Colorectal Cancer MetastaticPhase 2NCT07061210
An Explorative Study of HRS-2189 Combined With Adebrelimab and BP102 for Metastatic Colorectal Cancer
A Phase 2 study testing HRS-2189, Adebrelimab and BP102 in people with Colorectal Cancer Metastatic, run by Fudan University.
Trial summary
To evaluate the safety and efficacy of HRS-2189 combined with Adebrelimab and BP102 in the treatment of metastatic colorectal cancer 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?
- HRS-2189, Adebrelimab and BP102
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Jan 2027
- 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
- 1.18-75 years; 2.Histological confirmed metastatic colorectal cancer; 3.ECOG PS 0-1; 4.At least one measurable lesion (according to RECIST1.1); 5.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 treatments or medications received before the first study treatment as follows:
- Major surgery within 28 days before treatment (tissue biopsy for diagnostic purposes is allowed).
- Use of immunosuppressive drugs within 7 days before treatment, excluding intranasal and inhaled corticosteroids or physiological doses of systemic steroids (i.e., no more than 10 mg/day of prednisone or an equivalent dose of other corticosteroids);
Show all 17Show fewer
- Administration of immunomodulatory drugs (such as thymosin, interferon, interleukin) within 3 weeks before treatment;
- Vaccination with live attenuated vaccines within 28 days before treatment;
- Other systemic anti-tumor therapies within 28 days before treatment;
- Any active autoimmune disease or a history of autoimmune disease with an anticipated recurrence;
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Active infection or unexplained fever >38.5°C within 4 weeks before the first dose or on the day of the first dose (fever due to tumor may be included in the study at the investigator's discretion)；
- Within 6 months prior to study entry, any of the following conditions: myocardial infarction, severe/unstable angina, NYHA Class 2 or higher cardiac insufficiency, or clinically significant supraventricular/ventricular arrhythmia requiring clinical intervention; poorly controlled hypertension despite medication;
- History of severe bleeding (>30 mL per episode) within 3 months, hemoptysis (>5 mL per episode) within 1 month, or arterial/venous thrombotic events within 6 months before the first dose;
- Inability to swallow the study drug, or presence of factors affecting drug administration and absorption such as chronic diarrhea (including but not limited to irritable bowel syndrome, Crohn's disease, ulcerative colitis) or intestinal obstruction;
- Pregnant or breastfeeding women, or subjects of reproductive potential unwilling to use effective contraception;
- Presence of other severe physical or laboratory abnormalities that may increase the risk of study participation, interfere with study results, or patients deemed unsuitable for the study by the investigator.
About this study
To evaluate the safety and efficacy of HRS-2189 combined with Adebrelimab and BP102 in the treatment of metastatic colorectal cancer
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- HRS-2189, Adebrelimab, BP102
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-2189Drug
HRS-2189
AdebrelimabDrug
Adebrelimab
BP102Drug
BP102
| Study group | Role | What they receive |
|---|---|---|
| HRS-2189 + Adebrelimab + BP102 | Experimental | Not described Receives: Drug: HRS-2189; Drug: Adebrelimab; Drug: BP102 |
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 (4)
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
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
Adverse events (AEs)
AEs are assessed by NCI-CTCAE v5.0
Measured: From the first drug administration to within 90 days for the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Jan 2027 (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, Junjie Peng, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061210
- Sponsor's protocol ID
- CRC-IIT-HRS2189-SHR1316
- Status last verified
- Jun 2025
- First submitted
- 2 Jul 2025
- Last updated
- 11 Jul 2025
- 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 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Explorative Study of HRS-2189 Combined With Adebrelimab and BP102 for Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07061210
- Acronym / sponsor ID
- CRC-IIT-HRS2189-SHR1316
- 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
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 11 Jul 2025 (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.
To evaluate the safety and efficacy of HRS-2189 combined with Adebrelimab and BP102 in the treatment of metastatic colorectal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HRS-2189 + Adebrelimab + BP102 | Experimental | Drug: HRS-2189, Drug: Adebrelimab, Drug: BP102 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.18-75 years; 2.Histological confirmed metastatic colorectal cancer; 3.ECOG PS 0-1; 4.At least one measurable lesion (according to RECIST1.1); 5.Patients voluntarily enroll in the study.
Key exclusion criteria (17 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 treatments or medications received before the first study treatment as follows:
- Any active autoimmune disease or a history of autoimmune disease with an anticipated recurrence;
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 |
|---|---|---|
| HRS-2189HRS-2189 | Drug | HRS-2189 + Adebrelimab + BP102 |
| AdebrelimabAdebrelimab | Drug | HRS-2189 + Adebrelimab + BP102 |
| BP102BP102 | Drug | HRS-2189 + Adebrelimab + BP102 |
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.
4 secondary outcomes
Progression-Free Survival (PFS)
Time frame: assessed up to 1 year
Overall survival (OS)
Time frame: assessed up to 2 year
Disease Control Rate (DCR)
Time frame: assessed up to 1 year
Adverse events (AEs)
Time frame: From the first drug administration to within 90 days for the last dose
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 11 Jul 2025.
Related trials for Colorectal Cancer Metastatic
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Metastatic Colorectal Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Not yet recruitingPhase 1/2
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS-2189, Adebrelimab and BP102 in people with Colorectal Cancer Metastatic, run by Fudan University.
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 1 inclusion and 17 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 11 Jul 2025. 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 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 11 Jul 2025.