Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

Summary

IMCgp100-102 is a Phase I/II study of the weekly intra-patient escalation dose regimen with IMCgp100 as a single agent in patients with metastatic uveal melanoma (mUM). According to this regimen, all patients in the trial will receive 2 weekly doses of IMCgp100 at a dose level below the identified weekly recommended Phase II dose (RP2D-QW) and then a dose escalation will commence at the third weekly dose at C1D15. The Phase I testing of the intra-patient escalation dosing regimen is designed to achieve a higher exposure and maximal plasma concentration of IMCgp100 after doses at Cycle 1 Day 15 (C1D15) and thereafter .

Official Title

A Phase I/II Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Using the Intra-patient Escalation Dosing Regimen in Patients With Advanced Uveal Melanoma

Details

This is a Phase I/II clinical study of IMCgp100 in patients with advanced uveal melanoma. This is a Phase I/II study of IMCgp100 administered on a weekly basis with an intra-patient escalation dosing regimen. The intra-patient escalation occurs at the third weekly dose on Cycle 1 Day 15 (C1D15). According to this regimen, all patients in the trial will receive 2 weekly doses of IMCgp100 at a dose level below the identified weekly recommended Phase II dose (RP2D-QW) and then a dose escalation will commence at the third weekly dose at C1D15 with the goal to achieve a long-term dosing regimen at a dose higher than that identified for the straight weekly dosing regimen (RP2D-QW). The dose escalation will identify the intra-patient escalation regimen (RP2D-IE). The Phase I portion of the study was a standard 3+3 dose escalation design. The Phase 1 portion of the study is now complete. The recommended Phase II dose of the intra-patient escalation dose regimen (RP2D-IE) was identified and the 2 expansion cohorts in metastatic uveal melanoma will be completed. The cohorts will enroll patients with metastatic uveal melanoma and are defined based on prior therapy The expansion portion will enroll approximately 150 patients.

Keywords

Uveal Melanoma Tebentafusp IMCgp100 gp100 metastatic melanoma ImmTAC Immunotherapy Bispecific T cell receptor fusion protein Immune mobilizing monoclonal T cell receptor against cancer UM mUM Melanoma Uveal Neoplasms Dose escalation Dose expansion

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Male or female patients age ≥ 18 years of age at the time of informed consent
  2. Ability to provide and understand written informed consent prior to any study procedures
  3. Histologically or cytologically confirmed diagnosis of metastatic uveal melanoma (mUM)
  4. Surgically sterile patients or patients of child-bearing potential who agree to use highly effective methods of contraception during study dosing and for 6 months after last dose of study drug
  5. Human leukocyte antigen (HLA)-A*0201 positive
  6. ECOG Performance Status of 0 or 1 at Screening
  7. Patients in Phase 2 will include patients with previously treated uveal melanoma in the metastatic setting

You CAN'T join if...

  1. Presence of symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases that require doses of corticosteroids.
  2. History of severe hypersensitivity reactions to other biologic drugs or monoclonal antibodies
  3. Patient with any out-of-range laboratory values.
  4. Clinically significant cardiac disease or impaired cardiac function.
  5. Active infection requiring systemic antibiotic therapy.
  6. Known history of HIV infection.
  7. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection per institutional protocol.
  8. Patients receiving systemic treatment with systemic steroid therapy or any other immunosuppressive medication at any dose level that would interfere with the action of the study drugs in the opinion of the investigator
  9. Malignant disease, other than that being treated in this study.
  10. . Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results
  11. . Presence of NCI CTCAE ≥ grade 2 toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are excluded if ≥ NCI CTCAE grade 3) due to prior cancer therapy
  12. . Pregnant, likely to become pregnant, or lactating women.

Locations

  • University California, San Diego Moores Cancer Center
    La Jolla California 92093 United States
  • The Angeles Clinic and Research Institute - W LA Office
    Los Angeles California 90025 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Immunocore Ltd
ID
NCT02570308
Phase
Phase 1/2
Study Type
Interventional
Last Updated