RAS Wild-type Metastatic Colorectal CancerPhase 1NCT07829588
Pharmacokinetic (PK) Study of QL1203 and Vectibix® for the Treatment of RAS Wild-type Metastatic Colorectal Cancer
A Phase 1 study testing QL1203 + mFOLFOX6 and Vectibix®+ mFOLFOX6 in people with RAS Wild-type Metastatic Colorectal Cancer, run by Qilu Pharmaceutical Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- RAS Wild-type Metastatic Colorectal Cancer
- What is being tested?
- QL1203 + mFOLFOX6 and Vectibix®+ mFOLFOX6
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- 24 Nov 2026to 30 Aug 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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 .
- Being tested
- QL1203 + mFOLFOX6, Vectibix®+ mFOLFOX6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1203 + mFOLFOX6Drug
QL1203 (6mg/kg) combined with mFOLFOX6, Q2W
Vectibix®+ mFOLFOX6Drug
Vectibix® (6mg/kg) combined with mFOLFOX6, Q2W
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Not described Receives: Drug: QL1203 + mFOLFOX6 |
| Control Group | Active comparator | Not described Receives: Drug: Vectibix®+ mFOLFOX6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCtau, sd
Area under the serum concentration-time curve over one dosing interval after the first dose of QL1203 and Vectibix®
Measured: through the Cycle 1 (each cycle is 2 weeks)
AUCtau,ss,
Area under the serum concentration-time curve over one dosing interval at steady state (at Cycle 4)
Measured: through the Cycle 4 (each cycle is 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start24 Nov 2026 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RAS Wild-type Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829588
- Sponsor's protocol ID
- QL1203-103
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07829588
- Acronym / sponsor ID
- QL1203-103
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Nov 2026 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Drug: QL1203 + mFOLFOX6 |
| Control Group | Active comparator | Drug: Vectibix®+ mFOLFOX6 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QL1203 + mFOLFOX6QL1203 (6mg/kg) combined with mFOLFOX6, Q2W | Drug | Test Group |
| Vectibix®+ mFOLFOX6Vectibix® (6mg/kg) combined with mFOLFOX6, Q2W | Drug | Control Group |
Primary outcome
AUCtau, sd
Time frame: 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,
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QL1203 + mFOLFOX6 and Vectibix®+ mFOLFOX6 in people with RAS Wild-type Metastatic Colorectal Cancer, run by Qilu Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Xie, Master (13811865963, jing5.xie@qilu-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCtau, sd (time frame: through the Cycle 1 (each cycle is 2 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.