Trial · NCT00819169
QUILT-3.026: AMG 655 in Combination With AMG 479 in Advanced, Refractory Solid Tumors
NCT00819169, Phase 1, Phase 2, Terminated, NantCell, Inc.; results first posted 2024-08-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. QUILT-3.026: AMG 655 in Combination With AMG 479 in Advanced, Refractory Solid Tumors. Trials, record NCT00819169. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00819169
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- QUILT-3.026: AMG 655 in Combination With AMG 479 in Advanced, Refractory Solid Tumors
- NCT number
- NCT00819169
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 89 participants, actual
- Lead sponsor
- NantCell, Inc.
- Conditions
- Colorectal Cancer, Locally Advanced, Metastatic Cancer, Non-Small Cell Lung Cancer, Ovarian Cancer, Pancreatic Cancer, Sarcoma, Solid Tumors
- Interventions
- AMG 479, AMG 655
- First posted
- 2009-01-08
- Last updated
- 2024-08-20
- Results first posted
- 2024-08-20
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose-limiting Toxicities | 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. |
| Primary | Objective Response Rate | 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. |
| Secondary | Progression Free Survival | 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. |
| Secondary | To Evaluate Anti-AMG 655 Antibody Formation and Anti-AMG 479 Antibody Formation | Time from first dose up to 24 months | |
| Secondary | 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) | Median, minimum, and maximum concentration of AMG 655 at specified time points. |
| Secondary | 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) | Median, minimum, and maximum concentration of AMG 479 at specified time points. |
| Secondary | Time to Response | Time from first dose up to 24 months | 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. |
| Secondary | Duration of Response | Time from objective response to 24 months | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose-limiting Toxicities | Time from first dose up to 24 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Objective Response Rate | Time from first dose up to 24 months | A subject was included in the analysis if they received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression Free Survival | Time from first dose up to 24 months | months | MEDIAN | |
| SECONDARY | To Evaluate Anti-AMG 655 Antibody Formation and Anti-AMG 479 Antibody Formation | Time from first dose up to 24 months | Antibody Population = All subjects in the full analysis set tested for antibodies during the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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) | PK population = All subjects in the full analysis set who underwent blood sampling for PK evaluation during the study. | μg/mL | MEDIAN |
| SECONDARY | 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) | PK population = All subjects in the full analysis set who underwent blood sampling for PK evaluation during the study. | μg/mL | MEDIAN |
| SECONDARY | Time to Response | Time from first dose up to 24 months | Because no subjects in Part 2, and only one subject in Part 1, had an objective response the analyses of time to response was not calculated. | ||
| SECONDARY | Duration of Response | Time from objective response to 24 months | Because no subjects in Part 2, and only one subject in Part 1, had an objective response the analysis of duration of response was not calculated. |
Source ClinicalTrials.gov
Results by group90
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose-limiting Toxicities | Part 1 Cohort 1 | 0 | Participants | ||
| Number of Participants With Dose-limiting Toxicities | Part 1 Cohort 2 | 0 | Participants | ||
| Number of Participants With Dose-limiting Toxicities | Part 1 Cohort 3 | 0 | Participants | ||
| Objective Response Rate | Part 1 Cohort 1 | 1 | Participants | ||
| Objective Response Rate | Part 1 Cohort 2 | 0 | Participants | ||
| Objective Response Rate | Part 1 Cohort 3 | 0 | Participants | ||
| Objective Response Rate | Part 2 Cohort 1 | 0 | Participants | ||
| Objective Response Rate | Part 2 Cohort 2 | 0 | Participants | ||
| Objective Response Rate | Part 2 Cohort 3 | 0 | Participants | ||
| Objective Response Rate | Part 2 Cohort 4 | 0 | Participants |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part 1 Cohort 1 | 3 | |
| Overall Study | STARTED | Part 1 Cohort 2 | 3 | |
| Overall Study | STARTED | Part 1 Cohort 3 | 3 | |
| Overall Study | STARTED | Part 2 Cohort 1 | 15 | |
| Overall Study | STARTED | Part 2 Cohort 2 | 8 | |
| Overall Study | STARTED | Part 2 Cohort 3 | 16 | |
| Overall Study | STARTED | Part 2 Cohort 4 | 16 | |
| Overall Study | STARTED | Part 2 Cohort 5 | 9 | |
| Overall Study | STARTED | Part 2 Cohort 6 | 16 | |
| Overall Study | COMPLETED | Part 1 Cohort 1 | 0 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events2,052
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Cohort 1 | 2 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Cohort 2 | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Cohort 3 | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 Cohort 1 | 1 | 15 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 Cohort 2 | 0 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 Cohort 3 | 2 | 16 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 Cohort 4 | 1 | 16 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 Cohort 5 | 0 | 9 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 Cohort 6 | 0 | 15 | |
| other | Neutropenia | Blood and lymphatic system disorders | Part 1 Cohort 1 | 1 | 3 |
1 to 10 of 2,052Source ClinicalTrials.gov
See all 2,052 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1 Cohort 1 | 1 | 3 |
| Total, all-cause mortality | Part 1 Cohort 2 | 1 | 3 |
| Total, all-cause mortality | Part 1 Cohort 3 | 3 | 3 |
| Total, all-cause mortality | Part 2 Cohort 1 | 8 | 15 |
| Total, all-cause mortality | Part 2 Cohort 2 | 5 | 8 |
| Total, all-cause mortality | Part 2 Cohort 3 | 7 | 16 |
| Total, all-cause mortality | Part 2 Cohort 4 | 9 | 16 |
| Total, all-cause mortality | Part 2 Cohort 5 | 4 | 9 |
| Total, all-cause mortality | Part 2 Cohort 6 | 7 | 16 |
| Total, other adverse events | Part 1 Cohort 1 | 3 | 3 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24816908 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00819169
GET https://conductscience.org/api/trials/v1/NCT00819169/results?page=2