Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

A Dose Escalation and Expansion Study of MVC-101 in Patients With Advanced Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04844073
Recruitment Status : Recruiting
First Posted : April 14, 2021
Last Update Posted : September 22, 2021
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics and preliminary antitumor activity of MVC-101

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Head and Neck Carcinoma, Non-Small-Cell Lung Colorectal Neoplasms Drug: MVC-101 Phase 1 Phase 2

Detailed Description:
This Phase 1/2, open-label study will characterize safety, dose-limiting toxicities (DLTs), and maximum tolerated/ recommended phase 2 dose (MTD/RP2D) of MVC-101. Dose escalation will occur in a 1+3 and then 3+3 design in patients with advanced solid tumors. Once the MTD/RP2D is determined, a Cohort Expansion Phase will be enrolled to further characterize safety and initial anti-tumor activity in patients with HNSCC, CRC or NSCLC.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, First-in-Human, Open Label, Dose Escalation Study of MVC-101, An EGFR x CD3 COnditional Bispecific Redirected Activation (COBRA™) Protein in Patients With Unresectable Locally Advanced or Metastatic Cancer
Actual Study Start Date : March 8, 2021
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: MVC-101
CD3 engaging conditionally active bispecific protein binding EGFR and CD3
Drug: MVC-101
CD3 engaging conditionally active bispecific protein binding EGFR and CD3

Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events [ Time Frame: From time of study drug administration through the end of treatment or 28 days after the last dose of study drug ]
    Based on signs, symptoms, physical examination findings and/or laboratory results

Secondary Outcome Measures :
  1. Pharmacokinetics of MVC-101 measured by plasma concentration of MVC-101 [ Time Frame: Up to 54 weeks ]
  2. Immunogenicity of MVC-101 [ Time Frame: Up to 54 weeks ]
    Measured by plasma anti-drug antibodies

  3. Radiographic anti-tumor activity [ Time Frame: Up to 54 weeks ]
    Assessed using both conventional Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and a modified RECIST v1.1

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Tumor histologies:

    • Dose Escalation: Patients with histologically proven, unresectable, locally advanced or metastatic solid cancers that are considered to express EGFR
    • Cohort Expansion:

      • NSCLC that has progressed during or following treatment with platinum-based chemotherapy and an anti-PDx therapy NSCLC with EGFR mutation or ALK rearrangement must have progressed following available EGFR or ALK targeted therapy in addition to treatment with platinum-based chemotherapy
      • HNSCC that has progressed during or following treatment with an anti-PDx (unless ineligible, e.g. patients failing chemotherapy and PD-L1 CPS < 1) and platinum-based chemotherapy (unless ineligible/intolerant of platinum-based chemotherapy) for metastatic or recurrent disease
      • CRC

        • K-Ras WT: Patients who have progressed during or after, or are ineligible for, both irinotecan and oxaliplatin based chemotherapy and who are relapsed or refractory to at least 1 prior systemic therapy that included an anti-EGFR antibody
        • K-Ras mutant: Patients who have progressed during or after, or are ineligible for, both irinotecan and oxaliplatin based chemotherapy
  • ECOG performance status of ≤ 1
  • Measurable disease as per RECIST v1.1 criteria and documented by CT and/or MRI
  • Patients must allow acquisition of existing archival tumor sample, either a block or unstained slides.
  • Patients are required to consent for paired tumor biopsies: one in the screening period and on during the first cycle of treatment
  • Acceptable laboratory parameters and adequate organ reserve
  • Patients who have previously received an immune checkpoint prior to enrollment must have checkpoint inhibitor immune-related toxicity resolved to either Grade ≤ 1 or baseline
  • Patients with symptomatic central nervous system metastases must have been treated, be asymptomatic for ≥ 14 days, and must not have concurrent treatment or concurrent leptomeningeal disease / cord compression

Exclusion Criteria:

  • Patients with a history of known autoimmune disease with certain exceptions
  • Patients with clinically significant cardiovascular / vascular disease
  • Patients with clinically significant inflammatory gastrointestinal disorders
  • Patients with clinically significant pulmonary compromise
  • Major surgery or traumatic injury within 8 weeks from the date of first study dose
  • Unhealed wounds from surgery or injury
  • Treatment with radiation therapy < 2 weeks from the date of first study dose
  • Inflammatory process that has not resolved for ≥ 4 weeks from the date of first study dose

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04844073

Layout table for location contacts
Contact: Takeda Contact +1-877-825-3327

Layout table for location information
Australia, New South Wales
Scientia Clinical Research Limited, Corner High & Avoca Street, 5th Floor, Bright Building Recruiting
Randwick, New South Wales, Australia, 2031
Contact: Charlotte Lemech    Please contact   
Australia, South Australia
Southern Oncology Clinical Research Unit, 1 Flinders Drive Recruiting
Bedford Park, South Australia, Australia, 5042
Contact: Ganessan Kichenadasse    Please contact   
Australia, Victoria
Monash Health, Monash Medical Center, 246 Clayton Road Not yet recruiting
Clayton, Victoria, Australia, 3168
Contact: Sophia Frentzas    Please contact   
Peter MacCallum Cancer Centre, Grattan Street, Parkville, Medical Oncology, Level 2 Not yet recruiting
Melbourne, Victoria, Australia, 3052
Contact: Nathan Reader Wilson    Please contact   
Austin Hospital, 145 Studley Road, Intensive Care Unit Not yet recruiting
Heidelberg, Australia, 3084
Contact: Andrew Weickhardt    Please contact   
Sponsors and Collaborators
Layout table for investigator information
Study Director: Study Director Takeda
Layout table for additonal information
Responsible Party: Takeda Identifier: NCT04844073    
Other Study ID Numbers: CP-MVC-101-01
First Posted: April 14, 2021    Key Record Dates
Last Update Posted: September 22, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Takeda:
Unresectable locally advanced cancer
Metastatic cancer
EGFR expressing cancers
Squamous head and neck cancer
Lung cancer
Colon cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Non-Small-Cell Lung
Squamous Cell Carcinoma of Head and Neck
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Squamous Cell
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Head and Neck Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases