Locally Advanced or Metastatic Digestive Tract TumorsPhase 1NCT05631964
Phase I Clinical Study of BL-M07D1 in Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid Tumors
A Phase 1 study testing BL-M07D1 in people with Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid Tumors, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced or Metastatic Digestive Tract Tumors, Other Solid Tumors
- What is being tested?
- BL-M07D1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2023to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- Urine protein ≤2+ or ≤1000mg/24h.
- Albumin ≥30 g/L.
- A pregnancy test must be performed within 7 days of starting treatment for premenopausal women who are likely to have children, the serum/urine pregnancy must be negative, and the pregnancy must be non-lactation; All enrolled patients (male or female) should take adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.
Who cannot join
- 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.
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- 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.
- The poorly controlled pericardial effusion, pleural effusion and abdominal effusion with clinical symptoms were not suitable for inclusion by the researchers.
- 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.
- Patients with a history of allergy to recombinant humanized antibodies or human and mouse chimeric antibodies or to any excipient component of BL-M07D1.
- Previous recipients of organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT).
- In previous treatment with anthracyclines, the equivalent cumulative dose of doxorubicin was greater than 360 mg/m2.
- Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active hepatitis B virus infection (HBV-DNA copy number > lower limit of detection) or active hepatitis C virus infection (HCV antibody positive and HCV-RNA > lower limit of detection).
- Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.
- Had participated in another clinical trial within 4 weeks prior to the first dose (counting from the time of the last dose).
- A pregnant or nursing woman.
- Other conditions included in this clinical trial were not considered appropriate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University ShangHai Cancer Center
Shanghai, Shanghai Municipality, 200100
WeiJian Guo, PHD
Jian Zhang, PHD
About this study
Official title: 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
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.
Read the 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.
- Being tested
- BL-M07D1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL-M07D1Drug
Administration by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: BL-M07D1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: Up to 21 days after the first dose
Secondary outcomes (13)
Treatment-Emergent Adverse Event (TEAE)
TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B07D1 . The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M07D1 .
Measured: Up to approximately 24 months
Cmax
Maximum serum concentration (Cmax) of BL-M07D1 will be investigated.
Measured: Up to 21 days after the first dose
Tmax
Time to maximum serum concentration (Tmax) of BL-M07D1 will be investigated.
Measured: Up to 21 days after the first dose
T1/2
Half-life (T1/2) of BL-M07D1 will be investigated.
Measured: Up to 21 days after the first dose
AUC0-t
AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration.
Measured: Up to 21 days after the first dose
CL(Clearance)
To study the serum clearance rate of BL-M07D1 per unit time.
Measured: Up to 21 days after the first dose
Ctrough
Ctough is defined as the lowest serum concentration of BL-M07D1 prior to the next dose will be administered.
Measured: Up to 21 days after the first dose
Anti-drug antibody (ADA)
Frequency and titer of anti-BL-M07D1 antibody (ADA) will be evaluated.
Measured: Up to approximately 24 months
Phase Ib: Objective response rate (ORR)
ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.
Measured: Up to approximately 24 months
Phase Ib: Disease control rate (DCR)
The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]).
Measured: Up to approximately 24 months
Phase Ib:Duration of response (DOR)
The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.
Measured: Up to approximately 24 months
Phase Ib: Progression-free survival (PFS)
The PFS is defined as the time from the participant's first dose of BL-B07D1 to the first date of either disease progression or death, whichever occurs first.
Measured: Up to approximately 24 months
Phase Ib: Overall Survival(OS)
The time between the start of study medication and death.
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start5 Jan 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Digestive Tract TumorsStudies of the same condition, open and under way.
- More trials run by Sichuan Baili Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SystImmune Inc., Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Weijian Guo, PHD, Principal investigator, Fudan UniversityJian Zhang, PHD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631964
- Sponsor's protocol ID
- BL-M07D1-102
- Status last verified
- Aug 2026
- First submitted
- 13 Nov 2022
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05631964
- Acronym / sponsor ID
- BL-M07D1-102
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- SystImmune Inc., Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study treatment | Experimental | Drug: BL-M07D1Participants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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+.
Key exclusion criteria (24 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BL-M07D1Administration by intravenous infusion | Drug | Study treatment |
Primary outcome
Phase Ia: Dose Limited Toxicity (DLT)
Time frame: Up to 21 days after the first dose
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).
Phase Ia: Maximum Tolerated Dose (MTD)
Time frame: Up to 21 days after the first dose
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.
Phase Ib: Recommended Dose for Phase II Clinical Studies (RP2D)
Time frame: Up to 21 days after the first dose
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.
13 secondary outcomes
Treatment-Emergent Adverse Event (TEAE)
Time frame: Up to approximately 24 months
Cmax
Time frame: Up to 21 days after the first dose
Tmax
Time frame: Up to 21 days after the first dose
T1/2
Time frame: Up to 21 days after the first dose
AUC0-t
Time frame: Up to 21 days after the first dose
CL(Clearance)
Time frame: Up to 21 days after the first dose
Ctrough
Time frame: Up to 21 days after the first dose
Anti-drug antibody (ADA)
Time frame: Up to approximately 24 months
Phase Ib: Objective response rate (ORR)
Time frame: Up to approximately 24 months
Phase Ib: Disease control rate (DCR)
Time frame: Up to approximately 24 months
Phase Ib:Duration of response (DOR)
Time frame: Up to approximately 24 months
Phase Ib: Progression-free survival (PFS)
Time frame: Up to approximately 24 months
Phase Ib: Overall Survival(OS)
Time frame: Up to approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Weijian Guo, PHD principal investigator
Fudan University
Jian Zhang, PHD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BL-M07D1 in people with Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid Tumors, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sa Xiao, PHD (+86-15013238943, xiaosa@baili-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ia: Dose Limited Toxicity (DLT) (time frame: Up to 21 days after the first dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.