Spots Global Cancer Trial Database for NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma

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Trial Identification

Brief Title: NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma

Official Title: An Open-label, Phase I Study of NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma

Study ID: NCT04625205

Conditions

Unresectable Melanoma

Metastatic Melanoma

Interventions

NEO-PTC-01

IL-2

αPD-1 therapy

Study Description

Brief Summary: Study to investigate the safety and activity of NEO-PTC-01 in patients with unresectable or metastatic melanoma. NEO-PTC-01 is an autologous personalized T cell (PTC) product for adoptive cell therapy that is manufactured ex vivo and targets neoantigens displayed on the patient's tumor and the tumor microenvironment. The study will be conducted in two parts, Part 1 (Dose Finding) and Part 2 (Dose Expansion). The dose-finding part of the study will test two doses of NEO-PTC-01 and will be structured according to a 3+3 dose escalation design. After the highest tolerated NEO-PTC-01 dose is identified, 2 additional evaluations in Part 1 are planned, a cohort to investigate NEO-PTC-01 in combination with interleukin (IL)-2 and another cohort introducing α programmed cell death protein 1 (αPD-1) therapy. The dose expansion part of the study will test the dose deemed to be safe in the dose-finding part of the study in an expanded cohort of patients to further define the safety of NEO-PTC-01.

Detailed Description: