Advanced Solid TumorsPhase 1NCT07750132
Phase I Study of SM2275 Injection in Patients With Advanced Solid Tumors
A Phase 1 study testing SM2275 in people with Advanced Solid Tumors, run by Beijing StarMab Biomed Technology Ltd at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- SM2275
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2026to 2 Feb 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing
Xiaodan Liu, MD, 86-13241180800, xiaodan.liu@starmab.com.cn
Yanbin Liang, Ph.D, 86-13910340137, yanbin.liang@starmab.com.cn
About this study
Official title: A First-in-Human, Open-Label, Multicenter, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Antitumor Activity of SM2275 in Patients With Advanced Solid Tumors
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.
Read the detailed description
SM2275 is an investigational tetravalent VHH-based multispecific antibody targeting EGFR, PD-L1, CD28, and HSA.
SM2275 is designed to selectively promote CD28-mediated T-cell costimulation through simultaneous engagement of EGFR and PD-L1 expressed in the tumor microenvironment while blocking the PD-L1 immune checkpoint pathway. The HSA-binding domain is incorporated to prolong systemic exposure.
This first-in-human Phase Ia/Ib study will evaluate intravenous SM2275 in patients with advanced solid tumors.
Phase Ia will evaluate escalating dose levels using an adaptive dose-escalation strategy to characterize safety, identify DLTs, determine the MTD and/or RP2D, and characterize PK and PD.
Following dose escalation, Phase Ib will further evaluate safety and preliminary efficacy in selected expansion cohorts.
- Conditions
- Advanced Solid Tumors
- Being tested
- SM2275
- Keywords
- SM2275, EGFR, PD-L1, CD28, Multispecific antibody, immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SM2275Drug
Concentrated solution for injection, 100 mg/4 mL/vial. Administered intravenously according to preset dose levels and cycle intervals defined in protocol v1.0.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Phase Ia (Dose Escalation): Approximately 15-42 patients. Open-label, multiple dose-escalation design based on body-weight preset dose levels to determine DLT, MTD, and RP2D. Phase Ib (Dose Expansion): Approximately 30 patients. Expansion at the recommended dose (RP2D) determined by the investigator and sponsor in selected solid tumor cohorts. Receives: Drug: SM2275 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number of participants experiencing treatment-emergent adverse events (TEAEs), including severity and relationship to study treatment, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
Measured: From first dose through 28 days after the last dose (up to approximately 12 months)
Incidence of Dose-Limiting Toxicities (DLTs)
Number of participants experiencing dose-limiting toxicities (DLTs) during the DLT evaluation period according to protocol-defined criteria.
Measured: Cycle 1 (21 days)
Maximum Tolerated Dose (MTD)
Maximum tolerated dose (MTD), if reached, based on the occurrence of protocol-defined dose-limiting toxicities.
Measured: During dose escalation (up to approximately 12 months)
Recommended Phase II Dose (RP2D)
Recommended Phase II dose (RP2D) determined based on the overall assessment of safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity.
Measured: End of dose escalation (up to approximately 12 months)
Secondary outcomes (11)
Maximum Observed Plasma Concentration (Cmax)
Maximum observed plasma concentration (Cmax) of SM2275 following intravenous administration.
Measured: From first dose through end of treatment (up to approximately 12 months)
Time to Maximum Plasma Concentration (Tmax)
Time to reach maximum observed plasma concentration (Tmax) of SM2275.
Measured: From first dose through end of treatment (up to approximately 12 months)
Area Under the Plasma Concentration-Time Curve (AUC)
Area under the plasma concentration-time curve (AUC) of SM2275.
Measured: From first dose through end of treatment (up to approximately 12 months)
Terminal Elimination Half-life (t½)
Terminal elimination half-life (t½) of SM2275.
Measured: From first dose through end of treatment (up to approximately 12 months)
Apparent Clearance (CL)
Apparent systemic clearance (CL) of SM2275.
Measured: From first dose through end of treatment (up to approximately 12 months)
Apparent Volume of Distribution (Vz)
Apparent volume of distribution during the terminal phase (Vz) of SM2275.
Measured: From first dose through end of treatment (up to approximately 12 months)
Incidence of Anti-drug Antibodies (ADA)
Incidence of anti-drug antibodies (ADA) against SM2275.
Measured: Baseline through end of study (up to approximately 12 months)
Objective Response Rate (ORR)
Objective response rate (ORR), defined as the proportion of participants achieving a confirmed complete response (CR) or partial response (PR) according to RECIST Version 1.1.
Measured: From first documented response until disease progression or study completion (up to approximately 24 months)
Disease Control Rate (DCR)
Disease control rate (DCR), defined as the proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) according to RECIST Version 1.1.
Measured: Up to approximately 24 months
Duration of Response (DoR)
Duration of response (DoR), defined as the time from the first documented objective response (CR or PR) until disease progression or death.
Measured: Up to approximately 24 months
Progression-Free Survival (PFS)
Progression-free survival (PFS), defined as the time from the first dose of SM2275 to documented disease progression according to RECIST Version 1.1 or death from any cause, whichever occurs first
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start9 Oct 2026
- Primary completion20 Sep 2028 (estimated)
- Study completion2 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing StarMab Biomed Technology Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750132
- Sponsor's protocol ID
- SM2275-CN-001
- Status last verified
- Nov 2026
- First submitted
- 28 Jul 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Open-Label, Multicenter, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Antitumor Activity of SM2275 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07750132
- Acronym / sponsor ID
- SM2275-CN-001
- Conditions
- Advanced Solid Tumors
- Keywords
- SM2275, EGFR, PD-L1, CD28, Multispecific antibody, immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Beijing StarMab Biomed Technology LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2026 (actual)
- Primary completion
- 20 Sep 2028 (estimated)
- Study completion
- 2 Feb 2029 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
SM2275 is an investigational tetravalent VHH-based multispecific antibody targeting EGFR, PD-L1, CD28, and HSA.
SM2275 is designed to selectively promote CD28-mediated T-cell costimulation through simultaneous engagement of EGFR and PD-L1 expressed in the tumor microenvironment while blocking the PD-L1 immune checkpoint pathway. The HSA-binding domain is incorporated to prolong systemic exposure.
This first-in-human Phase Ia/Ib study will evaluate intravenous SM2275 in patients with advanced solid tumors.
Phase Ia will evaluate escalating dose levels using an adaptive dose-escalation strategy to characterize safety, identify DLTs, determine the MTD and/or RP2D, and characterize PK and PD.
Following dose escalation, Phase Ib will further evaluate safety and preliminary efficacy in selected expansion cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SM2275Phase Ia (Dose Escalation): Approximately 15-42 patients. Open-label, multiple dose-escalation design based on body-weight preset dose levels to determine DLT, MTD, and RP2D. Phase Ib (Dose Expansion): Approximately 30 patients. Expansion at the recommended dose (RP2D) determined by the investigator and sponsor in selected solid tumor cohorts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SM2275Concentrated solution for injection, 100 mg/4 mL/vial. Administered intravenously according to preset dose levels and cycle intervals defined in protocol v1.0. | Drug | 1 |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose through 28 days after the last dose (up to approximately 12 months)
Number of participants experiencing treatment-emergent adverse events (TEAEs), including severity and relationship to study treatment, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: Cycle 1 (21 days)
Number of participants experiencing dose-limiting toxicities (DLTs) during the DLT evaluation period according to protocol-defined criteria.
Maximum Tolerated Dose (MTD)
Time frame: During dose escalation (up to approximately 12 months)
Maximum tolerated dose (MTD), if reached, based on the occurrence of protocol-defined dose-limiting toxicities.
Recommended Phase II Dose (RP2D)
Time frame: End of dose escalation (up to approximately 12 months)
Recommended Phase II dose (RP2D) determined based on the overall assessment of safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity.
11 secondary outcomes
Maximum Observed Plasma Concentration (Cmax)
Time frame: From first dose through end of treatment (up to approximately 12 months)
Time to Maximum Plasma Concentration (Tmax)
Time frame: From first dose through end of treatment (up to approximately 12 months)
Area Under the Plasma Concentration-Time Curve (AUC)
Time frame: From first dose through end of treatment (up to approximately 12 months)
Terminal Elimination Half-life (t½)
Time frame: From first dose through end of treatment (up to approximately 12 months)
Apparent Clearance (CL)
Time frame: From first dose through end of treatment (up to approximately 12 months)
Apparent Volume of Distribution (Vz)
Time frame: From first dose through end of treatment (up to approximately 12 months)
Incidence of Anti-drug Antibodies (ADA)
Time frame: Baseline through end of study (up to approximately 12 months)
Objective Response Rate (ORR)
Time frame: From first documented response until disease progression or study completion (up to approximately 24 months)
Disease Control Rate (DCR)
Time frame: Up to approximately 24 months
Duration of Response (DoR)
Time frame: Up to approximately 24 months
Progression-Free Survival (PFS)
Time frame: Up to approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SM2275 in people with Advanced Solid Tumors, run by Beijing StarMab Biomed Technology Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaodan Liu, MD (86-13241180800, xiaodan.liu@starmab.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (TEAEs) (time frame: From first dose through 28 days after the last dose (up to approximately 12 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.