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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523273-41-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation | Experimental | Sequential groups of participants receive TD001 at escalating doses |
|
| RP2D dose expansion | Experimental | Groups of participants receive TD001 at the recommended Phase 2 doses (RP2Ds) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TD001 | Drug | Intravenous (IV) infusion at protocol-defined doses and schedules until disease progression or other reason to end treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | Treatment + follow-up (estimated 21 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma PK - AUC | Area under the concentration-time curve for total ADC, total antibody, and unconjugated payload | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| TOAD Clinical Operations | Contact | 41 41 556 64 01 | contact@toadonco.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University, Yale Cancer Center | Not yet recruiting | New Haven | Connecticut | 06520 | United States | |
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| ID | Term |
|---|---|
| D064129 | Prostatic Neoplasms, Castration-Resistant |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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3 + 3 dose escalation design followed by RP2D cohort expansion
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| Estimated 6-8 months |
| Plasma PK - AUCtau | Area under concentration-time curve from time zero to the end of the dosing interval for total ADC, total antibody, and unconjugated payload | Estimated 6-8 months |
| Plasma PK - Cmax | Maximum concentration for total ADC, total antibody, and unconjugated payload | Estimated 6-8 months |
| Plasma PK - Tmax | Time to maximum concentration for total ADC, total antibody, and unconjugated payload | Estimated 6-8 months |
| Plasma PK - T1/2 | Terminal elimination half-life for total ADC, total antibody, and unconjugated payload | Estimated 6-8 months |
| Plasma PK - Ctrough | Trough concentration for total ADC, total antibody, and unconjugated payload | Estimated 6-8 months |
| PSA50 response rate | ≥50% PSA decrease from baseline, per PCWG3 | Treatment (estimated 8 months) |
| Overall response rate | Best response of CR or PR per PCWG3-modified RECIST 1.1 | Treatment (estimated 8 months) |
| PSA progression-free survival | Per PCWG3 | Treatment + follow-up (estimated 21 months) |
| Radiographic progression-free survival | per PCWG3-modified RECIST 1.1 | Treatment + follow-up (estimated 21 months) |
| Duration of response | For PSA and radiographic response | Treatment + follow-up (estimated 21 months) |
| Disease control rate | Best response of CR, PR or SD | Treatment (estimated 8 months) |
| Overall survival | Treatment + follow-up (estimated 21 months) |
| Immunogenicity - prevalance and incidence of ADAs | ADAs against TD001 prior to first dose and at any time on treatment | Treatment period + follow-up (estimated 9 months) |
| Peter MacCallum Cancer Centre |
| Recruiting |
| Melbourne |
| Victoria |
| 3000 |
| Australia |
| Princess Margaret Cancer Centre | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
| Institut Bergonié | Recruiting | Bordeaux | 33076 | France |
| Hôpital Paris Saint Joseph | Recruiting | Paris | 75014 | France |
| Institut Gustave Roussy | Recruiting | Villejuif | 94805 | France |
| Vall d'Hebron Institute of Oncology | Recruiting | Barcelona | 08035 | Spain |
| D009369 |
| Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |