention Type: DRUG

oral androgen receptor inhibitor

Interventions

QLH12016

oral AR PROTAC

Intervention Type: DRUG

abiraterone acetate

oral CYP17 inhibitor

Intervention Type: DRUG

enzalutamide

oral androgen receptor inhibitor

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Signed the informed consent form.
• Male, aged ≥ 18 years.
• Life expectancy ≥ 3 months.
• Histologically or cytologically confirmed prostate adenocarcinoma.
• Metastatic prostate cancer.
• Organ function meet protocol requirements.
• Recovered from all reversible AEs related to previous anticancer treatments.

Exclusion Criteria

• Previous treatment with the following drugs:

1. AR PROTAC class drugs.

2. Other systemic anticancer therapy within 3 weeks or 5 half-lives prior to the first administration of the study treatment.

3. Taditional Chinese medicine with anti-tumor indications within 2 weeks prior to the first administration of the study treatment.

4. Drugs that may cause drug-drug interactions (DDI) with the study treatment.

5. Drugs known to prolong the QT interval or potentially cause torsades de pointes ventricular tachycardia

• Presence of central nervous system metastases, leptomeningeal metastasis, or spinal cord compression.
• Radiation therapy involving more than 25% of bone marrow within 4 weeks prior to the first administration of the investigational medicinal product; local radiation therapy within 2 weeks prior to the first administration of the investigational medicinal product.
• Treatment with other investigational drugs or major surgery within 4 weeks.
• Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption.
• With severe cardiovascular or cerebrovascular diseases or related history.
• Active, uncontrolled infections.
• History of other significant malignancies within 5 years.
• Moderate to severe pulmonary disease significantly affecting lung function.
• According to the investigator's judgment, there are comorbidities that seriously endanger subject safety or affect the subject's ability to complete the study.
• Allergy to any of the investigational medicinal products or their components.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Wanhai Xu, PHD

Role: CONTACT

xuwanhai@163.com

0451-86605612

Other Identifiers

QLH12016-201

Identifier Type: -

Identifier Source: org_study_id