Phase I Study of SM2275 Injection in Patients With Advanced Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing StarMab Biomed Technology Ltd
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- SM2275
Treatment groups
72 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov