A Study of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Lower Expression Gastrointestinal Cancer and Other Solid Tumors

Phase 1

Recruiting

• Conditions: Esophageal Cancer; Gastric Cancer; Pancreatic Cancer; Colorectal Cancer; Solid Tumor

• Registration Number: NCT06500052
• Lead Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-7-8
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Voluntarily sign the informed consent and follow the requirements of the protocol;<br><br> 2. No gender limit;<br><br> 3. Age: =18 years old and =75 years old (stage Ia); =18 years old (stage Ib);<br><br> 4. Expected survival time =3 months;<br><br> 5. The pathologic histology and/or cytology diagnosis of locally advanced or metastatic<br> positive HER2 / low expression of the digestive tract tumor and other solid tumor;<br><br> 6. Consent to provide archival tumor tissue samples or fresh tissue samples from<br> primary or metastatic lesions within 2 years;<br><br> 7. Must have at least one measurable lesion according to RECIST v1.1 definition;<br><br> 8. ECOG 0 or 1;<br><br> 9. Toxicity of previous antineoplastic therapy has returned to = grade 1 defined by<br> NCI-CTCAE v5.0;<br><br> 10. No severe cardiac dysfunction, left ventricular ejection fraction =50%;<br><br> 11. Organ function level must meet the requirements;<br><br> 12. Coagulation function: international normalized ratio =1.5, and activated partial<br> thromboplastin time =1.5ULN;<br><br> 13. Urine protein =2+ or =1000mg/24h;<br><br> 14. For premenopausal women with childbearing potential, a pregnancy test must be<br> performed within 7 days before the initiation of treatment, serum pregnancy must be<br> negative, and must be non-lactating; All the patients (no matter male or female)<br> shall be 6 months after the end of the treatment period and full barrier<br> precautions.<br><br>Exclusion Criteria:<br><br> 1. Anti-tumor therapy such as chemotherapy or biological therapy has been used within 4<br> weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were<br> administered within 6 weeks before the first dose; Oral drugs such as fluorouracil;<br><br> 2. History of severe heart disease;<br><br> 3. QT prolongation, complete left bundle branch block, III degree atrioventricular<br> block, frequent and uncontrollable arrhythmia;<br><br> 4. Active autoimmune and inflammatory diseases;<br><br> 5. Other malignant tumors diagnosed within 5 years before the first dose;<br><br> 6. Hypertension poorly controlled by two antihypertensive drugs;<br><br> 7. Patients with poor glycemic control before the first dose;<br><br> 8. Have to hormone treatment of interstitial lung disease, or the current with ILD or<br> suspected suffering from such diseases;<br><br> 9. Complicated pulmonary diseases leading to clinically severe respiratory function<br> impairment;<br><br> 10. Patients with massive or symptomatic effusions or poorly controlled effusions;<br><br> 11. Imaging examination showed that the tumor had invaded or wrapped around the chest,<br> neck, pharynx and other large blood vessels;<br><br> 12. Screening for unstable thrombotic events requiring therapeutic intervention within<br> the preceding 6 months;<br><br> 13. Patients with active central nervous system metastases;<br><br> 14. Patients with a history of allergy to recombinant humanized antibody or human-mouse<br> chimeric antibody or to any of the excipients of BL-M17D1;<br><br> 15. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;<br><br> 16. HIV antibody positive, active tuberculosis, active hepatitis B virus infection, or<br> active hepatitis C virus infection;<br><br> 17. Active infection requiring systemic therapy with serious infection within 4 weeks<br> before informed consent; There were indications of pulmonary infection or active<br> pulmonary inflammation within 2 weeks before informed consent;<br><br> 18. Participated in another clinical trial within 4 weeks before the first dose;<br><br> 19. Pregnant or lactating women;<br><br> 20. Patients with superior vena cava syndrome should not be rehydrated;<br><br> 21. A history of severe neurological or psychiatric illness;<br><br> 22. Severe unhealed wound, ulcer, or fracture within 4 weeks before signing the informed<br> consent;<br><br> 23. Subjects with clinically significant bleeding or obvious bleeding tendency within 4<br> weeks before signing the informed consent;<br><br> 24. History of intestinal obstruction, inflammatory bowel disease, or extensive bowel<br> resection or presence of Crohn's disease, ulcerative colitis, or chronic disease<br> Sexual diarrhea;<br><br> 25. Patients scheduled for vaccination or receiving live vaccine within 28 days before<br> the first dose;<br><br> 26. Other conditions for participation in the trial were not considered appropriate by<br> the investigator.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase Ia: Dose limiting toxicity (DLT);Phase Ia: Maximum tolerated dose (MTD);Phase Ib: Recommended Phase II Dose (RP2D)

Secondary Outcome Measures

Name	Time	Method
Treatment-Emergent Adverse Event (TEAE);Cmax;Tmax;T1/2;AUC0-t;CL (Clearance);Ctrough;ADA (anti-drug antibody);Phase Ib: Objective Response Rate (ORR);Phase Ib: Disease Control Rate (DCR);Phase Ib: Duration of Response (DOR)