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BRIEF 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

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


  • Org Study ID: IMCnyeso-101
  • Secondary ID:
  • NCT ID: NCT03515551
  • NCT Alias:
  • Sponsor: Immunocore Ltd - Industry
  • Source: Immunocore Ltd

Brief 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.

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 study consists of
2 Arms. In the first Arm (the dose escalation phase), IMCnyeso will be evaluated in 4
diseases (advanced non-small cell cancer (NSCLC), melanoma, urothelial carcinoma, and
synovial sarcoma). The primary objective of this Arm is to determine the maximum tolerated
dose (MTD) and/or recommended Phase II dose (RP2D) of IMCnyeso. The second Arm is an
expansion phase in which the dose determined in Arm 1 will be tested in 3 diseases (advanced
NSCLC, urothelial carcinoma and synovial sarcoma) to further evaluate the safety and assess
the anti-tumor activity of IMCnyeso

Overal Status Start Date Phase Study Type
Recruiting May 1, 2018 Phase 1/Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Recommended phase 2 dose (RP2D)

Primary Outcome 1 - Time Frame: From day 1 to day 28 of treatment

Primary Outcome 2 - Measure: Number of patients with treatment emergent AEs

Primary Outcome 2 - Time Frame: Safety will be assessed from informed consent through 90 days after end of treatment

Condition:

  • Melanoma
  • Advanced NSCLC
  • Urothelial Carcinoma
  • Synovial Sarcoma

Eligibility

Criteria:
Inclusion Criteria:

1. Male or female patients age ≥ 18 years of age at the time of informed consent

2. HLA-A*0201 positive, confirmed by central laboratory

3. NY-ESO-1 and/or LAGE-1A positive tumor confirmed by the central laboratory

4. Arm 1: Patients must be refractory to or intolerant to all existing therapies known to
provide clinical benefit for their condition.

5. Arm 2: Subjects will have received the following previous therapies:

1. NSCLC — PD-1/PD-L1 inhibitor

2. Patients with NSCLC and an EGFR or ALK genomic tumor aberration must have disease
progression after treatment with Health Authority-approved agents for these
aberrations

3. Urothelial cancer — PD-1/PD-L1 inhibitor

4. Synovial sarcoma — at least one prior chemotherapy regimen

6. Arm 1 only: Histologically confirmed diagnosis of advanced NSCLC, melanoma, urothelial
carcinoma, or synovial sarcoma

7. Arm 2 only: Histologically confirmed diagnosis of advanced NSCLC, urothelial
carcinoma, or synovial sarcoma

8. Arm 2 only: Disease amenable to biopsy

9. Arm 2 only: Measurable disease to RECIST v.1.1 criteria

Exclusion Criteria:

Impaired baseline organ function as evaluated by out-of-range laboratory values 2. History
of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or
monoclonal antibodies 3. Clinically significant cardiac disease or impaired cardiac
function 4. Presence of symptomatic or untreated central nervous system (CNS) metastases 5.
Active infection requiring systemic antibiotic therapy 6. Known history of human
immunodeficiency virus infection (HIV) 7. Active hepatitis B virus (HBV) or hepatitis C
virus (HCV) infection 8. Malignant disease, other than that being treated in this study 9.
Patients receiving systemic steroid therapy or any other systemic immunosuppressive
medication. Local steroid therapies are acceptable 10. Systemic anti-cancer therapy within
2 weeks of the first dose of study drug.

11. Major surgery within 2 weeks of the first dose of study drug 12. Radiotherapy within 2
weeks of the first dose of study drug, with the exception of palliative radiotherapy to a
limited field 13. Use of hematopoietic colony-stimulating growth factors (eg, G-CSF,
GM-CSF, M-CSF) ≤ 2 weeks prior to start of study drug 14. Pregnant, likely to become
pregnant, or lactating women
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: Rachael Easton, MD, PhD

Phone: 484-434-5261

Email: rachael.easton@immunocore.com

Locations

Facility Status Contact
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United States
Recruiting Takami Sato, MD
215-955-8874
Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States
Recruiting Hassane Zarour, MD
412-623-6121
Royal Marsden
Sutton,
United Kingdom
Recruiting Juanita Lopez, MD