NCT05958121

Brief Summary

The goal of this clinical trial is to evaluate the safety, tolerability and anti-tumor activity of IMA402 in patients with recurrent and/or refractory solid tumors. Primary objectives:

  • To determine the maximum tolerated doses and/or recommended doses for extensions for IMA402 as monotherapy and in combination with pembrolizumab (Phase Ia)
  • To characterize the safety and tolerability of IMA402 as monotherapy and in combination (Phase I/II)
  • To evaluate anti-tumor activity of IMA402 as monotherapy and in combination (Phase II) Secondary objectives:
  • To evaluate the initial anti-tumor activity of IMA402 as monotherapy and in combination (Phase I)
  • To evaluate anti-tumor activity of IMA402 as monotherapy and in combination (Phase II)
  • To describe the PK of IMA402 as monotherapy and in combination (Phase I/II)

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_1

Timeline
13mo left

Started Aug 2023

Longer than P75 for phase_1

Geographic Reach
2 countries

29 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Aug 2023Sep 2027

First Submitted

Initial submission to the registry

July 14, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 24, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

August 9, 2023

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

4.1 years

First QC Date

July 14, 2023

Last Update Submit

June 29, 2026

Conditions

Refractory CancerRecurrent CancerSolid Tumor, AdultCancer

Outcome Measures

Primary Outcomes (6)

  • Phase I: Number of patients with dose limiting toxicities (DLTs)

    24 months

  • Phase I/II: Number of patients with treatment-emergent adverse events (TEAEs)

    40 months

  • Phase I/II: Number of patients with serious TEAEs

    40 months

  • Phase I/II: Frequency of dose interruptions and reductions, permanent discontinuations

    40 months

  • Phase I/II: Duration of dose interruptions and reductions, permanent discontinuations

    40 months

  • 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)

    40 months

Secondary Outcomes (10)

  • Phase I: ORR based on BOR of CR and PR locally assessed using RECIST v1.1 and iRECIST

    37 months

  • Phase II: ORR based on BOR of CR and PR locally assessed using iRECIST

    40 months

  • 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

    40 months

  • Phase I/II: Duration of response (DOR) of CR or PR based on RECIST v1.1 and iRECIST

    40 months

  • Phase I/II: Progression-free survival (PFS) based on RECIST v1.1 and iRECIST

    40 months

  • +5 more secondary outcomes

Study Arms (3)

Dose escalation/de-escalation (Phase Ia)

EXPERIMENTAL

Dose-Finding of IMA402 as monotherapy or in combination with checkpoint inhibitor (Phase Ia)

Drug: IMA402Drug: IMA402 and checkpoint inhibitor

Dose extension (Phase Ib)

EXPERIMENTAL

Extension cohorts of IMA402 as monotherapy or in combination based on maximum tolerated dose (MTD) and/or recommended doses for extensions (RDEs) (Phase Ib)

Drug: IMA402Drug: IMA402 and checkpoint inhibitorDrug: IMA402 and chemotherapyDrug: IMA402 and IMA401Drug: IMA402 and monoclonal antibodyDrug: IMA402 and chemotherapy +/- monoclonal antibody

Dose extension (Phase II)

EXPERIMENTAL

Selected ISEC investigated on MTD/RDEs based on a manageable/favorable safety profile and initial signs of anti-tumor activity (Phase II)

Drug: IMA402Drug: IMA402 and checkpoint inhibitor

Interventions

IMA402DRUG

IV infusions

Dose escalation/de-escalation (Phase Ia)Dose extension (Phase II)Dose extension (Phase Ib)
IMA402 and checkpoint inhibitorDRUG

IMA402 IV infusions and checkpoint inhibitor

Dose escalation/de-escalation (Phase Ia)Dose extension (Phase II)Dose extension (Phase Ib)
IMA402 and chemotherapyDRUG

IMA402 IV infusions and chemotherapy

Dose extension (Phase Ib)
IMA402 and IMA401DRUG

IMA402 and IMA401 IV infusions

Dose extension (Phase Ib)
IMA402 and monoclonal antibodyDRUG

IMA402 IV infusions and monoclonal antibody

Dose extension (Phase Ib)
IMA402 and chemotherapy +/- monoclonal antibodyDRUG

IMA402 IV infusions and chemotherapy +/- monoclonal antibody

Dose extension (Phase Ib)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 indicated standard-of-care treatments per cohort
  • 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

You may not qualify if:

  • Other active malignancies that require treatment or that might interfere with the trial endpoints
  • The patient is pregnant or is breastfeeding
  • History of hypersensitivity to components of IMA402 or rescue medications; hypersensitivity to or contraindication according to current SmPC for respective combination medicinal product
  • The patient has concurrent severe and/or uncontrolled medical disease. Any other health condition that would, in the investigator's or sponsor'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, history of bleeding into brain metastases, known brain metastases who are receiving therapeutic anticoagulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Universitaetsklinikum Heidelberg AöR

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

Thoraxklinik Heidelberg gGmbH

Heidelberg, Baden-Wurttemberg, 69126, Germany

NOT YET RECRUITING

Universitaetsklinikum Mannheim GmbH

Mannheim, Baden-Wurttemberg, 68167, Germany

RECRUITING

Universitaetsklinikum Tuebingen AöR

Tübingen, Baden-Wurttemberg, 72076, Germany

NOT YET RECRUITING

Universitaetsklinikum Ulm AöR

Ulm, Baden-Wurttemberg, 89081, Germany

RECRUITING

Universitaetsklinikum Erlangen AöR

Erlangen, Bavaria, 91054, Germany

RECRUITING

Klinikum Nürnberg

Nuremberg, Bavaria, 90419, Germany

RECRUITING

Universitaetsklinikum Regensburg

Regensburg, Bavaria, 93053, Germany

RECRUITING

Universitaetsklinikum Wuerzburg AöR

Würzburg, Bavaria, 97080, Germany

RECRUITING

Goethe University Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

RECRUITING

Justus-Liebig-Universitaet Giessen

Giessen, Hesse, 35392, Germany

RECRUITING

Philipps-Universitaet Marburg

Marburg, Hesse, 35043, Germany

RECRUITING

Sana Klinikum Offenbach GmbH

Offenbach, Hesse, 63069, Germany

NOT YET RECRUITING

Elbe Kliniken Stade- Buxtehude Elbe Klinikum Buxtehude gGmbH

Buxtehude, Lower Saxony, 21614, Germany

RECRUITING

Universitaetsmedizin Goettingen

Göttingen, Lower Saxony, 37075, Germany

NOT YET RECRUITING

Universitaetsklinikum Bonn AöR

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

Marien Hospital Duesseldorf GmbH

Düsseldorf, North Rhine-Westphalia, 40479, Germany

RECRUITING

KEM I Evang. Kliniken Essen-Mitte gGmbH

Essen, North Rhine-Westphalia, 45136, Germany

RECRUITING

Universitaetsklinikum Essen AöR

Essen, North Rhine-Westphalia, 45147, Germany

RECRUITING

Johannes Wesling Klinikum Minden

Minden, North Rhine-Westphalia, 32429, Germany

RECRUITING

Universitaet Muenster

Münster, North Rhine-Westphalia, 48149, Germany

NOT YET RECRUITING

Klinikum Chemnitz gGmbH

Chemnitz, Saxony, 09116, Germany

RECRUITING

Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR

Dresden, Saxony, 01307, Germany

RECRUITING

University Of Leipzig

Leipzig, Saxony, 04103, Germany

RECRUITING

Universitaetsklinikum Magdeburg AöR

Magdeburg, Saxony-Anhalt, 39120, Germany

RECRUITING

Antoni von Leeuwenhoek- Netherlands Cancer Institute

Amsterdam, North Holland, 1066 CX, Netherlands

RECRUITING

Leiden Universitair Medisch Centrum

Leiden, South Holland, 2333 ZA, Netherlands

RECRUITING

Universitair Medisch Centrum Groningen

Groningen, 9713 GZ, Netherlands

RECRUITING

Universitair Medisch Centrum Utrecht

Utrecht, 3584 CX, Netherlands

RECRUITING

Related Links

MeSH Terms

Conditions

NeoplasmsRecurrence

Interventions

Drug TherapyAntibodies, Monoclonal

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Immatics Biotechnologies GmbH

    Immatics Biotechnologies GmbH

    STUDY DIRECTOR

Central Study Contacts

Immatics Biotechnologies GmbH

CONTACT

Please E-MailCtgovinquiries@immatics.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2023

First Posted

July 24, 2023

Study Start

August 9, 2023

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

July 1, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations

NL(4)DE(25)