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New treatment option for Advanced Esophageal Cancers
Official title Phase I Study of BC008-1A Injection in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06773507
What this study is testing
What is BC008-1A 900mg?
BC008-1A 900mg is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced esophageal cancers.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Cohort 1: Patients with inoperable, locally advanced or metastatic esophageal squamous cell carcinoma confirmed by histopathology or cytology. Those...
- Sign a written informed consent form before any study-specific procedures and be able to follow the visit schedules and related procedures stipulated...
- Male or female patients aged ≥ 18 years old.
- 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...
You likely can't join if
- Having been previously exposed to any anti-TIGIT drugs.
- Currently participating in another treatment clinical study, except for participation in observational (non-treatment) clinical studies or being in...
- 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...
- Having been treated with corticosteroid drugs or other immunosuppressive agents within 4 weeks before the first administration of the study drug.
See the full eligibility criteria
Who can 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...
- 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.
- 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...
- 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...
- Female people of childbearing age or male people whose partners are women of childbearing age must take effective contraceptive measures throughout the treatment period and within 6 months after the treatment period.
What rules you out
- Having been previously exposed to any anti-TIGIT drugs.
- Currently participating in another treatment clinical study, except for participation in observational (non-treatment) clinical studies or being in the survival follow-up stage of an treatment 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...
- Having been treated with corticosteroid drugs or other immunosuppressive agents within 4 weeks before the first administration of the study drug.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.