Clinical trial NCT05958121: IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors
Official title: A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Anti-Tumor Activity of IMA402, a Bispecific TCER® Targeting PRAME, in Patients With Recurrent and/or Refractory Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Refractory Cancer
Recurrent Cancer
Solid Tumor, Adult
Cancer
Lead sponsor: Immatics Biotechnologies GmbH
Sponsor class: INDUSTRY
First posted: 2023-07-24
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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)

Secondary objectives:

* 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)

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)

Eligibility criteria: 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

Primary outcomes:
measure: Phase I: Number of patients with dose limiting toxicities (DLTs)
timeFrame: 24 months
measure: Phase I/II: Number of patients with treatment-emergent adverse events (TEAEs)
timeFrame: 40 months
measure: Phase I/II: Number of patients with serious TEAEs
timeFrame: 40 months
measure: Phase I/II: Frequency of dose interruptions and reductions, permanent discontinuations
timeFrame: 40 months
measure: Phase I/II: Duration of dose interruptions and reductions, permanent discontinuations
timeFrame: 40 months
measure: 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)
timeFrame: 40 months
Secondary outcomes:
measure: Phase I: ORR based on BOR of CR and PR locally assessed using RECIST v1.1 and iRECIST
timeFrame: 37 months
measure: Phase II: ORR based on BOR of CR and PR locally assessed using iRECIST
timeFrame: 40 months
measure: 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
timeFrame: 40 months
measure: Phase I/II: Duration of response (DOR) of CR or PR based on RECIST v1.1 and iRECIST
timeFrame: 40 months
measure: Phase I/II: Progression-free survival (PFS) based on RECIST v1.1 and iRECIST
timeFrame: 40 months
measure: Phase I/II: Overall survival (OS)
timeFrame: 40 months
measure: Phase I/II: Determination of PK parameter: half-life (t1/2)
timeFrame: 40 months
measure: Phase I/II: Determination of PK parameter: minimal serum concentration (Cmin)
timeFrame: 40 months
measure: Phase I/II: Determination of PK parameter: maximal serum concentration (Cmax)
timeFrame: 40 months
measure: Phase I/II: Determination of PK parameter: area under the curve (AUC)
timeFrame: 40 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg AöR
state: Baden-Wuerttemberg
city: Mannheim
country: Germany
facility: Universitaetsklinikum Mannheim GmbH
state: Baden-Wuerttemberg
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm AöR
state: Baden-Wuerttemberg
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen AöR
state: Bavaria
city: Nuremberg
country: Germany
facility: Klinikum Nürnberg
state: Bavaria
city: Regensburg
country: Germany
facility: Universitaetsklinikum Regensburg
state: Bavaria
city: Wuerzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg AöR
state: Bavaria
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn AöR
state: North Rhine-Westphalia
city: Duesseldorf
country: Germany
facility: Marien Hospital Duesseldorf GmbH
state: North Rhine-Westphalia
city: Essen
country: Germany
facility: KEM I Evang. Kliniken Essen-Mitte gGmbH
state: North Rhine-Westphalia
city: Essen
country: Germany
facility: Universitaetsklinikum Essen AöR
state: North Rhine-Westphalia
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden
state: North Rhine-Westphalia
city: Magdeburg
country: Germany
facility: Universitaetsklinikum Magdeburg AöR
state: Saxony-Anhalt
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
state: Saxony
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
state: Saxony
city: Leipzig
country: Germany
facility: University Of Leipzig
state: Saxony
city: Amsterdam
country: Netherlands
facility: Antoni von Leeuwenhoek- Netherlands Cancer Institute
state: North Holland
city: Leiden
country: Netherlands
facility: Leiden Universitair Medisch Centrum
state: South Holland
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
Study officials:
affiliation: Immatics Biotechnologies GmbH
name: Immatics Biotechnologies GmbH
role: STUDY_DIRECTOR
References: