Colorectal CancerPhase 2NCT05684211
A Study of Ametumumab in Combination With Anti-PD-1 Monoclonal Antibody and FOLFIRI in Patients With RAS Wild-type Advanced Colorectal Cancer
A Phase 2 study testing Ametumumab, Anti-PD-1 monoclonal antibody and Cetuximab in people with Colorectal Cancer, run by Shanghai Celfuture Biotech Co., Ltd. at 1 site in China.
Trial summary
This is a multicenter, open-label, parallel-group, randomised, A phase IIb clinical trial of efficacy and safety of Ametumumab in combination with anti-PD-1 monoclonal antibody and FOLFIRI versus Ametumumab or Cetuximab in combination with FOLFIRI in patients with RAS wild-type advanced colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Ametumumab, Anti-PD-1 monoclonal antibody and Cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- Jan 2023to Jan 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign written informed consent; Age 18 ~ 85 years (inclusive), male or female;
- •Patients requiring first-line treatment for locally advanced colorectal cancer with distant metastasis or unresectable disease; Histologically or cytologically confirmed adenocarcinoma of the colon or rectum; RAS (KRAS, NRAS) gene is wild-type and no BRAF V600E mutation has been identified; Presence of at least one measurable lesion (non-radiation field) confirmed by CT or MRI that meets RECIST 1.1 criteria; Performance status (ECOG) score 0 or 1.
Who cannot join
- Previous chemotherapy for colorectal cancerPrevious treatment with anti-EGFR monoclonal antibodies Received systemic anti-tumor treatment approved or of other clinical studies within 4 weeks prior to the first dose.
- Radiotherapy or surgery within 4 weeks prior to enrollment, except for diagnostic biopsy Participation in other clinical trials within 4 weeks prior to enrollment; Severe skin disease requiring systemic treatment. Presence of serious clinical infection.\ Uncontrolled pleural effusion, pericardial effusion or peritoneal effusion after treatment.
Trial locations and contacts
1 site in 1 country.
China1 site
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Hongming Pan, MD, 13605716662, panhongming@zju.edu.cn
About this study
Official title: A Multicenter, Open-label, Parallel-group，Randomised, Phase IIb Trial of Efficacy and Safety of Ametumumab in Combination With Anti-PD-1 Monoclonal Antibody and FOLFIRI Versus Ametumumab or Cetuximab in Combination With FOLFIRI in Patients With RAS Wild-type Advanced Colorectal Cancer
This is a multicenter, open-label, parallel-group, randomised, A phase IIb clinical trial of efficacy and safety of Ametumumab in combination with anti-PD-1 monoclonal antibody and FOLFIRI versus Ametumumab or Cetuximab in combination with FOLFIRI in patients with RAS wild-type advanced colorectal cancer.
Read the detailed description
This is a multicenter, open-label, parallel-group, randomised, phase IIb trial. This study is to evaluate and compare the efficacy and safety of Ametumumab (anti-EGFR monoclonal antibody) combined with anti-PD-1 monoclonal antibody in first-line treatment of RAS wild-type colorectal cancer patients, as well as to assess the immunogenicity and pharmacokinetic profile and recommend dosing regimen for phase III clinical trials.Conditions and keywords.
- Conditions
- Colorectal Cancer
- Being tested
- Ametumumab, Anti-PD-1 monoclonal antibody, Cetuximab, FOLFIRI
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmetumumabDrug
A recombinant fully human anti-EGFR monoclonal antibody
Anti-PD-1 monoclonal antibodyDrug
Toripalimab 3 mg/kg，Intravenous titration，Q2W
CetuximabDrug
Cetuximab 500 mg/m2 ，Intravenous titration，Q2W
FOLFIRIDrug
Rinotecan hydrochloride，180mg/m2，intravenous titration，Q2W； 5 -Fluorouracil，400 mg/ m2, intravenous push, then 1200 mg/ m2 /day x 2 days, intravenous titration,Q2W; Calcium folinate,400mg/m2,intravenous titration，Q2W
| Study group | Role | What they receive |
|---|---|---|
| Ametumumab (QW) + anti-PD-1 monoclonal antibody+ FOLFIRI | Active comparator | Ametumumab 450 mg/m2 (QW) + anti-PD-1 monoclonal antibody (in the case of toripalimab 3 mg/kg, Q2W) + FOLFIRI; Receives: Drug: Ametumumab; Drug: Anti-PD-1 monoclonal antibody; Drug: FOLFIRI |
| Ametumumab(Q2W) + anti-PD-1 monoclonal antibody + FOLFIRI; | Active comparator | Ametumumab 450 mg/m2 (Q2W) + anti-PD-1 monoclonal antibody (in the case of toripalimab 3 mg/kg, Q2W) + FOLFIRI; Receives: Drug: Ametumumab; Drug: Anti-PD-1 monoclonal antibody; Drug: FOLFIRI |
| Ametumumab (Q2W) + FOLFIRI; | Active comparator | Ametumumab 450 mg/m2 (Q2W) + FOLFIRI Receives: Drug: Ametumumab; Drug: FOLFIRI |
| Cetuximab + FOLFIRI; | Active comparator | Cetuximab 500 mg/m2 (Q2W) + FOLFIRI Receives: Drug: Cetuximab; Drug: FOLFIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Measured: PFS will be measured from the date of first dose of study drug until first documented clinical or radiographic evidence of disease progression by RECIST 1.1, clinical progression, start of new therapy or death. approximately 45 months
Secondary outcomes (2)
Objective Response Rate (ORR)
Measured: ORR is defined as a CR or PR per RECIST version 1.1 recorded from the date of randomization until date of first documentation of PD, death, or start of new anti-cancer therapy, approximately 45 months.
incidence of adverse events
Measured: Incidence and severity of AEs graded according to the NCI CTCAE v5.0, Duration of study, approximately 45 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study startJan 2023 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Celfuture Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684211
- Sponsor's protocol ID
- WBP252-004
- Status last verified
- Jan 2023
- First submitted
- 4 Jan 2023
- Last updated
- 1 Feb 2023
- 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 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Parallel-group，Randomised, Phase IIb Trial of Efficacy and Safety of Ametumumab in Combination With Anti-PD-1 Monoclonal Antibody and FOLFIRI Versus Ametumumab or Cetuximab in Combination With FOLFIRI in Patients With RAS Wild-type Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05684211
- Acronym / sponsor ID
- WBP252-004
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Shanghai Celfuture Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 13 Jan 2023 (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 multicenter, open-label, parallel-group, randomised, A phase IIb clinical trial of efficacy and safety of Ametumumab in combination with anti-PD-1 monoclonal antibody and FOLFIRI versus Ametumumab or Cetuximab in combination with FOLFIRI in patients with RAS wild-type advanced colorectal cancer.
Detailed description
This is a multicenter, open-label, parallel-group, randomised, phase IIb trial. This study is to evaluate and compare the efficacy and safety of Ametumumab (anti-EGFR monoclonal antibody) combined with anti-PD-1 monoclonal antibody in first-line treatment of RAS wild-type colorectal cancer patients, as well as to assess the immunogenicity and pharmacokinetic profile and recommend dosing regimen for phase III clinical trials.Conditions and keywords.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ametumumab (QW) + anti-PD-1 monoclonal antibody+ FOLFIRI | Active comparator | Drug: Ametumumab, Drug: Anti-PD-1 monoclonal antibody, Drug: FOLFIRIAmetumumab 450 mg/m2 (QW) + anti-PD-1 monoclonal antibody (in the case of toripalimab 3 mg/kg, Q2W) + FOLFIRI; |
| Ametumumab(Q2W) + anti-PD-1 monoclonal antibody + FOLFIRI; | Active comparator | Drug: Ametumumab, Drug: Anti-PD-1 monoclonal antibody, Drug: FOLFIRIAmetumumab 450 mg/m2 (Q2W) + anti-PD-1 monoclonal antibody (in the case of toripalimab 3 mg/kg, Q2W) + FOLFIRI; |
| Ametumumab (Q2W) + FOLFIRI; | Active comparator | Drug: Ametumumab, Drug: FOLFIRIAmetumumab 450 mg/m2 (Q2W) + FOLFIRI |
| Cetuximab + FOLFIRI; | Active comparator | Drug: Cetuximab, Drug: FOLFIRICetuximab 500 mg/m2 (Q2W) + FOLFIRI |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Voluntarily sign written informed consent; Age 18 ~ 85 years (inclusive), male or female;
- •Patients requiring first-line treatment for locally advanced colorectal cancer with distant metastasis or unresectable disease; Histologically or cytologically confirmed adenocarcinoma of the colon or rectum; RAS (KRAS, NRAS) gene is wild-type and no BRAF V600E mutation has been identified; Presence of at least one measurable lesion (non-radiation field) confirmed by CT or MRI that meets RECIST 1.1 criteria; Performance status (ECOG) score 0 or 1.
Key exclusion criteria (2 listed)
- Previous chemotherapy for colorectal cancerPrevious treatment with anti-EGFR monoclonal antibodies Received systemic anti-tumor treatment approved or of other clinical studies within 4 weeks prior to the first dose.
- Radiotherapy or surgery within 4 weeks prior to enrollment, except for diagnostic biopsy Participation in other clinical trials within 4 weeks prior to enrollment; Severe skin disease requiring systemic treatment. Presence of serious clinical infection.\ Uncontrolled pleural effusion, pericardial effusion or peritoneal effusion after treatment.
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 |
|---|---|---|
| AmetumumabA recombinant fully human anti-EGFR monoclonal antibody | Drug | Ametumumab (Q2W) + FOLFIRI;, Ametumumab (QW) + anti-PD-1 monoclonal antibody+ FOLFIRI, Ametumumab(Q2W) + anti-PD-1 monoclonal antibody + FOLFIRI; |
| Anti-PD-1 monoclonal antibodyToripalimab 3 mg/kg，Intravenous titration，Q2W | Drug | Ametumumab (QW) + anti-PD-1 monoclonal antibody+ FOLFIRI, Ametumumab(Q2W) + anti-PD-1 monoclonal antibody + FOLFIRI; |
| CetuximabCetuximab 500 mg/m2 ，Intravenous titration，Q2W | Drug | Cetuximab + FOLFIRI; |
| FOLFIRIRinotecan hydrochloride，180mg/m2，intravenous titration，Q2W； 5 -Fluorouracil，400 mg/ m2, intravenous push, then 1200 mg/ m2 /day x 2 days, intravenous titration,Q2W; Calcium folinate,400mg/m2,intravenous titration，Q2W | Drug | Ametumumab (Q2W) + FOLFIRI;, Ametumumab (QW) + anti-PD-1 monoclonal antibody+ FOLFIRI, Ametumumab(Q2W) + anti-PD-1 monoclonal antibody + FOLFIRI;, Cetuximab + FOLFIRI; |
Primary outcome
Progression-free survival (PFS)
Time frame: PFS will be measured from the date of first dose of study drug until first documented clinical or radiographic evidence of disease progression by RECIST 1.1, clinical progression, start of new therapy or death. approximately 45 months
2 secondary outcomes
Objective Response Rate (ORR)
Time frame: ORR is defined as a CR or PR per RECIST version 1.1 recorded from the date of randomization until date of first documentation of PD, death, or start of new anti-cancer therapy, approximately 45 months.
incidence of adverse events
Time frame: Incidence and severity of AEs graded according to the NCI CTCAE v5.0, Duration of study, approximately 45 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ametumumab, Anti-PD-1 monoclonal antibody and Cetuximab in people with Colorectal Cancer, run by Shanghai Celfuture Biotech Co., Ltd. at 1 site in China.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact kongli Zhu, Master (15800363686, tsl-zukongli@tasly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: PFS will be measured from the date of first dose of study drug until first documented clinical or radiographic evidence of disease progression by RECIST 1.1, clinical progression, start of new therapy or death. approximately 45 months). 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 1 Feb 2023.