Clinical trial · Interventional
DEC003M in Prostate Cancer
A Phase 1 Study of DEC003M, an Antibody Drug Conjugate Targeting PSMA, for Advanced Stage Prostate Cancer
NCT07657806CI-TRIAL-00115444recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
This is an open-label, multicenter Phase 1 study of DEC003M, in patients with advanced stage prostate cancer. The study consists of a dose-escalation phase to determine the dose for expansion, followed by a dose-expansion phase to evaluate preliminary antitumor activity, safety, and pharmacokinetics.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DEC003M | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- DEC003M-001
- interventionNames
- Drug: DEC003M
Primary outcomes (3)
- measure
- Adverse event
- timeFrame
- Screening up to study completion, an average of 1 year.
- measure
- Dose-limiting toxicity (DLT)
- timeFrame
- 3 weeks
- measure
- Recommended Dose for Expansion (RDE)
- timeFrame
- Up to 24 months
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. At the time of informed consent, be ≥18 years of age. 2. Histologically confirmed adenocarcinoma of the prostate. 3. Metastatic castration-resistant prostate cancer (mCRPC) with documented disease progression despite androgen deprivation therapy. 4. Prior orchiectomy or medical castration, or continuous treatment with luteinizing hormone releasing hormone analogues (LHRHa) . 5. Measurable disease prior to enrollment. 6. Testosterone at castration level. 7. Progressed on standard therapy, or intolerant to standard therapy, or ineligible for standard therapy, or no standard therapy available. 8. At least 1 prior Androgen Receptor Pathway Inhibitor. 9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: 1. History of other malignancies. 2. Inadequate organ function. 3. Active autoimmune disease. 4. Active CNS involvement. 5. Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases. 6. Any prior medical history of ILD/pneumonitis. 7. Clinically significant corneal disorder or known severe dry eye. 8. Grade 2 or higher peripheral neuropathy. 9. Inadequate washout period for prior anticancer treatment. 10. Any known history of or suspicion for history of clinically significant liver disease . 11. Known hypersensitivity to any component of the DEC003M. 12. Prior treatment with a PSMA-targeted antibody therapy. 13. Other conditions judged by the investigator that may have effects on the patient's participation in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.