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

NCT00819169 | Terminated Phase 1 Results

• 2 other identifiers: 20070411QUILT-3.026
• Study Type: interventional
• Target: 89
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Keywords

AMG 655; AMG 479; Apoptosis; Monoclonal Antibody; Tumor Necrosis Factor; Insulin-like Growth Factor

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Dose-limiting Toxicities

  Incidence of adverse events and clinical laboratory abnormalities defined as DLTs. Dose-limiting toxicities included any grade 3 or higher hematologic or nonhematologic toxicity related to conatumumab or the combination of conatumumab with ganitumab except for lymphocytopenia and anemia.

  Time from first dose up to 24 months

• Objective Response Rate

  The objective response rate (ORR) is defined as confirmed complete response or partial response using modified Response Evaluation Criteria in Solid Tumors \[RECIST\]: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  Time from first dose up to 24 months

Secondary Outcomes (6)

• Progression Free Survival

  Time from first dose up to 24 months

• To Evaluate Anti-AMG 655 Antibody Formation and Anti-AMG 479 Antibody Formation

  Time from first dose up to 24 months

• To Evaluate the Concentration Level of AMG 655

  Cycle 1 Day 1 end of infusion; Cycle 3 Day 1 end of infusion (each cycle is 28 days, each infusion is up to 1 hour)

• To Evaluate the Concentration Level of AMG 479

  Cycle 1 Day 1 end of infusion; Cycle 3 Day 1 end of infusion (each cycle is 28 days, each infusion is up to 1 hour)

• Time to Response

  Time from first dose up to 24 months

Study Arms (4)

Part 1 Cohort 3

EXPERIMENTAL

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

Biological: AMG 479; Biological: AMG 655

Part 1 Cohort 1

EXPERIMENTAL

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

Biological: AMG 479; Biological: AMG 655

Part 1 Cohort 2

EXPERIMENTAL

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

Biological: AMG 479; Biological: AMG 655

Part 2

EXPERIMENTAL

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

Biological: AMG 479; Biological: AMG 655

Interventions

AMG 479 BIOLOGICAL

AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.

Part 1 Cohort 1; Part 1 Cohort 2; Part 1 Cohort 3; Part 2

AMG 655 BIOLOGICAL

AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.

Also known as: AMG 655 is also known as conatumumab.

Part 1 Cohort 1; Part 1 Cohort 2; Part 1 Cohort 3; Part 2

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• NantCell, Inc.: lead

Related Publications (2)

• Chawla S, Tabernero, J, Kindler, H., Reckamp, K., Chiorean, E., Azad, N., Lockhard, A., Hsu, CP., Baker, N., Galimi, F., Beltran, P., Baselga, J..Anticancer activity of the type I insulin-like growth factor receptor antagonist, ganitumab, in combination with the death receptor 5 agonist, conatumumab.Targeted Oncology;Tabernero J, Chawla SP, Kindler H, Reckamp K, Chiorean EG, Azad NS, Lockhart AC, Hsu CP, Baker NF, Galimi F, Beltran P, Baselga J. Anticancer activity of the type I insulin-like growth factor receptor antagonist, ganitumab, in combination with the death receptor 5 agonist, conatumumab. Target Oncol. 2014 May 11. [Epub ahead of print]

  BACKGROUND

• Tabernero J, Chawla SP, Kindler H, Reckamp K, Chiorean EG, Azad NS, Lockhart AC, Hsu CP, Baker NF, Galimi F, Beltran P, Baselga J. Anticancer activity of the type I insulin-like growth factor receptor antagonist, ganitumab, in combination with the death receptor 5 agonist, conatumumab. Target Oncol. 2015 Mar;10(1):65-76. doi: 10.1007/s11523-014-0315-z. Epub 2014 May 11.

  PMID: 24816908 DERIVED

Related Links

• AmgenTrials clinical trials website
• Related Info

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Carcinoma, Non-Small-Cell Lung; Ovarian Neoplasms; Pancreatic Neoplasms; Sarcoma

Interventions

ganitumab; conatumumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Pancreatic Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Results Point of Contact

• Title: Sandeep Bobby Reddy, Chief Medical Officer
• Organization: ImmunityBio

Bobby.Reddy@immunitybio.com

855-797-9277

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2009
• First Posted: January 8, 2009
• Study Start: January 16, 2009
• Primary Completion: August 10, 2011
• Study Completion: August 10, 2011
• Last Updated: August 20, 2024
• Results First Posted: August 20, 2024

Record last verified: 2024-07