A Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in mCRPC Patients

Hinova Pharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Metastatic Castration-resistant Prostate Cancer

Treatments: Drug: HP518 - Dose Escalation; Drug: HP518 -Dose Expansion

Study type: Interventional

Funder types: Industry

Identifiers

NCT06155084

HP518-01-01-03

Details and patient eligibility

About

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

Full description

This First in Human dose escalation and expansion study of HP518 in patients with progressive mCRPC after NHA and chemotherapy is being conducted not only to evaluate the safety and tolerability of orally administered HP518, but also to provide preliminary efficacy for the reference of future studies.

Enrollment: 84 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 small cell characteristics.
4. Has metastatic disease documented by 2 or more bone lesions by bone scan or soft tissue disease progression observed by CT/MRI at the beginning of study.
5. the progression of the disease after receiving at least one new endocrine therapy and progressing with at least first-line chemotherapy.
6. Must have recovered from toxicities related to any prior treatments
7. Ongoing ADT with LHRH agonist/antagonist therapy or history of bilateral orchiectomy.
8. ECOG performance status score of 0 to 1.

Exclusion criteria

1. Combination of research or commercially available drugs targeting AR
2. Has had any other anticancer treatments, including immunotherapy, chemotherapy, or radiotherapy (eg, 177LuPSMA-617, radium 223, PARP inhibitor) within 4 weeks prior to the first dose of HP518.
3. Has gastrointestinal disorder affecting absorption (e.g., gastrectomy).
4. Has significant cardiovascular disease.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

84 participants in 3 patient groups

Part 1 - Dose Escalation, 400mg/d (Cohort1)

Experimental group

Description:

Oral tablet(s), once daily in 28-day cycles

Treatment:

Drug: HP518 - Dose Escalation

Drug: HP518 - Dose Escalation

Part 1 - Dose Escalation 500mg/d (Cohort 2)

Experimental group

Description:

Oral tablet(s), once daily in 28-day cycles

Treatment:

Drug: HP518 - Dose Escalation

Drug: HP518 - Dose Escalation

Part 2 - Dose Expansion Oral tablet(s)

Experimental group

Description:

Oral tablet(s), once daily in 28-day cycles

Treatment:

Drug: HP518 -Dose Expansion