A Clinical Trial Evaluating the Safety of TD001 In Patients With PSMA-Expressing Metastatic Prostate Cancer
Recruiting · NCT07258407 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
TD001
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
7 locations listed across 1 US state.
- Yale University, Yale Cancer Center - New Haven, Connecticut, United States
- Vall d'Hebron Institute of Oncology - Barcelona, Spain
- Institut Bergonié - Bordeaux, France
- Hôpital Paris Saint Joseph - Paris, France
- Institut Gustave Roussy - Villejuif, France
- Princess Margaret Cancer Centre - Toronto, Ontario, Canada
- Peter MacCallum Cancer Centre - Melbourne, Victoria, Australia