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mCRCPhase 2NCT07355764

MA-CRC-II-016 SHR-1811

A Phase 2 study testing SHR-A1811 & Bevacizumab injection and Chemotherapeutic Combinations in people with mCRC and HER2, run by Peking Union Medical College Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

A randomized, controlled, multicenter clinical study of SHR-A1811 combined with bevacizumab for the second-line treatment of metastatic colorectal cancer Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
mCRC, HER2, Targeted Therapy
What is being tested?
SHR-A1811 & Bevacizumab injection and Chemotherapeutic Combinations
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
30 Dec 2025to 31 Jan 2028
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

  • -Provide a written informed consent form to voluntarily participate in this study.
  • Male or female subjects aged 18-75 years.
  • Patients with histologically or cytologically confirmed recurrent or metastatic colorectal adenocarcinoma that is not amenable to curative resection.
  • Patients who have experienced disease progression following first-line standard therapy with oxaliplatin combined with fluoropyrimidine-based drugs.
  • Patients with disease progression within 12 months after completion of neoadjuvant or adjuvant therapy are eligible for inclusion.
  • Patients who have previously received irinotecan as part of first-line therapy may be included if investigators from the leading center determine through discussion that the patient is likely to benefit from treatment in the control group.
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  • HER2 expression status: Includes patients with HER2 overexpression (IHC 3+ / IHC 2+ with FISH positivity) or HER2 low-to-moderate expression (IHC 2+ with FISH negativity or IHC 1+).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1.
  • Ability to provide a report documenting RAS/BRAF gene status.
  • Expected survival time of at least 6 months.
  • Presence of radiologically assessed measurable lesions at baseline (per RECIST 1.1 criteria). Measurable lesions should not have received prior local therapy such as radiotherapy. Lesions located within previously irradiated areas may be selected as target lesions if disease progression in these lesions is confirmed.
  • Adequate function of major organs, meeting the following requirements (administration of blood components or cell growth factors for corrective treatment is not allowed within 14 days prior to the first dose of study medication):
  • Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L Platelet count ≥ 100 × 10⁹/L Hemoglobin ≥ 90 g/L Serum albumin ≥ 30 g/L Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN) Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN Serum creatinine ≤ 1.5 × ULN or creatinine clearance rate > 60 mL/min (calculated by the Cockcroft-Gault formula) Activated Partial Thromboplastin Time (APTT) and International Normalized Ratio (INR) ≤ 1.5 × ULN. Patients receiving stable-dose anticoagulant therapy (e.g., low-molecular-weight heparin or warfarin) with INR within the expected therapeutic range for anticoagulants are eligible for screening.
  • For female subjects of childbearing potential:
  • A negative serum pregnancy test result is required within 3 days prior to the first dose, and the subject must not be breastfeeding.
  • Must agree to use effective contraceptive measures during the study period and for at least 7 months after the last dose of SHR-A1811, or for at least 6 months after the last dose of other study medications.
  • -For male subjects whose partners are of childbearing potential: The subject must have undergone surgical sterilization, or agree to use effective contraceptive measures during the study period and for at least 7 months after the last dose of SHR-A1811, or for at least 6 months after the last dose of other study medications.
  • Sperm donation is prohibited during the study period.

Who cannot join

  • Toxicities from prior anti-tumor therapies have not resolved to ≤ Grade 1 per the CTCAE v5.0 criteria (except for toxicities deemed to pose no safety risk by the investigator, e.g., alopecia) or to the levels specified in the inclusion/exclusion criteria.
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with a history of treated brain metastases may be enrolled provided that their brain metastases are stable, and they have not received steroid therapy for brain metastases for at least 28 days prior to study initiation. This exception does not apply to carcinomatous meningitis, as patients with carcinomatous meningitis are excluded regardless of clinical stability.
  • Known microsatellite instability-high (MSI-H) status confirmed by genetic testing or deficient mismatch repair (dMMR) status confirmed by immunohistochemistry.
  • A history of hypersensitivity to monoclonal antibodies, the formulation components of SHR-A1811, or anti-angiogenic agents.
  • Prior treatment with HER2-targeted antibody-drug conjugates (ADCs).
  • Major surgery, open biopsy, or severe trauma within 28 days prior to the first study drug administration.
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  • Patients with any severe and/or uncontrolled diseases, including:
  • Patients with inadequately controlled hypertension; Myocardial ischemia or myocardial infarction of Grade ≥1, cardiac arrhythmias (including QT interval ≥ 480 ms), or cardiac insufficiency of Grade ≥1; Active or uncontrolled severe infections; Hepatic diseases such as decompensated liver disease, active hepatitis B (HBV-DNA ≥ 10⁴ copies/mL or 2000 IU/mL) or active hepatitis C (positive for hepatitis C antibody with HCV-RNA level above the lower limit of quantification of the assay); Subjects with urine protein ≥ ++ on routine urinalysis and confirmed 24-hour urine protein quantification > 1.0 g.
  • Clinically significant bleeding symptoms or confirmed bleeding diathesis (e.g., gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis) within 3 months prior to the first study drug administration.
  • Arterial/venous thrombotic events (e.g., cerebrovascular accident including transient ischemic attack, cerebral hemorrhage, cerebral infarction; deep vein thrombosis; pulmonary embolism) within 6 months prior to the first study drug administration. Subjects with superficial venous thrombosis may be enrolled at the investigator's discretion.
  • Presence of another concurrent progressive malignancy requiring active treatment, with the exception of non-melanoma skin cancer and carcinoma in situ of the cervix that have undergone potential curative treatment.
  • Any other factors judged by the investigator that may force the subject to discontinue the study prematurely, including severe concurrent illnesses (including mental illnesses) requiring concomitant treatment, severely abnormal laboratory test results, family or social factors that may affect subject safety or the collection of trial data.

About this study

Official title: SHR-1811 Combined With Bevacizumab as Second-line Treatment in Patients Metastatic CRC

A randomized, controlled, multicenter clinical study of SHR-A1811 combined with bevacizumab for the second-line treatment of metastatic colorectal cancer

Being tested
SHR-A1811 & Bevacizumab injection, Chemotherapeutic Combinations
Keywords
SHR-1811, mCRC, second-line

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-A1811 & Bevacizumab injectionDrug

    Also called bevacizumab, chemotherapy

    HER2 ADC

  • Chemotherapeutic CombinationsDrug

    FOLFIRI+BEV

Study groups in NCT07355764
Study groupRoleWhat they receive
SHR-A1811 combined with bevacizumabActive comparatorSHR-A1811 with bevacizumab
Receives: Drug: SHR-A1811 & Bevacizumab injection
Chemotherapeutic CombinationsActive comparatorchemotherapy with bevacizumab
Receives: Drug: Chemotherapeutic Combinations

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    objective response rate

    Measured: The end of cycle 2 (each cycle is 21 days) for SHR-A1811+BEV group and the end of cycle 3 (each cycle is 14 days) for FOLFIRI+BEV group

Secondary outcomes (2)

  1. PFS

    progression free survival

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

  2. OS

    overall survival

    Measured: From data of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2026
  2. Study start30 Dec 2025 (estimated)
  3. Primary completion30 Jan 2028 (estimated)
  4. Study completion31 Jan 2028 (estimated)

Resources

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
Factorial
Model description
SHR-A1811 combined with bevacizumab; chemotherapy combined with bevacizumab
Masking
Single blind
Who is masked
Investigator
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07355764
Sponsor's protocol ID
K8750
Other IDs
K8750
Status last verified
Jan 2026
First submitted
17 Dec 2025
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR-A1811 & Bevacizumab injection and Chemotherapeutic Combinations in people with mCRC and HER2, run by Peking Union Medical College Hospital.

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 18 inclusion and 12 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 Jan 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 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?

ORR (time frame: The end of cycle 2 (each cycle is 21 days) for SHR-A1811+BEV group and the end of cycle 3 (each cycle is 14 days) for FOLFIRI+BEV group). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07355764.

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 Jan 2026.

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