Conditions

• Locally Advanced or Metastatic Solid Tumors
• Colorectal Cancer
• Gastric Cancer
• Pancreatic Cancer

Eligibility

Eligible Ages

Over 18 Years

Eligible Sex

All

Accepts Healthy Volunteers

No

Criteria

1. Willing to sign the informed consent form and follow the requirements specified in
the protocol.

2. Life expectancy ≥ 3 months.

3. Tumor specimen available for CDH17 testing, or agree to biopsy at baseline.

4. Patients with histologically and cytologically confirmed advanced or metastatic
solid tumor who have failed or intolerant to standard therapy, or without
alternative standard therapy.

5. Patients must have at least one measurable lesion according to the Response
Evaluation Criteria in Solid Tumors (RECIST v1.1).

6. The score of ECOG for performance status is 0 or 1.

7. Organ functions and coagulation function must meet the basic requirements.

8. Patients with childbearing potential must use effective contraception during the
treatment and for 6 months after the last dose of treatment.

Exclusion Criteria:

1. Patients with more than one cancer.

2. Received CDH17-targeting anti-tumor therapy; received other investigational product,
systemic corticosteroids or surgery for major organs within 4 weeks prior to the
first dose; received anti-tumor therapy within 3 weeks or within 5 half-lives prior
to the first dose, whichever is shorter; received radiotherapy within 2 weeks prior
to the first dose; received potent CYP3A4 inducers or inhibitors within 2 weeks
prior to the first dose or 5 half-lives of investigational product, whichever is
longer.

3. ≥Grade 2 toxic reaction or abnormal value of laboratory test caused by previous
anti-tumor treatment

4. Symptomatic Central nervous system and/or meninges metastasis.

5. History of severe cardiovascular diseases

6. Cerebrovascular accident, pulmonary embolism, or deep venous thrombosis within 3
months prior to the first dose, implantable venous infusion port or catheter-related
thrombosis, or superficial venous thrombosis

7. History of previous or combined interstitial pneumonia, current interstitial
pneumonia, or suspected interstitial pneumonia that cannot be ruled out through
imaging during screening, severe chronic obstructive pulmonary disease with
respiratory failure, severe pulmonary dysfunction, symptomatic bronchospasm, etc.

8. Poorly controlled pleural, peritoneal, and pelvic effusion, or combined pericardial
effusion

9. Infection of active hepatitis B, active hepatitis C, or HIV

10. Uncontrolled active bacterial, viral, fungal, rickettsial, or parasitic infections
requiring intravenous anti-infection therapy within 2 weeks prior to the first study
treatment

11. Known allergic reactions to any component of MRG007, or known Grade≥3 allergic
reactions to other prior anti-CDH17 (including investigational) or other monoclonal
antibody.

12. Other situations that are not suitable to participate a clinical trial per
investigator's judgement

Study Contact

Program Director
86-21-61637960
clinicaltrials@lepubiopharma.com