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

NCT03515551 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: IMCnyeso-101
• Study Type: interventional
• Target: 29
• Locations: 3 countries
• Sites: 12

Brief 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.

Conditions

Select Advanced Solid Tumors

Keywords

IMCnyeso; Immunotherapy

Outcome Measures

Primary Outcomes (4)

• 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

  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.

  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

  Up to 35 months

• Phase 2: Best Overall Response (BOR)

  Best overall response per RECIST v.1.1

  Up to 35 months

Secondary Outcomes (10)

• Phase 2: Number of Participants With Adverse Events

  Up to 35 months

• Phase 2: Number of Participants With No Dose Interruptions or Reductions

  Up to 35 months

• Phase 1: Number of Participants With Best Overall Response (BOR)

  Up to 35 months

• Phase 1 and Phase 2: Progression-free Survival

  Up to 35 months

• Phase 1 and Phase 2: Duration of Response

  Up to 35 months

Study Arms (2)

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.

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.

Drug: IMCnyeso

Interventions

IMCnyeso DRUG

Weekly IV infusions of IMCnyeso

Phase 1: Dose Escalation; Phase 2: Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Immunocore Ltd: lead

Study Sites (12)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

Location

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

UPMC - Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Tennessee Oncology NASH - SCRI

Nashville, Tennessee, 37203, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Sarah Cannon Research Institute UK

London, W1G 6AD, United Kingdom

Location

The Christie Hospital

Manchester, M20 4BX, United Kingdom

Location

Royal Marsden Hospital

Sutton, SW3 6JJ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 40054461 DERIVED

Results Point of Contact

• Title: Study Director
• Organization: Immunocore, Ltd

clinicaltrials@immunocore.com

1-844-IMMUNO-1

Study Officials

• Study Director

  Immunocore Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: May 3, 2018
• Study Start: June 15, 2018
• Primary Completion: May 10, 2021
• Study Completion: May 10, 2021
• Last Updated: March 11, 2022
• Results First Posted: March 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3); US (8); CA (1)