Evaluating BL-M17D1 for HER2 Positive Gastrointestinal Cancer

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Lower Expression Gastrointestinal Cancer and Other Solid Tumors

This study is testing a new drug called BL-M17D1 to see if it is safe and effective for people with advanced HER2 positive gastrointestinal cancer and other solid tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06500052 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter phase I clinical study aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of BL-M17D1 in patients with locally advanced or metastatic HER2 positive/lower expression gastrointestinal cancers and other solid tumors. The study will involve dose-escalation and expansion enrollment to determine the optimal dosing regimen. Participants will be monitored for adverse effects and treatment responses to gather data on the drug's effectiveness.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with locally advanced or metastatic HER2 positive/lower expression gastrointestinal cancers or other solid tumors.

Not a fit: Patients with severe cardiac dysfunction or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat HER2 positive gastrointestinal cancers.

How similar studies have performed: Other studies targeting HER2 positive cancers have shown promise, suggesting potential for success with this approach.

Eligibility criteria

Inclusion Criteria:

1. Voluntarily sign the informed consent and follow the requirements of the protocol;
2. No gender limit;
3. Age: ≥18 years old and ≤75 years old (stage Ia); ≥18 years old (stage Ib);
4. Expected survival time ≥3 months;
5. The pathologic histology and/or cytology diagnosis of locally advanced or metastatic positive HER2 / low expression of the digestive tract tumor and other solid tumor;
6. Consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 2 years;
7. Must have at least one measurable lesion according to RECIST v1.1 definition;
8. ECOG 0 or 1;
9. Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
11. Organ function level must meet the requirements;
12. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5ULN;
13. Urine protein ≤2+ or ≤1000mg/24h;
14. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, serum pregnancy must be negative, and must be non-lactating; All the patients (no matter male or female) shall be 6 months after the end of the treatment period and full barrier precautions.

Exclusion Criteria:

1. Anti-tumor therapy such as chemotherapy or biological therapy has been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral drugs such as fluorouracil;
2. History of severe heart disease;
3. QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
4. Active autoimmune and inflammatory diseases;
5. Other malignant tumors diagnosed within 5 years before the first dose;
6. Hypertension poorly controlled by two antihypertensive drugs;
7. Patients with poor glycemic control before the first dose;
8. Have to hormone treatment of interstitial lung disease, or the current with ILD or suspected suffering from such diseases;
9. Complicated pulmonary diseases leading to clinically severe respiratory function impairment;
10. Patients with massive or symptomatic effusions or poorly controlled effusions;
11. Imaging examination showed that the tumor had invaded or wrapped around the chest, neck, pharynx and other large blood vessels;
12. Screening for unstable thrombotic events requiring therapeutic intervention within the preceding 6 months;
13. Patients with active central nervous system metastases;
14. Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any of the excipients of BL-M17D1;
15. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
16. HIV antibody positive, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
17. Active infection requiring systemic therapy with serious infection within 4 weeks before informed consent; There were indications of pulmonary infection or active pulmonary inflammation within 2 weeks before informed consent;
18. Participated in another clinical trial within 4 weeks before the first dose;
19. Pregnant or lactating women;
20. Patients with superior vena cava syndrome should not be rehydrated;
21. A history of severe neurological or psychiatric illness;
22. Severe unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent;
23. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;
24. History of intestinal obstruction, inflammatory bowel disease, or extensive bowel resection or presence of Crohn's disease, ulcerative colitis, or chronic disease Sexual diarrhea;
25. Patients scheduled for vaccination or receiving live vaccine within 28 days before the first dose;
26. Other conditions for participation in the trial were not considered appropriate by the investigator.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Ruihua Xu — Sun Yat-sen University
• Study coordinator: Sa Xiao, PHD

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