Phase 1 Study of IBR854 in Locally Advanced Or Metastatic Solid Tumors (NCT06001684) | Clinical Trial Compass
CompletedPhase 1
Phase 1 Study of IBR854 in Locally Advanced Or Metastatic Solid Tumors
China19 participantsStarted 2023-09-01
Plain-language summary
This study is an open-label, phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of IBR854 cell injection in patients with unresectable, locally advanced, or metastatic solid tumors.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects volunteer to participate in this clinical study, are fully aware of the study and have signed the Informed Consent Form (ICF). Subjects are willing to follow and able to complete all trial procedures.
. Age: adult at the age of 18-75 (both inclusive), female or male.
. Subjects with histologically or cytologically confirmed, unresectable, locally advanced or metastatic solid tumors (which can be diagnosed with the use of tumor markers in combination with imaging for specific advanced tumors, such as liver cancer) who have no current standard of care.
. Eastern Cooperative Oncology Group (ECOG) score ≤2 and expected survival time \>3 months.
. According to the Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 criteria, the subjects have at least one target lesion (non-lymph node lesion with major diameter ≥ 1.0cm or lymph node lesion with minor diameter ≥ 1.5 cm). A lesion that is within the field of previous radiotherapy could not be considered a target unless there is radiographic evidence of progression.
. Organ function during screening should meet the following criteria:
. Subjects of reproductive age and their partners should agree to have no family planning and to use effective contraceptive methods for 6 months from signing the ICF until the last dose of the study drug is administered.
Exclusion criteria
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: From day1 to day 21
2
The incidence and severity of adverse events (AEs)
Timeframe: From day 1 to day 90 after the first dose
. Have received systemic antitumor therapy within 4 weeks or five half-lives of the drug (whichever is longer) before the first dose of the study drug: Systemic chemotherapy (2 weeks for oral fluorouracil, 6 weeks for mitomycin C and nitrosoureas), endocrine therapy, targeted therapy (2 weeks or 5 half-life for small molecule targeted therapy, whichever is longer), immunotherapy, radical radiotherapy, tumor embolization, Chinese herbal medicine for anti-tumor indications, etc. Or received palliative radiotherapy within 2 weeks before the first dose.
. Toxic effects from previous antitumor therapy have not returned to grade 1 or less (other than alopecia or fatigue).
. Any prior adoptive cellular immunotherapy.
. Active brain metastases (one of the following criteria: clinical symptoms; A new diagnosis; Progression after previous local treatment).
. Have undergone major organ surgery within 4 weeks prior to their first use of the study drug, or required elective surgery during the study period.
. Long-term (≥ 3 days) treatment with a glucocorticoid (prednisone \> 10 mg per day or equivalent) or another immunosuppressive agent is anticipated to be required during the study. Inhaled or topical steroid hormones are allowed in subjects without active autoimmune disease
. Have received a live or attenuated vaccine within 4 weeks before the first dose or plan to receive a live or attenuated vaccine during the study period.
. Have severe infections that cannot be controlled.