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

• Status: Terminated
• Trial end date: 2021-05-10
• Target enrollment: 0
• Participant gender: All

Summary

IMCnyeso is a new biological therapy designed for the treatment of cancers which express NY-ESO-1 and/or LAGE-1A. This is a first-in-human trial designed to evaluate the safety and efficacy of IMCnyeso in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for NY-ESO-1 and/or LAGE-A1.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Immunocore Ltd

Criteria

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. Measurable disease per RECIST v1.1

7. 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