Select Advanced Solid TumorsPhase 1/2NCT03515551

Safety and Efficacy of IMCnyeso in Advanced NY-ESO-1 and/or LAGE-1A Positive Cancers

A Phase 1/2 study testing IMCnyeso in people with Select Advanced Solid Tumors, run by Immunocore Ltd at 12 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

IMCnyeso is a bispecific fusion protein designed for the treatment of cancers that express NY-ESO-1 and/or LAGE-1A. This was a first-in-human trial designed to evaluate the safety and efficacy of IMCnyeso in HLA-A*02:01-positive adult participants whose cancer is positive for NY-ESO-1 and/or LAGE-A1. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Select Advanced Solid Tumors
What is being tested?: IMCnyeso
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 12 sitesin 3 countries
Study dates: 15 Jun 2018to 10 May 2021
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

HLA-A*0201 positive
NY-ESO-1 and/or LAGE-1A positive tumor
ECOG PS 0 or 1
Selected advanced solid tumors
Relapsed from, refractory to, or intolerant of standard therapy
If applicable, must agree to use highly effective contraception

Who cannot join

Symptomatic or untreated central nervous system metastasis
Inadequate washout from prior anticancer therapy
Significant ongoing toxicity from prior anticancer treatment
Impaired baseline organ function as evaluated by out-of-range laboratory values
Clinically significant cardiac disease
Active infection requiring systemic antibiotic therapy

Show all 11Show fewer

Known history of human immunodeficiency virus (HIV)
Active hepatitis B virus (HBV) or hepatitis C virus (HCV)
Ongoing treatment with systemic steroids or other immunosuppressive therapies
Significant secondary malignancy
Pregnancy or lactation

Trial locations and contacts

12 sites in 3 countries.

Country

City, postcode or hospital

12 sites in 3 countries

United States8 sites

University of Colorado Hospital
Aurora, Colorado, 80045
MD Anderson Cancer Center
Houston, Texas, 77030
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242
Tennessee Oncology NASH - SCRI
Nashville, Tennessee, 37203
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
UPMC - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110

Other trials in United States

United Kingdom3 sites

Sarah Cannon Research Institute UK
London, W1G 6AD
The Christie Hospital
Manchester, M20 4BX
Royal Marsden Hospital
Sutton, SW3 6JJ

Other trials in United Kingdom

Canada1 site

Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Phase I/II Study of IMCnyeso, HLA- A*0201-Restricted, NY-ESO-1- and LAGE-1A-specific Soluble T Cell Receptor and Anti-CD3 Bispecific Molecule, in HLA-A*0201 Positive Patients With Advanced NY-ESO-1 and/or LAGE - 1A Positive Cancer

Read the detailed description

This was planned to be a multi-center, open label, dose finding Phase 1/2 study of single agent IMCnyeso administered in participants with NY-ESO-1 and/or LAGE-A1 positive tumors. The primary objective of the dose escalation phase (Phase 1) was to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of IMCnyeso in participants with advanced solid tumors. Preliminary efficacy was to be evaluated in Phase 2. The study was terminated early (prior to initiation of Phase 2) by the Sponsor as a strategic decision (not based on any safety signal).

Conditions: Select Advanced Solid Tumors
Being tested: IMCnyeso
Keywords: IMCnyeso, Immunotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IMCnyesoDrug
Weekly IV infusions of IMCnyeso

Study groups in NCT03515551
Study group	Role	What they receive
Phase 1: Dose Escalation	Experimental	Four fixed-dose, dose escalation cohorts (Cohorts 1 to 4) and 3 intrapatient dose escalation cohorts (Cohorts 5 to 7) to establish the MTD/RP2D of IMCnyeso. Receives: Drug: IMCnyeso
Phase 2: Dose Expansion	Experimental	Three planned cohorts treated at the RP2D to make a preliminary assessment of the anti-tumor activity of IMCnyeso. Phase 2 was not initiated and data were not collected. Receives: Drug: IMCnyeso

What is being measured

The primary outcome is the main question the study is designed to answer.

Phase 1: Number of Participants With Dose-limiting Toxicities
Dose-limiting toxicities were defined as an adverse event or abnormal laboratory value assessed as having a suspected relationship to study drug that occurs within the evaluation period, from the first dose up until Day 28 after the first dose
Measured: Up to 35 months
Phase 1: Number of Participants With Adverse Events
Treatment-emergent adverse events are defined as any adverse event (AE) that started after the first dose of study drug up to 30 days after last dose of study drug, including abnormal laboratory values, vital signs, or electrocardiogram results. AE severity is graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Measured: Up to 35 months
Phase 1: Number of Participants With No Dose Interruptions or Reductions
Tolerability of study treatment was assessed by summarizing the number of participants with no treatment dose interruptions and dose reductions
Measured: Up to 35 months
Phase 2: Best Overall Response (BOR)
Best overall response per RECIST v.1.1
Measured: Up to 35 months

Secondary outcomes (10)

Phase 2: Number of Participants With Adverse Events
Treatment-emergent adverse events are defined as any adverse event (AE) that started after the first dose of study drug up to 30 days after last dose of study drug, including abnormal laboratory values, vital signs, or electrocardiogram results.
Measured: Up to 35 months
Phase 2: Number of Participants With No Dose Interruptions or Reductions
Tolerability of study treatment was assessed by summarizing the number of participants with no treatment dose interruptions and dose reductions
Measured: Up to 35 months
Phase 1: Number of Participants With Best Overall Response (BOR)
Number of participants with best overall response, including complete response, partial response, stable disease, and progressive disease, based on local Investigator assessment as defined in RECIST v.1.1.
Measured: Up to 35 months
Phase 1 and Phase 2: Progression-free Survival
Progression-free survival is defined as the time from first dose until the date of objective progression, or death from any cause, whichever occurs first.
Measured: Up to 35 months
Phase 1 and Phase 2: Duration of Response
Duration of response is defined as the time from the date of first documented objective response (CR or PR) until the date of documented disease progression or death.
Measured: Up to 35 months
Phase 1 and Phase 2: Overall Survival
Overall Survival is defined as the time (in months) from the date of randomization to the date of death due to any cause.
Measured: Up to 35 months
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last)
Measured: Predose and 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 1 and Cycle 1 Day 15
Maximum Observed Plasma Drug Concentration After Single Dose Administration (Cmax)
Measured: Predose and 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 1 and Cycle 1 Day 15
Time to Reach Maximum Plasma Concentration (Tmax)
Measured: Predose and 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 1 and Cycle 1 Day 15
Number of Participants With Anti-IMCnyeso Antibody Formation
Number of participants with positive treatment-boosted or treatment-induced anti-IMCnyeso antibody titers
Measured: Up to 35 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 201810 May 2021

First posted3 May 2018
Study start15 Jun 2018
Primary completion10 May 2021
Study completion10 May 2021

Why it stopped: Strategic decision to stop development and not based on any safety concerns

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Select Advanced Solid TumorsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03515551
Sponsor's protocol ID: IMCnyeso-101
Status last verified: Mar 2022
First submitted: 5 Apr 2018
Last updated: 11 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Lopez JS, Milhem M, Butler MO, Thistlethwaite F, Van Tine BA, D'Angelo SP, Johnson ML, Sato T, Arkenau HT, Edukulla R, Wustner J, Marshall S, Rodon J. Phase 1 study of IMCnyeso, a T cell receptor bispecific ImmTAC targeting NY-ESO-1-expressing malignancies. Cell Rep Med. 2025 Apr 15;6(4):101994. doi: 10.1016/j.xcrm.2025.101994. Epub 2025 Mar 6.
PubMed 40054461

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Select Advanced Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II Study of IMCnyeso, HLA- A*0201-Restricted, NY-ESO-1- and LAGE-1A-specific Soluble T Cell Receptor and Anti-CD3 Bispecific Molecule, in HLA-A*0201 Positive Patients With Advanced NY-ESO-1 and/or LAGE - 1A Positive Cancer
ClinicalTrials.gov ID: NCT03515551
Acronym / sponsor ID: IMCnyeso-101
Conditions: Select Advanced Solid Tumors
Keywords: IMCnyeso, Immunotherapy
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Strategic decision to stop development and not based on any safety concerns
Enrolment: 29 participants (actual)
Lead sponsor: Immunocore LtdIndustry (pharma, biotech, devices)
Study start: 15 Jun 2018 (actual)
Primary completion: 10 May 2021 (actual)
Study completion: 10 May 2021 (actual)
First posted: 3 May 2018 (actual)
Results: Posted 11 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Phase 1: Dose Escalation	Experimental	Drug: IMCnyesoFour fixed-dose, dose escalation cohorts (Cohorts 1 to 4) and 3 intrapatient dose escalation cohorts (Cohorts 5 to 7) to establish the MTD/RP2D of IMCnyeso.
Phase 2: Dose Expansion	Experimental	Drug: IMCnyesoThree planned cohorts treated at the RP2D to make a preliminary assessment of the anti-tumor activity of IMCnyeso. Phase 2 was not initiated and data were not collected.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

HLA-A*0201 positive
NY-ESO-1 and/or LAGE-1A positive tumor
ECOG PS 0 or 1
Selected advanced solid tumors
Relapsed from, refractory to, or intolerant of standard therapy

Key exclusion criteria (11 listed)

Symptomatic or untreated central nervous system metastasis
Inadequate washout from prior anticancer therapy
Significant ongoing toxicity from prior anticancer treatment
Impaired baseline organ function as evaluated by out-of-range laboratory values
Clinically significant cardiac disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IMCnyesoWeekly IV infusions of IMCnyeso	Drug	Phase 1: Dose Escalation, Phase 2: Dose Expansion

Primary outcome

Phase 1: Number of Participants With Dose-limiting Toxicities
Time frame: Up to 35 months
Dose-limiting toxicities were defined as an adverse event or abnormal laboratory value assessed as having a suspected relationship to study drug that occurs within the evaluation period, from the first dose up until Day 28 after the first dose
Phase 1: Number of Participants With Adverse Events
Time frame: Up to 35 months
Treatment-emergent adverse events are defined as any adverse event (AE) that started after the first dose of study drug up to 30 days after last dose of study drug, including abnormal laboratory values, vital signs, or electrocardiogram results. AE severity is graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Phase 1: Number of Participants With No Dose Interruptions or Reductions
Time frame: Up to 35 months
Tolerability of study treatment was assessed by summarizing the number of participants with no treatment dose interruptions and dose reductions
Phase 2: Best Overall Response (BOR)
Time frame: Up to 35 months
Best overall response per RECIST v.1.1

10 secondary outcomes

Phase 2: Number of Participants With Adverse Events
Time frame: Up to 35 months
Phase 2: Number of Participants With No Dose Interruptions or Reductions
Time frame: Up to 35 months
Phase 1: Number of Participants With Best Overall Response (BOR)
Time frame: Up to 35 months
Phase 1 and Phase 2: Progression-free Survival
Time frame: Up to 35 months
Phase 1 and Phase 2: Duration of Response
Time frame: Up to 35 months
Phase 1 and Phase 2: Overall Survival
Time frame: Up to 35 months
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last)
Time frame: Predose and 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 1 and Cycle 1 Day 15
Maximum Observed Plasma Drug Concentration After Single Dose Administration (Cmax)
Time frame: Predose and 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 1 and Cycle 1 Day 15
Time to Reach Maximum Plasma Concentration (Tmax)
Time frame: Predose and 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 1 and Cycle 1 Day 15
Number of Participants With Anti-IMCnyeso Antibody Formation
Time frame: Up to 35 months

Results and safety

Results posted to the registry on 11 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1: IMCnyeso 3 mcg	4	0
Phase 1: IMCnyeso 10 mcg	3	0
Phase 1: IMCnyeso 30 mcg	5	0
Phase 1: IMCnyeso 100 mcg	3	0
Phase 1: IMCnyeso 30-100 mcg	5	0
Phase 1: IMCnyeso 30-100-180 mcg	4	0
Phase 1: IMCnyeso 30-100-300 mcg	5	0

Primary outcome: Phase 1: Number of Participants With Dose-limiting Toxicities

Time frame: Up to 35 months. Count of participants. Unit: Participants

Measure	Phase 1: IMCnyeso 3 mcg n = 4	Phase 1: IMCnyeso 10 mcg n = 3	Phase 1: IMCnyeso 30 mcg n = 5	Phase 1: IMCnyeso 100 mcg n = 3	Phase 1: IMCnyeso 30-100 mcg n = 5	Phase 1: IMCnyeso 30-100-180 mcg n = 4	Phase 1: IMCnyeso 30-100-300 mcg n = 5
Value	0	0	0	0	0	0	2

Population analysed: The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug.

Primary outcome: Phase 1: Number of Participants With Adverse Events

Time frame: Up to 35 months. Count of participants. Unit: Participants

Measure	Phase 1: IMCnyeso 3 mcg n = 4	Phase 1: IMCnyeso 10 mcg n = 3	Phase 1: IMCnyeso 30 mcg n = 5	Phase 1: IMCnyeso 100 mcg n = 3	Phase 1: IMCnyeso 30-100 mcg n = 5	Phase 1: IMCnyeso 30-100-180 mcg n = 4	Phase 1: IMCnyeso 30-100-300 mcg n = 5
Any treatment-emergent adverse event (TEAE)	4	3	5	3	5	4	5
Any TEAE Grade ≥3	3	1	1	3	3	4	4
Any TEAE leading to death	0	0	0	0	0	0	0

Population analysed: The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug.

Primary outcome: Phase 1: Number of Participants With No Dose Interruptions or Reductions

Time frame: Up to 35 months. Count of participants. Unit: Participants

Measure	Phase 1: IMCnyeso 3 mcg n = 4	Phase 1: IMCnyeso 10 mcg n = 3	Phase 1: IMCnyeso 30 mcg n = 5	Phase 1: IMCnyeso 100 mcg n = 3	Phase 1: IMCnyeso 30-100 mcg n = 5	Phase 1: IMCnyeso 30-100-180 mcg n = 4	Phase 1: IMCnyeso 30-100-300 mcg n = 5
No dose interruption at any time	2	0	0	2	2	0	0
No dose reduction at any time	4	3	5	3	4	4	3

Population analysed: The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug.

Primary outcome: Phase 2: Best Overall Response (BOR)

Time frame: Up to 35 months

Population analysed: The study was terminated during Phase 1 due to strategic reasons; data were not collected or analyzed for any Phase 2 outcome measures.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 35 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1: IMCnyeso 3 mcg	3 of 4 (75%)	4 of 4 (100%)	4 of 4
Phase 1: IMCnyeso 10 mcg	1 of 3 (33.3%)	3 of 3 (100%)	1 of 3
Phase 1: IMCnyeso 30 mcg	1 of 5 (20%)	5 of 5 (100%)	2 of 5
Phase 1: IMCnyeso 100 mcg	1 of 3 (33.3%)	3 of 3 (100%)	2 of 3
Phase 1: IMCnyeso 30-100 mcg	2 of 5 (40%)	5 of 5 (100%)	2 of 5
Phase 1: IMCnyeso 30-100-180 mcg	3 of 4 (75%)	4 of 4 (100%)	4 of 4
Phase 1: IMCnyeso 30-100-300 mcg	3 of 5 (60%)	5 of 5 (100%)	1 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40054461Lopez JS, Milhem M, Butler MO, Thistlethwaite F, Van Tine BA, D'Angelo SP, Johnson ML, Sato T, Arkenau HT, Edukulla R, Wustner J, Marshall S, Rodon J. Phase 1 study of IMCnyeso, a T cell receptor bispecific ImmTAC targeting NY-ESO-1-expressing malignancies. Cell Rep Med. 2025 Apr 15;6(4):101994. doi: 10.1016/j.xcrm.2025.101994. Epub 2025 Mar 6.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Immunocore Ltd

12 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IMCnyeso in people with Select Advanced Solid Tumors, run by Immunocore Ltd at 12 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, United Kingdom, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Number of Participants With Dose-limiting Toxicities (time frame: Up to 35 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03515551, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.