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

ConditionAdvanced Solid Tumors

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorConvalife (Shanghai) Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-75 years (including those of 18 and 75 years old; patients over 60 years old cannot have more than 3 kinds of complications of heart, lung, liver and kidney function at the same time); the sex is not limited;after standard treatment as determined by the investigator, or for whom there is no standard treatment, or who refuse the standard treatment;

PTEN deficiency will be determined based on analysis of patient tumor samples and by testing PTEN protein expression using immunohistochemistry (IHC) at the central laboratory;

Have at least one measurable lesion that meets the requirements of RECIST 1.1 ; If the lesion previously treated with local therapy (radiotherapy, ablation, interventional therapy, etc.) is the only lesion, there must be unequivocal imaging evidence of disease progression in this lesion;

Disqualifiers

Patients who have progressed on previous treatment with any PI3K, mTOR or AKT inhibitors (except for patients who dropped out due to intolerance);

Known hypersensitivity to any ingredient of CVL237;

Those requiring OATP1B1 and OATP1B3 substrate drugs, CYP3A4/5 substrate drugs, moderate and potent cytochrome P450 3A4/5 inhibitors, and potent inducers of cytochrome P450 3A4/5 for treatment;

Received chemotherapy, radiotherapy, immunotherapy, biological agents, molecular targeted therapy or endocrine therapy and other antitumor drugs within 4 weeks before the first dose of the study drug, except for the following: nitrosoureas or mitomycin C within 6 weeks before the first dose of the study drug; oral fluorouracils and small molecular targeted drugs within 2 weeks before the first dose of the study drug or 5 half-lives of the drug (whichever is shorter);

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

98 Participants

are divided into 1 treatment group

Group A: Single-armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Objective response rate (ORR) in patients with PTEN deficiency as assessed according to RECIST v1.1

objective response rate (ORR), which refers to the proportion of patients whose tumor shrinkage reaches a certain amount and maintains for a certain time, including complete response (CR) and partial response (PR)

Time frame