Trial · NCT03531632
MGD007 Combined With MGA012 in Relapsed/Refractory Metastatic Colorectal Cancer
NCT03531632, Phase 1, Phase 2, Completed, MacroGenics; results first posted 2021-11-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. MGD007 Combined With MGA012 in Relapsed/Refractory Metastatic Colorectal Cancer. Trials, record NCT03531632. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03531632
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MGD007 Combined With MGA012 in Relapsed/Refractory Metastatic Colorectal Cancer
- NCT number
- NCT03531632
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 38 participants, actual
- Lead sponsor
- MacroGenics
- Conditions
- Colorectal Cancer Metastatic
- Interventions
- MGD007 + MGA012
- First posted
- 2018-05-22
- Last updated
- 2022-02-08
- Results first posted
- 2021-11-10
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events | Up to approximately 12 weeks | Adverse Events, Serious Adverse Events |
| Secondary | Peak Plasma Concentration | 7 weeks | PK of MGD007 and MGA012 in combination |
| Secondary | Number of Participants That Develop Anti-drug Antibodies | 1 year | Proportion of patients who develop anti-MGD007/MGA012 antibodies, immunogenicity |
| Secondary | The Number of Participants With Response Based on the Change in Tumor Volume | Every 8 weeks | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and immune related RECIST criteria: number of patients with either complete response (CR) or partial response (PR) will determine the Overall Response Rate (ORR) |
Source ClinicalTrials.gov
Outcomes4
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 Adverse Events | Up to approximately 12 weeks | All patients who received at least one dose of study drug and reporting at least one adverse event | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Peak Plasma Concentration | 7 weeks | PK assays were not performed since the Sponsor has decided not to continue clinical development of MGD007. | ||
| SECONDARY | Number of Participants That Develop Anti-drug Antibodies | 1 year | ADA assays were not performed since the Sponsor has decided not to continue clinical development of MGD007. | ||
| SECONDARY | The Number of Participants With Response Based on the Change in Tumor Volume | Every 8 weeks | Response evaluable population | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group9
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 Adverse Events | Dose Level 1 | 5 | Participants | ||
| Number of Participants With Adverse Events | Dose Level 2 | 3 | Participants | ||
| Number of Participants With Adverse Events | Dose Level 3 | 28 | Participants | ||
| The Number of Participants With Response Based on the Change in Tumor Volume | Dose Level 1 | Stable Disease | 0 | Participants | |
| The Number of Participants With Response Based on the Change in Tumor Volume | Dose Level 2 | Stable Disease | 1 | Participants | |
| The Number of Participants With Response Based on the Change in Tumor Volume | Dose Level 3 | Stable Disease | 10 | Participants | |
| The Number of Participants With Response Based on the Change in Tumor Volume | Dose Level 1 | Progressive Disease | 5 | Participants | |
| The Number of Participants With Response Based on the Change in Tumor Volume | Dose Level 2 | Progressive Disease | 2 | Participants | |
| The Number of Participants With Response Based on the Change in Tumor Volume | Dose Level 3 | Progressive Disease | 14 | Participants |
Source ClinicalTrials.gov
Participant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Level 1 | 5 | |
| Overall Study | STARTED | Dose Level 2 | 3 | |
| Overall Study | STARTED | Dose Level 3 | 28 | |
| Overall Study | Safety Population | Dose Level 1 | 5 | |
| Overall Study | Safety Population | Dose Level 2 | 3 | |
| Overall Study | Safety Population | Dose Level 3 | 28 | |
| Overall Study | Response Evaluable Population | Dose Level 1 | 5 | |
| Overall Study | Response Evaluable Population | Dose Level 2 | 3 | |
| Overall Study | Response Evaluable Population | Dose Level 3 | 24 | |
| Overall Study | COMPLETED | Dose Level 1 | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events339
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 | Dose Level 1 | 0 | 5 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Dose Level 2 | 1 | 3 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Dose Level 3 | 7 | 28 | 7 |
| other | Lymphopenia | Blood and lymphatic system disorders | Dose Level 1 | 3 | 5 | 3 |
| other | Lymphopenia | Blood and lymphatic system disorders | Dose Level 2 | 1 | 3 | 1 |
| other | Lymphopenia | Blood and lymphatic system disorders | Dose Level 3 | 1 | 28 | 1 |
| other | Tachycardia | Cardiac disorders | Dose Level 1 | 0 | 5 | 0 |
| other | Tachycardia | Cardiac disorders | Dose Level 2 | 1 | 3 | 1 |
| other | Tachycardia | Cardiac disorders | Dose Level 3 | 2 | 28 | 2 |
| other | Sinus tachycardia | Cardiac disorders | Dose Level 1 | 0 | 5 | 0 |
1 to 10 of 339Source ClinicalTrials.gov
See all 339 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Level 1 | 4 | 5 |
| Total, all-cause mortality | Dose Level 2 | 0 | 3 |
| Total, all-cause mortality | Dose Level 3 | 14 | 28 |
| Total, other adverse events | Dose Level 1 | 5 | 5 |
| Total, other adverse events | Dose Level 2 | 3 | 3 |
| Total, other adverse events | Dose Level 3 | 28 | 28 |
| Total, serious adverse events | Dose Level 1 | 1 | 5 |
| Total, serious adverse events | Dose Level 2 | 1 | 3 |
| Total, serious adverse events | Dose Level 3 | 14 | 28 |
Source ClinicalTrials.gov
Papers0
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/NCT03531632
GET https://conductscience.org/api/trials/v1/NCT03531632/events?page=2