Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

NantCell, Inc.

Intervention(s):

  • Biological: AMG 479
  • Biological: AMG 655

Phase:

Phase 1/Phase 2

Eligibility


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)

Ages Eligible for Study

16 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting