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

Part of paid clinical trials in Denver, Colorado.

Sponsor
Halda Therapeutics OpCo, Inc.
Study ID
NCT06800313
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Prostate Cancer (Adenocarcinoma)
  • Prostate Cancer Metastatic Disease

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HLD-0915 — DRUG
    A treatment cycle consists of 21 days. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.)

Study Details

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.

Key Dates

Start date
Feb 24, 2025
Status verified
Oct 2025
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
33 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: HLD-0915
    Oral HLD-0915 administered as a single agent on a 21-day treatment cycle.

Primary Outcome Measure

Phase 1: Frequency of dose-limiting toxicities (DLTs) [ Time Frame: 21 days ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Sarah Cannon Research Institute at HealthONEDenverColorado80218-
Yale - New Haven Hospital - Yale Cancer CenterNew HavenConnecticut06520-
Florida Cancer SpecialistsSarasotaFlorida34232-
Massachusetts General HospitalBostonMassachusetts02114-
START Midwest, LLCGrand RapidsMichigan49546-
Evelyn H. Lauder Breast and Imaging Center (BAIC)New YorkNew York10065-
Carolina Urologic Research Center, LLCMyrtle BeachSouth Carolina29572-
SCRI Oncology PartnersNashvilleTennessee37203-
NEXT AustinAustinTexas78758-
The University of Texas M.D. Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Denver, CO

By research site
Sarah Cannon Research Institute at HealthONE· Denver, COYale - New Haven Hospital - Yale Cancer Center· New Haven, CTFlorida Cancer Specialists· Sarasota, FLMassachusetts General Hospital· Boston, MASTART Midwest, LLC· Grand Rapids, MIEvelyn H. Lauder Breast and Imaging Center (BAIC)· New York, NY

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