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Clinical Trial · NCT06785636
A Phase 1b/2a Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With mCRPC
Overview
This is a dose-finding study to assess the safety and preliminary antitumor activity of Pocenbrodib alone or with darolutamide in patients with metastatic castration-resistant prostate cancer (mCRPC)
Sponsor
Unknown Organization
Phase
Phase 1/2
Contacts
Steve Kye, MD, MPH (CONTACT)
clinicaltrials@pathos.com
708-232-3791
ClinicalTrials.gov
NCT06785636Drug / Compound
vipivotide tetraxetan
Isotope(s):
LUTETIUM-177
Radioisotope: Lu-177
Theranostic Role: Therapeutic Agent & SPECT Imaging
T1/2 (Half-Life): 6.7 Days
Decay Mode: BETA, GAMMA
Energy: Eβeta max 497 keV, Gamma 113-208 keV
Range: In Tissue: 0.25-2mm
Decay Daughters: Hf177
Status: FDA Approvals: PLUVICTO® (2022), LUTATHERA® (2017)
Target(s):
- PSMA
Ligand Class: Small Molecules
Chelator: DOTA
Eligibility
Inclusion
- Metastatic disease, documented by imaging. Imaging performed within 56 days prior to Screening is acceptable1b / 2a
- Histologic documentation of prostate adenocarcinoma
Exclusion
- No prior chemotherapy for mCRPC
- 1 line of prior any ARPI therapy
- Must have received at least 2 cycles of PLUVICTO®
- Any liver metastases confirmed by biopsy or evidence of lesions \>1 cm consistent with liver metastases on imaging.
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