Treatment of patients with solid tumors with genetically modified patients' own T-cells, recognizing a particular tumor marker

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Immatics US Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

10 Aug 2020 → ongoing

Decision date (initial)

2024-08-27

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Immatics Biotechnologies GmbH · Immatics US Inc

External identifiers

EU CT number

2024-515114-41-00

EudraCT number

2019-002370-31

ClinicalTrials.gov

NCT03686124

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Dose response

1) To evaluate safety and tolerability of treatment with ACTengine® IMA203/IMA203CD8 products as monotherapy or in combination with nivolumab (Phase I)
2) To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for IMA203/IMA203CD8 (Phase I)
3) To evaluate safety and tolerability of treatment with ACTengine® IMA203 product as monotherapy (Phase II)
4) To evaluate the anti-tumor activity of IMA203 (Phase II)

Conditions and MedDRA coding

Solid tumors

Study design 3 periods

Regulatory references

Scientific advice from competent authorities

Paul-Ehrlich-Institut

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Patient must have pathologically confirmed advanced and/or metastatic solid tumor with defined tumor target expression
2. Patients ≥ 18 years of age
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
4. Confirmed HLA status
5. Adequate hepatic and renal function, acceptable coagulation status and adequate organ and marrow function
6. Patients must have measurable disease according to RECIST 1.1
7. Patients must have recovered from infections to Grade 1 or lower (Nivolumab combination arm)

Exclusion criteria 6

1. Patients with history of other malignancies or with active brain metastases
2. The patient is pregnant or is breastfeeding
3. Patients with prior allogenic stem cell transplantation or solid organ transplantation
4. History of hypersensitivity to CY, FLU or IL-2 and Rescue medication
5. The patient has concurrent severe and/or uncontrolled medical disease or any other condition that would, in the investigator's or sponsor's judgment, contraindicate the patient's participation in the clinical study because of safety concerns or compliance with clinical study procedures
6. Patients with a history of severe immune-related toxicities, defined as any Grade 3 or 4 toxicities related to prior PD1/PD-L1 inhibitor therapy (Nivolumab combination arm)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 5

1. Treatment-emergent adverse events (TEAEs) (Phase I/II)
2. Adverse Events of special interest (AESIs) (Phase I/II)
3. Serious TEAEs (Phase I/II)
4. Number of patients with dose-limiting toxicities (Phase I)
5. Objective response rate based on best overall response of complete response and partial response centrally assessed using RECIST 1.1 (Phase II)

Investigational products

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

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Immatics US Inc.

Sponsor organisation

Immatics US Inc.

Address

13203 Murphy Road

City

Stafford

Postcode

77477-4303

Country

United States

Scientific contact point

Organisation

Immatics US Inc.

Contact name

Clinical Development

Public contact point

Organisation

Immatics US Inc.

Contact name

Clinical Development

Third parties 14

Locations

1 EU/EEA country · 8 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 20 files

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

Application history

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