TD001 for Metastatic castration-resistant prostate cancer

Inclusion criteria

• {"criterion_text":"- Adult males with documented progressive mCRPC based on at least one of the following: o\tSerum PSA progression. o\tSoft-tissue or visceral progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) with Prostate Cancer Working Group 3 (PCWG3). o\tProgression of bone disease (2+2 PCWG3 criteria)."}
• {"criterion_text":"- At least one measurable metastatic lesion per RECIST 1.1."}
• {"criterion_text":"- Prior orchiectomy and/or ongoing ADT"}
• {"criterion_text":"- Received at least one androgen receptor pathway inhibitor (ARPI) and at least one but no more than two taxane agents (or be unsuitable for treatment). Participants with a homologous recombination repair (HRR) gene mutation must have received a poly (ADP-ribose) polymerase (PARP) inhibitor (or be unsuitable for treatment)"}
• {"criterion_text":"- (No further inclusion criteria text available in the provided data)"}

Exclusion criteria

• {"criterion_text":"- Previous treatment with strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223, or hemi-body irradiation, within 6 months prior to treatment start."}
• {"criterion_text":"- Systemic anticancer therapy including an investigational agent within 28 days prior to treatment start."}
• {"criterion_text":"- Known hypersensitivity to the components of the trial drug, its analogs, or excipients"}

Primary endpoints

• {"endpoint_text":"- Incidence and severity of DLTs during Cycle 1 (dose escalation only)","definition_or_measurement_approach":"DLTs assessed during Cycle 1 in the dose-escalation portion; used to determine dose-limiting toxicity incidence and severity (no further measurement details provided)."}
• {"endpoint_text":"- Incidence, severity, and relationship of AEs and SAEs","definition_or_measurement_approach":"All adverse events and serious adverse events will be recorded with incidence, severity and investigator-assessed relationship to study drug (specific grading/scales not provided)."}
• {"endpoint_text":"- Laboratory parameters","definition_or_measurement_approach":"Routine laboratory safety parameters will be monitored (no detailed list or thresholds provided)."}
• {"endpoint_text":"- Treatment discontinuations and treatment modifications due to AEs","definition_or_measurement_approach":"Counts and reasons for treatment discontinuations and modifications attributable to adverse events (no further specification provided)."}

Secondary endpoints

• {"endpoint_text":"- Plasma concentration profile parameters (AUC, AUClast, AUCtau, Cmax, Tmax, T1/2, and Ctrough) of total ADC, total antibody, and unconjugated exatecan payload","definition_or_measurement_approach":"Pharmacokinetic parameters for total ADC, total antibody and unconjugated exatecan measured from plasma samples (AUC, AUClast, AUCtau, Cmax, Tmax, T1/2, Ctrough)."}
• {"endpoint_text":"- Safety and efficacy endpoints","definition_or_measurement_approach":"General safety and efficacy assessments (no further detail provided)."}
• {"endpoint_text":"- PSA50 response rate","definition_or_measurement_approach":"Proportion of participants achieving ≥50% decline in PSA (PSA50); specific assessment timing not provided."}
• {"endpoint_text":"- ORR by investigator assessment","definition_or_measurement_approach":"Objective response rate per investigator assessment (likely per PCWG3-modified RECIST 1.1 for radiographic responses; exact assessment schedule not provided)."}
• {"endpoint_text":"- PSA PFS","definition_or_measurement_approach":"Progression-free survival as defined by PSA criteria (PCWG3-modified), specific definition/timing not provided."}
• {"endpoint_text":"- Radiographic PFS by investigator assessment","definition_or_measurement_approach":"Radiographic progression-free survival per investigator assessment using PCWG3-modified RECIST 1.1 (specific timing not provided)."}
• {"endpoint_text":"- Duration of response (PSA and radiographic by investigator assessment)","definition_or_measurement_approach":"Time from first documented response to progression or death assessed by PSA and radiographic criteria per investigator (no further detail)."}
• {"endpoint_text":"- Disease control rate","definition_or_measurement_approach":"Proportion of participants with response or stable disease (no further definition provided)."}
• {"endpoint_text":"- Overall survival","definition_or_measurement_approach":"Time from randomisation/enrolment to death from any cause (no further detail provided)."}
• {"endpoint_text":"- Prevalence and plasma titers of ADA against TD001","definition_or_measurement_approach":"Immunogenicity assessment measuring prevalence and plasma titers of anti-drug antibodies (ADA) against TD001 (assay details not provided)."}

France

Earliest CTIS Part Ii Submission Date

02-12-2025

Latest Decision Or Authorization Date

16-01-2026

Processing Time Days

45

Number Of Sites

3

Number Of Participants

55

Spain

Earliest CTIS Part Ii Submission Date

02-12-2025

Latest Decision Or Authorization Date

21-01-2026

Processing Time Days

50

Number Of Sites

1

Number Of Participants

55

Primary sponsor

Full Name

T.O.A.D. Oncology S.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

Suvoda LLC

Responsibilities

sponsorDuties codes: [3] (specific responsibilities not detailed)

Name

PPD Development LP

Responsibilities

sponsorDuties codes: [4] (specific responsibilities not detailed)

Third parties

• {"country":"Netherlands","full_name":"Xerimis B.V.","duties_or_roles":"sponsorDuties codes: [14,15]; code 15 value: IMP Qualified Person","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Oncology Therapeutic Development","duties_or_roles":"sponsorDuties codes: [1,10,11,12,2,5,6,7,8,9] (detailed role labels not provided)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties codes: [3]","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}