Phase 1
N=17
A Trial of CTT1403 for Metastatic Castration Resistant Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03822871 ↗Enrolled (actual)
17
Serious AEs
17.7%
Results posted
Mar 2024
Primary outcome: Primary: Frequency of Dose-limiting Toxicity at Escalating Dose Levels of CTT1403 — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- CTT1403 (Drug); CTT1057 (Drug); 68Ga-PSMA-11 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Cancer Targeted Technology
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Dose-limiting Toxicity at Escalating Dose Levels of CTT1403 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Objective Response Rate by RECIST v1.1 Criteria |
0; 1; 0; 1; 4; 2 | — |
| SECONDARY Assessment of Organ Dosimetry of CTT1403 by SPECT/CT Imaging |
0.608; 0.611; 0.760; 1.024; 0.579; 0.518 | — |
| SECONDARY Number of Participants With Change in Patient Reported Pain as Measured by Brief Pain Index |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY Assessment of Pharmacokinetics of CTT1403 |
0.747; 1.044; 0.699; 0.813; 0.680; 28.881 | — |
Summary
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03822871). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.