Clinical trial · Interventional

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

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

NCT07104110CI-TRIAL-00093128not yet recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Prostatic Neoplasms	Prostate Neoplasm	ALIAS	0.90

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
abiraterone acetate	Drug	Abiraterone Acetate	ALIAS
enzalutamide	Drug	Enzalutamide	ALIAS
QLH12016	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
QLH12016+NHA
interventionNames
1. Drug: QLH12016
2. Drug: abiraterone acetate
3. Drug: enzalutamide

Primary outcomes (5)

measure
The number of subjects with adverse events/serious adverse events (Phase Ib)
timeFrame
Throughout phase Ib (approximately 1 year)
description
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
measure
The number of subjects with dose-limiting toxicity (DLT), as defined in the protocol (Phase Ib)
timeFrame
From first dose of study treatment until the end of Cycle 1.
description

Eligibility

Eligibility (as posted)

Sex: Male
Minimum age: 18 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.