A Study of TRC003 in the Treatment of Patients With Progressive PSMA-positive mCRPC

Summary

The purpose of this study is to evaluate safety and tolerability, pharmacokinetics （PK）, efficacy of TRC003 injection in patients with progressive PSMA-positive mCRPC who have been treated with androgen receptor pathway inhibitor (ARPI) or taxane-based chemotherapy. We plan to recruit 90 participants who will be randomly assigned to 1 of 3 dose cohorts (30 cases per dose cohort) with up to 6 cycles of treatment in this study.

Eligibility

Inclusion Criteria:

* Participants must have the ability to understand and sign ICF.
* Participants must have histological, and/or cytological confirmation of adenocarcinoma of the prostate.
* Participants must have progressive mCRPC after treatment of ARPI or taxane-based chemotherapy.
* Participant must have been diagnosed with mCRPC with documented progressive disease.
* Participants must have prior orchiectomy and/or ongoing androgen-deprivation therapy with a castrate level of serum testosterone (\< 50 ng/dL or \< 1.7 nmol/L).
* Participants must have one or more PSMA-positive lesions whose PSMA uptake (SUVmax) is more than 2 fold of the blood pool.
* Participants with an ECOG performance status of 0 - 2.
* Participants must have adequate organ function
* For participants who have partners of childbearing potential: Partner and/or patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principal Investigator during the study and for 6 months after last investigational product administration.

Exclusion Criteria:

* Participants with mixed histology of prostate cancer (e.g., neuroendocrine).
* Any FDG-positive and PSMA-negative target lesions.
* Any investigational agents and other concurrent chemotherapy, targeted therapy, biologic agents, immunotherapy, radioligand therapy (androgen-deprivation therapy excepted) within 28 days or 5 half-lives prior to day of administration, whichever is longer.
* Previous treatment with any conventional external beam radiotherapy including hemi-body radiation within 6 weeks before enrollment.
* Previous bone-targeted therapy cannot be taken with a stable dose within 4 weeks before enrollment.
* Known hypersensitivity to the components of the study therapy or its analogs.
* Transfusion for the sole purpose of making a participant eligible for study inclusion within 28 days before administration.
* A superscan as seen in the baseline bone scan.
* Concurrent serious (as determined by the Investigator) medical conditions.
* Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment.

Conditions2

Interventions1

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