Search Cancer Clinical Trials

The Cancer Center offers patients access to a wide variety of clinical trials of promising new therapies. Use the search tool to find open protocols for your type of cancer.
Search by condition
Search By:
Protocol # 22-430

Status

Recruiting

Description

IMC-F106C is an immune-mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen PRAME. This is a first-in-human trial designed to evaluate the safety and efficacy of IMC-F106C in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME

Condition

  • Select Advanced Solid Tumors

Interventions

  • IMC-F106C
  • IMC-F106C and atezolizumab and pembrolizumab
  • IMC-F106C and chemotherapy
  • IMC-F106C and tebentafusp

Phase

Phase 1/Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Phase 1: Incidence of Dose-limiting toxicity (DLT)s
  • Phase 1: incidence and severity of adverse events (AE) and serious adverse events (SAE)
  • Phase 1: changes in laboratory parameters
  • Phase 1: changes in vital signs
  • Phase 1: changes in electrocardiogram parameters
  • Phase 1: dose interruptions, reductions, and discontinuations
  • Phase 2: Best overall response (BOR)

Secondary Outcome:

  • Phase I: Best Overall Response (BOR)
  • Progression-free survival (PFS)
  • Duration of response (DOR)
  • Overall survival
  • Pharmacokinetics Area under the plasma concentration-time curve (AUC)
  • Pharmacokinetics The maximum observed plasma drug concentration (Cmax)
  • Pharmacokinetics The time to reach maximum plasma concentration (Tmax)
  • Pharmacokinetics The elimination half-life (t1/2)
  • Incidence of anti-IMC-F106C antibody formation
  • Changes in lymphocyte counts over time
  • Changes in serum cytokines over time

Enrollment

170

Study Start Date

February 25, 2020

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Immunocore Ltd

Source

Immunocore Ltd

Official title

Phase 1/2 Study of IMC-F106C in Advance PRAME-Positive Cancers

Clinicaltrials.gov Identifier

NCT04262466

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.