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

Phase 2Not Yet RecruitingNCT07258407

T.O.A.D. Oncology SA180 enrolled

Overview

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).

This is a first-in-human, open-label, multicenter Phase 1/2 study with a dose escalation part to determine recommended Phase 2 doses (RP2Ds) of TD001 for further evaluation in an expansion part of the study. Multiple dosing schedules may be evaluated. The safety and preliminary efficacy endpoints of this study will support dose optimization in this patient population.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

180

Conditions

Metastatic Castration-Resistant Prostatic Cancer

Interventions

TD001DRUG

Intravenous (IV) infusion at protocol-defined doses and schedules until disease progression or other reason to end treatment

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Yale University, Yale Cancer Center

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Maximum tolerated dose (dose escalation)

Number of participants with dose-limiting toxicity; incidence of adverse events (AEs), serious AEs (SAEs), abnormal laboratory parameters, TD001 discontinuation or modification due to AEs, as assessed by CTCAE v6.0

Time frame: Treatment + follow-up (estimated 9 months)

Recommended Phase 2 doses (dose escalation)

Incidence of AEs, SAEs, abnormal laboratory parameters, TD001 discontinuation or modification due to AEs, as assessed by CTCAE v6.0

Time frame: Treatment + follow-up (estimated 9 months)

Safety/tolerability - incidence of AEs, SAEs, abnormal laboratory parameters (dose escalation + expansion)

AEs, SAEs, abnormal laboratory parameters by type, severity, and relatedness as assessed by CTCAE v6.0

Time frame: Treatment + follow-up (estimated 21 months)

Safety/tolerability - incidence of TD001 discontinuation or modification due to AEs (dose escalation + expansion)

AEs by type, severity, and relatedness as assessed by CTCAE v6.0

Time frame: Treatment + follow-up (estimated 21 months)

Secondary Outcomes

Plasma PK - AUC

Area under the concentration-time curve for total ADC, total antibody, and unconjugated payload

Time frame: Estimated 6-8 months

Plasma PK - AUClast

Area under concentration-time curve from time zero to the last measurable concentration for total ADC, total antibody, and unconjugated payload

Time frame: Estimated 6-8 months

Plasma PK - AUCtau

Central Contacts

TOAD Clinical Operations

CONTACT

41 41 556 64 01 contact@toadonco.com

Data from ClinicalTrials.gov

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