Trial · NCT07543744
A Comparative Study of Pharmacokinetics, Safety, and Immunogenicity of RPH-030 and Vectibix® in Patients With Metastatic Colorectal Cancer With Wild-type RAS as First-line Therapy in Combination With FOLFIRI
NCT07543744, Phase 1, Recruiting, R-Pharm
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Comparative Study of Pharmacokinetics, Safety, and Immunogenicity of RPH-030 and Vectibix® in Patients With Metastatic Colorectal Cancer With Wild-type RAS as First-line Therapy in Combination With FOLFIRI. Trials, record NCT07543744. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07543744
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Comparative Study of Pharmacokinetics, Safety, and Immunogenicity of RPH-030 and Vectibix® in Patients With Metastatic Colorectal Cancer With Wild-type RAS as First-line Therapy in Combination With FOLFIRI
- NCT number
- NCT07543744
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 180 participants, estimated
- Lead sponsor
- R-Pharm
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- RPH-030, Vectibix®, Irinotecan, Calcium Folinate, Fluorouracil
- First posted
- 2026-04-22
- Last updated
- 2026-04-22
Source ClinicalTrials.gov
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area under the pharmacokinetic curve "concentration-time" (AUC(0-336)) of panitumumab | Pre-dose on Day 1 (first administration) and 1, 3, 6, 8, 12 h post-dose; 24 (Day 2), 72 (Day 4), 96 (Day 5), 120 (Day 6), 192 (Day 9), 264 (Day 12), 336 (Day 15) h post-dose | Area under the pharmacokinetic curve "concentration-time" of panitumumab after the first (single dose) administration, truncated at the point before the second administration, i.e. up to 336 hours |
| Primary | Area under the pharmacokinetic curve "concentration-time" of panitumumab at steady state (AUC tau ss) | Pre-dose on Day 29 (third administration), and 1, 3, 6, 8, 12 h post-dose; 24 (Day 30), 72 (Day 32), 120 (Day 34), 192 (Day 37), 264 (Day 40), 336 (Day 43) h post-dose | Area under the pharmacokinetic curve "concentration-time" of panitumumab at steady state (after the third administration) (AUC tau ss) |
| Secondary | Maximum serum concentration of panitumumab after the first administration (Cmax) | Pre-dose on Day 1 (first administration) and 1, 3, 6, 8, 12 h post-dose; 24 (Day 2), 72 (Day 4), 96 (Day 5), 120 (Day 6), 192 (Day 9), 264 (Day 12), 336 (Day 15) h post-dose | Maximum serum concentration of panitumumab after the first administration (Cmax) |
| Secondary | Maximum serum concentration of panitumumab at steady state (Cmax ss) | Pre-dose on Day 29 (third administration), and 1, 3, 6, 8, 12 h post-dose; 24 (Day 30), 72 (Day 32), 120 (Day 34), 192 (Day 37), 264 (Day 40), 336 (Day 43) h post-dose | Maximum serum concentration of panitumumab at steady state (after the third administration) (Cmax ss) |
| Secondary | Minimum serum concentration of panitumumab at steady state (Cmin ss) | Pre-dose on Day 29 (third administration), and 1, 3, 6, 8, 12 h post-dose; 24 (Day 30), 72 (Day 32), 120 (Day 34), 192 (Day 37), 264 (Day 40), 336 (Day 43) h post-dose | Minimum serum concentration of panitumumab at steady state (in three administrations) (Cmin ss) |
| Secondary | Residual concentration of panitumumab at steady state (Ctrough) | Pre-dose on Day 29 (third administration), and 1, 3, 6, 8, 12 h post-dose; 24 (Day 30), 72 (Day 32), 120 (Day 34), 192 (Day 37), 264 (Day 40), 336 (Day 43) h post-dose | Residual concentration of panitumumab at steady state (before the third administration) (Ctrough) |
| Secondary | Proportion of patients (%) with adverse drug reactions (ADRs) of any severity | Up to day 729 | Proportion of patients (%) with adverse drug reactions (ADRs) of any severity |
| Secondary | Proportion of patients (%) with adverse events (AEs) of any severity | Up to day 729 | Proportion of patients (%) with adverse events (AEs) of any severity |
| Secondary | Proportion of patients (%) with AEs of severity grade ≥ 3 | Up to day 729 | Proportion of patients (%) with AEs of severity grade ≥ 3 according to CTCAE 5.0 |
| Secondary | Proportion of patients (%) with ADRs of severity grade ≥ 3 | Up to day 729 | Proportion of patients (%) with ADRs of severity grade ≥ 3 according to CTCAE 5.0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT07543744
GET https://conductscience.org/api/trials/v1/NCT07543744/registered?page=2