RECRUITING

A Study of HLD-0915 in Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC)

Conditions

Prostate Cancer Metastatic Disease Prostate Cancer (Adenocarcinoma)prostate cancer RIPTAC HLD-0915

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Assessment of the safety and efficacy of HLD-0915 as monotherapy in patients with metastatic castration resistant prostate cancer (mCRPC) that have progressed on prior systemic therapies, once a recommended dose for expansion (RDE) has been determined in Phase 1 of the trial.

Official Title

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

Quick Facts

Study Start:2025-02

Study Completion:2027-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06800313

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Males of age 18 years at the time of signing the informed consent form (ICF). 2. Able to understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures. 3. Patients must have histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. 4. Patients must have prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone. 5. Patients must have progressed on prior line(s) of therapy. 6. Patients must have progressive mCRPC defined as having demonstrated PSA progression on the prior regimen. PSA progression may have occurred with or without accompanying radiographic progression. 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 8. Life expectancy of at least 3 months. 9. Adequate hematological, renal, and hepatic function. 10. Able to swallow an oral medication. 11. Willing and able to adhere to the study visit schedule and other protocol requirements. 12. Patients on a stable bisphosphonate or denosumab regimen for 30 days prior to enrollment are eligible.	1. Has experienced a recent major bleed or has a known bleeding disorder. 2. Tumors exhibiting neuroendocrine or small cell carcinoma component by histopathology. 3. Receiving continuous corticosteroids at prednisone-equivalent dose of \>10 mg/day. 4. Has received systemic anti-cancer therapy (cytotoxic chemotherapy, biologic agent, checkpoint inhibitors, or radiation therapy) or investigational drugs within 2 weeks prior to first dose of study drug with certain exceptions requiring longer washout periods. 5. History of myocardial infarction or unstable angina within 6 months prior to enrollment, or clinically significant cardiac disease. 6. Known clinically significant active or chronic infection. 7. Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease.

Inclusion Criteria

Exclusion Criteria

1. Males of age 18 years at the time of signing the informed consent form (ICF).
2. Able to understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures.
3. Patients must have histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate.
4. Patients must have prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone.
5. Patients must have progressed on prior line(s) of therapy.
6. Patients must have progressive mCRPC defined as having demonstrated PSA progression on the prior regimen. PSA progression may have occurred with or without accompanying radiographic progression.
7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
8. Life expectancy of at least 3 months.
9. Adequate hematological, renal, and hepatic function.
10. Able to swallow an oral medication.
11. Willing and able to adhere to the study visit schedule and other protocol requirements.
12. Patients on a stable bisphosphonate or denosumab regimen for 30 days prior to enrollment are eligible.

1. Has experienced a recent major bleed or has a known bleeding disorder.
2. Tumors exhibiting neuroendocrine or small cell carcinoma component by histopathology.
3. Receiving continuous corticosteroids at prednisone-equivalent dose of \>10 mg/day.
4. Has received systemic anti-cancer therapy (cytotoxic chemotherapy, biologic agent, checkpoint inhibitors, or radiation therapy) or investigational drugs within 2 weeks prior to first dose of study drug with certain exceptions requiring longer washout periods.
5. History of myocardial infarction or unstable angina within 6 months prior to enrollment, or clinically significant cardiac disease.
6. Known clinically significant active or chronic infection.
7. Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease.

Contacts and Locations

Study Contact

Medical Monitor

CONTACT

475-210-0212

ProstateClinicalTrial@haldathera.com

Study Locations (Sites)

START Midwest, LLC

Grand Rapids, Michigan, 49546

United States

NEXT Austin

Austin, Texas, 78758

United States

Collaborators and Investigators

Sponsor: Halda Therapeutics OpCo, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02

Study Completion Date2027-03

Study Record Updates

Study Start Date2025-02

Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

prostate cancer
RIPTAC
HLD-0915

Additional Relevant MeSH Terms

Prostate Cancer Metastatic Disease
Prostate Cancer (Adenocarcinoma)