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IMA203 Product

Phase 1

Refractory Cancer | Monoclonal antibody | Oncology |Immatics N.V.|Last Updated: May 13, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment375

FDA Designations

No designations recorded

Clinical trial landscape

IMA203 Product · 1 trial · 4 indications

Phase 1 1
NCT03686124ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid TumorsRefractory Cancer
RECRUITING375 Analytics
PHASE1RECRUITING
ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors
Refractory CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Number of patients with dose-limiting toxicities (DLTs)

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

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

Phase 1 and Phase 2: Tumor Response
5 years

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

Secondary Endpoints

Phase 1 and 2: Persistence of TCR engineered T-cells
up to 5 years post treatment
Phase 1 and 2: Tumor response
up to 5 years
Phase 2: Patient reported quality of life
up to 5 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose Escalation A (closed to enrollment)EXPERIMENTALDose escalation of IMA203
Extension Cohort AEXPERIMENTALIMA203 at RP2D
Extension Cohort B (closed to enrollment)EXPERIMENTALIMA203 at RP2D + nivolumab
Extension Cohort AAEXPERIMENTALIMA203 at final RP2D (flat dose)
Uveal MelanomaEXPERIMENTALIMA203 at RP2D
Dose Escalation BEXPERIMENTALDose escalation of IMA203CD8
Extension Cohort CEXPERIMENTALIMA203CD8 at dose levels confirmed to be safe
Extension Cohort DEXPERIMENTALIMA203CD8 at dose levels confirmed to be safe; without IL-2
OvarianEXPERIMENTALIMA203CD8 monotherapy at dose levels confirmed to be safe
EndometrialEXPERIMENTALIMA203CD8 monotherapy at dose levels confirmed to be safe
Head and Neck, Lung, and Triple Negative Breast CancerEXPERIMENTALIMA203CD8 monotherapy at dose levels confirmed to be safe
Rare CancersEXPERIMENTALIMA203CD8 monotherapy at dose levels confirmed to be safe

Interventions

NameTypeDescription
IMA203 ProductBIOLOGICALThe 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 doseBIOLOGICALThe cell dose will be based on viable CD3+CD8+ HLA- Dextramer+ cells
IMA203CD8 ProductBIOLOGICALThe cell dose will be based on viable CD3+CD8+ HLA- Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula
NivolumabDRUGNivolumab will be given post IMA203/IMA203CD8 infusion, after hematologic recovery is achieved. Clinical supply provided by Bristol Myers Squibb.
IMADetect®DEVICEIMADetect® 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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * 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 w...

Countries:United StatesGermany
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Competitive Landscape -Cancer 5 trials (matched to "Refractory Cancer")

Frequently asked questions about IMA203 Product

What is IMA203 Product used for?

IMA203 Product is an investigational monoclonal antibody being developed for the treatment of refractory cancer, recurrent cancer, and solid tumors in adults. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who is developing IMA203 Product?

IMA203 Product is being developed by Immatics N.V., a biopharmaceutical company listed on the stock exchange under the ticker symbol IMTX. The company is conducting clinical trials for this investigational therapy in the United States and Germany.

What phase is IMA203 Product in?

IMA203 Product is currently in Phase 1 clinical development. It is an investigational drug being studied in a clinical trial for refractory and recurrent solid tumors. The drug has not yet been approved for commercial use.

What clinical trials is IMA203 Product in?

IMA203 Product is being studied in a Phase 1 clinical trial with the identifier NCT03686124. The trial is titled 'ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors' and is currently recruiting participants.

How does IMA203 Product work?

IMA203 Product is a monoclonal antibody, a type of targeted therapy designed to interact with specific proteins involved in cancer. The exact molecular target of IMA203 Product has not been disclosed in available information.