CVL237 Tablets in the Treatment of Advanced Solid Tumors With PTEN Deficiency

Advanced Solid Tumors Clinical Trial

Official title: A Single-arm, Open-label, Multicenter, Phase II Study of CVL237 Tablets in the Treatment of Advanced Solid Tumors With PTEN Deficiency

Status Not yet recruiting

Clinical Trial Summary

This is a single-arm, open-label, multicenter, phase II study of CVL237 tablets in the treatment of advanced solid tumors with PTEN deficiency. It is planned to enroll patients with PTEN deficiency advanced solid tumors of different tumor types (PTEN deficiency gastric cancer, prostate cancer, endometrial cancer, colorectal cancer, lung cancer, breast cancer and melanoma etc.) to evaluate the preliminary efficacy, safety and pharmacokinetic profile of CVL237 tablets in patients with PTEN deficiency advanced solid tumors of different tumor types.

Clinical Trial Description

"The predicted BSC (best supportive care treatment) ORR is 0.5% and the post-treatment ORR is 15% with 80% certainty and a significance level of 0.05 (bilateral). The first stage: After testing the drug on 10 patients in the first stage, the trial will be terminated if 0 respond; if any subject showed respond then enter the second stage; The second stage: If the trial goes on to the second stage, another 4 evaluation subjects could continue to be enrolled, a total of 14 patients will be studied. If the total number responding is less than or equal to 0, the drug is rejected.. If a subject falls off during the trial, i.e., the objective remission cannot be judged, the number of subjects should be completed.

The maximum number of qualified subjects for the 7 tumor types is 98 (in the best case, according to clinical practice, it is recommended to enroll a certain number of subjects for each tumor type, not exceeding 14).

CVL237 tablets, 200 mg, taken with food once daily for 28 consecutive days as a treatment cycle.

Tumors will be evaluated according to the Solid Tumor Efficacy Evaluation Criteria (RECIST version 1.1 criteria) and will be assessed every 2 cycles. Tumor assessment may be increased by the investigator as clinically indicated. Treatment periods may be administered continuously until the onset of intolerable adverse effects, disease progression, withdrawal of informed consent (ICF), lost to follow-up, death, or study termination, whichever occurs earliest. Efficacy of each tumor type will be analyzed independently.

Withdrawal from the study/termination of treatment for any reason required return to the study center for safety follow-up 30 days (±3 days) after the last dose. Patients will then enter a survival follow-up period until the full 2 years after the end of the trial/missing/death. All patients will be followed up every 12 weeks (±5 days) for survival, either by telephone with the subject, their family or local hospital.

Pharmacokinetic studies will be performed in 6-12 patients." ;

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

• NCT number: NCT06183736
• Study type: Interventional
• Source: Convalife (Shanghai) Co., Ltd.
• Contact: Ning Li, post doctorate
• Phone: 010-87788713
• Email: Lining@cicams.ac.cn
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 20, 2023
• Completion date: June 30, 2027