Colorectal Cancer MetastaticPhase 2NCT06679673
SHR-1701 Combined with SHR2554 and BP102 for MCRC
A Phase 2 study testing SHR-1701, BP102 and SHR2554 in people with Colorectal Cancer Metastatic, run by Fudan University at 1 site in China.
Trial summary
Response to oncologic treatment in mCRC is currently limited. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- SHR-1701, BP102 and SHR2554
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Dec 2024to Dec 2026
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years;
- Histological confirmed metastatic colorectal cancer;
- ECOG PS 0-1;
- At least one measurable lesion (according to RECIST1.1);
- Adequate hepatic, renal, coagulation, and hematologic functions;
- Agree to use contraception during the study and 3 months after the end of the study. Negative serum pregnancy test at screening for women of childbearing potential;
- Patients voluntarily enroll in the study.
Who cannot join
- The patient has had other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- Symptomatic brain or meningeal metastases (except for those whose BMS disease is stable for at least 4 weeks);
- Allergy to the study drug or any of its excipients;
- Prior treatment with immune checkpoint inhibitors;
- Received the following treatments before the first study treatment;
- Major surgery within 28 days before treatment (tissue biopsy for diagnostic purposes is permitted).
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- Prior use of immunosuppressive medications, excluding nasal and inhaled corticosteroids or physiologic doses of systemic steroids (i.e., no more than 10 mg/d prednisone or equivalent pharmacologic doses of other corticosteroids) within 7 days before treatment;
- Received immunomodulatory drugs within 3 weeks before treatment;
- Received live attenuated vaccine within 28 days before treatment;
- Receipt of other antitumor systemic therapy within 28 days prior to treatment;
- Presence of any active autoimmune disease or history of autoimmune disease with expected relapse;
- A known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
- Human immunodeficiency virus (HIV) infection or known AIDS, untreated active hepatitis, HBV-DNA ≥ 2500 IU/ml and abnormal liver function; hepatitis C or co-infection with hepatitis B and hepatitis C;
- A history of interstitial lung disease or non-infectious pneumonia, etc.;
- Within 6 months before enrollment, the following conditions: myocardial infarction, severe/unstable angina, NYHA class 2 or greater cardiac insufficiency, and clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention; hypertension with poorly controlled by medications;
- A history of severe bleeding within 3 months (>30 ml at a time) or hemoptysis within 1 month (>5 ml at a time) or a thromboembolic event (including pulmonary embolism, cerebral infarction, etc.) within 12 months;
- Surgical treatment (except biopsy) within 6 weeks or unhealed surgical incision;
- Long-standing unhealed wounds or fractures that have not healed properly
- Imaging showing that the tumor has invaded a vital vascular perimeter or if, in the judgment of the investigator, the patient's tumor has a very high likelihood of invading a vital blood vessel and causing a fatal hemorrhage during therapy
- A history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, or active gastrointestinal bleeding within 6 months before the first study treatment
- Urine routine showed urine protein ≥2+, and 24-hour urine protein level >1.0g;
- Unable to take the drug orally, or has a condition judged by the investigator to affect the absorption of the drug;
- Pregnancy, lactation, and unwillingness of reproductively active subjects to use effective contraception;
- Other conditions deemed by the investigator to be ineligible for inclusion in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Colorectal Surgery Fudan University Shanghai Caner Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: An Explorative Study of SHR-1701 Combined with SHR2554 and BP102(bevacizumab) for Metastatic Colorectal Cancer.
Response to oncologic treatment in mCRC is currently limited.
Read the detailed description
This is a single-center, open-labeled study exploring the efficacy and safety of SHR-1701 combined with SHR2554 and BP102 in the treatment of metastatic colorectal cancer (mCRC) .
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- SHR-1701, BP102, SHR2554
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1701Drug
SHR-1701
BP102Drug
BP102
SHR2554Drug
SHR2554
| Study group | Role | What they receive |
|---|---|---|
| SHR-1701+BP102±SHR2554 | Experimental | The first 6 subjects will be treated with SHR-1701+BP102, and the subsequent subjects will be treated with SHR-1701+BP102+SHR2554 Receives: Drug: SHR-1701; Drug: BP102; Drug: SHR2554 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
the proportion of patients with complete response or partial response, using RECIST v 1.1.
Measured: assessed up to 1 year
Secondary outcomes (3)
Disease Control Rate (DCR)
the proportion of patients with complete response, partial response or stable disease, using RECIST v 1.1.
Measured: assessed up to 1 year
Progression-Free Survival (PFS)
time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator
Measured: assessed up to 1 year
Overall survival (OS)
time from enrollment to death from any cause.
Measured: assessed up to 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study startDec 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ye Xu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679673
- Sponsor's protocol ID
- CRC-IIT-SHR1701-SHR2554-BP102
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Explorative Study of SHR-1701 Combined with SHR2554 and BP102(bevacizumab) for Metastatic Colorectal Cancer.
- ClinicalTrials.gov ID
- NCT06679673
- Acronym / sponsor ID
- CRC-IIT-SHR1701-SHR2554-BP102
- Conditions
- Colorectal Cancer Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Nov 2024 (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.
Response to oncologic treatment in mCRC is currently limited.
Detailed description
This is a single-center, open-labeled study exploring the efficacy and safety of SHR-1701 combined with SHR2554 and BP102 in the treatment of metastatic colorectal cancer (mCRC) .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-1701+BP102±SHR2554 | Experimental | Drug: SHR-1701, Drug: BP102, Drug: SHR2554The first 6 subjects will be treated with SHR-1701+BP102, and the subsequent subjects will be treated with SHR-1701+BP102+SHR2554 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-75 years;
- Histological confirmed metastatic colorectal cancer;
- ECOG PS 0-1;
- At least one measurable lesion (according to RECIST1.1);
- Adequate hepatic, renal, coagulation, and hematologic functions;
Key exclusion criteria (24 listed)
- The patient has had other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- Symptomatic brain or meningeal metastases (except for those whose BMS disease is stable for at least 4 weeks);
- Allergy to the study drug or any of its excipients;
- Prior treatment with immune checkpoint inhibitors;
- Received the following treatments before the first study 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 |
|---|---|---|
| SHR-1701SHR-1701 | Drug | SHR-1701+BP102±SHR2554 |
| BP102BP102 | Drug | SHR-1701+BP102±SHR2554 |
| SHR2554SHR2554 | Drug | SHR-1701+BP102±SHR2554 |
Primary outcome
Objective response rate (ORR)
Time frame: assessed up to 1 year
the proportion of patients with complete response or partial response, using RECIST v 1.1.
3 secondary outcomes
Disease Control Rate (DCR)
Time frame: assessed up to 1 year
Progression-Free Survival (PFS)
Time frame: assessed up to 1 year
Overall survival (OS)
Time frame: assessed up to 2 year
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 7 Nov 2024.
- Individual participant dataSharing planned: No
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CRC
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.
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 SHR-1701, BP102 and SHR2554 in people with Colorectal Cancer Metastatic, run by Fudan University 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 7 inclusion and 24 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 7 Nov 2024. 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?
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 Ye Xu, Prof. (+86-21-6417-5590, xu_shirley021@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: assessed up to 1 year). 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 7 Nov 2024.