A Study of HLD-0915 in Patients with mCRPC

• Research type

  Research Study

• Full title

  Phase 1/2 Study of HLD-0915 in Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC)

• IRAS ID

  1010726

• Contact name

  Hope Meely

• Contact email

  Hope.Meely@haldathera.com

• Sponsor organisation

  Halda Therapeutics OpCo, Inc.

• Clinicaltrials.gov Identifier

  NCT06800313

• Research summary

  Metastatic Castration Resistant Prostate Cancer (mCRPC) is a form of advanced prostate cancer. Prostate Cancer is the most common cancer in men. If the cancer spreads to other areas, this is known as metastases. Currently, patients with mCRPC have a poor prognosis and with a relatively short overall survival. There is a lack of meaningful effective therapies available that improve how the patient feels, functions and lives.

  Currently, the following treatment regimens are available:
  - chemotherapy (like docetaxel and cabazitaxel)
  - androgen receptor pathway inhibitors (like abiraterone acetate and enzalutamide)
  - radiopharmaceutical therapy (like radium-223)
  - poly ADP-ribose polymerase (PARP) inhibitors (like olaparib and rucaparib)

  The treatment being investigated in this study is HLD-0915. This is the first time HLD-0915 will be administered to humans. In this Phase 1/2 study, several doses of HLD-0915 will be tested.
  All participants will receive oral HLD-0915 administered once daily in 21-day treatment cycles at their assigned dose.

  This research study consists of 2 phases:
  - Phase 1: To determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDEs) of HLD-0915 in patients with mCRPC (dose-escalation).
  - Phase 2: To evaluate the anti-tumour activity of HLD-0915 administered at the recommended dose(s) in patients with mCRPC

  Globally approximately 120 eligible participants will be enrolled in Phase 1 and up to approximately 80 eligible participants enrolled in Phase 2. The total duration for participation is approximately 2 to 2.5 years (including screening and post treatment follow-up period).

  The study is sponsored by Halda Therapeutics OpCo, Inc.

• REC name

  North East - York Research Ethics Committee

• REC reference

  25/NE/0112

• Date of REC Opinion

  16 Jul 2025

• REC opinion

  Further Information Favourable Opinion