A Study of SI-B003, a PD-1/CTLA-4 Bispecific Antibody, in Patients With Advanced Solid Tumors (NCT04606472) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of SI-B003, a PD-1/CTLA-4 Bispecific Antibody, in Patients With Advanced Solid Tumors
China60 participantsStarted 2020-11-10
Plain-language summary
In phase Ia study, the safety and tolerability of SI-B003 in patients with recurrent or metastatic solid tumors will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) or maximum administered dose (MAD) for MTD is not reached of SI-B003.
In the phase Ib study, the safety and tolerability of SI-B003 in specific tumors will be further investigated by selecting multiple doses based on the results of phase Ia study or/and the fixed-dose administration method with the closest exposure level, and recommended phase II dose (RP2D) for phase II clinical studies will be determined.
Who can participate
Age range
18 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
. The participants could understand and sign the informed consent form, and must participate voluntarily.
. No gender limit.
. Age: ≥18 years old and ≤75 years old (phase Ia); ≥18 years old (phase Ib).
. Expected survival time ≥ 3 months.
. Histologically or cytologically confirmed recurrent or metastatic solid tumor, clinical stage IIIB/IV, with radiographic or other objective evidence of disease progression after standard therapy; Or subjects were patients with solid tumors that were refractory to treatment, patients with solid tumors that did not have standard treatment, or patients who could not tolerate or had contraindications to standard treatment.
. For the phase Ib study:
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
Phase Ia: Dose limiting toxicity (DLT)
Timeframe: Up to 28 days after the first dose of SI-B003
2
Phase Ia: Maximum tolerated dose (MTD)
Timeframe: Up to 28 days after the first dose of SI-B003
3
Phase Ia: Maximum administered dose (MAD)
Timeframe: Up to 28 days after the first dose of SI-B003
4
Phase Ia: Treatment-Emergent Adverse Event (TEAE)
Timeframe: Up to approximately 24 months
5
Phase Ib: Recommended Phase II Dose (RP2D)
Timeframe: Up to 28 days after the first dose of SI-B003
. Consent to provide archival tumor tissue or fresh tissue samples of the primary or metastatic tumor, if not available, at the discretion of the investigator (only for stage Ib );
. At least one measurable lesion that meets the definition of RECIST v1.1 at baseline (only for stage Ib).
Exclusion criteria
. Parenchymal or leptomeningeal metastases with clinical symptoms who were judged by the investigator to be ineligible for enrollment;
. Participants who participated in any other clinical trial within 28 days before the administration of this trial, except for clinical trials of marketed drugs;
. Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, major surgery, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other anti-tumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration; oral fluorouracil-like drugs such as S-1, capecitabine, or palliative radiotherapy within 2weeks prior to the first administration.
. Major surgery (investigator-defined) within 4 weeks before the first dose.
. In 14 days prior to administration of this study, those who have received systemic corticosteroids (\>10mg/day prednisone, or equivalent other corticosteroids) or immunosuppressive therapy should be excluded except for those who have received inhaled or topical corticosteroids, or hormone therapy of physiological replacement dose due to adrenal insufficiency.
. Pulmonary disease grade ≥3 according to NCI-CTCAE v5.0; Patients with existing interstitial lung disease (ILD).
. Severe systemic infection occurred within 4 weeks before screening, including but not limited to severe pneumonia caused by fungi, bacteria, viruses, bacteremia, or serious infectious complications.
. Participants at risk of active autoimmune diseases, or with a history of autoimmune diseases, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener syndrome (polyangiitis granuloma Disease, Graves' disease, rheumatoid arthritis, pituitary inflammation, uveitis), autoimmune hepatitis, systemic sclerosis, Hashimoto's thyroiditis, autoimmune vasculitis, autoimmune neuropathy (Guillain-Barré syndrome), etc. Except for the following conditions: Type I diabetes, hormone replacement therapy for stable hypothyroidism (including hypothyroidism caused by autoimmune thyroid disease), psoriasis or vitiligo that does not require systemic treatment.