Advanced Esophageal CancersPhase 1NCT06773507
Phase I Study of BC008-1A Injection in Patients With Advanced Solid Tumors
A Phase 1 study testing BC008-1A 900mg and BC008-1A 1200mg in people with Advanced Esophageal Cancers and Advanced Non-small Cell Lung Cancer (NSCLC), run by Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The goal of this study is to learn if BC008-1A given 900mg or 1200mg intravenously once every 3 weeks is safe and effective to treat patients with advanced esophageal cancer or advanced non-small cell lung cancer. It will also learn about the safety and pharmacokinetics of BC008-1A. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Esophageal Cancers, Advanced Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- BC008-1A 900mg and BC008-1A 1200mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2025to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cohort 1:
- Patients with inoperable, locally advanced or metastatic esophageal squamous cell carcinoma confirmed by histopathology or cytology. Those who have failed standard treatment or have no effective standard treatment available; Patients can provide the results of PD-L1 expression status within 1 year or agree to provide archived pathological tissues or fresh tissues within 1 year for testing.
- Cohort 2:
- Patients with non-small cell lung cancer (squamous cell carcinoma and adenocarcinoma) confirmed by histology or cytology, who have failed standard treatment or have no effective standard treatment available; Patients can provide archived pathological tissues or fresh pathological tissues within 1 year for PD-L1 testing, and the PD-L1 Tumor Proportion Score (TPS) ≥ 1%.
- Sign a written informed consent form before any study-specific procedures and be able to follow the visit schedules and related procedures stipulated in the protocol.
- Male or female patients aged ≥ 18 years old.
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- Expected survival time ≥ 12 weeks.
- According to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), there should be at least one measurable tumor lesion shown by CT or MRI examination (lesions that have not received radiotherapy before). If a lesion located in the irradiated area that has received radiotherapy previously clearly shows progression meeting the RECIST 1.1 criteria, such lesion can be regarded as a measurable lesion.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score is 0 or 1.
- Have sufficient hematopoietic, liver and kidney functions and meet the following laboratory test results before enrollment (no use of any cell growth factors, platelet or red blood cell transfusions, etc. within 1 week before the first dose of study treatment):
- Basically normal hematopoietic system: Absolute Neutrophil Count (ANC) ≥ 1.5 × 109/L, Platelet (PLT) ≥ 90 × 109/L, Hemoglobin (Hb) ≥ 90 g/L; Basically normal liver function: Total Bilirubin (TBIL) ≤ 1.5 × ULN (for subjects with liver metastases, Total Bilirubin ≤ 2.5 × ULN), Alanine Transaminase (ALT) ≤ 2.5 × ULN, Aspartate Transaminase (AST) ≤ 2.5 × ULN (for subjects with liver metastases, ALT ≤ 5 × ULN, AST ≤ 5 × ULN), Alkaline Phosphatase ≤ 2.5 × ULN (for subjects with liver or bone metastases, Alkaline Phosphatase ≤ 5 × ULN), Plasma Albumin (ALB) ≥ 28 g/L; Basically normal kidney function: Creatinine (Cr) ≤ 1.5 × ULN, or Creatinine Clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula); Basically normal coagulation function: International Normalized Ratio (INR) ≤ 1.5 × ULN or Prothrombin Time (PT) ≤ 1.5 × ULN or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN (for subjects receiving anticoagulant therapy, the investigator judges that INR, PT and APTT are all within the safe and effective treatment range without clinical conditions of active bleeding or increased bleeding risk).
- Female subjects of childbearing age or male subjects whose partners are women of childbearing age must take effective contraceptive measures throughout the treatment period and within 6 months after the treatment period.
Who cannot join
- Having been previously exposed to any anti-TIGIT drugs.
- Currently participating in another interventional clinical study, except for participation in observational (non-interventional) clinical studies or being in the survival follow-up stage of an interventional study.
- Having received any investigational drugs within 4 weeks prior to the first administration of the study drug.
- Having an autoimmune disease or a history of autoimmune diseases or related symptoms.
- Having received the last anti-tumor treatment within 4 weeks before the first administration of the study drug: systemic chemotherapy (the washout period for oral fluorouracil drugs is 2 weeks, and that for mitomycin C and nitrosourea drugs is 6 weeks), endocrine therapy, targeted therapy (the washout period for small molecule targeted therapy is 2 weeks or 5 half-lives, whichever is longer), immunotherapy, tumor embolization or treatment with traditional Chinese herbal medicines with anti-tumor indications, etc.
- Having been treated with corticosteroid drugs or other immunosuppressive agents within 4 weeks before the first administration of the study drug.
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- Having received a live attenuated vaccine within 4 weeks before the first administration of the study drug or planning to receive it during the study period.
- Having toxicity that has not recovered to grade 0 or 1 according to the NCI-CTCAE v5.0 caused by previous anti-tumor treatment within 4 weeks before the first dose of study treatment (excluding alopecia, fatigue or vitiligo), having unstable neuropathy or > grade 2 neuropathy induced by previous anti-tumor treatment, including having unresolved immune-related adverse events (irAE) after receiving immunotherapy and those who have experienced irAE ≥ grade 3.
- Having a history of pneumonia requiring steroid treatment, or having interstitial lung disease (including both past and present medical history).
- Currently having an active infection (e.g., acute bacterial infection, tuberculosis, active hepatitis B/hepatitis C, pulmonary infection, etc.).
- Known to have central nervous system (CNS) metastasis and/or spinal cord compression and/or carcinomatous meningitis, or having a history of leptomeningeal carcinoma.
- Being positive for hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg), and having HBV DNA higher than the upper limit of the normal value of the study center, or being judged by the doctor to have active hepatitis, being infected with hepatitis C virus (HCV), or being positive for human immunodeficiency virus (HIV) antibody, or being positive for Treponema pallidum antibody (Tp-Ab).
- Having poorly controlled cardiac clinical symptoms or diseases, such as uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg), unstable angina pectoris or having had a myocardial infarction within 6 months before enrollment in the trial, or having poorly controlled arrhythmia (including QTc interval ≥ 450 ms for men and ≥ 470 ms for women, with the QTc interval calculated by the Fridericia formula), etc.
- Having a cardiac function classification (NYHA) of grade III or IV, and having a left ventricular ejection fraction (LVEF) < 50% at rest.
- Having suffered from other malignant tumors within five years (except for completely cured or curable cancers, such as basal cell skin cancer or squamous cell skin cancer, localized low-risk prostate cancer, papillary thyroid cancer, or any type of carcinoma in situ that has been completely resected, such as carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, etc.).
- Being allergic to the components or excipients of the experimental drug, antibody drugs or any other therapeutic proteins (such as fresh frozen plasma, human serum albumin, cytokines or interleukins, etc.), or having a severe allergy history, or being suspected of having a severe allergic reaction (NCI-CTCAE v5.0 ≥ grade 3).
- Having a history of alcoholism, drug addiction or drug abuse within 1 year before screening.
- Having a clear history of neurological or psychiatric disorders in the past, such as epilepsy, dementia, or being poorly compliant.
- Pregnant or lactating women.
- Other circumstances that the investigator deems unsuitable for participation in this study.
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
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Xiubao Ren, 86-22-23109106
About this study
Official title: An Open-label, Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic (PK) Characteristics and Preliminary Efficacy of BC008-1A Injection in Subjects With Advanced Solid Tumors
The goal of this study is to learn if BC008-1A given 900mg or 1200mg intravenously once every 3 weeks is safe and effective to treat patients with advanced esophageal cancer or advanced non-small cell lung cancer. It will also learn about the safety and pharmacokinetics of BC008-1A.
Read the detailed description
This is an open-label clinical study aims to evaluate the safety, pharmacokinetic characteristics and preliminary efficacy of BC008-1A injection in subjects with advanced esophageal squamous cell carcinoma and advanced non-small cell lung cancer (squamous cell carcinoma and adenocarcinoma). There are two cohorts. Cohort 1 selects patients with advanced esophageal squamous cell carcinoma, and Cohort 2 selects subjects with advanced non-small cell lung cancer (squamous cell carcinoma and adenocarcinoma) with a PD-L1 TPS (Tumor Proportion Score) of ≥1%.
Cohort 1: Two dose groups will be set up. Subjects with advanced esophageal cancer will enter the low-dose group (900mg) or the high-dose group (1200mg) in parallel. Each subject will only receive the experimental drug of one dose group and will not participate in the studies of the other dose group.
Cohort 2: Two dose groups will be set up. Subjects with advanced non-small cell lung cancer (squamous cell carcinoma and adenocarcinoma) will enter the low-dose group (900mg) or the high-dose group (1200mg) in parallel. Each subject will only receive the experimental drug of one dose group and will not participate in the studies of the other dose group.
For both Cohort 1 and Cohort 2, BC008-1A injection will be administered once every 3 weeks, and 21 days will be regarded as one cycle. Subjects will continue to take the drug until disease progression occurs, or intolerable toxicity develops, or they are lost to follow-up, or withdraw their informed consent, or start a new anti-tumor treatment, or the investigator decides to withdraw them based on the subject's benefit situation.
- Being tested
- BC008-1A 900mg, BC008-1A 1200mg
- Keywords
- PD-1, TIGIT, Esophageal Cancer, non-small cell lung cancer
- Medical subject headings
- Esophageal Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BC008-1A 900mgBiological
BC008-1A 900mg will be administered once every 3 weeks until disease progression occurs, or intolerable toxicity develops, or they are lost to follow-up, or withdraw their informed consent, or start a new anti-tumor treatment, or the investigator decides to withdraw them based on the subject's benefit situation.
BC008-1A 1200mgBiological
BC008-1A 1200mg will be administered once every 3 weeks until disease progression occurs, or intolerable toxicity develops, or they are lost to follow-up, or withdraw their informed consent, or start a new anti-tumor treatment, or the investigator decides to withdraw them based on the subject's benefit situation.
| Study group | Role | What they receive |
|---|---|---|
| BC008-1A 900mg | Experimental | Not described Receives: Biological: BC008-1A 900mg |
| BC008-1A 1200mg | Experimental | Not described Receives: Biological: BC008-1A 1200mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Objective response rate per RECIST1.1
Measured: Up to 2 years
Secondary outcomes (10)
Disease control rate (DCR)
Defined as the proportion of subjects who achieved a best response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per RECIST 1.1.
Measured: Up to 2 years
Maximum Plasma Concentration (Cmax)
Measured: about 4 months
Immunogenicity
Percentage of anti-drug antibody (ADA) and positive subjects.
Measured: Up to 2 years
Adverse events
Incidence and severity of adverse events
Measured: Up to 2 years
Receptor occupancy
Receptor occupancy of TIGIT and PD-1 on peripheral CD3+, CD4+ and CD8+ T cells.
Measured: Up to 2 years
Progression-free survival (PFS)
The time interval from the first drug administration to progressive disease per RECIST 1.1 or death from any cause
Measured: Up to 2 years
Overall survival (OS)
The time interval from the first drug administration to death due to any cause.
Measured: Up to 2 years
Duration of response (DoR)
The time interval from the first response (CR or PR) to progressive disease per RECIST 1.1 or death from any cause
Measured: Up to 2 years
Time to response (TTR)
The time from the first drug administration to the first confirmation of Complete Response (CR) or Partial Response (PR) per RECIST 1.1.
Measured: Up to 2 years
Area under the curve (AUC)
Measured: about 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start12 May 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Esophageal CancersStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773507
- Sponsor's protocol ID
- leadingpharm2022010
- Status last verified
- Jul 2025
- First submitted
- 2 Jan 2025
- Last updated
- 9 Jul 2025
- 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 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic (PK) Characteristics and Preliminary Efficacy of BC008-1A Injection in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06773507
- Acronym / sponsor ID
- leadingpharm2022010
- Keywords
- PD-1, TIGIT, Esophageal Cancer, non-small cell lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study start
- 12 May 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 14 Jan 2025 (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.
The goal of this study is to learn if BC008-1A given 900mg or 1200mg intravenously once every 3 weeks is safe and effective to treat patients with advanced esophageal cancer or advanced non-small cell lung cancer. It will also learn about the safety and pharmacokinetics of BC008-1A.
Detailed description
This is an open-label clinical study aims to evaluate the safety, pharmacokinetic characteristics and preliminary efficacy of BC008-1A injection in subjects with advanced esophageal squamous cell carcinoma and advanced non-small cell lung cancer (squamous cell carcinoma and adenocarcinoma). There are two cohorts. Cohort 1 selects patients with advanced esophageal squamous cell carcinoma, and Cohort 2 selects subjects with advanced non-small cell lung cancer (squamous cell carcinoma and adenocarcinoma) with a PD-L1 TPS (Tumor Proportion Score) of ≥1%.
Cohort 1: Two dose groups will be set up. Subjects with advanced esophageal cancer will enter the low-dose group (900mg) or the high-dose group (1200mg) in parallel. Each subject will only receive the experimental drug of one dose group and will not participate in the studies of the other dose group.
Cohort 2: Two dose groups will be set up. Subjects with advanced non-small cell lung cancer (squamous cell carcinoma and adenocarcinoma) will enter the low-dose group (900mg) or the high-dose group (1200mg) in parallel. Each subject will only receive the experimental drug of one dose group and will not participate in the studies of the other dose group.
For both Cohort 1 and Cohort 2, BC008-1A injection will be administered once every 3 weeks, and 21 days will be regarded as one cycle. Subjects will continue to take the drug until disease progression occurs, or intolerable toxicity develops, or they are lost to follow-up, or withdraw their informed consent, or start a new anti-tumor treatment, or the investigator decides to withdraw them based on the subject's benefit situation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BC008-1A 900mg | Experimental | Biological: BC008-1A 900mg |
| BC008-1A 1200mg | Experimental | Biological: BC008-1A 1200mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Cohort 1:
- Patients with inoperable, locally advanced or metastatic esophageal squamous cell carcinoma confirmed by histopathology or cytology. Those who have failed standard treatment or have no effective standard treatment available; Patients can provide the results of PD-L1 expression status within 1 year or agree to provide archived pathological tissues or fresh tissues within 1 year for testing.
- Patients with non-small cell lung cancer (squamous cell carcinoma and adenocarcinoma) confirmed by histology or cytology, who have failed standard treatment or have no effective standard treatment available; Patients can provide archived pathological tissues or fresh pathological tissues within 1 year for PD-L1 testing, and the PD-L1 Tumor Proportion Score (TPS) ≥ 1%.
- Sign a written informed consent form before any study-specific procedures and be able to follow the visit schedules and related procedures stipulated in the protocol.
- Male or female patients aged ≥ 18 years old.
Key exclusion criteria (20 listed)
- Having been previously exposed to any anti-TIGIT drugs.
- Currently participating in another interventional clinical study, except for participation in observational (non-interventional) clinical studies or being in the survival follow-up stage of an interventional study.
- Having received any investigational drugs within 4 weeks prior to the first administration of the study drug.
- Having an autoimmune disease or a history of autoimmune diseases or related symptoms.
- Having received the last anti-tumor treatment within 4 weeks before the first administration of the study drug: systemic chemotherapy (the washout period for oral fluorouracil drugs is 2 weeks, and that for mitomycin C and nitrosourea drugs is 6 weeks), endocrine therapy, targeted therapy (the washout period for small molecule targeted therapy is 2 weeks or 5 half-lives, whichever is longer), immunotherapy, tumor embolization or treatment with traditional Chinese herbal medicines with anti-tumor indications, etc.
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 |
|---|---|---|
| BC008-1A 900mgBC008-1A 900mg will be administered once every 3 weeks until disease progression occurs, or intolerable toxicity develops, or they are lost to follow-up, or withdraw their informed consent, or start a new anti-tumor treatment, or the investigator decides to withdraw them based on the subject's benefit situation. | Biological | BC008-1A 900mg |
| BC008-1A 1200mgBC008-1A 1200mg will be administered once every 3 weeks until disease progression occurs, or intolerable toxicity develops, or they are lost to follow-up, or withdraw their informed consent, or start a new anti-tumor treatment, or the investigator decides to withdraw them based on the subject's benefit situation. | Biological | BC008-1A 1200mg |
Primary outcome
Objective response rate (ORR)
Time frame: Up to 2 years
Objective response rate per RECIST1.1
10 secondary outcomes
Disease control rate (DCR)
Time frame: Up to 2 years
Maximum Plasma Concentration (Cmax)
Time frame: about 4 months
Immunogenicity
Time frame: Up to 2 years
Adverse events
Time frame: Up to 2 years
Receptor occupancy
Time frame: Up to 2 years
Progression-free survival (PFS)
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to 2 years
Duration of response (DoR)
Time frame: Up to 2 years
Time to response (TTR)
Time frame: Up to 2 years
Area under the curve (AUC)
Time frame: about 4 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 9 Jul 2025.
- 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.
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 BC008-1A 900mg and BC008-1A 1200mg in people with Advanced Esophageal Cancers and Advanced Non-small Cell Lung Cancer (NSCLC), run by Sichuan Luzhou Buchang 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 12 inclusion and 20 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 9 Jul 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 Jianing Wang (86-13802107048, wangjianing@buchangbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Up to 2 years). 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 9 Jul 2025.