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MGF Igf-1-ec

IGF-1Ec, IGF-1Eb, Mechano-Growth Factor

Quick Stats
Studies 62
Trials 100
Completed PHASE1, PHASE2 INTERVENTIONAL NCT00630552

QUILT-2.019: A Study of AMG 655 or AMG 479 in Combination With Gemcitabine for Treatment of Metastatic Pancreatic Cancer

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This is a multi-center, 2-part study of AMG 655, AMG 479 or AMG 655-placebo plus gemcitabine as first-line treatment of subjects with metastatic pancreatic cancer. Part 1 is an open-label, dose-escalation phase 1b segment to determine the safety, tolerability and maximum tolerated dose of AMG 655 in combination with gemcitabine. Enrollment into part 1 of the study has been completed. Part 2 is a randomized, placebo-controlled phase 2 segment to estimate the efficacy as assessed by 6 month survival of AMG 655, AMG 479, or AMG 655-placebo in combination with gemcitabine. The phase 2 segment that will commence after dose selection in part 1. In part 2, subjects will be randomized 1:1:1 to AMG 655, AMG 479, or placebo in combination with gemcitabine.

Interventions

Name: Placebo
Type: OTHER
Description: Inactive dummy of AMG 655.
Name: AMG 479
Type: DRUG
Description: AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
Name: AMG 655
Type: DRUG
Description: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).

Primary Outcomes

Measure: Number of Participants With Dose Limiting Toxicities (DLTs; Phase 1b Portion Only)
TimeFrame: 28 days
Description: The incidence of adverse events and clinical laboratory abnormalities defined as DLTs. A DLT was defined as any grade 3 or higher hematologic or non-hematologic toxicity related to any study treatment.
Measure: Six Month Overall Survival Rate (Phase 2 Portion Only)
TimeFrame: 6 months
Description: The proportion of subjects alive at 6 months

Trial Information

NCT ID

NCT00630552

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE1, PHASE2

Sponsor

NantCell, Inc.

Last Updated

December 15, 2025