Trial · NCT04212221
MGD013 Monotherapy and Combination With Brivanib Dose Escalation and Expansion Study in Advanced Liver Cancer Patients
NCT04212221, Phase 1, Phase 2, Terminated, Zai Lab (Shanghai) Co., Ltd.; results first posted 2024-07-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. MGD013 Monotherapy and Combination With Brivanib Dose Escalation and Expansion Study in Advanced Liver Cancer Patients. Trials, record NCT04212221. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04212221
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MGD013 Monotherapy and Combination With Brivanib Dose Escalation and Expansion Study in Advanced Liver Cancer Patients
- NCT number
- NCT04212221
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 89 participants, actual
- Lead sponsor
- Zai Lab (Shanghai) Co., Ltd.
- Conditions
- Advanced Hepatocellular Carcinoma (HCC)
- Interventions
- MGD013 monotherapy, MGD013 in combination with Brivanib Alaninate
- First posted
- 2019-12-26
- Last updated
- 2024-07-23
- Results first posted
- 2024-07-23
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | The first two cycles (Cycle 1 and Cycle 2) of the study treatment(s). A cycle lasted for two weeks (14 days) in the study. | DLT was defined as the adverse events (AEs) listed in the protocol occurring within 4 weeks (the first 2 cycles, 28 days) after the investigational drugs which were at least possibly related to the study drugs. AE severity was graded from 1 to 5 according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. |
| Primary | Phase 1 and Phase 2: Safety | AEs would be collected throughout the clinical trial, from the signing of the informed consent form (ICF) to the end of the trial (until 30 days after the last dose of investigational drugs). Up to approximately 24 months. | All adverse events (AEs) occurring on or after the first study treatment were listed and summarized. Treatment-Emergent Adverse Event (TEAE) was defined as an AE that had an onset date or a worsening in severity from baseline on or after the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment (any component of combination treatment whichever was last) discontinuation. All adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. |
| Primary | Phase 2: Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) According to RECIST 1.1 | Radiologic examinations were conducted at baseline within 28 days prior to the start of study medication and every 8 weeks (±7 days) dated from the first day of the first cycle until disease progression. Up to approximately 24 months. | ORR was defined as the proportion of participants with a confirmed objective response, either complete response (CR) or partial response (PR), before progression based on RECIST v1.1. Participants who had no measurable disease at baseline and/or no post-baseline tumor assessment due to any reason will be considered nonresponders. An estimate of ORR was calculated for each treatment arm, and its 95% CI was calculated using the Clopper-Pearson method. |
| Secondary | Phase 2: Objective Response Rate (ORR) by Investigator Assessment According to RECIST 1.1 | Radiologic examinations were conducted at baseline within 28 days prior to the start of study medication and every 8 weeks (±7 days) dated from the first day of the first cycle until disease progression. Up to approximately 24 months. | ORR was defined as the proportion of participants with a confirmed objective response, either complete response (CR) or partial response (PR), before progression based on RECIST v1.1. Participants who had no measurable disease at baseline and/or no post-baseline tumor assessment due to any reason will be considered nonresponders. An estimate of ORR was calculated for each treatment arm, and its 95% CI was calculated using the Clopper-Pearson method. |
| Secondary | Phase 2: Disease Control Rate (DCR) by BICR / Investigator Assessment According to RECIST 1.1 | Radiologic examinations were conducted at basline within 28 days prior to the start of study medication and every 8 weeks (±7 days) dated from the first day of the first cycle until disease progression. Up to approximately 24 months. | DCR was defined as the percentage of participants who attained a best overall response status of CR, PR, and SD. If best overall response is SD, the SD should be stable SD, that is the date of SD should be at least 6 weeks after first dose. DCR was analyzed using the same methodology as specified for ORR. |
| Secondary | Phase 2: Time to Response (TTR) by Investigator Assessment According to RECIST 1.1 | Radiologic examinations were conducted at baseline within 28 days prior to the start of study medication and every 8 weeks (±7 days) dated from the first day of the first cycle until disease progression. Up to approximately 24 months. | TTR was defined as the time from the first dose date to the date of the earliest confirmed response assessed using RECIST V1.1. Only responders were included in the analysis. |
| Secondary | Phase 2: Duration of Response (DoR) by Investigator Assessment According to RECIST 1.1 | Radiologic examinations were conducted at baseline within 28 days prior to the start of study medication and every 8 weeks (±7 days) dated from the first day of the first cycle until disease progression. Up to approximately 24 months. | DoR was defined for subjects with a confirmed objective response as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurred first. Participants who had no progression or death would be censored. |
| Secondary | Phase 2: Progression-Free Survival (PFS) by Investigator Assessment According to RECIST 1.1 | Radiologic examinations were conducted at baseline within 28 days prior to the start of study medication and every 8 weeks (±7 days) dated from the first day of the first cycle until disease progression. Up to approximately 24 months. | PFS was defined as the time from the date of first dose of study treatment (any component of combination treatment whichever is first) to the first documented disease progression as determined by the investigator or BICR with the use of RECIST v1.1, or death from any cause, whichever occurred first. Kaplan-Meier methodology was used to estimate the median PFS for each treatment arm and to construct survival curves for each treatment arm. The Brookmeyer-Crowley methodology was used to construct the 95% CI for the median PFS for each treatment arm (Brookmeyer and Crowley 1982). |
| Secondary | Phase 2: Overall Survival (OS) | From the date of the first dose of study treatment to the date of death from any cause. Up to approximately 24 months. | OS was defined as the time from the date of the first dose of study treatment (any component of combination treatment whichever was first) to the date of death from any cause. Participants who were alive at the time of the analysis data cutoff would be censored at the last date they were known to be alive. Participants with no post-baseline information were censored at the date of the first dose of study treatment (any study treatment component for combo therapy). |
| Secondary | Phase 1: Objective Response Rate (ORR) by Investigator Assessment According to RECIST 1.1 | Radiologic examinations were conducted at baseline within 28 days prior to the start of study medication and every 8 weeks (±7 days) dated from the first day of the first cycle until disease progression. Up to approximately 24 months. | ORR was defined as the proportion of participants with a confirmed objective response, either complete response (CR) or partial response (PR), before progression based on RECIST v1.1. Participants who had no measurable disease at baseline and/or no post-baseline tumor assessment due to any reason will be considered nonresponders. An estimate of ORR was calculated for each treatment arm, and its 95% CI was calculated using the Clopper-Pearson method. |
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 | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | The first two cycles (Cycle 1 and Cycle 2) of the study treatment(s). A cycle lasted for two weeks (14 days) in the study. | All patients who received at least one dose of study treatment (any component of combination treatment whichever is first). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1 and Phase 2: Safety | AEs would be collected throughout the clinical trial, from the signing of the informed consent form (ICF) to the end of the trial (until 30 days after the last dose of investigational drugs). Up to approximately 24 months. | All patients who received at least one dose of study treatment (any component of combination treatment whichever is first). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2: Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) According to RECIST 1.1 | Radiologic examinations were conducted at baseline within 28 days prior to the start of study medication and every 8 weeks (±7 days) dated from the first day of the first cycle until disease progression. Up to approximately 24 months. | All patients who received at least one dose of study treatment (any component of combination treatment whichever is first) in phase 2. | percentage of participants | NUMBER |
| SECONDARY | Phase 2: Objective Response Rate (ORR) by Investigator Assessment According to RECIST 1.1 | Radiologic examinations were conducted at baseline within 28 days prior to the start of study medication and every 8 weeks (±7 days) dated from the first day of the first cycle until disease progression. Up to approximately 24 months. | All patients who received at least one dose of study treatment (any component of combination treatment whichever is first). | percentage of participants | NUMBER |
| SECONDARY | Phase 2: Disease Control Rate (DCR) by BICR / Investigator Assessment According to RECIST 1.1 | Radiologic examinations were conducted at basline within 28 days prior to the start of study medication and every 8 weeks (±7 days) dated from the first day of the first cycle until disease progression. Up to approximately 24 months. | All patients who received at least one dose of study treatment (any component of combination treatment whichever is first). | percentage of participants | NUMBER |
| SECONDARY | Phase 2: Time to Response (TTR) by Investigator Assessment According to RECIST 1.1 | Radiologic examinations were conducted at baseline within 28 days prior to the start of study medication and every 8 weeks (±7 days) dated from the first day of the first cycle until disease progression. Up to approximately 24 months. | All patients who received at least one dose of study treatment (any component of combination treatment whichever is first). | months | MEDIAN |
| SECONDARY | Phase 2: Duration of Response (DoR) by Investigator Assessment According to RECIST 1.1 | Radiologic examinations were conducted at baseline within 28 days prior to the start of study medication and every 8 weeks (±7 days) dated from the first day of the first cycle until disease progression. Up to approximately 24 months. | All patients who received at least one dose of study treatment (any component of combination treatment whichever is first). | months | MEDIAN |
| SECONDARY | Phase 2: Progression-Free Survival (PFS) by Investigator Assessment According to RECIST 1.1 | Radiologic examinations were conducted at baseline within 28 days prior to the start of study medication and every 8 weeks (±7 days) dated from the first day of the first cycle until disease progression. Up to approximately 24 months. | All patients who received at least one dose of study treatment (any component of combination treatment whichever is first). | months | MEDIAN |
| SECONDARY | Phase 2: Overall Survival (OS) | From the date of the first dose of study treatment to the date of death from any cause. Up to approximately 24 months. | All patients who received at least one dose of study treatment (any component of combination treatment whichever is first). | months | MEDIAN |
| SECONDARY | Phase 1: Objective Response Rate (ORR) by Investigator Assessment According to RECIST 1.1 | Radiologic examinations were conducted at baseline within 28 days prior to the start of study medication and every 8 weeks (±7 days) dated from the first day of the first cycle until disease progression. Up to approximately 24 months. | All patients who received at least one dose of study treatment (any component of combination treatment whichever is first). | percentage of participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group130
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | Phase 1: MGD013 120mg | 0 | Participants | ||
| Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | Phase 1: MGD013 240mg | 0 | Participants | ||
| Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | Phase 1: MGD013 400mg | 0 | Participants | ||
| Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | Phase 1: MGD013 600mg | 0 | Participants | ||
| Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | Phase 1: MGD013 400mg + Brivanib 400mg | 0 | Participants | ||
| Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | Phase 1: MGD013 600mg + Brivanib 400mg | 0 | Participants | ||
| Phase 1 and Phase 2: Safety | Phase 1: MGD013 120mg | Patients with at Least One TEAE | 1 | Participants | |
| Phase 1 and Phase 2: Safety | Phase 1: MGD013 240mg | Patients with at Least One TEAE | 3 | Participants | |
| Phase 1 and Phase 2: Safety | Phase 1: MGD013 400mg | Patients with at Least One TEAE | 3 | Participants | |
| Phase 1 and Phase 2: Safety | Phase 1: MGD013 600mg | Patients with at Least One TEAE | 6 | Participants |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1: MGD013 120mg | 1 | |
| Overall Study | STARTED | Phase 1: MGD013 240mg | 3 | |
| Overall Study | STARTED | Phase 1: MGD013 400mg | 3 | |
| Overall Study | STARTED | Phase 1: MGD013 600mg | 6 | |
| Overall Study | STARTED | Phase 1: MGD013 400mg + Brivanib 400mg | 3 | |
| Overall Study | STARTED | Phase 1: MGD013 600mg + Brivanib 400mg | 4 | |
| Overall Study | STARTED | Phase 2: MGD013 600mg Post-CPI Cohort | 33 | |
| Overall Study | STARTED | Phase 2: MGD013 600mg CPI-naive Cohort | 36 | |
| Overall Study | COMPLETED | Phase 1: MGD013 120mg | 0 | |
| Overall Study | COMPLETED | Phase 1: MGD013 240mg | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events944
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 | Phase 1: MGD013 120mg | 0 | 1 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: MGD013 240mg | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: MGD013 400mg | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: MGD013 600mg | 1 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: MGD013 400mg + Brivanib 400mg | 2 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: MGD013 600mg + Brivanib 400mg | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2: MGD013 600mg Post-CPI Cohort | 3 | 33 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2: MGD013 600mg CPI-naive Cohort | 7 | 36 | |
| other | Leukopenia | Blood and lymphatic system disorders | Phase 1: MGD013 120mg | 0 | 1 | |
| other | Leukopenia | Blood and lymphatic system disorders | Phase 1: MGD013 240mg | 0 | 3 |
1 to 10 of 944Source ClinicalTrials.gov
See all 944 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1: MGD013 120mg | 0 | 1 |
| Total, all-cause mortality | Phase 1: MGD013 240mg | 0 | 3 |
| Total, all-cause mortality | Phase 1: MGD013 400mg | 0 | 3 |
| Total, all-cause mortality | Phase 1: MGD013 600mg | 1 | 6 |
| Total, all-cause mortality | Phase 1: MGD013 400mg + Brivanib 400mg | 2 | 3 |
| Total, all-cause mortality | Phase 1: MGD013 600mg + Brivanib 400mg | 1 | 4 |
| Total, all-cause mortality | Phase 2: MGD013 600mg Post-CPI Cohort | 10 | 33 |
| Total, all-cause mortality | Phase 2: MGD013 600mg CPI-naive Cohort | 11 | 36 |
| Total, other adverse events | Phase 1: MGD013 120mg | 1 | 1 |
| Total, other adverse events | Phase 1: MGD013 240mg | 3 | 3 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 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.
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