Advanced Solid TumorsPhase 2NCT06183736
CVL237 Tablets in the Treatment of Advanced Solid Tumors With PTEN Deficiency
A Phase 2 study testing CVL237 tablets in people with Advanced Solid Tumors, run by Convalife (Shanghai) Co., Ltd. at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- CVL237 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2023to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 19Show fewer
- 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
- International Normalized Ratio (INR)≤ 1.5 × ULN
- Ejection fraction (LVEF) ≥ 50% and Fridericia-corrected QT interval (QTcF) < 450 ms for males and < 470 ms for females
- Eligible patients (males and females) of childbearing potential must agree to use a reliable method of contraception (hormonal or barrier method or abstinence) with their partner during the study and for at least 180 days after the last dose; Females of childbearing potential must not be breastfeeding, and females of childbearing potential must have a negative pregnancy test before the start of dosing;
- Voluntarily participate in this clinical trial, understand the study procedures and be able to sign the ICF in writing.
Who cannot join
- 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;
Show all 20Show fewer
- 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;
- Patients with a history of immune deficiency, including positive HIV test, or other acquired or congenital immune deficiency diseases, or a history of organ transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation;
- Had any heart disease within 6 months, including: (1) Angina pectoris; (2) Arrhythmia that requires medication or is clinically significant; (3) Myocardial infarction; (4) Cardiac failure; (5) Patients with any other heart disease judged by the investigator to be unsuitable for this study;
- Other concomitant diseases that seriously jeopardize the safety of the patient or affect the completion of the study [e.g. Uncontrolled hypertension (systolic/diastolic blood pressure ≥ 140/90 mmHg after administration of antihypertensive drugs), diabetes mellitus (HbA1c ≥ 8.0% (63.9 mmol/mol), thyroid disease, etc.] according to the judgment of the investigator;
- Received a live vaccine within 30 days prior to the first dose of the study drug, or plan to receive a live vaccine during the study;
- The investigator considers that there are other reasons for the unsuitability of the subject participating in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shuhang Wang contact
China1 site
Li Ning
Beijing, Beijing Municipality, 100010
Li Ning, 010-87788713, Lining@cicams.ac.cn
About this study
Official title: A Single-arm, Open-label, Multicenter, Phase II Study of CVL237 Tablets in the Treatment of Advanced Solid Tumors With PTEN Deficiency
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.
Read the detailed 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."
- Conditions
- Advanced Solid Tumors
- Being tested
- CVL237 tablets
- Keywords
- PTEN deficiency, gastric cancer, prostate cancer, endometrial cancer, colorectal cancer, lung cancer, breast cancer, melanoma, CVL237 Tablets
- Medical subject headings
- Stomach Neoplasms, Prostatic Neoplasms, Endometrial Neoplasms, Colorectal Neoplasms, Lung Neoplasms, Breast Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVL237 tabletsDrug
CVL237 tablets, 200 mg, taken with food once daily for 28 consecutive days as a treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: CVL237 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Throughout the study for approximately 2 years
Secondary outcomes (4)
Duration of response (DOR)
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.
Measured: Throughout the study for approximately 2 years
Disease control rate (DCR)
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
Measured: Throughout the study for approximately 2 years
Progression-free survival (PFS)
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;
Measured: Throughout the study for approximately 2 years
Overall survival (OS)
Overall survival (OS), defined as the time from enrollment to death due to any cause. Efficacy of each tumor type will be analyzed independently.
Measured: Throughout the study for approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start20 Dec 2023 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Convalife (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183736
- Sponsor's protocol ID
- CVL237-P2001
- Status last verified
- Dec 2023
- First submitted
- 26 Nov 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label, Multicenter, Phase II Study of CVL237 Tablets in the Treatment of Advanced Solid Tumors With PTEN Deficiency
- ClinicalTrials.gov ID
- NCT06183736
- Acronym / sponsor ID
- CVL237-P2001
- Conditions
- Advanced Solid Tumors
- Keywords
- PTEN deficiency, gastric cancer, prostate cancer, endometrial cancer, colorectal cancer, lung cancer, breast cancer, melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Convalife (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Dec 2023 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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."
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm | Experimental | Drug: CVL237 tabletsThis 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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;
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CVL237 tabletsCVL237 tablets, 200 mg, taken with food once daily for 28 consecutive days as a treatment cycle. | Drug | Single-arm |
Primary outcome
Objective response rate (ORR) in patients with PTEN deficiency as assessed according to RECIST v1.1
Time frame: Throughout the study for approximately 2 years
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)
4 secondary outcomes
Duration of response (DOR)
Time frame: Throughout the study for approximately 2 years
Disease control rate (DCR)
Time frame: Throughout the study for approximately 2 years
Progression-free survival (PFS)
Time frame: Throughout the study for approximately 2 years
Overall survival (OS)
Time frame: Throughout the study for approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shuhang Wang contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CVL237 tablets in people with Advanced Solid Tumors, run by Convalife (Shanghai) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ning Li, post doctorate (010-87788713, Lining@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) in patients with PTEN deficiency as assessed according to RECIST v1.1 (time frame: Throughout the study for approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.