Letzte Aktualisierung: 06.05.2026
Eierstockkrebs (Ovarialkarzinom) [C56]
IMA402-101
Studieninformationen
A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Anti-Tumor Activity of IMA402, a Bispecific T Cell-Engaging Receptor Molecule (TCER®) targeting PRAME, in Patients with Recurrent and/or Refractory Solid Tumors
Ziele
Primäres Prüfziel
To determine the maximum tolerated dose and/or recommended dose for extension for IMA402 (Phase I) To characterize the safety and tolerability of IMA402 (Phase I/II) To evaluate anti-tumor activity of IMA402 (Phase II)
Sekundäre Prüfziele für die Behandlungsarme:
To evaluate the initial anti-tumor activity of IMA402 (Phase I) To evaluate anti-tumor activity of IMA402 (Phase II) To describe the PK of IMA402 (Phase I/II)
Design
Design
Phase
Zentren
Datenerhebung
Interventionsgruppen
Verblindung
Erkrankung
Diagnose
Diagnosenbeschreibung
patients with a known high PRAME prevalence; i.e.: i) cutaneous and uveal melanoma, ii) endometrial carcinoma including uterine carcinosarcoma, iii) epithelial ovarian, fallopian tube and primary peritoneal cancer restricted to serous, clear cell and endometrioid subtypes (here abbreviated as EOFPC), iv) synovial sarcoma, and v) squamous non-small cell lung carcinoma (sqNSCLC)
Mutation
Patienten
Alter
Einschlusskriterien
Patients ≥ 18 years old Patients must have a specific pathologically confirmed and documented advanced and/or metastatic solid tumor indication Patients must have received or not be eligible for all available indicated standard-of-care treatments Measurable disease according to RECIST 1.1 Confirmed HLA status ECOG Performance Status of 0 to 1 Adequate baseline hematologic, hepatic and renal function, acceptable coagulation status
Ausschlusskriterien
Other active malignancies that require treatment or that might interfere with the trial endpoints (ongoing adjuvant anti-hormonal treatment is allowed) The patient is pregnant or is breastfeeding History of hypersensitivity to components of IMA402 or rescue medications, if no alternative treatment option is available The patient has concurrent severe and/or uncontrolled medical disease. Any other health condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical trial because of safety concerns or compliance with clinical trial procedures Patients with active brain metastases
Therapie
Intervention
Substanz
| Prüfplancode | IMA402-101 |
|---|---|
| EudraCT | - |
| Clinicaltrials.gov | NCT05958121 |
|---|---|
| ISRCTN | - |
| DRKS | - |
Zuständige Gesamtstudie
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Leiter der klinischen Prüfung (LKP)—
Studiengruppen/-zentrale
Kontakt Klinische Studien
CIO Aachen: Uniklinik RWTH Aachen, +49 (0) 241 80-85490
CIO Bonn: Uniklinik Bonn, +49 (0) 228 287-16036
CIO Köln: Uniklinik Köln, +49 (0) 221 478-0
CIO Düsseldorf: Uniklinik Düsseldorf, +49 (0) 211 81-04150 (Mo-Do)




