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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05958121
• Other study ID #: IMA402-101
• Secondary ID: 2022-503133-54-0
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 9, 2023
• Est. completion date: September 2027

Study information

• Verified date: May 2024
• Source: Immatics Biotechnologies GmbH
• Contact: Immatics Biotechnologies GmbH
• Phone: Please E-Mail
• Email: Ctgovinquiries[@]immatics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 145
• Est. completion date: September 2027
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Recurrence
• Recurrent Cancer
• Refractory Cancer
• Solid Tumor, Adult

Intervention

Biological:
• 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)

Locations

Country	Name	City	State
Germany	Universitaetsklinikum Bonn AöR	Bonn	North Rhine-Westphalia
Germany	Klinikum Chemnitz gGmbH	Chemnitz	Saxony
Germany	Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR	Dresden	Saxony
Germany	Marien Hospital Duesseldorf GmbH	Duesseldorf	North Rhine-Westphalia
Germany	Universitaetsklinikum Erlangen AöR	Erlangen	Bavaria
Germany	KEM I Evang. Kliniken Essen-Mitte gGmbH	Essen	North Rhine-Westphalia
Germany	Universitaetsklinikum Essen AöR	Essen	North Rhine-Westphalia
Germany	Universitaetsklinikum Heidelberg AöR	Heidelberg	Baden-Wuerttemberg
Germany	University Of Leipzig	Leipzig	Saxony
Germany	Universitaetsklinikum Magdeburg AöR	Magdeburg	Saxony-Anhalt
Germany	Universitaetsklinikum Mannheim GmbH	Mannheim	Baden-Wuerttemberg
Germany	Johannes Wesling Klinikum Minden	Minden	North Rhine-Westphalia
Germany	Klinikum Nürnberg	Nuremberg	Bavaria
Germany	Universitaetsklinikum Regensburg	Regensburg	Bavaria
Germany	Universitaetsklinikum Ulm AöR	Ulm	Baden-Wuerttemberg
Germany	Universitaetsklinikum Wuerzburg AöR	Wuerzburg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Immatics Biotechnologies GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase I: Number of patients with dose limiting toxicities (DLTs)		24 months
Primary	Phase I/II: Number of patients with treatment-emergent adverse events (TEAEs)		40 months
Primary	Phase I/II: Number of patients with serious TEAEs		40 months
Primary	Phase I/II: Frequency of dose interruptions and reductions, permanent discontinuations		40 months
Primary	Phase I/II: Duration of dose interruptions and reductions, permanent discontinuations		40 months
Primary	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	Phase I: ORR based on BOR of CR and PR locally assessed using RECIST v1.1 and iRECIST		37 months
Secondary	Phase II: ORR based on BOR of CR and PR locally assessed using iRECIST		40 months
Secondary	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
Secondary	Phase I/II: Duration of response (DOR) of CR or PR based on RECIST v1.1 and iRECIST		40 months
Secondary	Phase I/II: Progression-free survival (PFS) based on RECIST v1.1 and iRECIST		40 months
Secondary	Phase I/II: Overall survival (OS)		40 months
Secondary	Phase I/II: Determination of PK parameter: half-life (t1/2)		40 months
Secondary	Phase I/II: Determination of PK parameter: minimal serum concentration (Cmin)		40 months
Secondary	Phase I/II: Determination of PK parameter: maximal serum concentration (Cmax)		40 months
Secondary	Phase I/II: Determination of PK parameter: area under the curve (AUC)		40 months

External Links

•   Corporate Website