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

NCT07104110 | Not Yet Recruiting Phase 1

• 1 other identifier: QLH12016-201
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (5)

• The number of subjects with adverse events/serious adverse events (Phase Ib)

  Number of patients with adverse events and with serious adverse events including abnormal clinical observations, abnormal ECG parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline

  Throughout phase Ib (approximately 1 year)

• The number of subjects with dose-limiting toxicity (DLT), as defined in the protocol (Phase Ib)

  A DLT occurs during Cycle 1 (the DLT assessment period) that is assessed as related to study treatment.

  From first dose of study treatment until the end of Cycle 1.

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

  RP2D will be selected upon safety, PK and efficacy data.

  Throughout phase Ib (approximately 1 year)

• Objective Response Rate (ORR) (Phase II)

  Best response until progression, as defined by RECIST 1.1 and PCWG3

  From time of Informed Consent to confirmed progressive disease (approximately 1 year)

• Objective Response Rate (ORR) (Phase II)

  Proportion of subjects with ≥ 50% PSA decrease

  From time of Informed Consent to confirmed progressive disease (approximately 1 year).

Study Arms (1)

QLH12016+NHA

EXPERIMENTAL

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

Interventions

QLH12016 DRUG

oral AR PROTAC

QLH12016+NHA

abiraterone acetate DRUG

oral CYP17 inhibitor

QLH12016+NHA

enzalutamide DRUG

oral androgen receptor inhibitor

QLH12016+NHA

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Previous treatment with the following drugs:
• AR PROTAC class drugs.
• Other systemic anticancer therapy within 3 weeks or 5 half-lives prior to the first administration of the study treatment.
• Taditional Chinese medicine with anti-tumor indications within 2 weeks prior to the first administration of the study treatment.
• Drugs that may cause drug-drug interactions (DDI) with the study treatment.
• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate; enzalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Wanhai Xu, PHD

CONTACT

0451-86605612; xuwanhai@163.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: July 29, 2025
• First Posted: August 5, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: August 5, 2025

Record last verified: 2025-07