Pharmacokinetic (PK) Study of QL1203 and Vectibix® for the Treatment of RAS Wild-type Metastatic Colorectal Cancer

NCT07829588 — Phase 1, Not yet recruiting, 136 participants, Qilu Pharmaceutical Co., Ltd.

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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

Registry	NCT07829588
Status	Not yet recruiting
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	136 (Estimated)
Sponsor	Qilu Pharmaceutical Co., Ltd. (Industry)
Conditions	RAS Wild-type Metastatic Colorectal Cancer
Interventions	QL1203 + mFOLFOX6, Vectibix®+ mFOLFOX6 (Drug)
Dates	start 2026-11-24 (estimated), primary completion 2028-02-28 (estimated), completion 2028-08-30 (estimated), first posted 2026-09-21, last updated 2026-09-21

-Summary

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 .

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+Arms and interventions

Arm	Type	Interventions	Description
Test Group	Experimental	Drug: QL1203 + mFOLFOX6
Control Group	Active comparator	Drug: Vectibix®+ mFOLFOX6

QL1203 + mFOLFOX6 (Drug): QL1203 (6mg/kg) combined with mFOLFOX6, Q2W
Vectibix®+ mFOLFOX6 (Drug): Vectibix® (6mg/kg) combined with mFOLFOX6, Q2W

+Outcome measures

Primary outcomes

AUCtau, sd [through the Cycle 1 (each cycle is 2 weeks)]: Area under the serum concentration-time curve over one dosing interval after the first dose of QL1203 and Vectibix®
AUCtau,ss, [through the Cycle 4 (each cycle is 2 weeks)]: Area under the serum concentration-time curve over one dosing interval at steady state (at Cycle 4)

+Eligibility

Sex: All, ages: 18 Years to 100 Years

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.