JOURNAL ONKOLOGIE – STUDIE

IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05958121

Studienbeginn:
August 2023

Letztes Update:
26.03.2024

Wirkstoff:
IMA402 (Phase Ia), IMA402 (Phase Ib), IMA402 (Phase II)

Indikation (Clinical Trials):
Recurrence

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Immatics Biotechnologies GmbH

Collaborator:
-

Studienleiter

Immatics Biotechnologies GmbH
Study Director
Immatics Biotechnologies GmbH

Kontakt

Immatics Biotechnologies GmbH
Kontakt:
Phone: Please E-Mail
E-Mail: Ctgovinquiries@immatics.com» Kontaktdaten anzeigen

Studienlocations
(3 von 13)

Universitaetsklinikum Heidelberg AöR
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps

Universitaetsklinikum Ulm AöR
89081 Ulm
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps

Universitatsklinikum Erlangen AöR
91054 Erlangen
(Bayern)
GermanyRekrutierend» Google-Maps

Universitaetsklinikum Regensburg
93053 Regensburg
(Bayern)
GermanyRekrutierend» Google-Maps

Universitatsklinikum Wuerzburg AöR
97080 Wuerzburg
(Bayern)
GermanyRekrutierend» Google-Maps

Universitaetsklinikum Bonn AöR
53127 Bonn
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps

Marien Hospital Duesseldorf GmbH
40479 Duesseldorf
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps

Universitaetsklinikum Essen AöR
45147 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps

Johannes Wesling Klinikum Minden
32429 Minden
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps

Universitaetsklinikum Magdeburg AöR
39120 Magdeburg
(Sachsen-Anhalt)
GermanyNoch nicht rekrutierend» Google-Maps

Klinikum Chemnitz gGmbH
09116 Chemnitz
(Sachsen)
GermanyRekrutierend» Google-Maps

Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps

University Of Leipzig
04103 Leipzig
(Sachsen)
GermanyRekrutierend» Google-Maps

Alle anzeigen

Studien-Informationen

Detailed Description:

The study will be conducted in two phases:

- Phase Ia: Dose escalation/de-escalation

- Phase Ib: Dose extension

- Phase II: Dose extension in selected Indication-specific extension cohort(s) (ISEC)

Ein-/Ausschlusskriterien

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Studien-Rationale

Primary outcome:

1. Phase I: Number of patients with dose limiting toxicities (DLTs) (Time Frame - 24 months)

2. Phase I/II: Number of patients with treatment-emergent adverse events (TEAEs) (Time Frame - 40 months)

3. Phase I/II: Number of patients with serious TEAEs (Time Frame - 40 months)

4. Phase I/II: Frequency of dose interruptions and reductions, permanent discontinuations (Time Frame - 40 months)

5. Phase I/II: Duration of dose interruptions and reductions, permanent discontinuations (Time Frame - 40 months)

6. Phase II: Overall response rate (ORR) based on best overall response (BOR) of complete response (CR) and partial response (PR) locally assessed using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) (Time Frame - 40 months)

Secondary outcome:

1. Phase I: ORR based on BOR of CR and PR locally assessed using RECIST v1.1 and iRECIST (Time Frame - 37 months)

2. Phase II: ORR based on BOR of CR and PR locally assessed using iRECIST (Time Frame - 40 months)

3. Phase I/II: Disease control rate (DCR) of CR, PR or stable disease (SD) (lasting 6 or more weeks) following the initiation of IMA402 based on RECIST v1.1 and iRECIST (Time Frame - 40 months)

4. Phase I/II: Duration of response (DOR) of CR or PR based on RECIST v1.1 and iRECIST (Time Frame - 40 months)

5. Phase I/II: Progression-free survival (PFS) based on RECIST v1.1 and iRECIST (Time Frame - 40 months)

6. Phase I/II: Overall survival (OS) (Time Frame - 40 months)

7. Phase I/II: Determination of PK parameter: half-life (t1/2) (Time Frame - 40 months)

8. Phase I/II: Determination of PK parameter: minimal serum concentration (Cmin) (Time Frame - 40 months)

9. Phase I/II: Determination of PK parameter: maximal serum concentration (Cmax) (Time Frame - 40 months)

10. Phase I/II: Determination of PK parameter: area under the curve (AUC) (Time Frame - 40 months)

Studien-Arme

Experimental: Dose escalation/de-escalation (Phase Ia)
Dose-Finding of IMA402 (Phase Ia)
Experimental: Dose extension (Phase Ib)
IMA402 monotherapy extension cohorts based on maximum tolerated dose (MTD) and/or recommended doses for extensions (RDEs) (Phase Ib)
Experimental: Dose extension (Phase II)
Selected ISEC investigated on MTD/RDEs based on a manageable/favorable safety profile and initial signs of anti-tumor activity (Phase II)

Geprüfte Regime

IMA402 (Phase Ia):
Intravenous infusions in escalating dose levels
IMA402 (Phase Ib):
Treatment at MTD and/or RDE (Phase Ib)
IMA402 (Phase II):
Treatment at MTD/RDE based on a manageable/favorable safety profile and initial signs of anti-tumor activity of selected ISEC (Phase II)

Quelle: ClinicalTrials.gov

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