First in Human Study of YB1-X7 Injection (NCT06889675) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
First in Human Study of YB1-X7 Injection
36 participantsStarted 2025-03-15
Plain-language summary
This clinical trial is an open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetic, and preliminary efficacy of YB1-X7 injection in subjects with advanced solid tumors.
YB1-X7 injection is an attenuated Salmonella-based tumor therapy. It selectively accumulates in hypoxic tumor regions while being rapidly cleared from normal organs. After proliferating in the tumor microenvironment, YB1-X7 invades tumor cells and releases its therapeutic payload, leading to tumor cell death and tumor regression.
Conditions：To treat subjects with advanced and/or metastatic solid tumors who do not to respond to conventional standard treatment or who lack effective standard treatment.
Who can participate
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥18 years, no gender limitatlon
. Subjects with advanced or metastatic solid tumors confirmed by pathological histology.
. Subjects with advanced malignant solid tumors for whom standard treatment has failed or no other effective standard treatment available.
. At least one measurable solid tumor by RECIST 1.1.
. Subjects assigned to intratumoral injection must have at least one tumor that is suitable for biopsy or intratumoral injection.
. Life expectancy must be at least 3 months.
. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of dose limiting toxicity (DLTs)
Timeframe: Up to 28 days post first dose.
2
Adverse events (AEs)
Timeframe: From receiving study drug and throughout the study, until 28 days after the last dosing
3
Serious adverse events(SAEs)
Timeframe: From receiving study drug and throughout the study, until 28 days after the last dosing.
. Male and female subjects of childbearing potential should take effective contraceptive measures.
Exclusion criteria
.Pregnant or breastfeeding women. Subjects known to have a history of abuse of psychiatric drugs, alcoholism, or drug use.
.Subjects who have previously undergone oncolytic bacteria treatment. 4.Subjects planning to surgery, radiation therapy, or other local treatments for target lesions during the study.
.Subjects known to be allergic to the study drug or any of its excipients. 6.Subjects allergic or intolerant to antibiotics sensitive to Salmonella, such as amikacin cefpirome, ciprofloxacin,cefotaxime,meropenem.
.Subjects currently using antibiotics. 8.Subjects who have not recovered fom adverse reactions of prior treatments (treatment-related toxicity grade≤2, except for hair loss, pigmentation, and other tolerable events determined by the investigator).
.Subjects with active auto-immune diseases or prior diseases with recurrence potential (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except for clinically stable autoimmune thyroiditis.
0.Subjects with active or uncontrolled infections or unexplained fever≥38.5℃, including but not limited to bacterial infections, tuberculosis, herpes virus infections syphilis infections.
1.Subjects who underwent major surgery within 3 months prior to the first dose of the study drug (except for biopsies for diagnostic purposes).
2.Subjects who have received any anti-tumor treatment within 28 days or 5 half-lives prior to the first dose of the study drug, including chemotherapy, cell therapy, gene therapy, immunotherapy,biological agents, hormone therapy, targeted therapy, tumor drug embolization therapy.