Menu
Not yet recruiting NCT07104110

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

Phase I / Phase II Interventional Prostatic Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: QLH12016, abiraterone acetate, enzalutamide.
Who it may be relevant to
Registry conditions: Prostatic Neoplasms. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-Label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of QLH12016 in Combination With Novel Hormonal Agent in Subjects With Advanced Prostate Cancer

Overview

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.

Interventions

  • Drug QLH12016
    oral AR PROTAC
  • Drug abiraterone acetate
    oral CYP17 inhibitor
  • Drug enzalutamide
    oral androgen receptor inhibitor

Primary outcome measures

  • The number of subjects with adverse events/serious adverse events (Phase Ib) [Time frame: Throughout phase Ib (approximately 1 year)]
  • The number of subjects with dose-limiting toxicity (DLT), as defined in the protocol (Phase Ib) [Time frame: From first dose of study treatment until the end of Cycle 1.]
  • Recommended phase II dose (RP2D) (Phase Ib) [Time frame: Throughout phase Ib (approximately 1 year)]
  • Objective Response Rate (ORR) (Phase II) [Time frame: From time of Informed Consent to confirmed progressive disease (approximately 1 year)]
  • Objective Response Rate (ORR) (Phase II) [Time frame: From time of Informed Consent to confirmed progressive disease (approximately 1 year).]

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:
  • 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.
  • Allergy to any of the investigational medicinal products or their components.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07104110 · QLH12016-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗