Phase I Study of BC008-1A Injection in Patients With Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSichuan Luzhou Buchang Biopharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
BC008-1A 900mg
Biological/VaccineBC008-1A 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 1200mg
Biological/VaccineBC008-1A 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: BC008-1A 900mgExperimental treatment 1 intervention
Group B: BC008-1A 1200mgExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate (ORR)
Objective response rate per RECIST1.1
Time frame
Up to 2 yearsSecondary outcomes
1
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.
Time frame
Up to 2 years2
Maximum Plasma Concentration (Cmax)
Time frame
about 4 months3
Immunogenicity
Percentage of anti-drug antibody (ADA) and positive subjects.
Time frame
Up to 2 years4
Adverse events
Incidence and severity of adverse events
Time frame
Up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborator
Source ClinicalTrials.gov