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

NCT06183736 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: CVL237-P2001
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Solid Tumors

Keywords

PTEN deficiency; gastric cancer; prostate cancer; endometrial cancer; colorectal cancer; lung cancer; breast cancer; melanoma; CVL237 Tablets

Outcome Measures

Primary Outcomes (1)

• 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)

  Throughout the study for approximately 2 years

Secondary Outcomes (4)

• Duration of response (DOR)

  Throughout the study for approximately 2 years

• Disease control rate (DCR)

  Throughout the study for approximately 2 years

• Progression-free survival (PFS)

  Throughout the study for approximately 2 years

• Overall survival (OS)

  Throughout the study for approximately 2 years

Study Arms (1)

Single-arm

EXPERIMENTAL

This is a single-arm, open-label, multicenter, phase II study of CVL237 tablets in the treatment of advanced solid tumors with PTEN deficiency.All patients will be given CVL237 tablets, 200 mg, taken with food once daily for 28 consecutive days as a treatment cycle.

Drug: CVL237 tablets

Interventions

CVL237 tablets DRUG

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

Single-arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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;
• Eastern Cooperative Oncology Group (ECOG) score: 0-2;
• Expected survival time of more than 3 months;
• Good organ function level:
• Absolute neutrophil count (ANC)≥ 1.5 × 10\^9/L
• Platelets (PLT)≥ 75 × 10\^9/L
• Hemoglobin (Hb)≥ 90 g/L
• Total bilirubin (TBIL)≤ 1.5 × ULN
• Alanine aminotransferase (ALT)≤ 2.5 × ULN;Patients with liver metastases or liver cancer: ≤ 5 × ULN
• Aspartate aminotransferase (AST)≤ 2.5 × ULN;Patients with liver metastases or liver cancer: ≤ 5 × ULN
• Serum creatinine clearance (Ccl)≤ 1.5 × ULN, or ≥ 60 mL/min (calculated according to the Cockcroft-Gault formula)
• Activated partial thromboplastin time (APTT)≤ 1.5 × ULN

You may not qualify if:

• 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);
• Participated as a subject in a clinical trial within 4 weeks prior to the first dose of the study drug;
• Patients who have undergone major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first dose of the study drug, or require selective surgery during the study;
• Previously received allogeneic bone marrow transplantation or solid organ transplantation;
• Presence of third space fluid accumulation (such as massive pleural effusion and ascites) that cannot be controlled by drainage or other methods;
• The adverse reactions to previous antitumor treatment have not recovered to CTCAE 5.0 grade ≤ 1 (except for alopecia and other toxicities judged by the investigator to have no safety risk);
• Patients with active brain metastasis, meningeal metastasis and central nervous system (CNS) involvement, who are not suitable for enrollment as judged by the investigator;
• Participants with impairment of gastrointestinal (GI) function or GI disease that, in the judgment of the investigator, could significantly alter the absorption of the study drug (e.g., ulcerative disease, uncontrollable nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection);
• Subjects with a history of acute pancreatitis within 1 year prior to screening or subjects with a previous history of chronic pancreatitis;
• Uncontrolled pulmonary fibrosis, acute lung disease, interstitial lung disease, FEV1 (post-bronchiectasis) \< 70% predicted value at screening, or hepatic failure, etc.;
• Patients with active viral, bacterial, fungal or other infections requiring systemic treatment (such as active pulmonary tuberculosis), excluding nail bed fungal infection;
• Patients with HBV or HCV infection (defined as HbsAg and/or HbcAb positive and HBV DNA copies ≥ 1 × 104 copies/mL or ≥ 2000 IU/mL) or acute or chronic active hepatitis C;

Sponsors & Collaborators

• Convalife (Shanghai) Co., Ltd.: lead

Study Sites (1)

Li Ning

Beijing, Beijing Municipality, 100010, China

Location

MeSH Terms

Conditions

Stomach Neoplasms; Prostatic Neoplasms; Endometrial Neoplasms; Colorectal Neoplasms; Lung Neoplasms; Breast Neoplasms; Melanoma

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms

Central Study Contacts

Ning Li, post doctorate

CONTACT

010-87788713; Lining@cicams.ac.cn

Shuhang Wang

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2023
• First Posted: December 27, 2023
• Study Start: December 20, 2023
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2027
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)