AzTrials
AzTrials

Colorectal Cancer MetastaticPhase 2NCT07700719

SHR-A1904 in Advanced Colorectal Cancer: an Exploratory Study

A Phase 2 study testing SHR-A1904 in people with Colorectal Cancer Metastatic, run by Peking University Cancer Hospital & Institute at 1 site in China.

Not yet recruiting

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

Sites and contacts
Official record
Search all trials

Trial summary

To evaluate the safety and efficacy of SHR-A1904 in the advanced colorectal cancer after failure of standard therapy 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-A1904
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteChina
Study dates
28 Jul 2026to 28 Apr 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

  • Age 18-75 years, male or female.
  • Histologically or cytologically confirmed metastatic colorectal adenocarcinoma.
  • Failure of at least second-line standard systemic therapy, and must have received oxaliplatin, irinotecan, and fluoropyrimidine-based chemotherapy. Subjects who have received all three classes of chemotherapeutic agents in first-line therapy may be enrolled after first-line treatment failure. For subjects with dMMR/MSI-H tumors, prior anti-PD-1/PD-L1 antibody therapy must have failed.
  • At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1.
  • Life expectancy ≥ 3 months.
Show all 13Show fewer
  • Adequate major organ and bone marrow function before first dose of study drug, meeting the following criteria:
  • Hematology (without transfusion, G-CSF or other medical support within 14 days before study drug administration): Hemoglobin ≥ 90 g/L; Platelets (PLT) ≥ 100×10^9/L; White blood cells (WBC) ≥ 3.5×10^9/L; Absolute neutrophil count (ANC) ≥ 1.5×10^9/L.
  • Liver function: Total bilirubin (TBIL) ≤ 1.5×upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN (in case of liver metastases, AST/ALT ≤ 5×ULN is permitted).
  • Renal function: Creatinine ≤ 1.5×ULN or creatinine clearance ≥ 60 mL/min (calculated using the Cockcroft-Gault formula).
  • Coagulation: International normalized ratio (INR) ≤ 1.5×ULN (or INR 2-3 for patients on stable long-term warfarin therapy), and activated partial thromboplastin time (aPTT) and prothrombin time (PT) ≤ 1.5×ULN.
  • Male patients and female patients of childbearing potential must agree to use adequate and effective contraception during the study and for 12 months after the last dose. Female patients must not be breastfeeding and must have a negative serum pregnancy test (β-hCG) within 7 days before the first dose.
  • Willing to voluntarily participate in this study, sign informed consent form, have good compliance, and cooperate with follow-up.

Who cannot join

  • Known history of hypersensitivity to any component of the investigational product.
  • Received systemic anti-tumor therapy within 4 weeks before the start of study treatment. If prior anti-tumor therapy was small molecule targeted therapy, the interval between the end of that treatment and the first study treatment should be no less than 5 half-lives of the drug or 7 days, whichever is longer. If prior anti-tumor Chinese patent medicine was received, an interval of no less than 2 weeks between the end of that treatment and the first study treatment is allowed.
  • Toxicities and/or complications from prior interventions have not recovered to NCI-CTCAE grade ≤1 or to the level specified in the inclusion/exclusion criteria (except for toxicities deemed by the investigator to be safely manageable, such as alopecia, grade ≤2 peripheral neuropathy, etc.).
  • Currently participating in another clinical study, or the time from first study drug administration to the end of a previous clinical study (last dose) is less than 4 weeks or 5 half-lives of that study drug, whichever is shorter.
  • Received treatment with strong inhibitors or inducers of CYP3A4, CYP2D6, P-gp, or BCRP within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of study drug.
  • Major surgery within 28 days before the first dose of study treatment (major surgery refers to procedures requiring general anesthesia; at least 3 weeks of recovery time is required before study drug administration; tissue biopsy for diagnostic purposes is allowed).
Show all 20Show fewer
  • Presence of another active malignancy other than the primary tumor (except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder cancer, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, and gastrointestinal tumors confirmed to be cured by endoscopic mucosal resection). Patients with a history of prior malignancy (with disease cured for ≥2 years) may be enrolled.
  • Patients with untreated or active central nervous system (CNS) metastases or leptomeningeal metastases. If local treatment has been received and the patient's neurological symptoms have been stable for at least 2 weeks before the first dose, without requiring corticosteroids or requiring ≤10 mg/day prednisone (or equivalent), then participation is allowed.
  • Presence of serious complications of the primary tumor (e.g., perforation, obstruction, massive hemorrhage not manageable by medical therapy).
  • Uncontrolled or moderate to massive pleural effusion or pericardial effusion; clinically symptomatic moderate or severe ascites (i.e., requiring therapeutic paracentesis or drainage within 2 weeks before study treatment; patients with a small amount of ascites on imaging without clinical symptoms may be enrolled).
  • Uncontrolled hypertension or prior history of hypertensive crisis.
  • Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, second- or third-degree atrioventricular block, etc. Occurrence of acute coronary syndrome, congestive heart failure (New York Heart Association [NYHA] functional class ≥II), aortic dissection, stroke, or other grade ≥3 cardiovascular or cerebrovascular events within 6 months before the first dose.
  • Presence of any significant clinical or laboratory abnormality that, in the investigator's judgment, would affect safety evaluation, such as uncontrolled diabetes mellitus, chronic kidney disease, thyroid dysfunction, poorly controlled hypercholesterolemia despite medication, etc.
  • Active pulmonary tuberculosis, or history of active pulmonary tuberculosis infection within ≤48 weeks prior to screening, regardless of treatment status.
  • History of interstitial lung disease, or imaging findings at screening suggestive of or cannot rule out interstitial lung disease; or other moderate to severe pulmonary diseases that significantly affect lung function.
  • Subjects with active hepatitis B or active hepatitis C.
  • History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency disorders, or history of organ transplantation.
  • Severe infection within 4 weeks before the first dose, including but not limited to bacteremia requiring hospitalization, severe pneumonia, etc. Active infection of CTCAE grade ≥2 requiring systemic antibiotic therapy within 2 weeks before the first dose.
  • Pregnant or breastfeeding women, or patients of childbearing potential (males or females with less than one year of amenorrhea) who are unwilling to use contraceptive measures.
  • Any other condition that, in the investigator's judgment, would increase the risk of study participation, interfere with the study results, or make the subject unsuitable for this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jian Li contact

010-88196561

oncogene@163.com

China1 site

  • Peking University cancer hospital

    Beijing, Beijing Municipality, 100142

    Ting Xu, 010-88196088, xtmhxt@163.com

Other trials in China

About this study

To evaluate the safety and efficacy of SHR-A1904 in the advanced colorectal cancer after failure of standard therapy

Read the detailed description

This is a single-center, open-label, exploratory clinical trial designed to investigate the efficacy and safety of SHR-A1904 for the treatment of metastatic colorectal cancer.

Being tested
SHR-A1904

What participants receive

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

  • SHR-A1904Drug

    SHR-A1904

Study groups in NCT07700719
Study groupRoleWhat they receive
Arm 1Experimentalmetastatic colorectal cancer treated with SHR-A1904
Receives: Drug: SHR-A1904

What is being measured

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

  1. Incidence of treatment related adverse event [Safety and Tolerability]

    To identify the incidence of adverse events (AEs) and severe adverse events (SAEs) in clinical trial

    Measured: From the initiation of the first dose to 90 days after the last dose

  2. Objective response rate (ORR)

    To evaluate the efficacy of anti-tumor

    Measured: From enrollment to the end of treatment at 6 weeks

Secondary outcomes (4)

  1. Duration of Response (DOR)

    To evaluate the efficacy of anti-tumor

    Measured: From enrollment to the end of treatment at 6 weeks

  2. Disease control rate (DCR)

    To evaluate the efficacy of anti-tumor

    Measured: From enrollment to the end of treatment at 6 weeks

  3. Progression-free survival (PFS)

    To evaluate the efficacy of anti-tumor

    Measured: From enrollment to the end of treatment at 12 weeks

  4. Overall survival (OS)

    To evaluate the efficacy of anti-tumor

    Measured: From enrollment to the end of treatment at 12 months

Timeline

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

  1. First posted14 Jul 2026
  2. Study start28 Jul 2026 (estimated)
  3. Primary completion28 Nov 2027 (estimated)
  4. Study completion28 Apr 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07700719
Sponsor's protocol ID
CRC-IIT-SHRA1904
Status last verified
Jun 2026
First submitted
8 Jul 2026
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR-A1904 in people with Colorectal Cancer Metastatic, run by Peking University Cancer Hospital & Institute 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 13 inclusion and 20 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 14 Jul 2026. 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 Jian Li (010-88196561, oncogene@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment related adverse event [Safety and Tolerability] (time frame: From the initiation of the first dose to 90 days after the last dose). 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?

On the ClinicalTrials.gov record for NCT07700719.

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 14 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in