Trial · NCT01137006
An Open-Label, Dose-Escalation Study of IMC-20D7S In Participants With Malignant Melanoma
NCT01137006, Phase 1, Completed, Eli Lilly and Company; results first posted 2019-06-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Open-Label, Dose-Escalation Study of IMC-20D7S In Participants With Malignant Melanoma. Trials, record NCT01137006. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01137006
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-Label, Dose-Escalation Study of IMC-20D7S In Participants With Malignant Melanoma
- NCT number
- NCT01137006
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 27 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Malignant Melanoma
- Interventions
- IMC-20D7S (Cohort 1A), IMC-20D7S (Cohort 2A), IMC-20D7S (Cohort 3A), IMC-20D7S (Cohort 4A), IMC-20D7S (Cohort 1B), IMC-20D7S (Cohort 2B), IMC-20D7S (Cohort 3B)
- First posted
- 2010-06-04
- Last updated
- 2019-06-17
- Results first posted
- 2019-06-17
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of IMC-20D7S | Baseline to toxicity [up to end of Cycle 1 (4 or 6-week cycles)] | The MTD was defined as the dose preceding the dose level at which 2 participants experienced a dose-limiting toxicity (DLT) during treatment Cycle 1. A DLT was defined as any Grade 3 or above toxicity that emerged during study treatment and was clearly not attributable to malignant melanoma or co-medication and was possibly, probably, or definitely related to IMC-20D7S in the judgment of the investigator. No DLT was observed in the study; a provisional MTD was established. |
| Primary | Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | Baseline through 30 days post last dose (up to 31 weeks) | A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module. |
| Secondary | IMC-20D7S Pharmacokinetics (PK): Maximum Concentration (Cmax) | Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 hours (h) post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion. | A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted. |
| Secondary | IMC-20D7S PK: Minimal Concentration (Cmin) | Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion. | A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted. |
| Secondary | IMC-20D7S PK: Half-life (t½) | Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion. | A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted. |
| Secondary | IMC-20D7S PK: Clearance (Cl) | Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion. | A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted. |
| Secondary | IMC-20D7S PK: Area Under the Concentration Versus Time Curve (AUC) | Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion. | A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted. |
| Secondary | IMC-20D7S PK: Volume of Distribution (Vd) at Steady State | Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion. | A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted. |
| Secondary | Number of Participants Who Develop Antibodies Against IMC-20D7S (Immunogenicity) | Prior to the first and second infusion in each cycle up to Cycle 7 (4- and 6-week cycles) | Planned analyses for immunogenicity were not completed. A decision was made not to develop a validated immunogenicity assay because of the exploratory nature of the study and the analyses. |
| Secondary | Progression-Free Survival (PFS) | First dose to disease progression or death (up to 27 weeks) | PFS was determined for participants who went beyond their first disease assessment and completed at least 1 treatment beyond Week 1 of treatment Cycle 3. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) of IMC-20D7S | Baseline to toxicity [up to end of Cycle 1 (4 or 6-week cycles)] | Participants who completed Cycle 1 of treatment. | mg/kg q2w | NUMBER |
| PRIMARY | Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | Baseline through 30 days post last dose (up to 31 weeks) | Participants who received any amount of IMC-20D7S . | participants | NUMBER |
| SECONDARY | IMC-20D7S Pharmacokinetics (PK): Maximum Concentration (Cmax) | Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 hours (h) post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion. | No participant was analyzed. | ||
| SECONDARY | IMC-20D7S PK: Minimal Concentration (Cmin) | Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion. | No participant was analyzed. | ||
| SECONDARY | IMC-20D7S PK: Half-life (t½) | Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion. | No participant was analyzed. | ||
| SECONDARY | IMC-20D7S PK: Clearance (Cl) | Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion. | No participant was analyzed. | ||
| SECONDARY | IMC-20D7S PK: Area Under the Concentration Versus Time Curve (AUC) | Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion. | No participant was analyzed. | ||
| SECONDARY | IMC-20D7S PK: Volume of Distribution (Vd) at Steady State | Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion. | No participant was analyzed. | ||
| SECONDARY | Number of Participants Who Develop Antibodies Against IMC-20D7S (Immunogenicity) | Prior to the first and second infusion in each cycle up to Cycle 7 (4- and 6-week cycles) | No participant was analyzed. | ||
| SECONDARY | Progression-Free Survival (PFS) | First dose to disease progression or death (up to 27 weeks) | Participants who went beyond their first disease assessment and completed at least one treatment beyond Week 1 of treatment Cycle 3. | participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group29
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) of IMC-20D7S | IMC-20D7S | 20 | mg/kg q2w | ||
| Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | Cohort 1A (5 mg/kg, q2w) | SAEs | 1 | participants | |
| Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | Cohort 2A (10 mg/kg, q2w) | SAEs | 1 | participants | |
| Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | Cohort 3A (20 mg/kg, q2w) | SAEs | 5 | participants | |
| Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | Cohort 4A (30 mg/kg, q2w) | SAEs | 2 | participants | |
| Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | Cohort 1B (10 mg/kg, q3w) | SAEs | 0 | participants | |
| Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | Cohort 2B (20 mg/kg, q3w) | SAEs | 4 | participants | |
| Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | Cohort 3B (30 mg/kg, q3w) | SAEs | 0 | participants | |
| Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | Cohort 1A (5 mg/kg, q2w) | Other Non-Serious AEs | 3 | participants | |
| Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | Cohort 2A (10 mg/kg, q2w) | Other Non-Serious AEs | 3 | participants |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1A (5 mg/kg, q2w) | 3 | |
| Overall Study | STARTED | Cohort 2A (10 mg/kg, q2w) | 3 | |
| Overall Study | STARTED | Cohort 3A (20 mg/kg, q2w) | 8 | |
| Overall Study | STARTED | Cohort 4A (30 mg/kg, q2w) | 3 | |
| Overall Study | STARTED | Cohort 1B (10 mg/kg, q3w) | 3 | |
| Overall Study | STARTED | Cohort 2B (20 mg/kg, q3w) | 4 | |
| Overall Study | STARTED | Cohort 3B (30 mg/kg, q3w) | 3 | |
| Overall Study | Completed at Least 1 Treatment Cycle | Cohort 1A (5 mg/kg, q2w) | 3 | |
| Overall Study | Completed at Least 1 Treatment Cycle | Cohort 2A (10 mg/kg, q2w) | 3 | |
| Overall Study | Completed at Least 1 Treatment Cycle | Cohort 3A (20 mg/kg, q2w) | 8 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events756
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 | Cohort 1A (5 mg/kg, q2w) | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2A (10 mg/kg, q2w) | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 3A (20 mg/kg, q2w) | 0 | 8 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 4A (30 mg/kg, q2w) | 1 | 3 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1B (10 mg/kg, q3w) | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2B (20 mg/kg, q3w) | 0 | 4 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 3B (30 mg/kg, q3w) | 0 | 3 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort 1A (5 mg/kg, q2w) | 0 | 3 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort 2A (10 mg/kg, q2w) | 0 | 3 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort 3A (20 mg/kg, q2w) | 1 | 8 | 1 |
1 to 10 of 756Source ClinicalTrials.gov
See all 756 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1A (5 mg/kg, q2w) | ||
| Total, all-cause mortality | Cohort 2A (10 mg/kg, q2w) | ||
| Total, all-cause mortality | Cohort 3A (20 mg/kg, q2w) | ||
| Total, all-cause mortality | Cohort 4A (30 mg/kg, q2w) | ||
| Total, all-cause mortality | Cohort 1B (10 mg/kg, q3w) | ||
| Total, all-cause mortality | Cohort 2B (20 mg/kg, q3w) | ||
| Total, all-cause mortality | Cohort 3B (30 mg/kg, q3w) | ||
| Total, other adverse events | Cohort 1A (5 mg/kg, q2w) | 3 | 3 |
| Total, other adverse events | Cohort 2A (10 mg/kg, q2w) | 3 | 3 |
| Total, other adverse events | Cohort 3A (20 mg/kg, q2w) | 8 | 8 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01137006
GET https://conductscience.org/api/trials/v1/NCT01137006/results?page=2