Title
A Phase 1, Open-Label, Multicenter Study of JANX007 In Subjects With Metastatic Castration-Resistant Prostate Cancer

Description
A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer

Objective
Part 3 Objectives:
Primary
-To compare the safety and tolerability of 2 potential RP2D-Rs identified from Part 1 and Part 2
-To assess the safety and tolerability in taxane naïve subjects with mCRPC
-To assess safety and tolerability of JANX007 when administered via central venous (CV) port

Secondary
-To evaluate the PK profile of JANX007
-To evaluate the immunogenicity of JANX007
-To assess preliminary efficacy of the JANX007
-To evaluate the PK profile of JANX007 when administered via CV port
-To evaluate the immunogenicity of JANX007 when administered via CV port
- To assess preliminary efficacy of JANX007 when administered via CV port

Treatment This study is a first-in-human, Phase 1, open-label, multicenter study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and the preliminary efficacy of JANX007 in adults with metastatic castration-resistant prostate cancer (mCRPC).

Key Eligibility Inclusion Criteria:

Male >/=18 years of age at the time of signing informed consent

Histologically or cytologically confirmed adenocarcinoma of the prostate

For Dose Escalation and Backfill: Having mCRPC that progressed after at least one novel anti-androgen therapy and at least one taxane containing regimen. Participants who have actively refused a taxane containing regimen or are medically unsuitable to receive taxane are eligible

Adequate organ function

For Monotherapy Expansion Part a: Have received
For Monotherapy Expansion Part b: Have received <=/ 2 anti-androgen therapies in either the HSPC or CRPC settings

For Monotherapy Expansion Part d: Have received
For Combination Expansion: Have received

Applicable Disease Sites
Prostate

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital