Phase I Clinical Study of BL-M07D1 in Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid Tumors

NCT05631964 | Recruiting Phase 1

• 1 other identifier: BL-M07D1-102
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of BL-M07D1 for injection in Phase I clinical study of safety, tolerability, pharmacokinetic Characteristics, and initial efficacy in patients with locally advanced or metastatic digestive tract tumors and other solid tumors.

Conditions

Locally Advanced or Metastatic Digestive Tract Tumors; Other Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Phase Ia: Dose Limited Toxicity (DLT)

  The incidence and severity of adverse events (TEAE) during treatment were graded according to the National Cancer Institute Standard for Common Terminology for Adverse Events (NCI-CTCAE, v5.0).

  Up to 21 days after the first dose

• Phase Ia: Maximum Tolerated Dose (MTD)

  In the dose increment stage, the highest dose whose estimated DLT rate is closest to the target DLT rate but does not exceed the upper bound of the equivalent interval of DLT rate is selected as MTD.

  Up to 21 days after the first dose

• Phase Ib: Recommended Dose for Phase II Clinical Studies (RP2D)

  The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-M07D1.

  Up to 21 days after the first dose

Secondary Outcomes (13)

• Treatment-Emergent Adverse Event (TEAE)

  Up to approximately 24 months

• Cmax

  Up to 21 days after the first dose

• Tmax

  Up to 21 days after the first dose

• T1/2

  Up to 21 days after the first dose

• AUC0-t

  Up to 21 days after the first dose

Study Arms (1)

Study treatment

EXPERIMENTAL

Participants receive BL-M07D1 as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Drug: BL-M07D1

Interventions

BL-M07D1 DRUG

Administration by intravenous infusion

Study treatment

Eligibility Criteria

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

You may qualify if:

• Sign informed consent voluntarily and follow protocol requirements.
• No gender limitation.
• Age: ≥18 years and ≤75 years (phase Ia); ≥18 years old (phase Ib).
• The expected survival time is ≥3 months.
• Patients with locally advanced or metastatic HER2-positive/low-expression digestive tract tumors and other solid tumors that are not operable and have been confirmed by histopathology and/or cytology, have failed standard therapy, are not available for standard therapy, or are not currently applicable for standard therapy; HER2 positive: IHC 3+, or IHC 2+ and ISH positive; Low HER2 expression: IHC 2+ and ISH negative, or IHC 1+.
• Agree to provide archived tumor tissue samples or fresh tissue samples from the primary or metastatic lesion within 2 years (to detect HER2 expression or amplification in tumor pathological tissue and explore its correlation with effectiveness indicators of BL-M07D1); If a subject is unable to provide a tumor tissue sample, he/she may be enrolled after an investigator's evaluation if other admission criteria are met.
• There must be at least one measurable lesion that meets the RECIST v1.1 definition.
• ECOG score 0 or 1.
• The toxicity of previous antitumor therapy was restored to ≤1 as defined by NCI-CTCAE v5.0(except for asymptomatic laboratory abnormalities considered by the investigators, such as elevated ALP, hyperuricemia, and elevated blood glucose; Toxicities with no safety risk, such as hair loss, hyperpigmentation, grade 2 peripheral neurotoxicity, etc.).
• No serious cardiac abnormality, left ventricular ejection fraction ≥50%.
• The level of organ function must meet the following requirements and meet the following standards:
• Bone marrow function: absolute neutrophil count (ANC) ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥90 g/L;
• Liver function: total bilirubin (TBIL≤1.5 ULN), AST and ALT ≤2.5 ULN in patients without liver metastasis, AST and ALT ≤5.0 ULN in patients with liver metastasis;
• Kidney function: Creatinine (Cr) ≤1.5 ULN, or creatinine clearance (Ccr) ≥50 mL/min (based on Cockcroft and Gault formula).
• Coagulation function: International Standardized ratio (INR) ≤1.5, and activated partial thrombin time (APTT) ≤1.5ULN.

You may not qualify if:

• Antitumor therapy such as chemotherapy, biotherapy, immunotherapy, radical radiotherapy, major surgery, targeted therapy (including small-molecule tyrosine kinase inhibitors) within 4 weeks prior to initial administration or within 5 half-lives, whichever is shorter; Mitomycin and nitrosourea were administered within 6 weeks before the first administration. Oral fluorouracil drugs such as Tizio, capecitabine, or palliative radiotherapy within 2 weeks prior to initial administration; Traditional Chinese medicines or proprietary Chinese medicines with anti-tumor indications should be administered within 2 weeks before the first administration.
• Previously received ADC drug therapy with camptothecin derivatives (topoisomerase I inhibitors) as toxins (Phase Ib only).
• History of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥2 (CTCAE 5.0), New York Heart Society (NYHA) ≥2 heart failure, history of transmural myocardial infarction, unstable angina, etc.
• Prolonged QT interval (QTcF \> 450 msec in men or 470 msec in women), complete left bundle branch block, and degree III atrioventricular block.
• Active autoimmune or inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease, and Hashimoto's thyroiditis, other than type I diabetes, hypothyroidism that can be controlled by alternative therapy alone, skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis).
• Other malignancies developed within 3 years of enrollment, excluding:(1)radical cervical carcinoma in situ or non-melanoma skin cancer;(2)the second primary cancer that has been completely cured and no recurrence within 3 years;(3)The researchers believed that both primary cancers could benefit from this study;(4)The investigators have clearly ruled out which primary tumor source the metastases belong to.
• Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring therapeutic intervention within 6 months prior to screening; Thrombus formation associated with infusion set is excluded.
• Hypertension poorly controlled by antihypertensive medications (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg).
• According to CTCAE v5.0, patients were defined as ≥3 lung disease, ≥2 radiation lung disease, present or history of interstitial lung disease (ILD).
• Patients who received lung radiation therapy within 6 months with total dose ≥30 Gy.
• Patients with active central nervous system metastases. But the researchers believe that patients with stable brain parenchymal metastases can be included. The definition of stability should meet the following four requirements:
• Seizures-free status lasting \> 12 weeks with or without antiepileptic medication;
• No need for glucocorticoids;
• Two consecutive MRI scans (scan interval at least 4 weeks) showed stable imaging status;
• Asymptomatic patients stable for more than 1 month after treatment.

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead
• SystImmune Inc.: collaborator
• Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Fudan University ShangHai Cancer Center

Shanghai, Shanghai Municipality, 200100, China

RECRUITING

Study Officials

• Weijian Guo, PHD

  Fudan University

  PRINCIPAL INVESTIGATOR

• Jian Zhang, PHD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sa Xiao, PHD

CONTACT

+86-15013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2022
• First Posted: November 30, 2022
• Study Start: January 5, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)