Safety and Efficacy of IMC-C103C as Monotherapy and in Combination With Atezolizumab

NCT03973333 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: IMC-C103C-101
• Study Type: interventional
• Target: N/A
• Locations: 3 countries
• Sites: 19

Brief Summary

IMC-C103C is an immune mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen MAGE-A4. This is a first-in-human trial designed to evaluate the safety and efficacy of IMC-C103C in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for MAGE-A4.

Conditions

Select Advanced Solid Tumors

Keywords

ImmTAC, IMC-C103C, MAGE-A4, immunotherapy

Outcome Measures

Primary Outcomes (7)

• Phase 1: Incidence of dose-limiting toxicities (DLT)

  From first dose to DLT period (28 days)

• Phase 1: incidence and severity of adverse events (AE)

  from first dose to 30 days after the last dose

• Phase 1: changes in laboratory parameters

  Abnormalities will be classified according to NCI CTCAE v5.0

  from first dose to 30 days after the last dose

• Phase 1: changes in vital signs

  Abnormalities will be classified according to NCI CTCAE v5.0

  from first dose to 30 days after the last dose

• Phase 1: changes in electrocardiogram parameters

  QT intervals corrected for heart rate using Fridericia's (cube root) correction (QTcF) interval absolute values and changes from baseline will be summarized

  from first dose to 30 days after the last dose

• Phase 1: dose interruptions, reductions, and discontinuations

  from first dose through last dose (anticipated for up to 12-24 months)

• Phase 2: Best overall response (BOR)

  from first dose to approximately 2 years

Secondary Outcomes (17)

• Phase 2: incidence and severity of adverse events (AE)

  from first dose to 30 days after the last dose

• Phase 2: changes in laboratory parameters

  from first dose to 30 days after the last dose

• Phase 2: changes in vital signs

  from first dose to 30 days after the last dose

• Phase 2: changes in electrocardiogram parameters

  from first dose to 30 days after the last dose

• Phase 2: dose interruptions, reductions, and discontinuations

  from first dose through last dose (anticipated for up to 12-24 months)

Study Arms (4)

IMC-C103C - Monotherapy IV dose escalation

EXPERIMENTAL

n= approximately 50 patients to establish the MTD/expansion dose

Drug: IMC-C103C

IMC-C103C and atezolizumab dose escalation

EXPERIMENTAL

n=approximately 12 patients to establish the MTD/expansion dose

Drug: IMC-C103C; Drug: Atezolizumab

IMC-C103C - expansion

EXPERIMENTAL

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

Drug: IMC-C103C

IMC-C103C monotherapy SC dose escalation

EXPERIMENTAL

Patients will be enrolled n=9-12 to establish the MTD/expansion dose

Drug: IMC-C103C

Interventions

IMC-C103C DRUG

Weekly IV infusions

IMC-C103C - Monotherapy IV dose escalation; IMC-C103C - expansion; IMC-C103C and atezolizumab dose escalation

Atezolizumab DRUG

IV infusions every 3 weeks

Also known as: TECENTRIQ

IMC-C103C and atezolizumab dose escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HLA-A\*02:01 positive
• MAGE-A4 positive tumor
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) \[ECOG PS\] 0 or 1
• Selected advanced solid tumors
• Relapsed from, refractory to, or intolerant of standard therapy
• Measurable disease per RECIST v1.1 (expansion)
• If applicable, must agree to use highly effective contraception

You may not qualify if:

• Symptomatic or untreated central nervous system metastasis
• Inadequate washout from prior anticancer therapy
• Significant ongoing toxicity from prior anticancer treatment
• Impaired baseline organ function as evaluated by out-of-range laboratory values
• Clinically significant cardiac disease
• Active infection requiring systemic antibiotic therapy
• Known history of human immunodeficiency virus (HIV)
• Active hepatitis B virus (HBV) or hepatitis C virus (HCV)
• Ongoing treatment with systemic steroids or other immunosuppressive therapies
• Significant secondary malignancy
• Pregnancy or lactation

Sponsors & Collaborators

• Immunocore Ltd: lead

Study Sites (19)

The Angeles Clinic and Research Institute

Los Angeles, California, 90025, United States

Location

University of California Davis Comprehenvise Cancer Center

Sacramento, California, 95817, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

The University of Chicago Medicine & Biological Sciences

Chicago, Illinois, 60637, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Oklahoma University Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

UPMC Cancer Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Sarah Cannon Research Institute at Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Hospital Universitario Vall d'Hebron

Barcelona, 8035, Spain

Location

Clinica Universidad Navarra

Madrid, 28027, Spain

Location

Hospital Universitario La Paz - PPDS

Madrid, 28046, Spain

Location

Clinica Universidad Navarra

Pamplona, 31008, Spain

Location

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, G12 OYN, United Kingdom

Location

The Clatterbridge Hospital Cancer Center

Bebington, CH634JY, United Kingdom

Location

Sarah Cannon Research Institute

London, W1G 6AD, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Royal Marsden Hospital

Sutton, SM2 5PT, United Kingdom

Location

MeSH Terms

Interventions

atezolizumab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential from arm monotherapy IV dose escalation is opened first; then monotherapy SC dose escalation, monotherapy expansion and combination dose escalation may run

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: June 4, 2019
• Study Start: May 17, 2019
• Primary Completion: September 25, 2023
• Study Completion: September 25, 2023
• Last Updated: October 18, 2024

Record last verified: 2024-10

Locations

GB (5); ES (4); US (10)