Clinical trial · Interventional
Safety and Efficacy of IMCnyeso in Advanced NY-ESO-1 and/or LAGE-1A Positive Cancers
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Strategic decision to stop development and not based on any safety concerns
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Select Advanced Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMCnyeso | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase 1: Dose Escalation
- description
- 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.
- interventionNames
- Drug: IMCnyeso
- type
- EXPERIMENTAL
- label
- Phase 2: Dose Expansion
- description
- 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.
- interventionNames
- Drug: IMCnyeso
Primary outcomes (4)
- measure
- Phase 1: Number of Participants With Dose-limiting Toxicities
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. HLA-A\*0201 positive 2. NY-ESO-1 and/or LAGE-1A positive tumor 3. ECOG PS 0 or 1 4. Selected advanced solid tumors 5. Relapsed from, refractory to, or intolerant of standard therapy 6. If applicable, must agree to use highly effective contraception Exclusion Criteria: 1. Symptomatic or untreated central nervous system metastasis 2. Inadequate washout from prior anticancer therapy 3. Significant ongoing toxicity from prior anticancer treatment 4. Impaired baseline organ function as evaluated by out-of-range laboratory values 5. Clinically significant cardiac disease 6. Active infection requiring systemic antibiotic therapy 7. Known history of human immunodeficiency virus (HIV) 8. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) 9. Ongoing treatment with systemic steroids or other immunosuppressive therapies 10. Significant secondary malignancy 11. Pregnancy or lactation
References
Publications (1)
- DERIVEDLopez 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