NCT07829588Not yet recruitingPhase 1
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 · Last updated 21 Sept 2026
Brief summary (registry, in English)
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 .
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 136 (estimated)
- First submitted
- 9 Sept 2026
- Start date
- 24 Nov 2026
- Primary completion date
- 28 Feb 2028
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Diseases
- Colorectal cancer
- NCT number
- NCT07829588
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 136
- From 24 Nov 2026 to the primary completion date, 28 Feb 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous systemic treatment: The time from the last dose of neoadjuvant or adjuvant therapy to disease recurrence is \> 6 months.
Other illness
- Participants with a history of malignancies other than colorectal cancer within 5 years prior to the first dose.
Lab values
- Previous treatment with epidermal growth factor receptor (EGFR) targeted drugs for colorectal cancer.
Other
- Trial participants known to have high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR).
- Presence of active central nervous system metastases.
- Trial participants (both male and female) who are unwilling to accept effective contraception; female trial participants who are pregnant or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.