A Clinical Study of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer

NCT07198633 | Not Yet Recruiting Phase 1

• 1 other identifier: QLC5508-202
• Study Type: interventional
• Target: 212
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is an open-label, multicenter Phase Ib/II clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of QLC5508 in combination with NHA (abiraterone or enzalutamide), QLC5508 in combination with QLH12016, QLC5508 in combination with QLH12016 and NHA (abiraterone or enzalutamide), and QLH12016 in combination with NHA (abiraterone or enzalutamide) in subjects with advanced prostate cancer. The study consists of two stages: Phase Ib: is the combination dose-escalation stage, during which the recommended Phase II dose (RP2D) will be determined. Phase II is the efficacy exploration stage, in which, based on the RP2D established in Phase Ib, the therapeutic efficacy will be further evaluated in the target indication.

Conditions

Advanced Prostate Cancer

Outcome Measures

Primary Outcomes (6)

• Maximum tolerated dose (MTD) (Phase Ib)

  MTD is defined as the previous dose level at which 2 or more out of 2-6 subjects experienced a DLT

  At the end of Day 28 after the first dose

• Maximum administered dose (MAD)(Phase Ib)

  MAD is defined as follows: a) based on PK data, it is anticipated that at this dose level, the dose-exposure plateau has been reached, b) based on existing safety data, it is judged that dose escalation following this dose level will have a large safety risk or subject intolerance, or c) based on the PK-PD model, it suggested that the optimal target concentration of safety and efficacy has been explored.

  At the end of Day 28 after the first dose

• recommended phase II dose (RP2D) (Phase Ib)

  The RP2D will be comprehensively evaluated based on the safety, PK characteristics, and efficacy data from the Phase Ib study.

  Through phase Ib completion, an average of 1 year.

• The incidence and severity of adverse events (AE) (Phase Ib)

  Incidence and severity of adverse events (AEs) evaluated according to the NCI-CTCAE v5.0

  Through phase Ib completion, an average of 1 year.

• PSA50 response（Phase II）

  Proportion of subjects with ≥ 50% PSA decrease

  From Screening to confirmed progressive disease (approximately 1 year)

• Objective response rate (ORR) (phase II)

  Best response until progression, as defined by RECIST 1.1 and PCGW3.

  From Screening to confirmed progressive disease (approximately 1 year)

Study Arms (4)

QLC5508+NHA

EXPERIMENTAL

Drug: QLC5508; Drug: abiraterone acetate; Drug: enzalutamide

QLC5508+QLH12016

EXPERIMENTAL

Drug: QLC5508; Drug: QLH12016

QLC5508+QLH12016+NHA

EXPERIMENTAL

Drug: QLC5508; Drug: abiraterone acetate; Drug: enzalutamide; Drug: QLH12016

QLH12016+NHA

EXPERIMENTAL

Drug: QLC5508; Drug: abiraterone acetate; Drug: enzalutamide

Interventions

QLC5508 DRUG

B7H3 ADC; QLC5508 will be administered by injection at the dose and dosing frequency specified in the protocol.

QLC5508+NHA; QLC5508+QLH12016; QLC5508+QLH12016+NHA; QLH12016+NHA

abiraterone acetate DRUG

An oral CYP17 inhibitor; abiraterone acetate will be administered orally at the dose and dosing frequency specified in the protocol

QLC5508+NHA; QLC5508+QLH12016+NHA; QLH12016+NHA

enzalutamide DRUG

An oral androgen receptor inhibitor; enzalutamide will be administered orally at the dose and dosing frequency specified in the protocol.

QLC5508+NHA; QLC5508+QLH12016+NHA; QLH12016+NHA

QLH12016 DRUG

An oral androgen receptor PROTAC; QLH12016 will be administered orally at the dose and dosing frequency specified in the protocol

QLC5508+QLH12016; QLC5508+QLH12016+NHA

Eligibility Criteria

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

You may qualify if:

• The subject voluntarily agrees to participate and has signed the informed consent form.
• Male, aged ≥18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• Life expectancy of at least 3 months.
• Histologically or cytologically confirmed adenocarcinoma of the prostate.
• Radiologically confirmed metastatic prostate cancer.
• For subjects with mCRPC, serum testosterone must be at castrate levels, and they must have demonstrated either PSA progression or radiographic progression.
• Must have undergone surgical castration or be willing to receive medical castration.
• For Phase Ib, subjects must have experienced failure, intolerance, or refusal of standard therapy.
• Adequate function of major organs as defined by the protocol.
• Agreement to use effective contraception during the study (except for subjects who have undergone bilateral orchiectomy).
• Sufficient blood samples must be provided during the screening period for genetic mutation testing.

You may not qualify if:

• Prior treatment with the following agents: AR PROTAC, abiraterone, enzalutamide, or B7H3-targeted therapies.
• Presence of central nervous system (CNS) metastases, leptomeningeal metastases, or spinal cord compression requiring hormonal therapy.
• Receipt of extensive radiotherapy within 4 weeks prior to the first administration of the investigational medicinal product.
• Treatment with other investigational drugs or major surgery within 4 weeks prior to the first administration of the investigational medicinal product.
• Presence of factors that may affect drug administration, intake, or absorption.
• History of epilepsy, or a condition that could provoke seizures within 12 months prior to the first administration of the investigational medicinal product.
• Known history of substance abuse, alcoholism, or drug addiction; or prior history of significant neurological or psychiatric disorders, including dementia or hepatic encephalopathy.
• Presence of severe cardiovascular or cerebrovascular disease.
• Active, uncontrolled infection.
• Clinically uncontrolled third-space fluid accumulation prior to the first administration of the investigational medicinal product.
• History of other malignancies within 5 years prior to the first administration of the investigational medicinal product.
• Presence of moderate to severe pulmonary disease that significantly impairs lung function.
• For subjects receiving QLC5508, history of non-infectious interstitial lung disease (ILD) or pneumonitis.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

MeSH Terms

Interventions

Abiraterone Acetate; enzalutamide

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Xin Yao, PHD

CONTACT

18622221103; yaoxin@tjmuch.com

Study Design

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

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 30, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 30, 2025

Record last verified: 2025-09