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Esophageal CancerPhase 1NCT06500052

A Study of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Lower Expression Gastrointestinal Cancer and Other Solid Tumors

A Phase 1 study testing BL-M17D1 in people with Esophageal Cancer and Gastric Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is an open, multicenter, dose-escalation and expansion-enrollment nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M17D1 in locally advanced or metastatic HER2 positive/lower expression gastrointestinal cancer and other… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
BL-M17D1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
24 Jul 2024to Aug 2026
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

  • Voluntarily sign the informed consent and follow the requirements of the protocol;
  • No gender limit;
  • Age: ≥18 years old and ≤75 years old (stage Ia); ≥18 years old (stage Ib);
  • Expected survival time ≥3 months;
  • 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;
  • Consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 2 years;
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  • Must have at least one measurable lesion according to RECIST v1.1 definition;
  • ECOG 0 or 1;
  • Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
  • No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
  • Organ function level must meet the requirements;
  • Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5ULN;
  • Urine protein ≤2+ or ≤1000mg/24h;
  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sa Xiao, PHD contact

15013238943

xiaosa@baili-pharm.com

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

    Ruihua Xu

    Ruihua Xu

    Recruiting

Other trials in China

About this study

Official title: 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 an open, multicenter, dose-escalation and expansion-enrollment nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M17D1 in locally advanced or metastatic HER2 positive/lower expression gastrointestinal cancer and other solid tumors.

Being tested
BL-M17D1
Medical subject headings
Esophageal Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BL-M17D1Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

Study groups in NCT06500052
Study groupRoleWhat they receive
BL-M17D1ExperimentalParticipants receive BL-M17D1 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-M17D1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase Ia: Dose limiting toxicity (DLT)

    DLTs are assessed according to NCI-CTCAE v5.0 during the first cycle and defined as occurrence of any of the toxicities in DLT definition if judged by the investigator to be possibly, probably or definitely related to study drug administration.

    Measured: Up to 21 days after the first dose

  2. Phase Ia: Maximum tolerated dose (MTD)

    MTD is defined as the highest dose level at which no more than 1 in 6 participants experienced a DLT during the first cycle .

    Measured: Up to 21 days after the first dose

  3. Phase Ib: Recommended Phase II Dose (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-M17D1.

    Measured: Up to approximately 24 months

Secondary outcomes (11)

  1. 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-M17D1 . The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M17D1.

    Measured: Up to approximately 24 months

  2. Cmax

    Maximum serum concentration (Cmax) of BL-M17D1 will be investigated.

    Measured: Up to approximately 24 months

  3. Tmax

    Time to maximum serum concentration (Tmax) of BL-M17D1 will be investigated.

    Measured: Up to approximately 24 months

  4. T1/2

    Half-life (T1/2) of BL-M17D1 will be investigated.

    Measured: Up to approximately 24 months

  5. 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 approximately 24 months

  6. CL (Clearance)

    CL in the serum of BL-M17D1 per unit of time will be investigated.

    Measured: Up to approximately 24 months

  7. Ctrough

    Ctrough is defined as the lowest serum concentration of BL-M17D1 prior to the next dose will be administered.

    Measured: Up to approximately 24 months

  8. ADA (anti-drug antibody)

    Frequency of anti-BL-M17D1 antibody (ADA) will be investigated.

    Measured: Up to approximately 24 months

  9. 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

  10. 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

  11. 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2024
  2. Study start24 Jul 2024
  3. Primary completionAug 2026 (estimated)
  4. Study completionAug 2026 (estimated)

Resources

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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06500052
Sponsor's protocol ID
BL-M17D1-102
Status last verified
Sep 2025
First submitted
8 Jul 2024
Last updated
18 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BL-M17D1 in people with Esophageal Cancer and Gastric Cancer, 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 14 inclusion and 26 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 18 Sep 2025. 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 (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 limiting 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?

On the ClinicalTrials.gov record for NCT06500052.

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 18 Sep 2025.

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