A Phase I, Open-Label, Multicenter Study of JANX007 in Subjects with Metastatic Castration-Resistant Prostate Cancer
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Study Summary
To evaluate safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and the preliminary efficacy of JANX007 administered as a single agent in adults subjects with metastatic castration-resistant prostate cancer (mCRPC).
To evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of JANX007 administered as monotherapy or in combination in adult patients with advanced metastatic castration-resistant prostate cancer (mCRPC).
To assess JANX007 monotherapy at two dose regimens (0.3/2/6mg and 0.3/2/9mg) with dosing administered once weekly or once every two weeks in mCRPC patients who have progressed on or after novel hormonal therapy (NHT).
- Prior solid organ transplant
- Prior treatment with PSMA-targeted CAR-T cell therapy or PSMA-CD3, PSMA-CD28 or other CD3 T-cell engaging bispecific antibodies or radioligand therapy
- Clinically significant cardiovascular disease
- For Monotherapy Expansion Part a: Prior receipt of any treatment other than an ARPI or taxane in the mCRPC setting
- For Monotherapy Expansion Part b: Prior receipt of any treatment other than an anti-androgen therapy or prior receipt of a taxane containing regimen or more than 1 prior line of therapy for mCRPC
- For Monotherapy Part d: More than 1 prior line of therapy for mCRPC or prior receipt of any treatment other than an anti-androgen therapy and PARP inhibitor for mCRPC or prior receipt of a taxane in the mCRPC setting
- For Combination expansion: More than 1 prior line of therapy for mCRPC or prior receipt of any treatment other than a taxane for mCRPC or prior receipt of Darolutamide or prior receipt of a taxane for HSPC
- Active clinically significant infection (bacterial, viral, fungal, mycobacteria or other)
- Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment
- Prior solid organ transplant
- Prior treatment with PSMA-targeted CAR-T cell therapy or PSMA-CD3, PSMA-CD28 or other CD3 T-cell engaging bispecific antibodies
- Clinically significant cardiovascular disease
- Active clinically significant infection (bacterial, viral, fungal, mycobacteria or other)
- Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment
Clinical Study Information for Healthcare Providers
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