Clinical Study of SM3321 With Solid Tumors (NCT06087770) | Clinical Trial Compass
CompletedPhase 1
Clinical Study of SM3321 With Solid Tumors
China7 participantsStarted 2023-12-07
Plain-language summary
The purpose of this study is to evaluate the Safety and Tolerability of SM3321 in patients with locally advanced or metastatic solid tumors
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
. Male or female aged 18 years or older.
. Subjects with histologically or cytologically confirmed unrespectable locally advanced or metastatic solid tumors.
. The subject's disease progresses after receiving adequate standard treatment or is intolerant to standard treatment or has no effective standard treatment options available.
. Subjects in this study must have at least one evaluable lesion (based on RECIST v1.1).
. Expected survival ≥12 weeks
. ECOG PS score 0-2 points
. The function of the major organs is basically normal, and the laboratory examination within 7 days or less before the first administration meets the following standards:
. Female subjects of reproductive age must have a negative blood pregnancy test within 3 days prior to the first use of the study drug; Eligible subjects (men and women) who are fertile (defined as sexually mature and biologically fertile) must agree to use a reliable contraceptive method (hormonal or barrier method or abstinence, etc.) with their partner during the study period and for at least 6 months after the last dose.
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
Maximum tolerated dose
Timeframe: DLT observation period: 28 days after the first dose [i.e., 1 Cycle ]
2
Phase II recommended dose（RP2D)
Timeframe: DLT observation period: 28 days after the first dose [i.e., 1 Cycle ]
3
Safety evaluation-1
Timeframe: Screen Period(Day-28~Day-1),Cycle 1 (Day1, 2, 3, 4, 6, 8, 15,22, 23, 24, 25,27） (Cycle 2~Cycle N) Day 1±3 Days, within 7 days after stop dosing, 30±5 days after last dosing, 90±5 days after last dosing (1 Cycle=28 Days)
4
Safety evaluation-2
Timeframe: Screen Period(Day-28~Day-1),Cycle 1 (Day1, 8, 15,22） (Cycle 2~Cycle N) Day 1±3 Days, within 7 days after stop dosing, 30±5 days after last dosing, 90±5 days after last dosing (1 Cycle=28 Days)
5
Safety evaluation-3
Timeframe: On the day of dosing, within 1 hour before dosing, every 15±5 minutes during dosing, at the end of dosing (within 5 minutes), and every 30±5 minutes after dosing. within 4 hours after the end of the first dosing
6
Safety evaluation-4
Timeframe: Screen Period(Day-28~Day-1),Cycle 1 (Day1, 8, 15,22） (Cycle 2~Cycle N) Day 1±3 Days, within 7 days after stop dosing, 30±5 days after last dosing, 90±5 days after last dosing (1 Cycle=28 Days)
. Known allergy to SM3321 or its formulation components.
. Previously received the following anti-tumor therapy:
. Chemotherapy, targeted therapy, immunotherapy, or other anticancer therapy within 28 days or 5 half-lives (whichever is shorter) prior to initial administration of the investigational therapy, except for the following:
. Radiotherapy received within 4 weeks prior to the first dosing of the study treatment, allowing a single fractionated radiotherapy for symptom relief.
. The subject has participated in any other clinical study and received the trial drug within 28 days prior to the first administration of the study drug.
. Major surgery within 28 days before dosing or major surgery expected during the study period.
. There was acute toxicity from prior antitumor therapy that had not returned to ≤ grade 1 or baseline levels specified by the inclusion criteria prior to first administration (based on NCI-CTCAE v5.0).
. Uncontrolled or severe cardiovascular disease, including but not limited to any of the following:
7
Safety evaluation-5
Timeframe: Within 1 hour before dosing, 30 minutes after ending dosing, and 30 minutes after starting dosing 4 hours
8
Safety evaluation-6
Timeframe: Scans or examinations are performed during the screening period and when clinically indicated
9
Safety evaluation-7
Timeframe: Screen Period(Day-28~Day-1), (Cycle 2~Cycle N) Day 1±3 Days, within 7 days after stop dosing (1 Cycle=28 Days)