Safety and Efficacy of IMC-C103C as Monotherapy and in Combination With Atezolizumab
NCT ID: NCT03973333
Last Updated: 2024-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2019-05-17
2023-09-25
Brief Summary
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Detailed Description
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1. To identify the maximum tolerated dose (MTD) and/or expansion dose of IMC-C103C as a single agent administered intravenously (IV) and subcutaneously (SC) once weekly (Q1W) and administered Q1W in combination with once every 3 weeks (Q3W) atezolizumab.
2. To assess the preliminary anti-tumor activity of IMC-C103C in one or more selected indications, as a single agent administered Q1W.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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IMC-C103C - Monotherapy IV dose escalation
n= approximately 50 patients to establish the MTD/expansion dose
IMC-C103C
Weekly IV infusions
IMC-C103C and atezolizumab dose escalation
n=approximately 12 patients to establish the MTD/expansion dose
IMC-C103C
Weekly IV infusions
Atezolizumab
IV infusions every 3 weeks
IMC-C103C - expansion
Patients will be enrolled n=9-24 per expansion cohort (up to 4 total): metastatic/unresectable tumors of interest patients treated at the expansion dose of IMC-C103C to assess preliminary anti-tumor efficacy
IMC-C103C
Weekly IV infusions
IMC-C103C monotherapy SC dose escalation
Patients will be enrolled n=9-12 to establish the MTD/expansion dose
IMC-C103C
Weekly subcutaneous Injection
Interventions
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IMC-C103C
Weekly IV infusions
Atezolizumab
IV infusions every 3 weeks
IMC-C103C
Weekly subcutaneous Injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. MAGE-A4 positive tumor
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) \[ECOG PS\] 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 (expansion)
7. If applicable, must agree to use highly effective contraception
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Immunocore Ltd
INDUSTRY
Responsible Party
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Locations
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The Angeles Clinic and Research Institute
Los Angeles, California, United States
University of California Davis Comprehenvise Cancer Center
Sacramento, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
The University of Chicago Medicine & Biological Sciences
Chicago, Illinois, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
UPMC Cancer Center
Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute at Tennessee Oncology
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Clinica Universidad Navarra
Madrid, , Spain
Hospital Universitario La Paz - PPDS
Madrid, , Spain
Clinica Universidad Navarra
Pamplona, , Spain
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom
The Clatterbridge Hospital Cancer Center
Bebington, , United Kingdom
Sarah Cannon Research Institute
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Royal Marsden Hospital
Sutton, , United Kingdom
Countries
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Other Identifiers
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IMC-C103C-101
Identifier Type: -
Identifier Source: org_study_id
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