SHR-A1904 in Advanced Colorectal Cancer: an Exploratory Study

NCT07700719 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: CRC-IIT-SHRA1904
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colorectal Cancer Metastatic

Outcome Measures

Primary Outcomes (2)

• 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

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

• Objective response rate (ORR)

  To evaluate the efficacy of anti-tumor

  From enrollment to the end of treatment at 6 weeks

Secondary Outcomes (4)

• Duration of Response (DOR)

  From enrollment to the end of treatment at 6 weeks

• Disease control rate (DCR)

  From enrollment to the end of treatment at 6 weeks

• Progression-free survival (PFS)

  From enrollment to the end of treatment at 12 weeks

• Overall survival (OS)

  From enrollment to the end of treatment at 12 months

Study Arms (1)

Arm 1

EXPERIMENTAL

metastatic colorectal cancer treated with SHR-A1904

Drug: SHR-A1904

Interventions

SHR-A1904 DRUG

SHR-A1904

Arm 1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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).
• 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.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead
• Beijing GoBroad Hospital: collaborator

Study Sites (1)

Peking University cancer hospital

Beijing, Beijing Municipality, 100142, China

Location

Central Study Contacts

Jian Li

CONTACT

010-88196561; oncogene@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: July 28, 2026
• Primary Completion (Estimated): November 28, 2027
• Study Completion (Estimated): April 28, 2028
• Last Updated: July 14, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)