NCT02291614 is a Phase 1 clinical trial of AMG 211 in GI Adenocarcinoma, sponsored by Amgen.

Who is sponsoring NCT02291614?

NCT02291614 is sponsored by Amgen.

What drugs are being tested in NCT02291614?

Interventions in NCT02291614: AMG 211.

What condition does NCT02291614 study?

NCT02291614 studies GI Adenocarcinoma.

Is NCT02291614 still recruiting?

NCT02291614 is currently terminated. Last updated 16 March 2021.

Are results published for NCT02291614?

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

Last reviewed 2021-03-16 · How we verify

NCT02291614

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

A Phase 1 Study of AMG 211 in Participants With Advanced Gastrointestinal Cancer

Terminated Phase 1 Results posted Last updated 16 March 2021

What this trial tests

Phase 1 trial testing AMG 211 in GI Adenocarcinoma in 45 participants. Terminated before completion.

Timeline

27 November 2014

Primary endpoint
6 November 2017

9 January 2018

Quick facts

Lead sponsor	Amgen
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	45
Start date	27 November 2014
Primary completion	6 November 2017
Estimated completion	9 January 2018
Sites	5 locations across Netherlands, Germany

Drugs / interventions tested

AMG 211 — full drug profile →

Conditions studied

GI Adenocarcinoma — all drugs for GI Adenocarcinoma →

Sponsor

Amgen — full company profile →

Who can join

18 and older, any sex, with GI Adenocarcinoma. 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 (DLTs) Primary · 28 days

A DLT was defined as any of the following occurring during the first 28 days of treatment and regarded by the investigator and/or sponsor as related to AMG 211. Hematological DLTs: absolute neutrophil count (ANC) \< 0.5 × 10⁹ cells/L for ≥ 7 days; febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection) with ANC \< 0.5 × 10⁹ cells/L and fever ≥ 38.5°C; platelets \< 25 × 10⁹ cells/L ≥ 7 days. Non-hematological DLTs: any AMG 211-related ≥ grade 3 non-hematological toxicity, excluding nausea and vomiting not refractory to anti-emetics, flare-up of

Group	Value	95% CI
AMG 211 200 µg/Day for 7/14 Days	0
AMG 211 200 µg/Day for 14 Days	0
AMG 211 400 µg/Day for 14 Days	0
AMG 211 800 µg/Day for 14 Days	0
AMG 211 1600 µg/Day for 14 Days	0
AMG 211 1600 µg/Day for 28 Days	0
AMG 211 3200 µg/Day for 14 Days	0
AMG 211 3200 µg/Day for 28 Days	0
AMG 211 6400 µg/Day for 14 Days	0
AMG 211 6400 µg/Day for 28 Days	0
AMG 211 12,800 µg/Day for 28 Days	0

Maximum Observed Concentration (Cmax) of AMG 211 in Cycle 1 in Participants Who Received Dosing for 7 or 14 Days Secondary · Cycle 1: Predose, 2, 6, 24, 48-96, and 168 (for 14-day dosing groups only) hours after the start of infusion, at the end of infusion (Day 8 or Day 15), and 0.5, 2, 4, 8, and 24 hours after the end of infusion.

Levels of AMG 211 in plasma samples collected during this study were analyzed using an electrochemiluminiscence assay. The lower limit of quantification (LLOQ) of the assay was 0.10 ng/mL.

Group	Value	95% CI
AMG 211 200 µg/Day for 7/14 Days	5.32	± 2.26
AMG 211 200 µg/Day for 14 Days	11.5	± 7.21
AMG 211 400 µg/Day for 14 Days	13.9	± 1.13
AMG 211 800 µg/Day for 14 Days	19.8	± 3.67
AMG 211 1600 µg/Day for 14 Days	55.1	± 11.0
AMG 211 3200 µg/Day for 14 Days	116	± 32.4
AMG 211 6400 µg/Day for 14 Days	129	± 51.0

Number of Participants With Treatment Emergent Adverse Events (TEAEs) Primary · From first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).

An adverse event (AE) was defined as any untoward medical occurrence, which does not necessarily have a causal relationship with study treatment. A serious adverse event (SAE) was defined as an event that: was fatal or life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/borth defect; or other significant medical event. A TEAE was defined as any AE starting on or after the first dose of study drug and up to and including 30 days after the end of last dose of study

Any TEAE

Group	Value	95% CI
AMG 211 200 µg/Day for 7/14 Days	3
AMG 211 200 µg/Day for 14 Days	3
AMG 211 400 µg/Day for 14 Days	3
AMG 211 800 µg/Day for 14 Days	5
AMG 211 1600 µg/Day for 14 Days	3
AMG 211 1600 µg/Day for 28 Days	3
AMG 211 3200 µg/Day for 14 Days	6
AMG 211 3200 µg/Day for 28 Days	3
AMG 211 6400 µg/Day for 14 Days	3
AMG 211 6400 µg/Day for 28 Days	10
AMG 211 12,800 µg/Day for 28 Days	2

Grade ≥ 2 TEAE

Group	Value	95% CI
AMG 211 200 µg/Day for 7/14 Days	3
AMG 211 200 µg/Day for 14 Days	3
AMG 211 400 µg/Day for 14 Days	3
AMG 211 800 µg/Day for 14 Days	5
AMG 211 1600 µg/Day for 14 Days	3
AMG 211 1600 µg/Day for 28 Days	3
AMG 211 3200 µg/Day for 14 Days	6
AMG 211 3200 µg/Day for 28 Days	3
AMG 211 6400 µg/Day for 14 Days	1
AMG 211 6400 µg/Day for 28 Days	10
AMG 211 12,800 µg/Day for 28 Days	2

Grade ≥ 3 TEAE

Group	Value	95% CI
AMG 211 200 µg/Day for 7/14 Days	1
AMG 211 200 µg/Day for 14 Days	2
AMG 211 400 µg/Day for 14 Days	2
AMG 211 800 µg/Day for 14 Days	4
AMG 211 1600 µg/Day for 14 Days	1
AMG 211 1600 µg/Day for 28 Days	2
AMG 211 3200 µg/Day for 14 Days	4
AMG 211 3200 µg/Day for 28 Days	3
AMG 211 6400 µg/Day for 14 Days	1
AMG 211 6400 µg/Day for 28 Days	8
AMG 211 12,800 µg/Day for 28 Days	2

Grade ≥ 4 TEAE

Group	Value	95% CI
AMG 211 200 µg/Day for 7/14 Days	0
AMG 211 200 µg/Day for 14 Days	0
AMG 211 400 µg/Day for 14 Days	1
AMG 211 800 µg/Day for 14 Days	1
AMG 211 1600 µg/Day for 14 Days	1
AMG 211 1600 µg/Day for 28 Days	1
AMG 211 3200 µg/Day for 14 Days	1
AMG 211 3200 µg/Day for 28 Days	1
AMG 211 6400 µg/Day for 14 Days	0
AMG 211 6400 µg/Day for 28 Days	1
AMG 211 12,800 µg/Day for 28 Days	0

Serious TEAE (STEAE)

Group	Value	95% CI
AMG 211 200 µg/Day for 7/14 Days	1
AMG 211 200 µg/Day for 14 Days	2
AMG 211 400 µg/Day for 14 Days	2
AMG 211 800 µg/Day for 14 Days	4
AMG 211 1600 µg/Day for 14 Days	2
AMG 211 1600 µg/Day for 28 Days	1
AMG 211 3200 µg/Day for 14 Days	6
AMG 211 3200 µg/Day for 28 Days	3
AMG 211 6400 µg/Day for 14 Days	1
AMG 211 6400 µg/Day for 28 Days	9
AMG 211 12,800 µg/Day for 28 Days	1

TEAE leading to discontinuation of AMG 211

Group	Value	95% CI
AMG 211 200 µg/Day for 7/14 Days	0
AMG 211 200 µg/Day for 14 Days	0
AMG 211 400 µg/Day for 14 Days	0
AMG 211 800 µg/Day for 14 Days	2
AMG 211 1600 µg/Day for 14 Days	0
AMG 211 1600 µg/Day for 28 Days	0
AMG 211 3200 µg/Day for 14 Days	0
AMG 211 3200 µg/Day for 28 Days	1
AMG 211 6400 µg/Day for 14 Days	0
AMG 211 6400 µg/Day for 28 Days	3
AMG 211 12,800 µg/Day for 28 Days	0

STEAE leading to discontinuation of AMG 211

Group	Value	95% CI
AMG 211 200 µg/Day for 7/14 Days	0
AMG 211 200 µg/Day for 14 Days	0
AMG 211 400 µg/Day for 14 Days	0
AMG 211 800 µg/Day for 14 Days	2
AMG 211 1600 µg/Day for 14 Days	0
AMG 211 1600 µg/Day for 28 Days	0
AMG 211 3200 µg/Day for 14 Days	0
AMG 211 3200 µg/Day for 28 Days	1
AMG 211 6400 µg/Day for 14 Days	0
AMG 211 6400 µg/Day for 28 Days	3
AMG 211 12,800 µg/Day for 28 Days	0

Non-STEAE leading to discontinuation of AMG 211

Group	Value	95% CI
AMG 211 200 µg/Day for 7/14 Days	0
AMG 211 200 µg/Day for 14 Days	0
AMG 211 400 µg/Day for 14 Days	0
AMG 211 800 µg/Day for 14 Days	0
AMG 211 1600 µg/Day for 14 Days	0
AMG 211 1600 µg/Day for 28 Days	0
AMG 211 3200 µg/Day for 14 Days	0
AMG 211 3200 µg/Day for 28 Days	0
AMG 211 6400 µg/Day for 14 Days	0
AMG 211 6400 µg/Day for 28 Days	0
AMG 211 12,800 µg/Day for 28 Days	0

Maximum Observed Concentration (Cmax) of AMG 211 in Cycle 1 in Participants Who Received Dosing for 28 Days Secondary · Cycle 1: Predose, 2, 6, 24, 48-96, and 168 hours after the start of infusion, Day 15, at the end of infusion (Day 29), and 0.5, 2, 4, 8, and 24 hours after the end of infusion.

Group	Value	95% CI
AMG 211 1600 µg/Day for 28 Days	45.4	± 8.86
AMG 211 3200 µg/Day for 28 Days	150	± 68.6
AMG 211 6400 µg/Day for 28 Days	145	± 45.0
AMG 211 12,800 µg/Day for 28 Days	398	± 99999

Area Under the Serum Concentration-Time Curve (AUC) From Time 0 to the Last Quantifiable Concentration in Cycle 1 in Participants Who Received Dosing for 7 or 14 Days Secondary · Cycle 1: Predose, 2, 6, 24, 48-96, and 168 (for 14-day dosing groups only) hours after the start of infusion, at the end of infusion (Day 8 or Day 15), and 0.5, 2, 4, 8, and 24 hours after the end of infusion.

Area under the serum concentration-time curve (AUC) from time 0 to the last quantifiable concentration was estimated using the linear trapezoidal method.

Group	Value	95% CI
AMG 211 200 µg/Day for 7/14 Days	29.7	± 19.4
AMG 211 200 µg/Day for 14 Days	138	± 84.7
AMG 211 400 µg/Day for 14 Days	172	± 23.0
AMG 211 800 µg/Day for 14 Days	214	± 77.5
AMG 211 1600 µg/Day for 14 Days	617	± 186
AMG 211 3200 µg/Day for 14 Days	1540	± 936
AMG 211 6400 µg/Day for 14 Days	1420	± 666

Area Under the Serum Concentration-Time Curve (AUC) From Time 0 to the Last Quantifiable Concentration in Cycle 1 in Participants Who Received Dosing for 28 Days Secondary · Cycle 1: Predose, 2, 6, 24, 48-96, and 168 hours after the start of infusion, Day 15, at the end of infusion (Day 29), and 0.5, 2, 4, 8, and 24 hours after the end of infusion.

Area under the serum concentration-time curve (AUC) from time 0 to the last quantifiable concentration was estimated using the linear trapezoidal method.

Group	Value	95% CI
AMG 211 1600 µg/Day for 28 Days	1040	± 245
AMG 211 3200 µg/Day for 28 Days	3250	± 1700
AMG 211 6400 µg/Day for 28 Days	2610	± 1940
AMG 211 12,800 µg/Day for 28 Days	6080	± 99999

Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUCinf) in Cycle 1 in Participants Who Received Dosing for 7 or 14 Days Secondary · Cycle 1: Predose, 2, 6, 24, 48-96, and 168 (for 14-day dosing groups only) hours after the start of infusion, at the end of infusion (Day 8 or Day 15), and 0.5, 2, 4, 8, and 24 hours after the end of infusion.

Area under the serum concentration-time curve from time 0 to infinity was estimated using the linear trapezoidal method

Group	Value	95% CI
AMG 211 200 µg/Day for 7/14 Days	30.0	± 19.3
AMG 211 200 µg/Day for 14 Days	140	± 85.6
AMG 211 400 µg/Day for 14 Days	173	± 23.4
AMG 211 800 µg/Day for 14 Days	215	± 77.5
AMG 211 1600 µg/Day for 14 Days	619	± 186
AMG 211 3200 µg/Day for 14 Days	1540	± 938
AMG 211 6400 µg/Day for 14 Days	1430	± 673

Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUCinf) in Cycle 1 in Participants Who Received Dosing for 28 Days Secondary · Cycle 1: Predose, 2, 6, 24, 48-96, and 168 hours after the start of infusion, Day 15, at the end of infusion (Day 29), and 0.5, 2, 4, 8, and 24 hours after the end of infusion.

Area under the serum concentration-time curve from time 0 to infinity was estimated using the linear trapezoidal method

Group	Value	95% CI
AMG 211 1600 µg/Day for 28 Days	1040	± 245
AMG 211 3200 µg/Day for 28 Days	3260	± 1710
AMG 211 6400 µg/Day for 28 Days	3180	± 2070
AMG 211 12,800 µg/Day for 28 Days	6530	± 99999

Terminal Half-life (T1/2) of AMG-211 in Cycle 1 in Participants Who Received Dosing for 7 or 14 Days Secondary · Cycle 1: Predose, 2, 6, 24, 48-96, and 168 (for 14-day dosing groups only) hours after the start of infusion, at the end of infusion (Day 8 or Day 15), and 0.5, 2, 4, 8, and 24 hours after the end of infusion.

Terminal half-life (t1/2,z) calculated as t1/2,z = ln(2)/λz, where λz was the first-order terminal rate constant estimated via linear regression of the terminal log-linear phase.

Group	Value	95% CI
AMG 211 200 µg/Day for 7/14 Days	10.4	± 3.34
AMG 211 200 µg/Day for 14 Days	10.3	± 0.703
AMG 211 400 µg/Day for 14 Days	10.2	± 4.37
AMG 211 800 µg/Day for 14 Days	7.25	± 2.63
AMG 211 1600 µg/Day for 14 Days	7.78	± 2.37
AMG 211 3200 µg/Day for 14 Days	10.3	± 1.72
AMG 211 6400 µg/Day for 14 Days	11.9	± 3.53

Terminal Half-life of AMG-211 in Cycle 1 in Participants Who Received Dosing for 28 Days Secondary · Cycle 1: Predose, 2, 6, 24, 48-96, and 168 hours after the start of infusion, Day 15, at the end of infusion (Day 29), and 0.5, 2, 4, 8, and 24 hours after the end of infusion.

Terminal half-life (t1/2,z) calculated as t1/2,z = ln(2)/λz, where λz was the first-order terminal rate constant estimated via linear regression of the terminal log-linear phase.

Group	Value	95% CI
AMG 211 1600 µg/Day for 28 Days	11.1	± 3.45
AMG 211 3200 µg/Day for 28 Days	6.48	± 5.16
AMG 211 6400 µg/Day for 28 Days	8.81	± 4.58
AMG 211 12,800 µg/Day for 28 Days	15.2	± 99999

Concentration of AMG 211 at Steady State (Css) in Cycle 1 in Participants Who Received Dosing for 7 or 14 Days Secondary · Cycle 1: Predose, 2, 6, 24, 48-96, and 168 (for 14-day dosing groups only) hours after the start of infusion, at the end of infusion (Day 8 or Day 15), and 0.5, 2, 4, 8, and 24 hours after the end of infusion

Css was calculated as the average concentration between achievement of plateau and the end of infusion.

Group	Value	95% CI
AMG 211 200 µg/Day for 7/14 Days	4.32	± 3.27
AMG 211 200 µg/Day for 14 Days	9.92	± 6.05
AMG 211 400 µg/Day for 14 Days	12.4	± 1.73
AMG 211 800 µg/Day for 14 Days	16.6	± 4.42
AMG 211 1600 µg/Day for 14 Days	45.3	± 12.9
AMG 211 3200 µg/Day for 14 Days	88.0	± 26.4
AMG 211 6400 µg/Day for 14 Days	96.9	± 50.8

Concentration of AMG 211 at Steady State (Css) in Cycle 1 in Participants Who Received Dosing for 28 Days Secondary · Cycle 1: Predose, 2, 6, 24, 48-96, and 168 hours after the start of infusion, Day 15, at the end of infusion (Day 29), and 0.5, 2, 4, 8, and 24 hours after the end of infusion.

Css was calculated as the average concentration between achievement of plateau and the end of infusion.

Group	Value	95% CI
AMG 211 1600 µg/Day for 28 Days	35.9	± 7.50
AMG 211 3200 µg/Day for 28 Days	130	± 63.9
AMG 211 6400 µg/Day for 28 Days	109	± 36.1
AMG 211 12,800 µg/Day for 28 Days	306	± 99999

Adverse events — posted to ClinicalTrials.gov

Time frame: All-cause mortality: from enrollment date to end of study date (median time frame was 84 days). Serious and other adverse events: from first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

AMG 211 200 µg/Day for 7/14 Days

Serious: 1/3 (33%)

Deaths: 0/3

AMG 211 200 µg/Day for 14 Days

Serious: 2/3 (67%)

Deaths: 0/3

AMG 211 400 µg/Day for 14 Days

Serious: 2/3 (67%)

Deaths: 1/3

AMG 211 800 µg/Day for 14 Days

Serious: 4/5 (80%)

Deaths: 0/5

AMG 211 1600 µg/Day for 14 Days

Serious: 2/3 (67%)

Deaths: 1/3

AMG 211 1600 µg/Day for 28 Days

Serious: 1/3 (33%)

Deaths: 1/3

AMG 211 3200 µg/Day for 14 Days

Serious: 6/6 (100%)

Deaths: 1/6

AMG 211 3200 µg/Day for 28 Days

Serious: 3/3 (100%)

Deaths: 0/3

AMG 211 6400 µg/Day for 14 Days

Serious: 1/3 (33%)

Deaths: 0/3

AMG 211 6400 µg/Day for 28 Days

Serious: 9/10 (90%)

Deaths: 1/10

AMG 211 12,800 µg/Day for 28 Days

Serious: 1/2 (50%)

Deaths: 2/2

Serious adverse events (45 terms)

Reaction	System	AMG 211 200 µg/Day for 7/1…	AMG 211 200 µg/Day for 14 …	AMG 211 400 µg/Day for 14 …	AMG 211 800 µg/Day for 14 …	AMG 211 1600 µg/Day for 14…	AMG 211 1600 µg/Day for 28…	AMG 211 3200 µg/Day for 14…	AMG 211 3200 µg/Day for 28…	AMG 211 6400 µg/Day for 14…	AMG 211 6400 µg/Day for 28…	AMG 211 12,800 µg/Day for …
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Ascites	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Ileus	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Oesophageal varices haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Discomfort	General disorders	—	—	—	—	—	—	—	—	—	—	—
General physical health deterioration	General disorders	—	—	—	—	—	—	—	—	—	—	—
Influenza like illness	General disorders	—	—	—	—	—	—	—	—	—	—	—
Bile duct obstruction	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—
Cholangitis	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—
Hepatic infarction	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—
Cytokine release syndrome	Immune system disorders	—	—	—	—	—	—	—	—	—	—	—
Catheter site infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Device related infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Enterobacter bacteraemia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Febrile infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Respiratory tract infection viral	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Staphylococcal sepsis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (154 terms — click to expand)

Reaction	System	AMG 211 200 µg/Day for 7/1…	AMG 211 200 µg/Day for 14 …	AMG 211 400 µg/Day for 14 …	AMG 211 800 µg/Day for 14 …	AMG 211 1600 µg/Day for 14…	AMG 211 1600 µg/Day for 28…	AMG 211 3200 µg/Day for 14…	AMG 211 3200 µg/Day for 28…	AMG 211 6400 µg/Day for 14…	AMG 211 6400 µg/Day for 28…	AMG 211 12,800 µg/Day for …
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Catheter site pain	General disorders	—	—	—	—	—	—	—	—	—	—	—
Mucosal inflammation	General disorders	—	—	—	—	—	—	—	—	—	—	—
Pain	General disorders	—	—	—	—	—	—	—	—	—	—	—
Oral herpes	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—
Hiccups	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—
Arrhythmia	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—
Tachycardia	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—
Hypothyroidism	Endocrine disorders	—	—	—	—	—	—	—	—	—	—	—
Eye irritation	Eye disorders	—	—	—	—	—	—	—	—	—	—	—
Lacrimation increased	Eye disorders	—	—	—	—	—	—	—	—	—	—	—
Vision blurred	Eye disorders	—	—	—	—	—	—	—	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain lower	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Abnormal faeces	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Anal incontinence	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Ascites	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Defaecation urgency	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Abdominal pain, Ascites, Pyrexia, Constipation, Diarrhoea, Ileus, Nausea, Oesophageal varices haemorrhage.

Data from ClinicalTrials.gov NCT02291614 adverse events section.

Sponsor's own description

The purpose of this Phase 1 study is to determine if AMG 211 given as a continous intravenous (IV) infusion is safe and tolerable in adult participants that have advanced gastrointestinal adenocarcinoma. The study will be conducted in multiple sites and test increasing doses of AMG 211. The safety of participants will be monitored by intensive assessment of vital signs, electrocardiograms, physical examinations, and laboratory tests. Efficacy will be assessed by the usual imaging procedures and their interpretation.

Publications & conference data

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

Emerging new therapeutic antibody derivatives for cancer treatment.
Jin S, Sun Y, Liang X, Gu X, et al · · 2022 · cited 304× · PMID 35132063 · DOI 10.1038/s41392-021-00868-x
A multicenter phase 1 study of solitomab (MT110, AMG 110), a bispecific EpCAM/CD3 T-cell engager (BiTE®) antibody construct, in patients with refractory solid tumors.
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Trial protocol + status: ClinicalTrials.gov NCT02291614 (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 Amgen
Last refreshed: 16 March 2021

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/NCT02291614.

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NCT02291614

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