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Phase I Study of 225Ac-J591 Plus 177Lu-PSMA Small Molecule for Progressive Metastatic Castration Resistant Prostate Cancer

Who is this study for? Patients with Prostate Cancer
What treatments are being studied? 225Ac-J591+177Lu-PSMA-I&T+68Ga-PSMA-11
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This is a phase I dose-escalation study of 225Ac-J591 administered together with 177Lu-PSMA small molecule. Both drugs are designed to deliver radiation to prostate cancer cells; they are known as radionuclide conjugates (radiation linked to antibodies/molecules that recognize prostate cancer cells). This phase of the study (phase I) will determine the highest dose of the study intervention that can be safely given.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• Histologically or cytologically confirmed adenocarcinoma of prostate

• Documented progressive metastatic CRPC based on Prostate Cancer Working Group 3 (PCWG3) criteria, which includes at least one of the following criteria: PSA progression, Objective radiographic progression in soft tissue, New bone lesions

• ECOG performance status of 0-2

• Have serum testosterone \< 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH/GnRH analogue (agonist/antagonist) if they have not undergone bilateral orchiectomy

• Have previously been treated with at least one of the following: Androgen receptor signaling inhibitor (such as enzalutamide), CYP 17 inhibitor (such as abiraterone acetate)

• Have previously received taxane chemotherapy, been determined to be ineligible for taxane chemotherapy by their physician or refused taxane chemotherapy

• Age \> 18 years

• Patients must have normal organ and marrow function as defined below: Absolute neutrophil count: \>2,000 cells/mm3, Hemoglobin: ≥9 g/dL, Platelet count: \>150,000 x 109/uL, Serum creatinine: \<1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min/1.73 m2 by Cockcroft-Gault, Serum total bilirubin: \<1.5 x ULN (unless due to Gilbert's syndrome in which case direct bilirubin must be normal), Serum AST and ALT: \<1.5 x ULN in the absence of liver metastases; \<3 x ULN if due to liver metastases (in both circumstances bilirubin must meet entry criteria)

• Ability to understand, and the willingness to sign, a written informed consent document

Locations
United States
New York
Brooklyn Methodist Hospital - New York Presbyterian
RECRUITING
Brooklyn
Weill Cornell Medicine New York Presbyterian
RECRUITING
New York
Contact Information
Primary
GUONC Research Team
guonc@med.cornell.edu
212-746-1480
Time Frame
Start Date: 2021-06-30
Estimated Completion Date: 2029-12
Participants
Target number of participants: 42
Treatments
Experimental: Combination of 225Ac-J591 and 177Lu-PSMA-I&T
Participants who received the combination of 225Ac-J591 and 177Lu-PSMA-I\&T, along with 68Ga-PSMA-11.
Experimental: Combination of 225Ac-J591 and 177Lu-PSMA-617
Participants will receive the study drugs 225Ac-J591 and 177Lu-PSMA-617, along with 68Ga-PSMA-11.
Authors
Scott Tagawa
Related Therapeutic Areas
Sponsors
Leads: Weill Medical College of Cornell University

This content was sourced from clinicaltrials.gov

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