Trial · NCT03474640
Safety, Tolerability and Pharmacokinetics of an Anti-PD-1 Monoclonal Antibody in Subjects With Advanced Malignancies
NCT03474640, Phase 1, Completed, TopAlliance Biosciences; results first posted 2024-11-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety, Tolerability and Pharmacokinetics of an Anti-PD-1 Monoclonal Antibody in Subjects With Advanced Malignancies. Trials, record NCT03474640. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03474640
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability and Pharmacokinetics of an Anti-PD-1 Monoclonal Antibody in Subjects With Advanced Malignancies
- NCT number
- NCT03474640
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 184 participants, actual
- Lead sponsor
- TopAlliance Biosciences
- Conditions
- Advanced Malignancies
- Interventions
- Part A, Part B
- First posted
- 2018-03-22
- Last updated
- 2024-11-22
- Results first posted
- 2024-11-22
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Through study completion, an estimated period of approximately 2 years. | To assess the number of treatment-related adverse events in the toripalimab arm as assessed by CTCAE v4.0 |
| Secondary | Objective Response Rate (ORR) | Every 8 weeks (Part A) or every 9 weeks (Part B) through study completion, an estimated duration of 2 years. | The treatment effect of Toripalimab was assessed using RECIST 1.1 to determine objective response rate. ORR was defined and analyzed as the number of subjects achieving BOR of CR or PR, divided by the number of treated subjects. Subjects without at least one post-baseline radiological assessment were treated as non-responders. ORR was presented by dose cohort in Part A and tumor type in Part B, with 95% confidence intervals. |
| Secondary | Disease Control Rate (DCR) | Every 8 weeks (Part A) or every 9 weeks (Part B) through study completion, an estimated duration of 2 years. | The treatment effect of Toripalimab was assessed using RECIST 1.1 to determine objective response rate. ORR was defined and analyzed as the number of subjects achieving BOR of CR, PR, or SD divided by the number of treated subjects. Subjects without at least one post-baseline radiological assessment were treated as non-responders. DCR was presented by dose cohort in Part A and tumor type in Part B, with 95% confidence intervals. |
| Secondary | Progression-Free Survival (PFS) | Every 8 weeks (Part A) or every 9 weeks (Part B) through study completion, an estimated duration of 2 years. | The treatment effect of Toripalimab was assessed using RECIST 1.1 to determine progression-free survival time. PFS was defined as the time from the first dose of toripalimab to the first PD or death due to any cause, whichever occurred first and was analyzed separately for each cohort in Part B only, |
| Secondary | Overall Survival (OS) | Through study completion, an estimated duration of 2 years. | The treatment effect of Toripalimab was assessed using RECIST 1.1 to determine overall survival (OS) analysis by tumor type in Part B. OS was defined as the time from date the first dose of toripalimab until death due to any cause. OS time for subjects not achieving the endpoint was censored at the last known alive date. |
Source ClinicalTrials.gov
Outcomes5
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 Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Through study completion, an estimated period of approximately 2 years. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Objective Response Rate (ORR) | Every 8 weeks (Part A) or every 9 weeks (Part B) through study completion, an estimated duration of 2 years. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Disease Control Rate (DCR) | Every 8 weeks (Part A) or every 9 weeks (Part B) through study completion, an estimated duration of 2 years. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression-Free Survival (PFS) | Every 8 weeks (Part A) or every 9 weeks (Part B) through study completion, an estimated duration of 2 years. | months | MEDIAN | |
| SECONDARY | Overall Survival (OS) | Through study completion, an estimated duration of 2 years. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group39
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 Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Part A: 80 mg | 2 | Participants | ||
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Part A: 240 mg | 5 | Participants | ||
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Part A: 480 mg | 5 | Participants | ||
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Part B: Sarcoma | 33 | Participants | ||
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Part B: Other Tumors | 2 | Participants | ||
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Part B: Esophageal | 7 | Participants | ||
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Part B: Gastric/GEJ | 15 | Participants | ||
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Part B: Biliary Tract | 27 | Participants | ||
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Part B: Neuroendocrine | 14 | Participants | ||
| Objective Response Rate (ORR) | Part A: 80 mg | 0 | Participants |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Toripalimab 80 mg Repeat Dose Every 14 Days | 3 | |
| Overall Study | STARTED | Toripalimab 240 mg Repeat Dose Every 14 Days | 8 | |
| Overall Study | STARTED | Toripalimab 480 mg Repeat Dose Every 14 Days | 7 | |
| Overall Study | STARTED | Biliary Tract Cancer | 42 | |
| Overall Study | STARTED | Sarcoma | 59 | |
| Overall Study | STARTED | Esophageal Cancer | 11 | |
| Overall Study | STARTED | Gastric Cancer | 29 | |
| Overall Study | STARTED | Neuroendocrine Cancer | 22 | |
| Overall Study | STARTED | Other Tumors | 3 | |
| Overall Study | COMPLETED | Toripalimab 80 mg Repeat Dose Every 14 Days | 0 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events279
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 | Skin and Subcutaneous Disorder | Skin and subcutaneous tissue disorders | Toripalimab 80 mg Every 14 Days | 0 | 3 | |
| other | Skin and Subcutaneous Disorder | Skin and subcutaneous tissue disorders | Toripalimab 240 mg Every 14 Days | 2 | 8 | |
| other | Skin and Subcutaneous Disorder | Skin and subcutaneous tissue disorders | Toripalimab 480 mg Every 14 Days | 2 | 7 | |
| other | Skin and Subcutaneous Disorder | Skin and subcutaneous tissue disorders | Sarcoma | 9 | 59 | |
| other | Skin and Subcutaneous Disorder | Skin and subcutaneous tissue disorders | Other Tumors | 2 | 3 | |
| other | Skin and Subcutaneous Disorder | Skin and subcutaneous tissue disorders | Esophogeal | 0 | 11 | |
| other | Skin and Subcutaneous Disorder | Skin and subcutaneous tissue disorders | Gastric/GEJ | 6 | 29 | |
| other | Skin and Subcutaneous Disorder | Skin and subcutaneous tissue disorders | Biliary Tract | 2 | 42 | |
| other | Skin and Subcutaneous Disorder | Skin and subcutaneous tissue disorders | Neuroendocrine | 5 | 22 | |
| other | Investigations | Investigations | Toripalimab 80 mg Every 14 Days | 1 | 3 |
1 to 10 of 279Source ClinicalTrials.gov
See all 279 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Toripalimab 80 mg Every 14 Days | 1 | 3 |
| Total, all-cause mortality | Toripalimab 240 mg Every 14 Days | 2 | 8 |
| Total, all-cause mortality | Toripalimab 480 mg Every 14 Days | 0 | 7 |
| Total, all-cause mortality | Sarcoma | 12 | 59 |
| Total, all-cause mortality | Other Tumors | 0 | 3 |
| Total, all-cause mortality | Esophogeal | 2 | 11 |
| Total, all-cause mortality | Gastric/GEJ | 9 | 29 |
| Total, all-cause mortality | Biliary Tract | 12 | 42 |
| Total, all-cause mortality | Neuroendocrine | 3 | 22 |
| Total, other adverse events | Toripalimab 80 mg Every 14 Days | 2 | 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 |
|---|---|
| 39816916 | DERIVED |
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/NCT03474640
GET https://conductscience.org/api/trials/v1/NCT03474640/results?page=2