This is a single-arm, open-label, multicenter, Phase Ib/II clinical trial of CVL237 tablets in combination with serplulimab injection for the treatment of advanced solid tumors with PTEN loss or low expression
Aged 18 to 75 years (inclusive of both endpoints), regardless of gender；
Patients with locally advanced or metastatic solid tumors (gastric cancer, endometrial cancer, cervical cancer, ovarian cancer, lung cancer, breast cancer, and other tumor types) confirmed by histology or cytology, and with PTEN loss or low expression. Patients who have experienced disease progression after standard treatment or have intolerable toxicities from prior therapies, or for whom no standard treatment is available, as determined by the investigator. For breast cancer participants, PTEN low expression is limited to those who have relapsed or metastasized after prior treatment with trastuzumab and/or CDK4/6 inhibitors;
PTEN loss or low expression confirmed by IHC staining. The definition of PTEN loss or low expression is referenced as follows: Using a dual-scoring method, score the percentage of positive cells: 0% = 0 points; 1-25% = 1 point; 26-50% = 2 points; 51-75% = 3 points; ≥76% = 4 points. Score the staining intensity: no staining = 0 points; light brownish-yellow = 1 point; brownish-yellow = 2 points; brown = 3 points. Add the scores from the two categories. A total score of 0-2 is classified as "A," 3-6 as "B," and ≥7 as "C." "A" indicates negative expression and is defined as PTEN loss; "B" indicates PTEN positive with low expression; "C" indicates PTEN positive with high expression;
ECOG Performance Status (PS) of 0-1;
Surgery or Trauma: Undergone major organ surgery or experienced significant trauma within 4 weeks before the first administration of the study drug, or requires elective surgery during the trial period; undergone core needle biopsy or other minor surgeries (excluding central venous catheterization or port-a-cath implantation) within 7 days before the first dose;
Insufficient Washout Period for Prior Anti-tumor Treatments;
Inability to Swallow, Chronic Diarrhea, or Bowel Obstruction: Presence of factors that may affect the intake and absorption of the study drug;
Unhealed Wounds or Interventions: Unhealed wounds, abdominal fistulas, gastrointestinal stent placement, or extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months before the first dose;
Single group
CVL237 tablets
DrugCVL237 tablets, 200 mg, taken with food once daily for 28 consecutive days as a treatment cycle.
Primary study endpoints
Phase Ib: DLT (Dose-Limiting Toxicity)
Primary Outcome Measure
Phase Ib: RP2D (Recommended Phase 2 Dose)
Primary Outcome Measure
Phase Ib: MTD (Maximum Tolerated Dose) of CVL237 in combination with Serplulimab injection in patients with advanced solid tumors characterized by PTEN loss or low expression;
Primary Study Endpoints
Phase II: Progression-free survival (PFS) assessed according to RECIST v1.1 criteria.
Secondary Endpoints：
Duration of response (DOR),defined as the time from the first tumor assessment of CR or PR to the first tumor assessment of PD or death due to any cause.
Secondary Study Endpoints
Disease control rate (DCR),which refers to the proportion of patients whose tumors shrink or remain stable for a certain time (mainly for solid tumors), including CR, PR and SD
Secondary Study Endpoints
Progression-free survival (PFS), defined as the time from the start of study treatment to any documented tumor progression or death due to any cause, whichever occurs first;
Secondary Study Endpoints
Overall survival (OS), defined as the time from enrollment to death due to any cause. Efficacy of each tumor type will be analyzed independently.
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