QUILT-3.026: AMG 655 in Combination With AMG 479 in Advanced, Refractory Solid Tumors

NantCell

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Metastatic Cancer; Locally Advanced; Sarcoma; Solid Tumors; Ovarian Cancer; Pancreatic Cancer; Non-Small Cell Lung Cancer; Colorectal Cancer

Treatments: Biological: AMG 655; Biological: AMG 479

Study type: Interventional

Funder types: Industry

Identifiers

NCT00819169

20070411

QUILT-3.026 (Other Identifier)

Details and patient eligibility

About

This is a multi-center, 2-part phase 1b/2 study of AMG 655 in combination with AMG 479 to be conducted in the United States and Spain.

Part 1 is a dose escalation segment to identify a dose of AMG 655 in combination with AMG 479 that is safe and tolerable.

Part 2 will evaluate the safety and estimate the efficacy of AMG 655 at the dose selected in Part 1 in combination with AMG 479 for the treatment of patients with advanced NSCLC (non-squamous histology; squamous histology), CRC, pancreatic cancer, ovarian cancer, and sarcoma.

Enrollment: 89 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Part 1: Histologically or cytologically confirmed, locally advanced or metastatic, treatment-refractory solid tumors
• Part 2: Histologically or cytologically confirmed, locally advanced or metastatic: NSCLC (squamous or non-squamous cell carcinoma; up to 2 prior treatment regimens), Colorectal Cancer (up to 2 prior treatment regimens), Pancreatic Cancer (up to 1 prior treatment regimen), Ovarian cancer (up to 2 prior treatment regimens), or Sarcoma (up to 2 prior treatment regimens), according to cohort availability
• Eastern Cooperative Group (ECOG performance status of 0 or 1
• Women or men ≥16 years of age
• Adequate hematology, renal, hepatic, coagulation and glycemic function.

Exclusion criteria

• Presence of uncontrolled central nervous system (CNS) disease
• Systemic chemotherapy, hormonal therapy, immunotherapy, experimental or approved anticancer proteins/antibodies therapy ≤28 days before enrollment.
• Prior treatment with death receptor agonists (including but not limited to rhApo2L/TRAIL [AMG951], apomab, mapatumumab, lexatumumab, CS-1008)
• Prior treatment with IGF receptor antagonists (including but not limited to CP-751, 871, MK0646, AVE1642 or IMC-A12)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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89 participants in 4 patient groups

Part 1 Cohort 3

Experimental group

Description:

AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle)

Treatment:

Biological: AMG 479

Biological: AMG 655

Part 1 Cohort 1

Experimental group

Description:

AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle)

Treatment:

Biological: AMG 479

Biological: AMG 655

Part 1 Cohort 2

Experimental group

Description:

AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle)

Treatment:

Biological: AMG 479

Biological: AMG 655

Part 2

Experimental group

Description:

AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg Q3W, or the MTD, as determined in Part 1 of the study

Treatment:

Biological: AMG 479

Biological: AMG 655