Phase I Study of SM2275 Injection in Patients With Advanced Solid Tumors

NCT07750132 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: SM2275-CN-001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Solid Tumors; Metastatic Solid Tumors

Keywords

SM2275 EGFR PD-L1 CD28 VHH Multispecific Antibody Immunotherapy Solid Tumor First-in-Human

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  Cycle 1 (21 days)

• Maximum Tolerated Dose (MTD)

  Maximum tolerated dose (MTD), if reached, based on the occurrence of protocol-defined dose-limiting toxicities.

  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.

  End of dose escalation (up to approximately 12 months)

Secondary Outcomes (11)

• Maximum Observed Plasma Concentration (Cmax)

  From first dose through end of treatment (up to approximately 12 months)

• Time to Maximum Plasma Concentration (Tmax)

  From first dose through end of treatment

• Area Under the Plasma Concentration-Time Curve (AUC)

  From first dose through end of treatment

• Terminal Elimination Half-life (t½)

  From first dose through end of treatment

• Apparent Clearance (CL)

  From first dose through end of treatment

Study Arms (1)

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.

Drug: SM2275

Interventions

SM2275 DRUG

Concentrated solution for injection, 100 mg/4 mL/vial. Administered intravenously according to preset dose levels and cycle intervals defined in protocol v1.0.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Beijing StarMab Biomed Technology Ltd: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

Central Study Contacts

Xiaodan Liu, MD

CONTACT

86-13241180800; xiaodan.liu@starmab.com.cn

Yanbin Liang, Ph.D

CONTACT

86-13910340137; yanbin.liang@starmab.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 6, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): February 2, 2029
• Last Updated: August 6, 2026

Record last verified: 2026-07

Locations

CN (1)