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NCT07104110NOT_YET_RECRUITINGanonymous

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

Sponsor

Source record

Qilu Pharmaceutical Co., Ltd.

Phase

Source record

Phase 1/2

Modality

AI-normalized

small molecule

Target

AI-normalized

Androgen Receptor (AR) via PROTAC mechanism

Indication / condition

AI-normalized

Prostatic Neoplasms

Intervention

Source record

QLH12016, abiraterone acetate, enzalutamide

Source & freshness

Source record

NCT ID

NCT07104110

Original source

ClinicalTrials.gov

Source last updated

Aug 05, 2025

Ingested at

Jun 12, 2026

Internal sync

Jun 12, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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View original source fields

NCT ID

NCT07104110

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

Sponsor

Qilu Pharmaceutical Co., Ltd.

Status

NOT_YET_RECRUITING

Phase

Phase 1/2

Condition raw

Prostatic Neoplasms

Condition normalized

Prostatic Neoplasms

Modality raw

small molecule

Modality normalized

small molecule

Target raw

Androgen Receptor (AR) via PROTAC mechanism

Target normalized

Androgen Receptor (AR) via PROTAC mechanism

Interventions

QLH12016, abiraterone acetate, enzalutamide

Public preview

Source record

QLH12016, an investigational oral AR PROTAC, is being evaluated in combination with novel hormonal agents (NHA) such as abiraterone acetate and enzalutamide for the treatment of advanced prostate cancer. The prostate cancer therapeutics market is projected to grow significantly, driven by increasing incidence rates and advancements in treatment options. The combination therapy approach may provide a competitive edge against existing monotherapies and combinations, particularly in patients who have progressed on standard treatments. Qilu Pharmaceutical Co., Ltd. is positioning itself in a niche segment of the prostate cancer market, which could enhance its portfolio and market share if the trial demonstrates favorable safety and efficacy outcomes. Diligence should focus on the competitive landscape, particularly the performance of existing therapies and emerging candidates in similar indications.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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