NCT00819169 is a Phase 1, PHASE2 clinical trial of AMG 479 in Colorectal Cancer, sponsored by NantCell, Inc..

Who is sponsoring NCT00819169?

NCT00819169 is sponsored by NantCell, Inc..

What drugs are being tested in NCT00819169?

Interventions in NCT00819169: AMG 479, AMG 655.

What condition does NCT00819169 study?

NCT00819169 studies Colorectal Cancer, Locally Advanced, Metastatic Cancer, Non-Small Cell Lung Cancer, Ovarian Cancer, Pancreatic Cancer, Sarcoma, Solid Tumors.

Is NCT00819169 still recruiting?

NCT00819169 is currently terminated. Last updated 20 August 2024.

Are results published for NCT00819169?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-08-20 · How we verify

NCT00819169

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 1, PHASE2 Results posted Last updated 20 August 2024

What this trial tests

Phase 1, PHASE2 trial testing AMG 479 in Colorectal Cancer in 89 participants. Terminated before completion.

Timeline

16 January 2009

Primary endpoint
10 August 2011

10 August 2011

Quick facts

Lead sponsor	NantCell, Inc.
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	89
Start date	16 January 2009
Primary completion	10 August 2011
Estimated completion	10 August 2011

Drugs / interventions tested

AMG 479 — full drug profile →
AMG 655 — full drug profile →

Conditions studied

Colorectal Cancer — all drugs for Colorectal Cancer →
Locally Advanced — all drugs for Locally Advanced →
Metastatic Cancer — all drugs for Metastatic Cancer →
Non-Small Cell Lung Cancer — all drugs for Non-Small Cell Lung Cancer →

Sponsor

NantCell, Inc. — full company profile →

Who can join

16 and older, any sex, with Colorectal Cancer or Locally Advanced. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Dose-limiting Toxicities Primary · Time from first dose up to 24 months

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.

Group	Value	95% CI
Part 1 Cohort 1	0
Part 1 Cohort 2	0
Part 1 Cohort 3	0

Objective Response Rate Primary · Time from first dose up to 24 months

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.

Group	Value	95% CI
Part 1 Cohort 1	1
Part 1 Cohort 2	0
Part 1 Cohort 3	0
Part 2 Cohort 1	0
Part 2 Cohort 2	0
Part 2 Cohort 3	0
Part 2 Cohort 4	0
Part 2 Cohort 5	0
Part 2 Cohort 6	0

Progression Free Survival Secondary · Time from first dose up to 24 months

Progression-free survival is defined as the number of days from study day 1 (first dose of investigational product) to the first observation of disease progression (by modified RECIST; or clinical progression, whichever came first) or death due to any cause. Disease progression by RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.

Group	Value	95% CI
Part 1 Cohort 1	1.4	1.1 – 15.4
Part 1 Cohort 2	4.9	1.6 – 5.5
Part 1 Cohort 3	1.3	1.1 – 2.4
Part 2 Cohort 1	1.6	1.3 – 3.7
Part 2 Cohort 2	3.3	1.9 – 5.4
Part 2 Cohort 3	1.5	1.3 – 2.6
Part 2 Cohort 4	1.4	1.2 – 2.3
Part 2 Cohort 5	2.8	1.6 – 3.9
Part 2 Cohort 6	1.3	1.2 – 1.7

To Evaluate Anti-AMG 655 Antibody Formation and Anti-AMG 479 Antibody Formation Secondary · Time from first dose up to 24 months

AMG 655 - Binding antibody positive at any time

Group	Value	95% CI
Part 1 Cohort 1	0
Part 1 Cohort 2	0
Part 1 Cohort 3	0
Part 2 Cohort 1	0
Part 2 Cohort 2	0
Part 2 Cohort 3	0
Part 2 Cohort 4	1
Part 2 Cohort 5	0
Part 2 Cohort 6	0

AMG 655 - Neutralizing antibody positive at any time

Group	Value	95% CI
Part 1 Cohort 1	0
Part 1 Cohort 2	0
Part 1 Cohort 3	0
Part 2 Cohort 1	0
Part 2 Cohort 2	0
Part 2 Cohort 3	0
Part 2 Cohort 4	0
Part 2 Cohort 5	0
Part 2 Cohort 6	0

AMG 479 - Binding antibody positive at any time

Group	Value	95% CI
Part 1 Cohort 1	0
Part 1 Cohort 2	0
Part 1 Cohort 3	0
Part 2 Cohort 1	2
Part 2 Cohort 2	0
Part 2 Cohort 3	0
Part 2 Cohort 4	0
Part 2 Cohort 5	0
Part 2 Cohort 6	0

AMG 479 - Neutralizing antibody positive at any time

Group	Value	95% CI
Part 1 Cohort 1	0
Part 1 Cohort 2	0
Part 1 Cohort 3	0
Part 2 Cohort 1	0
Part 2 Cohort 2	0
Part 2 Cohort 3	0
Part 2 Cohort 4	0
Part 2 Cohort 5	0
Part 2 Cohort 6	0

To Evaluate the Concentration Level of AMG 655 Secondary · 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)

Median, minimum, and maximum concentration of AMG 655 at specified time points.

Cycle 1-End of Infusion

Group	Value	95% CI
Part 1 Cohort 1	17.5	17.3 – 19.4
Part 1 Cohort 2	59.0	59.0 – 59.0
Part 1 Cohort 3	313	261 – 365
Part 2 Cohort 1	244	240 – 247
Part 2 Cohort 2	266	266 – 266
Part 2 Cohort 3	240	115 – 319
Part 2 Cohort 4	224	130 – 293
Part 2 Cohort 5	327	275 – 341
Part 2 Cohort 6	247	91.3 – 392

Cycle 3-End of infusion

Group	Value	95% CI
Part 1 Cohort 1	23.6	23.6 – 23.6
Part 1 Cohort 2	62.3	62.3 – 62.3
Part 1 Cohort 3	302	302 – 302
Part 2 Cohort 1	448	448 – 448
Part 2 Cohort 3	311	233 – 380
Part 2 Cohort 4	253	253 – 253
Part 2 Cohort 5	423	356 – 490
Part 2 Cohort 6	371	328 – 466

To Evaluate the Concentration Level of AMG 479 Secondary · 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)

Median, minimum, and maximum concentration of AMG 479 at specified time points.

Cycle 1-End of infusion

Group	Value	95% CI
Part 1 Cohort 1	272	198 – 279
Part 1 Cohort 2	268	268 – 268
Part 1 Cohort 3	303	257 – 349
Part 2 Cohort 1	215	193 – 237
Part 2 Cohort 2	297	297 – 297
Part 2 Cohort 3	227	130 – 634
Part 2 Cohort 4	236	121 – 391
Part 2 Cohort 5	324	248 – 439
Part 2 Cohort 6	254	169 – 445

Cycle 3-End of Infusion

Group	Value	95% CI
Part 1 Cohort 1	308	308 – 308
Part 1 Cohort 3	338	338 – 338
Part 2 Cohort 1	404	404 – 404
Part 2 Cohort 3	262	205 – 364
Part 2 Cohort 4	249	249 – 249
Part 2 Cohort 5	323	300 – 381
Part 2 Cohort 6	365	244 – 420

Adverse events — posted to ClinicalTrials.gov

Time frame: All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1 Cohort 1

Serious: 2/3 (67%)

Deaths: 1/3

Part 1 Cohort 2

Serious: 0/3 (0%)

Deaths: 1/3

Part 1 Cohort 3

Serious: 2/3 (67%)

Deaths: 3/3

Part 2 Cohort 1

Serious: 3/15 (20%)

Deaths: 8/15

Part 2 Cohort 2

Serious: 6/7 (86%)

Deaths: 5/8

Part 2 Cohort 3

Serious: 2/16 (13%)

Deaths: 7/16

Part 2 Cohort 4

Serious: 3/16 (19%)

Deaths: 9/16

Part 2 Cohort 5

Serious: 3/9 (33%)

Deaths: 4/9

Part 2 Cohort 6

Serious: 2/15 (13%)

Deaths: 7/16

Serious adverse events (36 terms)

Reaction	System	Part 1 Cohort 1	Part 1 Cohort 2	Part 1 Cohort 3	Part 2 Cohort 1	Part 2 Cohort 2	Part 2 Cohort 3	Part 2 Cohort 4	Part 2 Cohort 5	Part 2 Cohort 6
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Pericardial Effusion	Cardiac disorders	—	—	—	—	—	—	—	—	—
Ileus	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Metastases To Small Intestine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—
Small Intestinal Obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Abdominal Pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Gastrointestinal Haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Intestinal Obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—
Jaundice	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—
Urinary Tract Infection	Infections and infestations	—	—	—	—	—	—	—	—	—
Humerus Fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—
Blood Amylase Increased	Investigations	—	—	—	—	—	—	—	—	—
Blood Bilirubin	Investigations	—	—	—	—	—	—	—	—	—
Malignant Neoplasm Progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—
Metastases To Central Nervous System	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—
Peripheral Motor Neuropathy	Nervous system disorders	—	—	—	—	—	—	—	—	—
Somnolence	Nervous system disorders	—	—	—	—	—	—	—	—	—

Other adverse events (192 terms — click to expand)

Reaction	System	Part 1 Cohort 1	Part 1 Cohort 2	Part 1 Cohort 3	Part 2 Cohort 1	Part 2 Cohort 2	Part 2 Cohort 3	Part 2 Cohort 4	Part 2 Cohort 5	Part 2 Cohort 6
Fatigue	General disorders	—	—	—	—	—	—	—	—	—
Decreased Appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Back Pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Chest Pain	General disorders	—	—	—	—	—	—	—	—	—
Weight Decreased	Investigations	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Sinus Tachycardia	Cardiac disorders	—	—	—	—	—	—	—	—	—
Abdominal Distension	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Abdominal Pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Abdominal Pain Upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Pain	General disorders	—	—	—	—	—	—	—	—	—
Drug Hypersensitivity	Immune system disorders	—	—	—	—	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Pain In Extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—
Enteritis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Mucosal Inflammation	General disorders	—	—	—	—	—	—	—	—	—
Alanine Aminotransferase	Investigations	—	—	—	—	—	—	—	—	—
Breath Sounds Abnormal	Investigations	—	—	—	—	—	—	—	—	—
Haemoglobin Decreased	Investigations	—	—	—	—	—	—	—	—	—
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Deep Vein Thrombosis	Vascular disorders	—	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Hyperglycaemia, Pleural Effusion, Dyspnoea, Pericardial Effusion, Ileus, Metastases To Small Intestine, Pneumonia, Small Intestinal Obstruction.

Data from ClinicalTrials.gov NCT00819169 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

TRAIL on trial: preclinical advances in cancer therapy.
Stuckey DW, Shah K. · · 2013 · cited 216× · PMID 24076237 · DOI 10.1016/j.molmed.2013.08.007
Death receptors as targets in cancer.
Micheau O, Shirley S, Dufour F. · · 2013 · cited 151× · PMID 23638798 · DOI 10.1111/bph.12238
Principles of antibody-mediated TNF receptor activation.
Wajant H. · · 2015 · cited 111× · PMID 26292758 · DOI 10.1038/cdd.2015.109
Insulin/IGF-driven cancer cell-stroma crosstalk as a novel therapeutic target in pancreatic cancer.
Mutgan AC, Besikcioglu HE, Wang S, Friess H, et al · · 2018 · cited 87× · PMID 29475434 · DOI 10.1186/s12943-018-0806-0
Trial Watch: Immunostimulatory cytokines.
Vacchelli E, Galluzzi L, Eggermont A, Galon J, et al · · 2012 · cited 70× · PMID 22754768 · DOI 10.4161/onci.20459
Insulin-Like Growth Factor-1 Signaling in Lung Development and Inflammatory Lung Diseases.
Wang Z, Li W, Guo Q, Wang Y, et al · · 2018 · cited 64× · PMID 30018981 · DOI 10.1155/2018/6057589
Insulin-like growth factor: current concepts and new developments in cancer therapy.
King ER, Wong KK. · · 2012 · cited 57× · PMID 21875414 · DOI 10.2174/157489212798357930
Trial Watch: Immunostimulatory cytokines.
Vacchelli E, Eggermont A, Fridman WH, Galon J, et al · · 2013 · cited 47× · PMID 24073369 · DOI 10.4161/onci.24850

Verify or expand the search:

Other trials of AMG 479

Trials testing the same drug.

NCT01708161 — A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors · Phase 1, PHASE2 · terminated
NCT01562899 — A Study of MEK162 and AMG 479 in Patients With Selected Solid Tumors · Phase 1, PHASE2 · terminated
NCT01318642 — Ganitumab in Locally Advanced Unresectable Adenocarcinoma of the Pancreas · Phase 2 · terminated
NCT01231347 — QUILT-2.014: Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas · Phase 3 · completed
NCT00791154 — QUILT-2.013: First-Line Treatment for Extensive Stage Small Cell Lung Cancer · Phase 1, PHASE2 · terminated

Other recruiting trials for Colorectal Cancer

Currently open trials in the same condition.

NCT07152821 — Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcino · Phase 3 · recruiting
NCT07353645 — KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer · Phase 1, PHASE2 · recruiting
NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
NCT07523919 — Functional and Respiratory Determinants of Long-Term Colorectal Cancer Outcomes · recruiting
NCT07529301 — Functional and Respiratory Predictors of Early Postoperative Outcomes · recruiting

Other NantCell, Inc. trials

Trials by the same sponsor.

NCT03127098 — QUILT-3.040: ETBX-011 (Ad5 [E1-, E2b-]-CEA(6D)) Vaccine in Combination With ALT-803 (Super-agonist IL-15) in Subjects Ha · Phase 1, PHASE2 · terminated
NCT02383498 — QUILT-3.011 Phase 2 Yeast-Brachyury Vaccine Chordoma · Phase 2 · completed
NCT01856920 — QUILT-3.006 for Recurrent Medullary Thyroid Cancer · Phase 2 · completed
NCT01231347 — QUILT-2.014: Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas · Phase 3 · completed
NCT01147965 — QUILT-3.038: Active Immunotherapy CEA Vaccine in Patients With Malignancies Expressing CEA · Phase 1, PHASE2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00819169 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by NantCell, Inc.
Last refreshed: 20 August 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00819169.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing