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
| NCT ID | NCT07543744 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | R-Pharm |
| Condition | Metastatic Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2025-04-17 |
| Primary Completion | 2026-05-15 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
The primary objective of this study is to demonstrate equivalence of pharmacokinetic properties, and comparability of safety and immunogenicity parameters of RPH-030 and Vectibix® following a single (first) intravenous administration to patients with mCRC with wild-type RAS genes as 1-line therapy in combination with FOLFIRI. The additional objective is to perform a pilot evaluation of the efficacy of RPH-030 and Vectibix® following a single (first) intravenous administration to patients with mCRC with wild-type RAS genes as 1-line therapy in combination with FOLFIRI.
Eligibility Criteria
Inclusion Criteria: 1. A voluntarily signed and dated Informed Consent form (ICF) of the patient 2. Histologically verified (documented results of respective examinations available) metastatic colorectal adenocarcinoma (in case the results of previous examinations are not available, the diagnosis will be verified in the central laboratory during screening upon receipt and evaluation of the results before randomization) 3. Patient consent to undergo a screening biopsy if archival tissue samples are unavailable for histological diagnosis verification 4. Patients with metastatic colorectal cancer (mCRC), either de novo metastatic or recurrent with distant metastases, who are candidates for first-line therapy 5. RAS wild-type (WT) status 6. ECOG status 0-1 7. Presence of at least one measurable lesion according to RECIST 1.1 criteria (patients with a single measurable bone lesion are not eligible) 8. Absence or resolution of toxic effects from prior therapy (neoadjuvant/adjuvant) or surgic
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.