AzTrials
AzTrials

Gastric CancerPhase 3NCT07518147

A Study Comparing BL-M05D1 With the Investigator's Choice of Treatment Regimen in Patients With Claudin (CLDN)18.2-Positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GC/GEJC) Who Have Received Prior First-Line Treatment

A Phase 3 study testing BL-M05D1, Paclitaxel and Docetaxel in people with Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by Biokin (Shanghai) Biopharmaceutical 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
Search all trials

Trial summary

This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M05D1 in patients with Claudin (CLDN) 18.2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJC) who have received prior first-line treatment. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
BL-M05D1, Paclitaxel and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
438 participants
Where
1 siteChina
Study dates
15 May 2026to Dec 2029
Phase
Phase 3
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 form and comply with protocol requirements;
  • No gender restriction;
  • Age: ≥18 years and ≤75 years;
  • Expected survival time ≥3 months;
  • Pathologically confirmed locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma;
  • Patients who have failed prior first-line standard treatment, with evidence of definitive radiological progression;
Show all 14Show fewer
  • Able to provide archived or fresh tumor tissue;
  • Have radiologically evaluable lesions according to RECIST 1.1 criteria;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  • Toxicity from prior antitumor therapy has recovered to ≤Grade 1 as defined by NCI-CTCAE v6.0;
  • No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
  • Organ function levels must meet the requirements;
  • Urine protein ≤1+ or <1000 mg/24 h;
  • For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment; serum pregnancy testing must exclude pregnancy, and the participant must not be breastfeeding; all enrolled trial participants and their partners must agree to use adequate highly effective contraception throughout the entire treatment period and for 7 months (women) and 4 months (men) after treatment completion, and it is recommended that additional contraceptive methods be used concurrently.

Who cannot join

  • Prior anti-tumor therapy;
  • Positive HER2 expression in tumor tissue;
  • History of severe cardiovascular and cerebrovascular diseases;
  • QT interval prolongation, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias;
  • Any thrombotic event within 6 months before randomization;
  • Active autoimmune diseases and inflammatory diseases;
Show all 22Show fewer
  • Diagnosis of other malignancies within 3 years before the first dose;
  • Hypertension poorly controlled with two antihypertensive drugs;
  • History of interstitial lung disease (ILD) treated with hormones, etc.;
  • Concurrent pulmonary diseases resulting in clinically severe respiratory impairment;
  • Severe infection, etc. occurring within 4 weeks before the first use of the study drug;
  • Patients with poorly controlled blood glucose;
  • Patients with active central nervous system metastases;
  • Patients with massive serous cavity effusion, or serous cavity effusion with symptoms, or poorly controlled serous cavity effusion;
  • Imaging examinations indicating that the tumor has invaded or encased major vessels in the chest, neck, pharynx, etc.;
  • Patients with a history of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M05D1;
  • Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
  • Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
  • Pregnant or breastfeeding women;
  • Esophageal or gastric varices requiring intervention within the past three months, etc.;
  • History of intestinal obstruction, inflammatory bowel disease, or extensive bowel resection, etc.;
  • Patients with other severe physical or laboratory abnormalities or poor compliance, etc., which may increase the risk of participating in the study, or interfere with the study results, and patients deemed unsuitable for participation in this study 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

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

    Lin Shen

    Recruiting

Other trials in China

About this study

Official title: A Randomized Controlled Phase III Clinical Study Comparing BL-M05D1 for Injection With the Investigator's Choice of Treatment Regimen in Patients With Claudin (CLDN) 18.2-positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GC/GEJC) Who Have Received Prior First-line Treatment

This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M05D1 in patients with Claudin (CLDN) 18.2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJC) who have received prior first-line treatment.

Read the detailed description

In this trial, the experimental group receives BL-M05D1, with each treatment cycle lasting 3 weeks. The control group receives investigator-selected treatment regimens: paclitaxel, docetaxel, or irinotecan.

Medical subject headings
Stomach Neoplasms

What participants receive

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

  • BL-M05D1Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • PaclitaxelDrug

    Administration by intravenous infusion for a cycle of 4 weeks.

  • DocetaxelDrug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • Irinotecan hydrochlorideDrug

    Administration by intravenous infusion for a cycle of 2 weeks.

Study groups in NCT07518147
Study groupRoleWhat they receive
BL-M05D1ExperimentalParticipants receive BL-M05D1 in 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-M05D1
Paclitaxel or Docetaxel or Irinotecan hydrochlorideActive comparatorParticipants receive Paclitaxel or Docetaxel or Irinotecan hydrochloride in the first cycle. 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: Paclitaxel; Drug: Docetaxel; Drug: Irinotecan hydrochloride

What is being measured

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

  1. Overall survival (OS)

    Overall survival (OS) is defined as the time between the subject's randomization date and subject's death.

    Measured: Up to approximately 24 months

Secondary outcomes (14)

  1. Progression-free survival (PFS)

    Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.

    Measured: Up to approximately 24 months

  2. Objective Response Rate (ORR)

    Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).

    Measured: Up to approximately 24 months

  3. Disease Control Rate (DCR)

    Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.

    Measured: Up to approximately 24 months

  4. Duration of Response (DOR)

    Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.

    Measured: Up to approximately 24 months

  5. Time to Response (TTR)

    Time to Response (TTR) is defined as the time from randomization to the first documented response (CR or PR) according to RECIST v1.1 criteria.

    Measured: Up to approximately 24 months

  6. 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-M05D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M05D1.

    Measured: Up to approximately 24 months

  7. Cmax

    Cmax is defined as the maximum observed drug concentration in plasma after administration.

    Measured: Up to approximately 24 months

  8. Tmax

    Tmax is defined as the time required to reach the maximum drug concentration in plasma following drug administration.

    Measured: Up to approximately 24 months

  9. T1/2

    T1/2 is defined as the time required for the plasma concentration of a drug to decrease by 50% during the elimination phase.

    Measured: Up to approximately 24 months

  10. 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

  11. CL (Clearance)

    Clearance (CL) is the volume of plasma from which a drug is completely removed per unit time.

    Measured: Up to approximately 24 months

  12. Ctrough

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

    Measured: Up to approximately 24 months

  13. Anti-drug antibody (ADA)

    Frequency of anti-BL-M05D1 antibody (ADA) will be investigated.

    Measured: Up to approximately 24 months

  14. Neutralizing Antibody(NAb)

    Frequency of anti-BL-M05D1 neutralizing antibodies will be investigated.

    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 posted8 Apr 2026
  2. Study start15 May 2026
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2029 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
438 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07518147
Sponsor's protocol ID
BL-M05D1-301
Status last verified
Oct 2026
First submitted
2 Apr 2026
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BL-M05D1, Paclitaxel and Docetaxel in people with Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by Biokin (Shanghai) Biopharmaceutical 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 22 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 2 Nov 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Overall survival (OS) (time frame: Up to approximately 24 months). 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 NCT07518147.

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 2 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in