Can a new infusion drug shrink Hard-to-Treat tumors?
NCT ID NCT07750132
First seen Aug 06, 2026 · Last updated Sep 09, 2026 · Updated 3 times
Summary
This early-stage trial is testing an investigational drug called SM2275 in people with advanced or metastatic solid tumors that have progressed after standard treatment or for which no standard therapy exists. The study aims to find the safest dose, understand how the drug behaves in the body, and look for early signs that it can fight tumors. Participants receive SM2275 by intravenous infusion, and the trial will monitor side effects and immune responses.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SM2275, an investigational drug given by intravenous infusion
- What this could lead to
- If SM2275 proves safe and shows antitumor activity, it could become a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
- What could go wrong
- This is an early-phase, first-in-human study, so the drug may not be effective or may cause unexpected side effects. The results will only establish safety and dosing, not proof of benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 study treatment. Exclusion Criteria: * Insufficient washout period from prior anticancer therapy before the first dose of study treatment. * Prior anticancer immunotherapy permanently discontinued due to immune-related toxicity, history of Grade 3 or higher immune-related adverse events (irAEs), or history of Grade 2 or higher immune-related myocarditis considered by the investigator to make the participant unsuitable for study participation. * History of severe infusion-related reactions associated with prior EGFR-targeted therapy. * Receipt of antitumor vaccines or cellular immunotherapy within 3 months before the first dose of study treatment. * Presence of another active malignancy requiring treatment. * Adverse events from prior anticancer therapy that have not recovered to Grade 1 or baseline, except for alopecia, skin pigmentation of any grade, or Grade 2 or lower peripheral sensory neuropathy. * Active autoimmune disease requiring systemic immunosuppressive therapy. * Major surgery, open biopsy, or significant traumatic injury within 4 weeks before the first dose; planned major surgery during the study; or incomplete recovery from prior surgery. * Active central nervous system (CNS) tumors. * Symptomatic heart failure (New York Heart Association Class II or higher). * Uncontrolled hypertension (systolic blood pressure greater than 150 mmHg or diastolic blood pressure greater than 100 mmHg despite optimal medical therapy). * Fridericia-corrected QT interval (QTcF) greater than 470 milliseconds based on the average of triplicate screening electrocardiograms. * Acute coronary syndrome, acute myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), or coronary artery bypass graft (CABG) surgery within 6 months before the first dose. * Cardiomyopathy of any etiology or clinically significant valvular heart disease. * Clinically significant arrhythmias requiring medical treatment (well-controlled atrial fibrillation is permitted). * Transient ischemic attack (TIA) or stroke within 6 months before screening. * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage at least once per month or ongoing clinical intervention. * Active infection requiring systemic antibacterial or antiviral therapy within 14 days before the first dose. Participants receiving stable antiviral therapy for hepatocellular carcinoma or controlled hepatitis B virus (HBV) or hepatitis C virus (HCV) infection are permitted. * Active or uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Participants with controlled HBV or HCV receiving stable antiviral therapy may be eligible. * Known human immunodeficiency virus (HIV) infection. * Receipt of systemic immunosuppressive medication within 14 days before the first dose, unless permitted by the protocol. * History of interstitial lung disease (ILD), pneumonitis, suspected ILD or pneumonitis that cannot be excluded by screening imaging, or severe chronic obstructive pulmonary disease (COPD). * History of severe hypersensitivity to monoclonal antibodies or history of anaphylaxis within 6 months before screening. * History of allogeneic organ transplantation or graft-versus-host disease (GvHD). * Receipt of a live vaccine within 4 weeks before the first dose. * Known substance abuse or psychiatric disorder that, in the opinion of the investigator, would interfere with study participation or protocol compliance. * Pregnant or breastfeeding women, or participants planning to conceive or father a child during the study and for at least 6 months after the last dose of study treatment. * Any medical condition, laboratory abnormality, or other clinical circumstance that, in the opinion of the investigator, would make the participant unsuitable for study participation or could interfere with the interpretation of study results.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a drug duo shrink Hard-to-Treat tumors?
- Can a cocktail of immune boosters shrink Hard-to-Treat tumors?