Clinical trial · Interventional
Safety, Preliminary Efficacy and Pharmacokinetics of ASN001 in Metastatic Castrate Resistant Prostate Cancer
A Phase 1/2, Open-Label, Uncontrolled, Multiple-Dose Escalation, Cohort Expansion And Extension Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of ASN001 In Subjects With Metastatic Progressive Castrate Resistant Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business Decision
Summary
Brief summary (as posted)
This study will be conducted in three parts. Part A is a dose-escalation study to determine two safe and tolerable doses of ASN001 for men with metastatic castration resistant prostate cancer. Part A will also characterize the pharmacokinetics and pharmacodynamics of the ASN001 through blood sampling. Subjects in Part B will receive one of two doses identified in Part A to determine which one is more effective, and collect additional pharmacokinetic data. Part C is an extension for subjects completing either Part A or B.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of the Prostate | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Neoplasms, Prostate | Prostate Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasms, Prostatic | Neoplasm | ONTOLOGY_EXACT | 0.85 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Neoplasms, Castration-resistant | Prostate Neoplasm | ONTOLOGY_EXACT | 0.85 |
| Prostatic Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ASN001: Escalating dose Part A | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ASN001: Escalating dose Part A
- description
- The dose of ASN001 will be based on the assigned study group. The initial dose level of ASN001 will be 50 mg daily. After a safety review, the dose may be escalated for the next group of subjects. Additional dose levels are 100 mg, 200 mg, 300 mg, and 400 mg.
- interventionNames
- Drug: ASN001: Escalating dose Part A
Primary outcomes (1)
- measure
- Determine the maximum tolerated dose (MTD) of ASN001
- timeFrame
- First 28 days
- description
- The MTD will be determined by evaluating the number of subjects with treatment related dose limiting toxicity.
Secondary outcomes (4)
- measure
- Calculate the pharmacokinetic profile of ASN001
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Histologically confirmed adenocarcinoma of the prostate. * Ongoing androgen deprivation therapy with a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist, or bilateral orchiectomy and serum testosterone level \< 50 ng/dL (\< 0.5 ng/mL, \< 1.7 nmol/L) at screening * Metastatic disease documented by computed tomography (CT)/magnetic resonance imaging (MRI) or bone scan. * Progressive disease despite ongoing androgen deprivation therapy. * Adequate liver, kidney, and bone marrow function * Life expectancy of at least 3 months * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at screening * Patients with prior cytotoxic chemotherapy are eligible to participate if they have been progression free for at least 12 months since the initiation of cytotoxic chemotherapy Exclusion Criteria: * Patients with rapidly progressive disease who are candidates for other approved therapies such as docetaxel, abiraterone, and enzalutamide. * Prior therapy with abiraterone, orteronel, ketoconazole, or any other Cytochrome P450 (CYP) 17 lyase inhibitor; enzalutamide or other experimental androgen receptor antagonist; or experimental immunotherapy agent. * History of impaired adrenal gland function * Any investigational treatments for any condition within 4 weeks prior to the start of study treatment. * Therapy with herbal products known to effect PSA, or estrogen within 30 days prior to the start of study medication * Known gastrointestinal disease or condition that affects the absorption of ASN001, or difficulty swallowing large capsules. * Use of systemic glucocorticoid (eg, prednisone, dexamethasone) within 14 days prior to the start of study medication * Major surgery within 30 days of study medication * Known brain metastasis * Previous history of another cancer within 5 years, except completely removed basal or squamous cell skin cancer. * Serious concurrent medical conditions including: serious heart disease, heart conduction abnormalities, persistent infection, uncontrolled psychiatric illness, liver cirrhosis, chronic liver disease, active or symptomatic viral hepatitis, any other condition that may place the subject at an increased risk or confound the results of the study.
References
Publications (0)
Data not yet available