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, as Monotherapy or in Combination with a Checkpoint Inhibitor in Patients with Recurrent and/or Refractory Solid Tumors

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Immatics Biotechnologies GmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

9 Aug 2023 → ongoing

Decision date (initial)

2023-07-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Immatics Biotechnologies GmbH

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Efficacy, Safety, Pharmacokinetic

1) To determine the maximum tolerated doses (MTDs) and/or recommended doses for extensions (RDEs) for IMA402 as monotherapy and in combination with pembrolizumab (Phase Ia)
2a) To characterize the safety and tolerability of IMA402 as monotherapy and in combination (Phase I)
2b) To characterize the safety and tolerability of IMA402 as monotherapy and in combination (Phase II)
3) To evaluate the anti-tumor activity of IMA402 as monotherapy and in combination (Phase II)

Conditions and MedDRA coding

Solid Tumors

Study design 3 periods

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, Federal Institute For Drugs And Medical Devices, Paul Ehrlich Institute

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Patients ≥ 18 years old
2. Pathologically confirmed and documented advanced or metastatic malignancies with defined PRAME tumor target expression as per cohort
3. Confirmed HLA status
4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
6. Patients must have received or not be eligible for indicated standard-of-care treatments per cohort
7. Adequate baseline hematologic, renal and hepatic function, acceptable coagulation status

Exclusion criteria 5

1. Other active malignancies that require treatment or that might interfere with the trial endpoints
2. Patient is pregnant or is breastfeeding
3. History of hypersensitivity to components of IMA402 or rescue medications; hypersensitivity to or contraindication according to current SmPC for respective combination medicinal product
4. 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
5. Patients with active CNS metastases, history of bleeding into brain metastases, known brain metastases who are receiving therapeutic anticoagulation

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 5

1. Number of patients with dose-limiting toxicities (Phase Ia)
2. Number of patients with treatment-emergent adverse events (TEAEs) (Phase I/II)
3. Number of patients with serious TEAEs (Phase I/II)
4. Frequency and duration of dose interruptions and reductions, permanent discontinuations (Phase I/II)
5. Objective response rate based on best overall response of complete response and partial response locally assessed using RECIST 1.1 (Phase II)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Immatics Biotechnologies GmbH

Sponsor organisation

Immatics Biotechnologies GmbH

Address

Paul-Ehrlich-Straße 15, Waldhäuser Waldhäuser

City

Tübingen

Postcode

72076

Country

Germany

Scientific contact point

Organisation

Immatics Biotechnologies GmbH

Contact name

Clinical Development

Public contact point

Organisation

Immatics Biotechnologies GmbH

Contact name

Clinical Development

Third parties 12

Locations

2 EU/EEA countries · 29 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 27 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

9 submissions — initial application plus substantial / non-substantial modifications