NCT00819169 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1, PHASE2
Status at capture: TERMINATED
Registry last update: 2024-08-20

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Dose-limiting Toxicities

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outcome · POSTED

Objective Response Rate

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outcome · POSTED

Progression Free Survival

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outcome · POSTED

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

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outcome · POSTED

To Evaluate the Concentration Level of AMG 655

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outcome · POSTED

To Evaluate the Concentration Level of AMG 479

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outcome · POSTED

Time to Response

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outcome · POSTED

Duration of Response

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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)
healthy Volunteers: false
minimum Age: 16 Years
sex: ALL
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle)
intervention Names
Biological: AMG 479
Biological: AMG 655
label
Part 1 Cohort 3
type
EXPERIMENTAL
description
AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle)
intervention Names
Biological: AMG 479
Biological: AMG 655
label
Part 1 Cohort 1
type
EXPERIMENTAL
description
AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle)
intervention Names
Biological: AMG 479
Biological: AMG 655
label
Part 1 Cohort 2
type
EXPERIMENTAL
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
intervention Names
Biological: AMG 479
Biological: AMG 655
label
Part 2
type
EXPERIMENTAL

interventions

arm Group Labels
Part 1 Cohort 1
Part 1 Cohort 2
Part 1 Cohort 3
Part 2
description
AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
name
AMG 479
type
BIOLOGICAL
arm Group Labels
Part 1 Cohort 1
Part 1 Cohort 2
Part 1 Cohort 3
Part 2
description
AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
name
AMG 655
other Names
AMG 655 is also known as conatumumab.
type
BIOLOGICAL

Study design

allocation

NON_RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 89
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Number of Participants With Dose-limiting Toxicities
time Frame
Time from first dose up to 24 months
description
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.
measure
Objective Response Rate
time Frame
Time from first dose up to 24 months

secondary Outcomes

description
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.
measure
Progression Free Survival
time Frame
Time from first dose up to 24 months
measure
To Evaluate Anti-AMG 655 Antibody Formation and Anti-AMG 479 Antibody Formation
time Frame
Time from first dose up to 24 months
description
Median, minimum, and maximum concentration of AMG 655 at specified time points.
measure
To Evaluate the Concentration Level of AMG 655
time Frame
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)
description
Median, minimum, and maximum concentration of AMG 479 at specified time points.
measure
To Evaluate the Concentration Level of AMG 479
time Frame
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)
description
Time to response is the time from study day 1 to the first observation of an objective response. Subjects without an objective response are excluded from the analysis of this endpoint. Objective response is defined as a tumor response assessment of either complete response or partial response per modified Response Evaluation Criteria in Solid Tumors (RECIST) and will be determined based on the Investigator-reported assessment only for subjects with measurable disease at baseline. Per RECIST v 1.1: 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.
measure
Time to Response
time Frame
Time from first dose up to 24 months
description
Duration of response is defined as the number of days between the date of first objective response to the time of the first progressive disease (per modified Response Evaluation Criteria in Solid Tumors \[RECIST\] or clinical progression, whichever occurs first) or death due to any cause. Objective response is defined as a tumor response assessment of either complete response or partial response per modified RECIST where a complete response is the disappearance of all target lesions and 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. Per RECIST v 1.1, disease progression 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.
measure
Duration of Response
time Frame
Time from objective response to 24 months

Full study description

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.

Source references

references

citation
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
type
BACKGROUND