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ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors

ConditionsRefractory CancerRecurrent CancerSolid Tumor, AdultCancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorImmatics US, Inc.

About this trial

The study's purpose is to establish the safety and tolerability of IMA203/IMA203CD8 products with or without combination with nivolumab in patients with solid tumors that express preferentially expressed antigen in melanoma (PRAME).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must have recurrent/progressing and/or refractory solid tumors and must have received or not be eligible for all available indicated standard of care treatment.

Eastern Cooperative Oncology Group (ECOG) performance status 0-1

HLA-A*02:01 positive

For patients with ovarian/fallopian tube cancer only: Patients must have confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer.

Disqualifiers

History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years

Pregnant or breastfeeding

Serious autoimmune disease Note: At the discretion of the investigator, these patients may be included if their disease is well controlled without the use of immunosuppressive agents.

History of cardiac conditions as per protocol

Trial design

Design model

Parallel

Treatments tested in this trial

  • IMA203 Product

    Biological/Vaccine

    The cell dose will be based on viable CD3+CD8+ HLA- Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula

  • IMA203 product- flat dose

    Biological/Vaccine

    The cell dose will be based on viable CD3+CD8+ HLA- Dextramer+ cells

  • IMA203CD8 Product

    Biological/Vaccine

    The cell dose will be based on viable CD3+CD8+ HLA- Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula

  • Nivolumab

    Drug

    Nivolumab will be given post IMA203/IMA203CD8 infusion, after hematologic recovery is achieved. Clinical supply provided by Bristol Myers Squibb.

  • IMADetect®

    Device

    IMADetect® is developed as a companion diagnostic to aid in selecting patients with relapsed and/or refractory solid cancers who might be eligible for enrollment in Immatics clinical trials.

Treatment groups

375 Participants
are divided into 12 treatment groups

12

Treatment groups

See each treatment group below.

Group A: Dose Escalation A (closed to enrollment)Experimental treatment 2 interventions
Group B: Extension Cohort AExperimental treatment 2 interventions
Group C: Extension Cohort B (closed to enrollment)Experimental treatment 2 interventions
Group D: Extension Cohort AAExperimental treatment 2 interventions
Group E: Uveal MelanomaExperimental treatment 2 interventions
Group F: Dose Escalation BExperimental treatment 2 interventions
Group G: Extension Cohort CExperimental treatment 2 interventions
Group H: Extension Cohort DExperimental treatment 2 interventions
Group I: OvarianExperimental treatment 2 interventions
Group J: EndometrialExperimental treatment 2 interventions
Group K: Head and Neck, Lung, and Triple Negative Breast CancerExperimental treatment 2 interventions
Group L: Rare CancersExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Phase 1: Determine the MTD and/or recommended dose for extension for IMA203/IMA203CD8

Number of patients with dose-limiting toxicities (DLTs)

Time frame
28 days
2

Phase 1 and Phase 2: Number and grade of treatment emergent adverse events and adverse events of special interest in subjects treated.

Treatment emergent adverse events (TEAEs), Adverse events of special interest (AESIs) and Treatment-emergent serious adverse events (TESAEs).

Time frame
35 days
3

Phase 1 and Phase 2: Tumor Response

Objective response rate (ORR) based on best overall response (BOR) of complete response (CR) and partial response (PR) centrally assessed (by a BICR1) using RECIST1.1

Time frame
5 years

Secondary outcomes

1

Phase 1 and 2: Persistence of TCR engineered T-cells

Measurement of TCR-engineered T cells in peripheral blood

Time frame
up to 5 years post treatment
2

Phase 1 and 2: Tumor response

Overall response rate, duration of response, disease control rate and progression free survival based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Overall survival.

Time frame
up to 5 years
3

Phase 2: Patient reported quality of life

Quality of Life questionnaires (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and EuroQol 5-Dimension 5-Level questionnaire). Higher score indicates worsening of patient's condition.

Time frame
up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Immatics US, Inc.

Lead sponsor

Source ClinicalTrials.gov
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