A first-in-human study to determine a safe dose of the drug TD001 to treat patients with metastatic prostate cancer that expresses the PSMA protein.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

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

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

30 Jan 2026 → ongoing

Decision date (initial)

2026-01-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

T.O.A.D. Oncology SA

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Safety, Pharmacokinetic, Efficacy

Dose Escalation
• To determine the MTD and RP2Ds of administration schedules of TD001
• To evaluate the safety and tolerability of administration schedules of TD001
Dose Expansion
• To evaluate the safety and tolerability of the RP2D(s) of TD001 with administration schedules

Secondary objectives 5

1. To characterize the PK and exposure-safety/response pharmacodynamics profiles of TD001
2. To assess PSA response rate
3. To assess preliminary antitumor activity of TD001 based on the radiographic response rate per PCWG3-modified RECIST 1.1
4. To assess radiographic and biochemical PFS per PCWG3-modified RECIST 1.1
5. To characterize the immunogenicity of TD001

Conditions and MedDRA coding

Metastatic castration-resistant prostate cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Adult males with documented progressive mCRPC based on at least one of the following: o Serum PSA progression. o Soft-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 Progression of bone disease (2+2 PCWG3 criteria).
2. At least one measurable metastatic lesion per RECIST 1.1.
3. Prior orchiectomy and/or ongoing ADT
4. 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)

Exclusion criteria 3

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Incidence and severity of DLTs during Cycle 1 (dose escalation only)
2. Incidence, severity, and relationship of AEs and SAEs
3. Laboratory parameters
4. Treatment discontinuations and treatment modifications due to AEs

Secondary endpoints 10

1. Plasma concentration profile parameters (AUC, AUClast, AUCtau, Cmax, Tmax, T1/2, and Ctrough) of total ADC, total antibody, and unconjugated exatecan payload
2. Safety and efficacy endpoints
3. PSA50 response rate
4. ORR by investigator assessment
5. PSA PFS
6. Radiographic PFS by investigator assessment
7. Duration of response (PSA and radiographic by investigator assessment)
8. Disease control rate
9. Overall survival
10. Prevalence and plasma titers of ADA against TD001

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

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

Sponsor organisation

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

Address

Rue Du Rhone 65

City

Geneva

Postcode

1204

Country

Switzerland

Scientific contact point

Organisation

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

Contact name

Mohamed Bekradda

Public contact point

Organisation

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

Contact name

Fabrice Bourdel

Third parties 5

Locations

2 EU/EEA countries · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications