Clinical trial · Interventional
A Trial of CTT1403 for Metastatic Castration Resistant Prostate Cancer
A Phase 1 Trial for Evaluation of Safety and 177Lu Radiation Dosimetry of CTT1403: A Peptidomimetic Inhibitor of Prostate Specific Membrane Antigen, in Metastatic Castration Resistant Prostate Cancer (mCRPC)
NCT03822871CI-TRIAL-00075281completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to find the highest dose level of study drug, CTT1403, that can be safely administered to patients with metastatic castration resistant prostate cancer (mCRPC).
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-PSMA-11 | Drug | — | UNRESOLVED |
| CTT1057 | Drug | — | UNRESOLVED |
| CTT1403 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- description
- Escalating doses of 0.75 GBq - 2.0 GBq of CTT1403
- interventionNames
- Drug: CTT1403
- Drug: CTT1057
- Drug: 68Ga-PSMA-11
- type
- EXPERIMENTAL
- label
- Dose Escalation/Expansion
- description
- Escalating doses of 3.0 GBq - 9.0 GBq of CTT1403
- interventionNames
- Drug: CTT1403
- Drug: CTT1057
- Drug: 68Ga-PSMA-11
Primary outcomes (2)
- measure
- Frequency of Dose-limiting Toxicity at Escalating Dose Levels of CTT1403
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically confirmed prostate adenocarcinoma that is metastatic and castration resistant (mCRPC). * At least 3 metastatic foci avid for PSMA-specific PET agent (CTT1057) uptake on Screening PSMA PET. * Has received docetaxol, ineligible for docetaxol, or refused docetaxol for the treatment of prostate cancer. * Has progression by the PCWG3 criteria during or after treatment with either abiraterone or enzalutamide * Male Age ≥ 18 years. * Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (see Appendix 2). * Demonstrate adequate organ function Exclusion Criteria: * Has received previous treatment with radium-223 or another radiopharmaceutical within 3 months prior to first dose of CTT1403. * Has received prior systemic anti-cancer therapy (excluding radiopharmaceutical) within 14 days, or 5 half-lives, whichever is shorter, prior to first dose of CTT1403. * Has received external-beam radiation within 14 days prior to first dose of CTT1403. * Has received cabazitaxel for the treatment of mCRPC. * Has received previous treatment with a therapeutic targeting PSMA. * Has an additional active malignancy requiring therapy that may confound the assessment of the study endpoints. * Has clinically significant cardiovascular disease * Has a history of untreated brain metastases * Has evidence of diffuse bone marrow involvement by prostate cancer in the judgment of study investigator. * Clinically significant urinary obstruction or moderate/severe hydronephrosis on baseline imaging. * Has a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days before CTT1403 administration. * Has known positive status for chronic hepatitis B or hepatitis C * Known or suspected myelodysplastic syndrome. * Has any medical condition which in the opinion of the Investigator places the patient at an unacceptably high risk for toxicities.
References
Publications (0)
Data not yet available
No reference posted for this study.