Trial · NCT07435324
A Comparative Study of Efficacy and Safety of RPH-002 and Erbitux® in Unresectable Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma
NCT07435324, Phase 3, Completed, R-Pharm
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Comparative Study of Efficacy and Safety of RPH-002 and Erbitux® in Unresectable Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma. Trials, record NCT07435324. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07435324
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Comparative Study of Efficacy and Safety of RPH-002 and Erbitux® in Unresectable Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma
- NCT number
- NCT07435324
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 161 participants, actual
- Lead sponsor
- R-Pharm
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Interventions
- RPH-002, Erbitux®, Cisplatin, Docetaxel
- First posted
- 2026-02-27
- Last updated
- 2026-07-14
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective response rate (%) (ORR) | At Visits 6 (Day 36), 12 (Day 78), and 18 (Day 120) | Objective response rate (%) (ORR) for a period of up to 18 weeks of therapy inclusive The objective response rate (ORR) is defined as the percentage of patients in each treatment group who achieve a complete or partial tumor response to therapy according to RECIST 1.1 criteria: * Complete Response (CR) - disappearance of all target lesions, confirmed by CT scans for at least 4 weeks; the short axis of any lymph node previously considered pathological (target or non-target) must be \<10 mm * Partial Response (PR) - at least a 30% decrease in the sum of diameters of target lesions, maintained for at least 4 weeks compared with baseline (screening) measurements |
| Secondary | Disease Control Rate (%) (DCR; CR + PR + SD) | At Visits 6 (Day 36), 12 (Day 78), and 18 (Day 120) | Disease Control Rate (DCR; CR + PR + SD), %, achieved within up to 18 weeks from the start of study treatment (inclusive) The disease control rate is defined as the percentage of patients in a given treatment group who achieve a complete response, partial response, or stable disease during therapy, in accordance with RECIST 1.1 criteria: * Complete Response (CR) - disappearance of all target lesions, confirmed by CT scans for at least 4 weeks; the short axis of any lymph node previously considered pathological (target or non-target) must be \<10 mm * Partial Response (PR) - at least a 30% decrease in the sum of diameters of target lesions, maintained for at least 4 weeks compared with baseline (screening) measurements * Stable Disease (SD) - neither sufficient shrinkage in the sum of diameters to qualify as partial response nor sufficient increase to qualify as progressive disease compared with the smallest sum recorded during the study |
| Secondary | Proportion of patients (%) with adverse drug reactions (ADRs) of any severity | Up to Day 365 | 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 365 | Proportion of patients (%) with adverse events (AEs) of any severity |
| Secondary | Proportion of patients (%) with AEs of severity grade ≥ 3 | Up to Day 365 | 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 365 | Proportion of patients (%) with ADRs of severity grade ≥ 3 according to CTCAE 5.0 |
| Secondary | Proportion of patients (%) with serious adverse events (SAEs) | Up to Day 365 | Proportion of patients (%) with serious adverse events (SAEs) |
| Secondary | Proportion of patients (%) with serious adverse drug reactions (SADRs) | Up to Day 365 | Proportion of patients (%) with serious adverse drug reactions (SADRs) |
| Secondary | Proportion of patients (%) who required discontinuation of treatment due to development of ADRs/SADRs | Up to Day 365 | Proportion of patients (%) who required discontinuation of treatment due to development of ADRs/SADRs |
| Secondary | Proportion of patients (%) who developed anti-drug antibodies (ADA) to cetuximab | Pre-dose in Period 1 on Days 1, 15, 29, 57, and 85, and 28 ± 3 days post-last infusion; pre-dose in Period 2 on Days 6, 12, 18, 24, 30, and 36 | Proportion of patients (%) who developed anti-drug antibodies (ADA) to cetuximab |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 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/NCT07435324
GET https://conductscience.org/api/trials/v1/NCT07435324/registered