Clinical trial · Interventional
Pharmacokinetic (PK) Study of QL1203 and Vectibix® for the Treatment of RAS Wild-type Metastatic Colorectal Cancer
A Randomized, Double-Blind, Parallel-Controlled, Multicenter Phase I Study to Evaluate the Pharmacokinetic Similarity Between QL1203 (Vectibix® Biosimilar Candidate) and Panitumumab (EU-Vectibix®) in Combination With mFOLFOX6 Respectively in Patients With RAS Wild-Type Metastatic Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
This is a randomized, double-blind, parallel-controlled, multicenter clinical trial to evaluate the pharmacokinetic similarity between QL1203 and Vectibix® in patients with RAS wild-type metastatic colorectal cancer. Eligible trial participants will be randomized in a 1:1 ratio to either the QL1203 or Vectibix® groups, to received QL1203 + mFOLFOX6 and the control group received Vectibix® + mFOLFOX6. PK profiles, immunogenicity, safety and preliminary efficacy will be evaluated and compared between two groups .
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| RAS Wild-type Metastatic Colorectal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QL1203 + mFOLFOX6 | Drug | — | UNRESOLVED |
| Vectibix®+ mFOLFOX6 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Test Group
- interventionNames
- Drug: QL1203 + mFOLFOX6
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- interventionNames
- Drug: Vectibix®+ mFOLFOX6
Primary outcomes (2)
- measure
- AUCtau, sd
- timeFrame
- through the Cycle 1 (each cycle is 2 weeks)
- description
- Area under the serum concentration-time curve over one dosing interval after the first dose of QL1203 and Vectibix®
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Voluntarily participate, have read, understood and signed the informed consent form (ICF), and are able to follow the study procedures. * Male or female aged ≥18 years. * Metastatic colorectal adenocarcinoma confirmed by histology or cytology, and not suitable for radical surgery, radiotherapy, radiofrequency ablation and other local treatments. * Wild-type RAS and wild-type BRAF. * At least 1 definite measurable tumor lesion according to RECIST v1.1. * Eastern Cooperative Oncology Group Performance Status (ECOG PS) score 0-1. * Have adequate organ function. Exclusion Criteria: * Previous systemic treatment: The time from the last dose of neoadjuvant or adjuvant therapy to disease recurrence is \> 6 months. * Previous treatment with epidermal growth factor receptor (EGFR) targeted drugs for colorectal cancer. * Trial participants known to have high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR). * Presence of active central nervous system metastases. * Participants with a history of malignancies other than colorectal cancer within 5 years prior to the first dose. * Trial participants (both male and female) who are unwilling to accept effective contraception; female trial participants who are pregnant or breastfeeding.
References
Publications (0)
Data not yet available