Last updated 2 months ago
Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors
727 patients around the world
Available in Spain, Brazil, United States
The IMC-F106C-101 Phase 1/2 study will be evaluated in patients with
metastatic/unresectable tumors which include select Advanced Solid Tumors and will be
conducted in two phases.
1. Phase 1: To identify the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2
dose (RP2D) of brenetafusp as a single agent and administered in combination with
chemotherapies, targeted therapies, and monoclonal antibodies.
2. Phase 2: To assess the efficacy of brenetafusp in selected advanced solid tumors.
Immunocore Ltd
1Research sites
727Patients around the world
This study is for people with
Solid tumors
Advanced tumors
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Ecog ps 0 or 1.Hla-a*02:01 positive.Prame positive tumor.Relapsed from, refractory to, or intolerant of standard therapies; or, in combination with standard therapies.If applicable, must agree to use highly effective contraception.
- Symptomatic or untreated central nervous system metastasis.Recent bowel obstruction.Ongoing ascites or effusion requiring recent drainages.Significant immune-mediated adverse event with prior immunotherapy (patients in checkpoint inhibitor combination treatment).Inadequate washout from prior anticancer therapy.Significant ongoing toxicity from prior anticancer treatment.Out-of-range laboratory values.Clinically significant lung, heart, or autoimmune disease.Ongoing requirement for immunosuppressive treatment.Prior solid organ or bone marrow transplant.Active hepatitis b virus (hbv), hepatitis c virus (hcv), or human immunodeficiency virus (hiv) infection.Significant secondary malignancy.Hypersensitivity to study drug or excipients.Antibiotics, vaccines or surgery within 2-4 weeks prior to the first dose of study intervention.Pregnant or lactating.Any other contraindication for applicable combination partner based on local prescribing information.
Sites
Hospital Nossa Senhora da Conceição
Recruiting
SponsorImmunocore Ltd
Conditions
Solid tumorsAdvanced tumors
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04262466
