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RECRUITINGPHASE1

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

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Initial Efficacy of BL-M07D1 for Injection in Patients With Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid Tumors

NCT05631964•Sichuan Baili Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Detailed Description

Phase Ia: To observe the safety and tolerability of BL-M07D1 in patients with locally advanced or metastatic digestive tract tumors and other solid tumors, determine the MTD and DLT of BL-M07D1, and evaluate the pharmacokinetic characteristics and immunogenicity of BL-M07D1. Phase Ib: To further observe the safety and tolerability of BL-M07D1 at the Phase Ia recommended dose and determine RP2D. To evaluate the initial efficacy, pharmacokinetic characteristics and immunogenicity of BL-M07D1.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Sign informed consent voluntarily and follow protocol requirements.
•2. No gender limitation.
•3. Age: ≥18 years and ≤75 years (phase Ia); ≥18 years old (phase Ib).
•4. The expected survival time is ≥3 months.
•5. 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+.
•6. 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.
•7. There must be at least one measurable lesion that meets the RECIST v1.1 definition.
•8. ECOG score 0 or 1.
•9. 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.).
•10. No serious cardiac abnormality, left ventricular ejection fraction ≥50%.
+8 more criteria

Exclusion Criteria

•1. 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.
•2. Previously received ADC drug therapy with camptothecin derivatives (topoisomerase I inhibitors) as toxins (Phase Ib only).
•3. 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.
•4. Prolonged QT interval (QTcF \> 450 msec in men or 470 msec in women), complete left bundle branch block, and degree III atrioventricular block.
•5. 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).
•6. 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.
•7. 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.
•8. The poorly controlled pericardial effusion, pleural effusion and abdominal effusion with clinical symptoms were not suitable for inclusion by the researchers.
•9. Hypertension poorly controlled by antihypertensive medications (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg).
•10. According to CTCAE v5.0, patients were defined as ≥3 lung disease, ≥2 radiation lung disease, present or history of interstitial lung disease (ILD).
+14 more criteria

Locations (1)

Fudan University ShangHai Cancer Center

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

January 5, 2023

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2027

Last Updated

September 26, 2025

Enrollment

ESTIMATED participants

Conditions

Locally Advanced or Metastatic Digestive Tract TumorsOther Solid Tumors

Interventions

BL-M07D1

DRUG

Contacts

Sa Xiao, PHD

CONTACT

+86-15013238943 xiaosa@baili-pharm.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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