BL-M09D1 for advanced or metastatic gastrointestinal and other solid tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M09D1 for Injection in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors

This trial will test whether a new drug called BL-M09D1 is safe, how the body handles it, and whether it might help adults with locally advanced or metastatic gastrointestinal or other solid tumors that have not responded to standard treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06954077 on ClinicalTrials.gov

What this trial studies

This is an open-label, multicenter, nonrandomized phase 1 trial using a dose-escalation design followed by expanded-enrollment cohorts to characterize safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of BL-M09D1. Adult patients with pathologically confirmed locally advanced or metastatic gastrointestinal or other solid tumors who have failed standard therapies and have at least one measurable lesion by RECIST v1.1 are eligible. Investigators will collect archival or fresh tumor tissue, monitor adverse events per NCI-CTCAE v5.0, and obtain serial blood samples for pharmacokinetic analysis. Dose-limiting toxicities will guide dose escalation and chosen doses will be evaluated further in expansion cohorts to gather initial efficacy signals.

Who should consider this trial

Good fit: Adults (≥18 years) with pathologically confirmed locally advanced or metastatic gastrointestinal or other solid tumors that progressed after standard treatment, ECOG performance status 0–1, measurable disease by RECIST v1.1, adequate organ and coagulation function, and willingness to provide tumor tissue are the ideal candidates.

Not a fit: Patients with poor performance status (ECOG >1), inadequate organ or cardiac function, uncontrolled comorbidities, or those who still have effective standard therapy options are unlikely to benefit from this phase 1 dose-finding trial.

Why it matters

Potential benefit: If successful, BL-M09D1 could provide a new treatment option that slows tumor growth or shrinks tumors for patients with advanced gastrointestinal or other solid tumors who have exhausted standard therapies.

How similar studies have performed: Early-phase trials of other targeted or novel biologic agents in similar advanced solid tumor populations have occasionally shown responses in selected patients, but BL-M09D1 itself is a novel agent being tested in humans in this protocol.

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 (phase Ia); ≥18 years old (phase Ib);
4. Expected survival time ≥3 months;
5. Pathologically and/or cytologically confirmed locally advanced or metastatic gastrointestinal tumors and other solid tumors that failed standard treatment;
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 (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤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 enrolled patients (regardless of male or female) should use adequate barrier contraception during the whole treatment cycle and for 6 months after the end of treatment;
15. Participants were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.

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;
4. Active autoimmune and inflammatory diseases;
5. Other malignant tumors diagnosed within 5 years before the first dose;
6. Unstable thrombotic events requiring therapeutic intervention within 6 months before the first dose;
7. Poorly controlled hypertension;
8. Patients with poor glycemic control;
9. History of ILD requiring steroid therapy, or current ILD or ≥ grade 2 radiation pneumonitis;
10. Complicated pulmonary diseases leading to clinically severe respiratory function impairment;
11. Symptoms of active central nervous system metastasis;
12. Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any of the ingredients of BL-M09D1;
13. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
14. Anthracycline cumulative dose \> 360 mg/m2 in previous (new) adjuvant therapy;
15. HIV antibody positive, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
16. Active infection requiring systemic therapy within 4 weeks before the first dose of study drug; Signs of pulmonary infection or active pulmonary inflammation within 2 weeks before the first dose;
17. Pleural, abdominal, pelvic or pericardial effusion requiring drainage and/or with symptoms within 4 weeks before the first dose of study drug;
18. Use of another clinical trial within 4 weeks or 5 half-lives before the first dose;
19. Pregnant or lactating women;
20. 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

• Study coordinator: Sa Xiao, PHD

Conditions Gastrointestinal Tumor; Solid Tumor