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 range18 Years
SexALL
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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.
✓. 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.
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.
.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.