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R01 / Gastric Cancer / Squamous Cell Lung Cancer · Phase 1 Trial
ClinicalTrials.gov · September 8, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registered Phase 1b trial of the oral agent R01 in advanced solid tumors (squamous cell lung cancer, gastric cancer, esophageal cancer) designed to evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy. No results are yet posted in this registry record; the study is not yet recruiting.
Phase 1, Interventional, Single Group, Open label, Treatment purpose. Squamous Cell Lung Cancer, Gastric Cancer, Esophageal Cancer; age from 18 Years; to 75 Years. Intervention: Experimental: R01 Oral Monotherapy. n = 18. 1 site: China.
This is a registered Phase 1b trial of the oral agent R01 in advanced solid tumors (squamous cell lung cancer, gastric cancer, esophageal cancer) designed to evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy. No results are yet posted in this registry record; the study is not yet recruiting.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This record describes a planned study only and carries no clinical implications until results are generated and published. Clinicians should not interpret the registration as evidence of efficacy or safety.
This is a Phase 1b trial registration with no results posted; it describes a planned open-label, single-arm safety and dose-escalation study in early-stage drug development.
As stated by the source record.
Quoted from the source exactly as published.
This record describes a planned study only and carries no clinical implications until results are generated and published. Clinicians should not interpret the registration as evidence of efficacy or safety.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07806500). This is a study registration, not published results. Lead sponsor: Beijing Anjianxi Bio-Medical Technology Co., Ltd.. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 18 participants (ESTIMATED). Conditions: Squamous Cell Lung Cancer, Gastric Cancer, Esophageal Cancer. Interventions: DRUG: R01. Primary outcome measures: Number of Participants with Dose-Limiting Toxicities (DLTs) , Cycle 1 (21 days); Determination of Maximum Tolerated Dose (MTD) and/or Expansion Dose , From the beginning of first patient in (FPl) to the end of dose escalation phase up to approximately 9 months; Objective Response Rate (ORR) , From the beginning of first patient in (FPl) to the end of dose expansion phase up to approximately 4 months; Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) , From first dose to 30 days after last dose. Brief summary: This is a Phase I（Ib）, open-label, single-arm clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of R01 administered orally as monotherapy twice daily (BID) in patients with advanced solid tumors, including squamous cell lung cancer, gastric cancer , and esophageal cancer. Patients with advanced squamous cell lung cancer, gastric cancer , and esophageal cancer will be enrolled. All subjects will receive oral R01 monotherapy and will undergo physical examinations, laboratory tests, radiographic tumor response assessments, biological sample collection, and safety follow-ups as specified in the protocol. The study comprises two consecutive sub-stages: a dose-bridging escalation stage (i.e., a dose escalation stage designed to bridge from the highest dose evaluated in Phase Ia) and a dose expansion stage. The dose escalation follows a classic '3+3' design at three dose levels (240, 320, and 400 mg BID). The 400 mg dose may be initiated after the Safety Review Committee (SRC) review based on safety and PK data. The primary objectives of this stage are to characterize dose-limiting toxicities (DLTs), determine the maximum tolerated dose (MTD), and establish the recommended Phase II dose (RP2D). The dose expansion stage will be conducted at the RP2D in selected indication cohorts, with a planned enrollment of at least 6 subjects per cohort (including subjects with the corresponding indications enrolled at the same dose level during the dose escalation stage), to further evaluate the safety, tolerability, PK characteristics, and preliminary antitumor efficacy at this dose level. With respect to study endpoints: during the dose escalation stage, the primary endpoints are the incidence of DLTs, the MTD, and/or the determination of the expansion dose (RP2D); secondary endpoints include PK parameters of R01 and its metabolites, objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). During the dose expansion stage, the primary endpoints are ORR and the incidence and severity of treatment-related adverse events (TRAEs); secondary endpoints include duration of response (DOR), time to response (TTR), DCR, PFS, OS, and steady-state PK parameters.
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