A Clinical Trial Evaluating the Safety of TD001 In Patients With PSMA-Expressing Metastatic Prostate Cancer

Summary

This study will evaluate the safety, tolerability, drug levels (pharmacokinetics) and preliminary antitumor activity of TD001, an antibody-drug conjugate (ADC) targeting prostate-specific membrane antigen (PSMA), in men with metastatic PSMA-expressing castration-resistant prostate cancer (CRPC).

Eligibility

Inclusion Criteria:

* Patient must fully understand the study requirements and voluntarily sign informed consent.
* PSMA-expressing metastatic CRPC with documented progression based on serum PSA, RECIST 1.1 with PCWG3, and/or bone disease.
* At least one measurable metastatic lesion per RECIST 1.1.
* Adequate organ function.
* Prior orchiectomy and/or ongoing androgen deprivation therapy.
* Prior treatment with at least one androgen receptor pathway inhibitor (ARPI) drug.

Exclusion Criteria:

* Previous treatment with strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223, or hemi-body irradiation, within 6 months before treatment.
* Systemic anticancer therapy including an investigational agent within 28 days before treatment.
* Known hypersensitivity to the components of TD001, its analogs, or excipients.
* Current dyspnea at rest, other disease requiring continuous oxygen therapy, or history of pneumonitis

Conditions2

Locations1 site

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