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

Inclusion criteria

• ✓. 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;
• ✓. Life expectancy of ≥3 months;
• ✓. Presence of at least one measurable lesion according to RECIST v1.1 criteria;
• ✓. Sufficient bone marrow and organ function levels (no use of blood products and/or hematopoietic growth factors within 14 days prior to the start of study treatment):
• ✓. Fertile eligible study participants (both male and female) must agree to use a reliable method of contraception (hormonal or barrier methods or abstinence, etc.) with their partner during the trial and for at least 6 months after the last dose of study drug; Women of childbearing potential must not breastfeed. Women of childbearing potential must also have a negative pregnancy test prior to the first dose of study drug;