Locally Advanced or Metastatic Solid TumorsPhase 2NCT07446049
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
A Phase 2 study testing CVL237 tablets in people with Locally Advanced or Metastatic Solid Tumors and PTEN Loss or Low Expression, run by Convalife (Shanghai) Co., Ltd..
Trial summary
This is 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced or Metastatic Solid Tumors, PTEN Loss or Low Expression
- What is being tested?
- CVL237 tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 8 Apr 2028
- 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 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;
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- 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;
- Voluntarily participating in this clinical trial, understanding the study procedures, and being able to provide written informed consent.
Who cannot join
- Surgery or Trauma: Undergone major organ surgery or experienced significant trauma within 4 weeks before the first administration of the study drug, or requires elective surgery during the trial period; undergone core needle biopsy or other minor surgeries (excluding central venous catheterization or port-a-cath implantation) within 7 days before the first dose;
- Insufficient Washout Period for Prior Anti-tumor Treatments;
- Inability to Swallow, Chronic Diarrhea, or Bowel Obstruction: Presence of factors that may affect the intake and absorption of the study drug;
- Unhealed Wounds or Interventions: Unhealed wounds, abdominal fistulas, gastrointestinal stent placement, or extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months before the first dose;
- Uncontrolled Effusions: Presence of uncontrolled pleural effusion, ascites, or pericardial effusion;
- Concurrent Use of Certain Medications: Currently using medications that are substrates of OATP1B1 and OATP1B3, CYP3A4/5 substrates, moderate or strong CYP3A4/5 inhibitors, or strong CYP3A4/5 inducers, and cannot discontinue or switch to alternative treatments before starting the study treatment;
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- Central Nervous System (CNS) Metastases or Meningitis: Participants with untreated or active CNS metastases (e.g., brain edema, requiring steroid intervention, or progressive brain metastases) and/or carcinomatous meningitis. However, participants with CNS metastases who have received adequate local treatment (surgery or radiotherapy) and have no progression on imaging at screening after completion of local treatment may be eligible. Participants must have stable neurological symptoms for at least 2 weeks before the first dose and not require corticosteroid treatment;
- History of Severe Allergic Reactions: Known history of severe allergic reactions to multiple medications;
- Immune-related Adverse Events (irAEs): Participants who experienced ≥ Grade 3 irAEs or ≥ Grade 2 immune-related myocarditis during prior immunotherapy are not eligible;
- Active or Potentially Recurrent Autoimmune Diseases: Participants with any active or history of autoimmune diseases that may recur (e.g., systemic lupus erythematosus, rheumatoid arthritis, vasculitis), except for clinically stable autoimmune thyroid disease or Type I diabetes;
- Systemic Corticosteroid or Immunosuppressive Therapy: Participants who received systemic corticosteroids (prednisone > 10 mg/day or equivalent) or other immunosuppressive agents within 14 days before the first dose of study drug. Exceptions include: Use of topical, ocular, intra-articular, nasal, or inhaled corticosteroids; Short-term (≤7 days) use of corticosteroids (≤10 mg prednisone equivalent) for prophylaxis or treatment of non-autoimmune allergic conditions (e.g., preventing contrast agent allergy);
- Interstitial Pneumonia or Severe Pulmonary Diseases: Known or suspected interstitial pneumonia; other severe pulmonary diseases significantly affecting respiratory function within 3 months before the first dose, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia/bronchiolitis obliterans; non-infectious pulmonary inflammation requiring steroid treatment;
- Infectious Diseases: Positive HIV test; participants with active chronic hepatitis B or active hepatitis C. Carriers of hepatitis B virus, stable hepatitis B after treatment (HBV DNA copy number below the detection limit of the testing center or deemed stable by the investigator), and cured hepatitis C patients (HCV RNA test result below the detection limit of the testing center) may be eligible;
- Unresolved Adverse Events from Prior Anti-tumor Treatment: Adverse events from prior anti-tumor treatment that have not resolved to ≤ Grade 1 (CTCAE 5.0), except for alopecia or other toxicities deemed non-threatening by the investigator;
- Severe Infections: Severe infection within 4 weeks before starting study treatment, including but not limited to bacteremia; active infection within 2 weeks before starting treatment requiring intravenous antibiotics;
- Active Tuberculosis: History or CT evidence of active pulmonary tuberculosis within 1 year before enrollment;
- Serious Cardiovascular or Cerebrovascular Events: Acute coronary syndrome, congestive heart failure (NYHA functional class ≥ II), aortic dissection, cerebral hemorrhage, stroke, or deep vein thrombosis within 6 months before the first dose;
- Vaccination: Received live or attenuated vaccines within 30 days before the first dose of study drug, or planned to receive live or attenuated vaccines during the trial;
- Other Primary Malignancies: History of other primary malignancies within 5 years before the first dose, except for cured basal cell carcinoma, squamous cell carcinoma of the skin, cervical carcinoma in situ, etc;
- History of Allogeneic Organ or Hematopoietic Stem Cell Transplantation: Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplantation；
- Other Conditions Deemed Ineligible by the Investigator: Such as alcohol or drug abuse, history of significant neurological or psychiatric disorders (e.g., epilepsy, dementia), or poor compliance.
About this study
This is 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
Read the detailed description
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
- Being tested
- CVL237 tablets
- Keywords
- CVL237, Patients with PTEN loss or low expression, Patients with locally advanced or metastatic solid tumors, gastric cancer, endometrial cancer, cervical cancer, ovarian cancer, lung cancer, breast cancer, other tumor types
- Medical subject headings
- Stomach Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Ovarian Neoplasms, Lung Neoplasms, Breast Neoplasms
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 |
|---|---|---|
| CVL237 tablets | Experimental | Two predefined doses of CVL237 tablets are set (100 mg/day and 200 mg/day). The starting dose is 100 mg/day, taken orally with food, once daily, continuously, with each treatment cycle lasting 28 days. Participants should take the medication at approximately the same time each day. Serplulimab injection, 200 mg, will be administered via intravenous infusion every 2 weeks. Each 28-day period constitutes one treatment cycle in this study. When dosing on the same day, CVL237 tablets should be taken orally first, followed by an intravenous infusion of Serplulimab at least 30 minutes later.
Dose Level 1: CVL237 tablet 100 mg + Serplulimab injection 200 mg, intravenous infusion every 2 weeks;
Dose Level 2: CVL237 tablet 200 mg + Serplulimab injection 200 mg, intravenous infusion every 2 weeks. Receives: Drug: CVL237 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary study endpoints
Phase Ib: DLT (Dose-Limiting Toxicity)
Measured: Up to day 28
Primary Outcome Measure
Phase Ib: RP2D (Recommended Phase 2 Dose)
Measured: up to day 28
Primary Outcome Measure
Phase Ib: MTD (Maximum Tolerated Dose) of CVL237 in combination with Serplulimab injection in patients with advanced solid tumors characterized by PTEN loss or low expression;
Measured: up to day 28
Primary Study Endpoints
Phase II: Progression-free survival (PFS) assessed according to RECIST v1.1 criteria.
Measured: Up to day 90
Secondary outcomes (4)
Secondary Endpoints：
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
Secondary Study Endpoints
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
Secondary Study Endpoints
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
Secondary Study Endpoints
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 posted3 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion9 Jan 2028 (estimated)
- Study completion8 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic 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
- 180 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
- NCT07446049
- Sponsor's protocol ID
- CVL237-S1001
- Status last verified
- Feb 2026
- First submitted
- 26 Jun 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07446049
- Acronym / sponsor ID
- CVL237-S1001
- Keywords
- CVL237, Patients with PTEN loss or low expression, Patients with locally advanced or metastatic solid tumors, gastric cancer, endometrial cancer, cervical cancer, ovarian cancer, lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Convalife (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 9 Jan 2028 (estimated)
- Study completion
- 8 Apr 2028 (estimated)
- First posted
- 3 Mar 2026 (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 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
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CVL237 tablets | Experimental | Drug: CVL237 tabletsTwo predefined doses of CVL237 tablets are set (100 mg/day and 200 mg/day). The starting dose is 100 mg/day, taken orally with food, once daily, continuously, with each treatment cycle lasting 28 days. Participants should take the medication at approximately the same time each day. Serplulimab injection, 200 mg, will be administered via intravenous infusion every 2 weeks. Each 28-day period constitutes one treatment cycle in this study. When dosing on the same day, CVL237 tablets should be taken orally first, followed by an intravenous infusion of Serplulimab at least 30 minutes later. Dose Level 1: CVL237 tablet 100 mg + Serplulimab injection 200 mg, intravenous infusion every 2 weeks; Dose Level 2: CVL237 tablet 200 mg + Serplulimab injection 200 mg, intravenous infusion every 2 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (21 listed)
- Surgery or Trauma: Undergone major organ surgery or experienced significant trauma within 4 weeks before the first administration of the study drug, or requires elective surgery during the trial period; undergone core needle biopsy or other minor surgeries (excluding central venous catheterization or port-a-cath implantation) within 7 days before the first dose;
- Insufficient Washout Period for Prior Anti-tumor Treatments;
- Inability to Swallow, Chronic Diarrhea, or Bowel Obstruction: Presence of factors that may affect the intake and absorption of the study drug;
- Unhealed Wounds or Interventions: Unhealed wounds, abdominal fistulas, gastrointestinal stent placement, or extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months before the first dose;
- Uncontrolled Effusions: Presence of uncontrolled pleural effusion, ascites, or pericardial effusion;
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 | CVL237 tablets |
Primary outcome
Primary study endpoints
Time frame: Up to day 28
Phase Ib: DLT (Dose-Limiting Toxicity)
Primary Outcome Measure
Time frame: up to day 28
Phase Ib: RP2D (Recommended Phase 2 Dose)
Primary Outcome Measure
Time frame: up to day 28
Phase Ib: MTD (Maximum Tolerated Dose) of CVL237 in combination with Serplulimab injection in patients with advanced solid tumors characterized by PTEN loss or low expression;
Primary Study Endpoints
Time frame: Up to day 90
Phase II: Progression-free survival (PFS) assessed according to RECIST v1.1 criteria.
4 secondary outcomes
Secondary Endpoints：
Time frame: Throughout the study for approximately 2 years
Secondary Study Endpoints
Time frame: Throughout the study for approximately 2 years
Secondary Study Endpoints
Time frame: Throughout the study for approximately 2 years
Secondary Study Endpoints
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 3 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CVL237 tablets in people with Locally Advanced or Metastatic Solid Tumors and PTEN Loss or Low Expression, run by Convalife (Shanghai) Co., Ltd..
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 9 inclusion and 21 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 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary study endpoints (time frame: Up to day 28). The study lists 4 primary outcomes in all. 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 3 Mar 2026.