A Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in mCRPC Patients
Recruiting
Phase 1
Phase 2
Interventional Study
Metastatic Castration-resistant Prostate Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Male
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 84 (estimated)
- Sponsor
- Hinova Pharmaceuticals Inc. · Industry
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About This Trial
The overall objective of this Phase 1 study is to evaluate the safety, PK,and anti-tumor activity of daily oral dosing with HP518,selecting the RP2D of HP518 based on assessments of patients with progressive mCRPC in dose-escalation phase
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Male, age ≥18
2. Patients with androgen receptor (AR) ligand binding domain (LBD) activation mutations (the dose expansion part of stage II)
3. Has histologically confirmed adenocarcinoma of the prostate, but there are no known significant neuroendocrine differentiation or sm…
Contacts