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

Phase 2TerminatedNCT03515551

Immunocore Ltd29 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Select Advanced Solid Tumors

Interventions

IMCnyesoDRUG

Weekly IV infusions of IMCnyeso

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

University of Colorado Hospital

Aurora, Colorado, United States

University of Iowa Hospital and Clinics

Iowa City, Iowa, United States

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 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

Time frame: Up to 35 months

Phase 2: Best Overall Response (BOR)

Best overall response per RECIST v.1.1

Time frame: Up to 35 months

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

Tolerability of study treatment was assessed by summarizing the number of participants with no treatment dose interruptions and dose reductions

Data from ClinicalTrials.gov

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