Description:
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.
Title
- Brief Title: Safety and Efficacy of IMCnyeso in Advanced NY-ESO-1 and/or LAGE-1A Positive Cancers
- 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
Clinical Trial IDs
- ORG STUDY ID:
IMCnyeso-101
- NCT ID:
NCT03515551
Conditions
- Select Advanced Solid Tumors
Interventions
| Drug | Synonyms | Arms |
|---|
| IMCnyeso | | IMCnyeso dose Escalation Phase with approximately 4-10 cohorts |
Purpose
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.
Detailed Description
This is a multi-center, open label, dose finding Phase 1/2 study of single agent IMCnyeso
administered in patients with NY-ESO-1 and/or LAGE-A1 positive tumors. The primary objective
of the dose escalation phase (Arm 1) is to determine the maximum tolerated dose (MTD) and/or
recommended Phase II dose (RP2D) of IMCnyeso in patients with advanced solid tumors.
Preliminary efficacy will be evaluated in Arm 2.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| IMCnyeso dose Escalation Phase with approximately 4-10 cohorts | Experimental | Phase (Arm 1) n=approximately 27 patients to establish the MTD/RP2D | |
| IMCnyeso expansion with 3 cohorts | Experimental | n=9-24/cohort treated at the RP2D to make a preliminary assessment of the anti-tumor activity of IMCnyeso | |
Eligibility 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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Phase I: Incidence of dose-limiting toxicities (DLT) |
| Time Frame: | from first dose to end of DLT period (up until Day 28 after first dose) |
| Safety Issue: | |
| Description: | Abnormalities will be classified according to NCI CTCAE version 4.03 |
Secondary Outcome Measures
| Measure: | Phase II: incidence and severity of adverse events (AE) |
| Time Frame: | first dose to 30 days after the last dose |
| Safety Issue: | |
| Description: | |
| Measure: | Phase II: changes in laboratory parameters |
| Time Frame: | from first dose to 30 days after the last dose |
| Safety Issue: | |
| Description: | Abnormalities will be classified according to NCI CTCAE version 4.03 |
| Measure: | Phase II: changes in body temperature |
| Time Frame: | from first dose to 30 days after the last dose |
| Safety Issue: | |
| Description: | Body temperature will be measured throughout the study. Both absolute values and changes from Baseline will be reported. |
| Measure: | Phase II: changes in pulse |
| Time Frame: | from first dose to 30 days after the last dose |
| Safety Issue: | |
| Description: | Pulse will be measured throughout the study. Both absolute values and changes from Baseline will be reported. |
| Measure: | Phase II: changes in respiratory rate |
| Time Frame: | from first dose to 30 days after the last dose |
| Safety Issue: | |
| Description: | Respiratory rate will be measured throughout the study. Both absolute values and changes from Baseline will be reported. |
| Measure: | Phase II: changes in blood pressure |
| Time Frame: | from first dose to 30 days after the last dose |
| Safety Issue: | |
| Description: | Blood pressure will be measured throughout the study. Both absolute values and changes from Baseline will be reported. |
| Measure: | Phase II: changes in electrocardiogram parameters |
| Time Frame: | from first dose to 30 days after the last dose |
| Safety Issue: | |
| Description: | QTcF interval absolute values and changes from Baseline |
| Measure: | Phase II: dose interruptions, reductions, and discontinuations |
| Time Frame: | first dose through last dose (anticipated up to 1 year) |
| Safety Issue: | |
| Description: | Tolerability of study treatment will be assessed by summarizing the number of treatment dose interruptions and dose reductions. |
| Measure: | Phase I: Best overall response (BOR) |
| Time Frame: | from first dose to approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Progression-free survival |
| Time Frame: | from first dose to approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Duration of response |
| Time Frame: | from first dose to approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Overall survival |
| Time Frame: | from first dose to approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Pharmacokinetics Area under the plasma concentration-time curve (AUC) |
| Time Frame: | 2 weeks (AUC will be assessed weekly for 2 weeks) |
| Safety Issue: | |
| Description: | |
| Measure: | Pharmacokinetics The maximum observed plasma drug concentration after single dose administration (Cmax) |
| Time Frame: | 2 weeks (AUC will be assessed weekly for 2 weeks) |
| Safety Issue: | |
| Description: | |
| Measure: | Pharmacokinetics The time to reach maximum plasma concentration (Tmax) |
| Time Frame: | 2 weeks (AUC will be assessed weekly for 2 weeks) |
| Safety Issue: | |
| Description: | |
| Measure: | Pharmacokinetics The elimination half-life (t1/2) |
| Time Frame: | 2 weeks (AUC will be assessed weekly for 2 weeks) |
| Safety Issue: | |
| Description: | |
| Measure: | Immunogenicity the incidence of anti-IMCnyeso antibody formation Immunogenicity the incidence of anti-IMCnyeso antibody formation |
| Time Frame: | 6-12 months (AUC will be assessed monthly for 6-12 months) |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Terminated |
| Lead Sponsor: | Immunocore Ltd |
Trial Keywords
Last Updated
July 8, 2021
