Trial · NCT03320330
Pepinemab in Treating Younger Patients With Recurrent, Relapsed, or Refractory Solid Tumors
NCT03320330, Phase 1, Phase 2, Completed, Children's Oncology Group; results first posted 2022-04-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pepinemab in Treating Younger Patients With Recurrent, Relapsed, or Refractory Solid Tumors. Trials, record NCT03320330. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03320330
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pepinemab in Treating Younger Patients With Recurrent, Relapsed, or Refractory Solid Tumors
- NCT number
- NCT03320330
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 26 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Recurrent Malignant Solid Neoplasm, Recurrent Osteosarcoma, Refractory Malignant Solid Neoplasm, Refractory Osteosarcoma
- Interventions
- Laboratory Biomarker Analysis, Pepinemab, Pharmacological Study
- First posted
- 2017-10-25
- Last updated
- 2024-07-15
- Results first posted
- 2022-04-26
Source ClinicalTrials.gov
Registered outcomes12
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 | Up to 28 days | Frequency (%) of patients with dose limiting toxicities by dose level and study part. |
| Primary | Patients Who Had Grade 3 or Above Toxicities With the Three Attributions, 'DEFINITE', 'POSSIBLE','PROBABLE' | Up to 28 days | Frequency of patients experiencing at least grade 3 toxicity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 by dose level and study part. |
| Primary | Half-life | Prior to, at the end of, and 2 hours after infusion on day 1 of cycles 1-2; days 4 & 8 of cycle 1; prior to and the end of infusion on day 15 of cycle 1; prior to start of infusion on day 15 of cycle 2; prior to start of infusion on day 1 of cycles 3+ | Mean and standard deviation for the time required for the serum concentration to fall to 50% of its starting dose by dose level and study part. |
| Primary | Time to Maximum Concentration (T Max) | Prior to, at the end of, and 2 hours after infusion on day 1 of cycles 1-2; days 4 & 8 of cycle 1; prior to and the end of infusion on day 15 of cycle 1; prior to start of infusion on day 15 of cycle 2; prior to start of infusion on day 1 of cycles 3+ | Mean and standard deviation for the time at which the maximum (peak) serum concentration occurs by dose level and study part. |
| Primary | Maximum Concentration (C Max) | Prior to, at the end of, and 2 hours after infusion on day 1 of cycles 1-2; days 4 & 8 of cycle 1; prior to and the end of infusion on day 15 of cycle 1; prior to start of infusion on day 15 of cycle 2; prior to start of infusion on day 1 of cycles 3+ | Mean and standard deviation for the maximum (peak) serum concentration by dose level and study part. |
| Primary | Area Under Curve (AUC) | Prior to, at the end of, and 2 hours after infusion on day 1 of cycles 1-2; days 4 & 8 of cycle 1; prior to and the end of infusion on day 15 of cycle 1; prior to start of infusion on day 15 of cycle 2; prior to start of infusion on day 1 of cycles 3+ | Mean and standard deviation for the area under the drug concentration over time curve by dose level and study part. |
| Primary | Clearance | Prior to, at the end of, and 2 hours after infusion on day 1 of cycles 1-2; days 4 & 8 of cycle 1; prior to and the end of infusion on day 15 of cycle 1; prior to start of infusion on day 15 of cycle 2; prior to start of infusion on day 1 of cycles 3+ | Mean and standard deviation for the rate of elimination of the drug by dose level and study part. |
| Primary | Disease Control Rate (Part A) | Up to 4 months | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no new lesions detected and \<20% increase in sum of smallest diameters of lesions; Disease Control Rate = CR + PR + SD |
| Primary | Response (Complete Response or Partial Response) (Part B) | Up to 168 days | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no new lesions detected and \<20% increase in sum of smallest diameters of lesions; Disease Control Rate = CR + PR + SD |
| Secondary | T-lymphocyte Saturation | Up to 28 days | Mean and standard deviation for blood samples that will be evaluated for T-lymphocyte saturation by VX15/2503 utilizing a validated flow-cytometry based assay on cycle 1 day 28 (prior to cycle 2 day 1). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
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 | Up to 28 days | The patients who had DLT in dose escalation course. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Patients Who Had Grade 3 or Above Toxicities With the Three Attributions, 'DEFINITE', 'POSSIBLE','PROBABLE' | Up to 28 days | Part A and B Patients | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Half-life | Prior to, at the end of, and 2 hours after infusion on day 1 of cycles 1-2; days 4 & 8 of cycle 1; prior to and the end of infusion on day 15 of cycle 1; prior to start of infusion on day 15 of cycle 2; prior to start of infusion on day 1 of cycles 3+ | all toxicity evaluable patients | hours | MEAN |
| PRIMARY | Time to Maximum Concentration (T Max) | Prior to, at the end of, and 2 hours after infusion on day 1 of cycles 1-2; days 4 & 8 of cycle 1; prior to and the end of infusion on day 15 of cycle 1; prior to start of infusion on day 15 of cycle 2; prior to start of infusion on day 1 of cycles 3+ | All toxicity evaluable patients | hours | MEAN |
| PRIMARY | Maximum Concentration (C Max) | Prior to, at the end of, and 2 hours after infusion on day 1 of cycles 1-2; days 4 & 8 of cycle 1; prior to and the end of infusion on day 15 of cycle 1; prior to start of infusion on day 15 of cycle 2; prior to start of infusion on day 1 of cycles 3+ | All toxicity evaluable patients | ug/ml | MEAN |
| PRIMARY | Area Under Curve (AUC) | Prior to, at the end of, and 2 hours after infusion on day 1 of cycles 1-2; days 4 & 8 of cycle 1; prior to and the end of infusion on day 15 of cycle 1; prior to start of infusion on day 15 of cycle 2; prior to start of infusion on day 1 of cycles 3+ | All toxicity evaluable patients | hr*ug/ml | MEAN |
| PRIMARY | Clearance | Prior to, at the end of, and 2 hours after infusion on day 1 of cycles 1-2; days 4 & 8 of cycle 1; prior to and the end of infusion on day 15 of cycle 1; prior to start of infusion on day 15 of cycle 2; prior to start of infusion on day 1 of cycles 3+ | All toxicity evaluable patients | ml/hr | MEAN |
| PRIMARY | Disease Control Rate (Part A) | Up to 4 months | participants | NUMBER | |
| PRIMARY | Response (Complete Response or Partial Response) (Part B) | Up to 168 days | participants | NUMBER | |
| SECONDARY | T-lymphocyte Saturation | Up to 28 days | All Eligible Patients | percent of T-lymphocyte Saturation | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group30
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 A: 20 mg/kg (Phase 1) | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities | Part A PK: 20 mg/kg (Expansion) | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities | Part B: 20 mg/kg (Phase 2) | 1 | Participants | ||
| Patients Who Had Grade 3 or Above Toxicities With the Three Attributions, 'DEFINITE', 'POSSIBLE','PROBABLE' | Part A: 20 mg/kg (Phase 1) | 0 | Participants | ||
| Patients Who Had Grade 3 or Above Toxicities With the Three Attributions, 'DEFINITE', 'POSSIBLE','PROBABLE' | Part A PK: 20 mg/kg (Expansion) | 1 | Participants | ||
| Patients Who Had Grade 3 or Above Toxicities With the Three Attributions, 'DEFINITE', 'POSSIBLE','PROBABLE' | Part B: 20 mg/kg (Phase 2) | 3 | Participants | ||
| Half-life | Part A: 20 mg/kg (Phase 1) | 281 | Standard Deviation 176 | hours | |
| Half-life | Part A PK: 20 mg/kg (Expansion) | 221 | Standard Deviation 48 | hours | |
| Half-life | Part B: 20 mg/kg (Phase 2) | 162 | Standard Deviation 64 | hours | |
| Time to Maximum Concentration (T Max) | Part A: 20 mg/kg (Phase 1) | 1.9 | Standard Deviation 1.1 | hours |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A: 20 mg/kg (Phase 1) | 6 | |
| Overall Study | STARTED | Part A PK: 20 mg/kg (Expansion) | 6 | |
| Overall Study | STARTED | Part B: 20 mg/kg (Phase 2) | 14 | |
| Overall Study | COMPLETED | Part A: 20 mg/kg (Phase 1) | 0 | |
| Overall Study | COMPLETED | Part A PK: 20 mg/kg (Expansion) | 1 | |
| Overall Study | COMPLETED | Part B: 20 mg/kg (Phase 2) | 0 | |
| Overall Study | NOT COMPLETED | Part A: 20 mg/kg (Phase 1) | 6 | |
| Overall Study | NOT COMPLETED | Part A PK: 20 mg/kg (Expansion) | 5 | |
| Overall Study | NOT COMPLETED | Part B: 20 mg/kg (Phase 2) | 14 |
Source ClinicalTrials.gov
Adverse events693
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 | Abdominal distension | Gastrointestinal disorders | Part A: 20 mg/kg (Phase 1) | 1 | 6 | |
| other | Abdominal distension | Gastrointestinal disorders | Part A PK: 20 mg/kg (Expansion) | 0 | 6 | |
| other | Abdominal distension | Gastrointestinal disorders | Part B: 20 mg/kg (Phase 2) | 1 | 14 | |
| other | Abdominal pain | Gastrointestinal disorders | Part A: 20 mg/kg (Phase 1) | 1 | 6 | |
| other | Abdominal pain | Gastrointestinal disorders | Part A PK: 20 mg/kg (Expansion) | 0 | 6 | |
| other | Abdominal pain | Gastrointestinal disorders | Part B: 20 mg/kg (Phase 2) | 2 | 14 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Part A: 20 mg/kg (Phase 1) | 0 | 6 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Part A PK: 20 mg/kg (Expansion) | 0 | 6 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Part B: 20 mg/kg (Phase 2) | 2 | 14 | |
| other | Agitation | Psychiatric disorders | Part A: 20 mg/kg (Phase 1) | 0 | 6 |
1 to 10 of 693Source ClinicalTrials.gov
See all 693 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: 20 mg/kg (Phase 1) | 1 | 6 |
| Total, all-cause mortality | Part A PK: 20 mg/kg (Expansion) | 0 | 6 |
| Total, all-cause mortality | Part B: 20 mg/kg (Phase 2) | 3 | 14 |
| Total, other adverse events | Part A: 20 mg/kg (Phase 1) | 6 | 6 |
| Total, other adverse events | Part A PK: 20 mg/kg (Expansion) | 6 | 6 |
| Total, other adverse events | Part B: 20 mg/kg (Phase 2) | 14 | 14 |
| Total, serious adverse events | Part A: 20 mg/kg (Phase 1) | 4 | 6 |
| Total, serious adverse events | Part A PK: 20 mg/kg (Expansion) | 4 | 6 |
| Total, serious adverse events | Part B: 20 mg/kg (Phase 2) | 10 | 14 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1CA097452 | Pediatric Phase 1/Pilot Consortium | WEIGEL, BRENDA J. | CHILDREN'S HOSP OF PHILADELPHIA | NATIONAL CANCER INSTITUTE | 2009 to 2018 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Part A: 20 mg/kg (Phase 1) vs Part A PK: 20 mg/kg (Expansion): Disease Control Rate (Part A) |
Source Trial comparisons
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/NCT03320330
GET https://conductscience.org/api/trials/v1/NCT03320330/results?page=2