Phase I Study of SM2275 Injection in Patients With Advanced Solid Tumors (NCT07750132) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Phase I Study of SM2275 Injection in Patients With Advanced Solid Tumors
China72 participantsStarted 2026-08-01
Plain-language summary
This is a first-in-human, multicenter, open-label Phase Ia/Ib study evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary antitumor activity of SM2275 in patients with advanced or metastatic solid tumors who have progressed after standard therapy or for whom no standard treatment is available.
Phase Ia includes dose escalation to evaluate safety, identify dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D). Phase Ib will further evaluate safety, PK, PD, and preliminary antitumor activity in expansion cohorts.
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 participants aged 18 years or older.
* Able to understand the study requirements and voluntarily provide written informed consent before any study-specific procedures.
* Histologically or cytologically confirmed advanced or metastatic EGFR-positive and PD-L1-positive solid tumor that has progressed following standard therapy, is intolerant to standard therapy, or for which no effective standard therapy is available, including but not limited to head and neck squamous cell carcinoma, non-small cell lung cancer, unresectable advanced colorectal cancer, and renal clear cell carcinoma.
* Able to provide archived tumor tissue or other tumor samples as required by the protocol during the screening period.
* At least one measurable lesion according to RECIST Version 1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy of at least 12 weeks.
* Adequate hematologic, hepatic, renal, cardiac, and other organ function as defined in the protocol.
* Left ventricular ejection fraction (LVEF) greater than 50% as determined by echocardiography (ECHO) or multigated acquisition (MUGA) scan.
* Female participants of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose of study treatment.
* Male participants and female participants of childbearing potential must agree to use highly effective contraception during the study and for at least 6 months after the last dose of…
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 Treatment-Emergent Adverse Events (TEAEs)
Timeframe: From first dose through 28 days after the last dose (up to approximately 12 months)
2
Incidence of Dose-Limiting Toxicities (DLTs)
Timeframe: Cycle 1 (21 days)
3
Maximum Tolerated Dose (MTD)
Timeframe: During dose escalation (up to approximately 12 months)
4
Recommended Phase II Dose (RP2D)
Timeframe: End of dose escalation (up to approximately 12 months)