Advanced Solid TumorPhase 1/2CVL006-T1003NCT07615660
Clinical Study of CVL006 Combination With 9MW2821
A Phase 1/2 study testing CVL006 in combination with 9MW2821 in people with Advanced Solid Tumor, run by Convalife (Shanghai) Co., Ltd..
Trial summary
This study is a multi-center, open-label, dose-escalation and dose-optimized phase I/II clinical trial. Objective: To determine the safety, tolerability, PK characteristics and preliminary efficacy data of CVL006 combined with 9MW821 patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- CVL006 in combination with 9MW2821
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2026to 30 Apr 2029
- Phase
- Phase 1/2
- 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
- Age: 18-75 years old (inclusive), no restriction on gender.
- Patients with histologically or cytologically confirmed advanced solid tumors. Cohort A: Squamous cell carcinoma of the head and neck; the primary tumor must arise from the oral cavity, oropharynx, hypopharynx or larynx, excluding nasopharyngeal tumors, salivary gland tumors and/or parotid gland tumors.
- For Phase Ib participants: Advanced solid tumors with failure of prior standard therapy. For Phase II part, Cohort A: Recurrent or metastatic disease not curable by local therapy. Participants must have no prior systemic therapy, unless the prior systemic therapy was completed more than 6 months ago as adjuvant or neoadjuvant treatment. Participants who received prior PD-1/PD-L1 inhibitors in curative therapy are eligible if at least 12 months have elapsed since the last dose of anti-PD-L1 agent. Cohort B: No prior systemic therapy for locally advanced or metastatic disease. For patients who received adjuvant/neoadjuvant therapy or curative chemoradiotherapy, disease progression within 6 months after the last treatment is regarded as first-line setting.
- For Phase II: PD-L1 Combined Positive Score (CPS) ≥ 1 confirmed by local or central immunohistochemistry (IHC). If no PD-L1 testing result is available, participants shall submit archived or fresh tumor tissue samples during screening for central laboratory testing of programmed death ligand-1 (PD-L1) and Nectin4. The central PD-L1 testing result must be obtained prior to enrollment. Participants with known PD-L1 results confirming CPS ≥ 1 shall submit archived or fresh tissue samples for exploratory analysis within 5 days after enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1.
- Estimated survival time ≥ 3 months.
Show all 13Show fewer
- At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
- Adequate bone marrow and organ function (no blood components and/or hematopoietic growth factors administered within 14 days prior to the initiation of study treatment):
- Hemoglobin (HB) ≥ 90 g/L; Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹/L; Platelet (PLT) ≥ 90×10⁹/L; Total bilirubin < 1.5×ULN (for participants with confirmed Gilbert's syndrome, total bilirubin ≤ 3×ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3×ULN; Serum creatinine ≤ 1.5×ULN or creatinine clearance ≥ 60 mL/min (calculated by the Cockcroft-Gault formula); nternational Normalized Ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5×ULN;
- Urinalysis protein ≤ 1+; or if urine protein ≥ 2+, 24-hour urine protein < 1 g.
- Females of childbearing potential must agree to abstain from heterosexual intercourse or use highly effective contraceptive methods from the signing of informed consent until at least 6 months after the last dose of study drug. Serum HCG test must be negative within 7 days prior to study treatment initiation, and participants must be non-lactating. (A positive serum pregnancy test requires exclusion of pregnancy, and enrollment can only be confirmed after discussion with the sponsor.)
- Male patients with female partners of childbearing potential must agree to abstain from intercourse or use highly effective contraceptive methods from the signing of informed consent until at least 6 months after the last dose of study drug. Male participants must also agree not to donate sperm during the same period.
- Participants voluntarily join the study, sign the informed consent form, and have good treatment compliance.
Who cannot join
- 1. Participants with active central nervous system (CNS) metastases are excluded. Participants with previously treated CNS metastases are eligible only if all of the following criteria are met: The CNS metastases have been clinically stable for ≥ 6 weeks prior to screening; If steroid therapy is required for CNS metastases, participants are on a stable steroid dose equivalent to ≤ 20 mg/day prednisone for at least 2 weeks; Baseline imaging shows no evidence of new or enlarging brain metastases; Participants have no leptomeningeal disease.
- Participants with other malignant tumors within 5 years prior to the first dose of study drug, except adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, locally confined prostate cancer after radical resection, ductal carcinoma in situ after radical resection, and papillary thyroid carcinoma after radical resection.
- Participants with tumors judged by the Investigator to be prone to bleeding, including those with imaging evidence of tumor invasion into or encasement of major blood vessels on screening imaging.
- Participants with prior exposure to VEGF/PD-1 (PD-L1) bispecific antibodies or Nectin4-targeted therapy.
- Participants with severe cardiovascular and cerebrovascular diseases, including but not limited to:
- Severe cardiac rhythm or conduction abnormalities within 6 months prior to the first study drug dose, such as ventricular arrhythmias requiring clinical intervention, second- or third-degree atrioventricular block; History of acute coronary syndrome, congestive heart failure (New York Heart Association [NYHA] functional class ≥ II), or aortic dissection within 6 months prior to the first dose; History of arteriovenous thromboembolic events within 6 months prior to the first dose, such as cerebrovascular accident (transient ischemic attack, cerebral hemorrhage, stroke), deep vein thrombosis and pulmonary embolism; Left ventricular ejection fraction (LVEF) < 50% within 28 days prior to the first dose; Mean QTcF interval averaged from 3 baseline 12-lead (or more) electrocardiograms at rest: QTcF > 470 ms (female) or QTcF > 450 ms (male).
Show all 27Show fewer
- Participants with persistent clinically significant toxicities (≥ Grade 2, alopecia excluded) related to prior therapy (including systemic therapy, radiotherapy or surgery). Participants with persistent ≥ Grade 2 immune-related hypothyroidism or panhypopituitarism are excluded. Participants with persistent immune-related colitis, uveitis, myocarditis, pneumonitis, or other immune-related adverse events requiring high-dose steroid therapy (> 20 mg/day prednisone or equivalent) are excluded. Participants with well-controlled ≤ Grade 2 immune-related hypothyroidism or panhypopituitarism on stable hormone replacement therapy (if applicable) are eligible. Participants with ≥ Grade 2 sensory or motor neuropathy are excluded.
- Participants with active autoimmune diseases or a history of autoimmune diseases prone to recurrence (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis), excluding clinically stable autoimmune thyroid disease and type 1 diabetes mellitus.
- Participants who have undergone major surgery within 4 weeks prior to the first study drug dose; received radiotherapy, chemotherapy, biological agents, investigational drugs, and/or immunotherapy for antitumor purposes within 2 weeks prior to the first dose; or received traditional Chinese medicine with antitumor indications within 2 weeks prior to the first dose.
- Participants with a history of steroid-dependent (non-infectious) pneumonitis/interstitial lung disease or currently suffering from such diseases; history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonia; or evidence of active pneumonitis on chest CT during screening.
- Participants judged by the Investigator to have an expected survival of less than 3 months and/or rapidly progressive disease (e.g., tumor bleeding, uncontrolled tumor pain).
- Participants with a history of esophageal gastric varices, severe peptic ulcer, unhealed wounds, abdominal fistula, intra-abdominal abscess or acute gastrointestinal bleeding within 6 months prior to the first dose; history of gastrointestinal perforation and/or fistula, severe gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), or extensive intestinal resection (partial colectomy or extensive small bowel resection) within 6 months prior to the first dose.
- Participants with a history of immunodeficiency including positive HIV test; active hepatitis B infection (HBV DNA above the upper limit of normal of the local study center) or hepatitis C infection (anti-HCV positive and HCV RNA above the lower limit of quantification of the assay).
- Participants with active pulmonary tuberculosis infection within 1 year prior to enrollment confirmed by medical history or CT examination; or those with a history of active pulmonary tuberculosis infection more than 1 year ago without standard anti-tuberculosis treatment.
- Participants with a history of bleeding tendency or coagulation disorders and/or clinically significant bleeding symptoms or risks within 4 weeks prior to the first dose, including but not limited to:
- a. Gastrointestinal bleeding;
- b. Hemoptysis (coughing up ≥ 15 mL fresh blood or blood clots);
- c. Epistaxis;
- d. Receiving therapeutic anticoagulation prior to the first dose.
- Participants with a history of hypertensive crisis or hypertensive encephalopathy; persistent hypertension within 1 month prior to the first dose with systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg despite oral antihypertensive treatment.
- Participants with uncontrolled diabetes within 3 months prior to the first study treatment dose, defined as: Glycated hemoglobin (HbA1c) ≥ 8%; or HbA1c between 7% and < 8% accompanied by unexplained diabetes-related symptoms (polyuria or polydipsia).
- Participants with active or prior history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis or chronic diarrhea).
- Participants with a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Participants who have received live attenuated vaccines within 30 days prior to the first dose or plan to receive live vaccines during the study period.
- Participants with known active keratitis or corneal ulcer are excluded; participants with superficial punctate keratitis under adequate treatment are allowed to be enrolled.
- Participants requiring use of strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) within 2 weeks prior to the first study dose and during the study period (concomitant use of strong CYP3A4 inhibitors or inducers is prohibited; representative drugs are listed in the appendix).
- Participants with any other conditions judged by the Investigator that may interfere with study results or lead to premature study termination, such as alcohol abuse, drug abuse, uncontrolled severe diseases (including psychiatric disorders) requiring combined medication, significantly abnormal laboratory parameters, family/social factors, or any other conditions that may compromise participant safety or affect study data collection.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase Ib/II Clinical Study of CVL006 Combination With 9MW2821 in Advanced Solid Tumors
This study is a multi-center, open-label, dose-escalation and dose-optimized phase I/II clinical trial. Objective: To determine the safety, tolerability, PK characteristics and preliminary efficacy data of CVL006 combined with 9MW821 patients with advanced solid tumors.
Read the detailed description
In this Phase Ib study, dose escalation of CVLL006 combined with 9MW2821 (at a fixed dose) will be conducted using a 3+3 design:
Initially, 3 study participants will be enrolled into the starting dose level for DLT observation.
If no DLT occurs in all 3 participants after completion of the DLT observation period, dose escalation to the next dose level may proceed.
If 1 out of the 3 participants experiences a DLT, an additional 3 participants will be enrolled.
If no DLT is observed in the additional 3 participants, dose escalation to the next dose level may proceed.
If a DLT occurs in any of the additional 3 participants, dose escalation will be terminated.
If ≥2 out of the initial 3 participants experience DLTs, dose escalation will be terminated immediately.
Under normal circumstances, each study participant will receive study drug from only one dose level, and intra-individual dose escalation is not permitted.
The addition of new dosing schedules and dose levels will be determined through discussion between the investigator and the sponsor, based on available study data including safety, tolerability, pharmacokinetic (PK), and efficacy profiles.
If a participant fails to complete the DLT observation period for reasons other than DLT (including but not limited to withdrawal from the study during the DLT observation period), a replacement participant may be enrolled.
- Conditions
- Advanced Solid Tumor
- Being tested
- CVL006 in combination with 9MW2821
- Keywords
- Advanced Solid Tumor, Combination medication, DLT, RP2D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVL006 in combination with 9MW2821Drug
CVL006 in combination with 9MW2821
CVL006 in combination with 9MW2821Drug
CVL006 in combination with 9MW2821
| Study group | Role | What they receive |
|---|---|---|
| Arm 1： | Experimental | Arm 1：CVL006 10 mg/kg +9MW2821 1.5mg/kg D1/D15 Q4W， Receives: Drug: CVL006 in combination with 9MW2821 |
| Arm 2： | Experimental | Arm 2：CVL006 20 mg/kg +9MW2821 1.5mg/kg D1/D15 Q4W， Receives: Drug: CVL006 in combination with 9MW2821 |
| Arm3： | Experimental | Arm3： CVL006 20 mg/kg D1/D15 +9MW2821 1.25mg/kg D1/D8/D15 Q4W。 Receives: Drug: CVL006 in combination with 9MW2821 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
DLT（Dose-Limiting Toxicity and RP2D（ Recommended Phase 2 Dose）of phase I in patients with advanced solid tumors
Measured: From date of randomization until the date of first documented progression, assessed up to 36 months
Secondary outcomes (1)
Secondary Outcome Measure
Efficacy endpoints for Phase I and Phase II: Evaluated by the investigators based on RECISTv1.1 criteria, including objective response rate (ORR)
Measured: From date of randomization until the date of first documented progression, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start15 May 2026 (estimated)
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study is a multi-center, open-label, dose-escalation and dose-optimized phase I/II clinical trial. Objective: To determine the safety, tolerability, PK characteristics and preliminary efficacy data of CVL006 combined with 9MW2821 in patients with advanced solid tumors.
- Masking
- None (open label)
- Enrolment
- 108 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
- NCT07615660
- Sponsor's protocol ID
- CVL006-T1003
- Acronym
- CVL006-T1003
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/II Clinical Study of CVL006 Combination With 9MW2821 in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07615660
- Acronym / sponsor ID
- CVL006-T1003 / CVL006-T1003
- Conditions
- Advanced Solid Tumor
- Keywords
- Advanced Solid Tumor, Combination medication, DLT, RP2D
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Convalife (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 29 May 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 study is a multi-center, open-label, dose-escalation and dose-optimized phase I/II clinical trial. Objective: To determine the safety, tolerability, PK characteristics and preliminary efficacy data of CVL006 combined with 9MW821 patients with advanced solid tumors.
Detailed description
In this Phase Ib study, dose escalation of CVLL006 combined with 9MW2821 (at a fixed dose) will be conducted using a 3+3 design:
Initially, 3 study participants will be enrolled into the starting dose level for DLT observation.
If no DLT occurs in all 3 participants after completion of the DLT observation period, dose escalation to the next dose level may proceed.
If 1 out of the 3 participants experiences a DLT, an additional 3 participants will be enrolled.
If no DLT is observed in the additional 3 participants, dose escalation to the next dose level may proceed.
If a DLT occurs in any of the additional 3 participants, dose escalation will be terminated.
If ≥2 out of the initial 3 participants experience DLTs, dose escalation will be terminated immediately.
Under normal circumstances, each study participant will receive study drug from only one dose level, and intra-individual dose escalation is not permitted.
The addition of new dosing schedules and dose levels will be determined through discussion between the investigator and the sponsor, based on available study data including safety, tolerability, pharmacokinetic (PK), and efficacy profiles.
If a participant fails to complete the DLT observation period for reasons other than DLT (including but not limited to withdrawal from the study during the DLT observation period), a replacement participant may be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study is a multi-center, open-label, dose-escalation and dose-optimized phase I/II clinical trial. Objective: To determine the safety, tolerability, PK characteristics and preliminary efficacy data of CVL006 combined with 9MW2821 in patients with advanced solid tumors.
| Arm | Type | Receives |
|---|---|---|
| Arm 1： | Experimental | Drug: CVL006 in combination with 9MW2821Arm 1：CVL006 10 mg/kg +9MW2821 1.5mg/kg D1/D15 Q4W， |
| Arm 2： | Experimental | Drug: CVL006 in combination with 9MW2821Arm 2：CVL006 20 mg/kg +9MW2821 1.5mg/kg D1/D15 Q4W， |
| Arm3： | Experimental | Drug: CVL006 in combination with 9MW2821Arm3： CVL006 20 mg/kg D1/D15 +9MW2821 1.25mg/kg D1/D8/D15 Q4W。 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age: 18-75 years old (inclusive), no restriction on gender.
- Patients with histologically or cytologically confirmed advanced solid tumors. Cohort A: Squamous cell carcinoma of the head and neck; the primary tumor must arise from the oral cavity, oropharynx, hypopharynx or larynx, excluding nasopharyngeal tumors, salivary gland tumors and/or parotid gland tumors.
- For Phase Ib participants: Advanced solid tumors with failure of prior standard therapy. For Phase II part, Cohort A: Recurrent or metastatic disease not curable by local therapy. Participants must have no prior systemic therapy, unless the prior systemic therapy was completed more than 6 months ago as adjuvant or neoadjuvant treatment. Participants who received prior PD-1/PD-L1 inhibitors in curative therapy are eligible if at least 12 months have elapsed since the last dose of anti-PD-L1 agent. Cohort B: No prior systemic therapy for locally advanced or metastatic disease. For patients who received adjuvant/neoadjuvant therapy or curative chemoradiotherapy, disease progression within 6 months after the last treatment is regarded as first-line setting.
- For Phase II: PD-L1 Combined Positive Score (CPS) ≥ 1 confirmed by local or central immunohistochemistry (IHC). If no PD-L1 testing result is available, participants shall submit archived or fresh tumor tissue samples during screening for central laboratory testing of programmed death ligand-1 (PD-L1) and Nectin4. The central PD-L1 testing result must be obtained prior to enrollment. Participants with known PD-L1 results confirming CPS ≥ 1 shall submit archived or fresh tissue samples for exploratory analysis within 5 days after enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1.
Key exclusion criteria (27 listed)
- 1. Participants with active central nervous system (CNS) metastases are excluded. Participants with previously treated CNS metastases are eligible only if all of the following criteria are met: The CNS metastases have been clinically stable for ≥ 6 weeks prior to screening; If steroid therapy is required for CNS metastases, participants are on a stable steroid dose equivalent to ≤ 20 mg/day prednisone for at least 2 weeks; Baseline imaging shows no evidence of new or enlarging brain metastases; Participants have no leptomeningeal disease.
- Participants with other malignant tumors within 5 years prior to the first dose of study drug, except adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, locally confined prostate cancer after radical resection, ductal carcinoma in situ after radical resection, and papillary thyroid carcinoma after radical resection.
- Participants with tumors judged by the Investigator to be prone to bleeding, including those with imaging evidence of tumor invasion into or encasement of major blood vessels on screening imaging.
- Participants with prior exposure to VEGF/PD-1 (PD-L1) bispecific antibodies or Nectin4-targeted therapy.
- Participants with severe cardiovascular and cerebrovascular diseases, including but not limited to:
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 |
|---|---|---|
| CVL006 in combination with 9MW2821CVL006 in combination with 9MW2821 | Drug | Arm 1：, Arm 2： |
| CVL006 in combination with 9MW2821CVL006 in combination with 9MW2821 | Drug | Arm3： |
Primary outcome
Primary Outcome Measure
Time frame: From date of randomization until the date of first documented progression, assessed up to 36 months
DLT（Dose-Limiting Toxicity and RP2D（ Recommended Phase 2 Dose）of phase I in patients with advanced solid tumors
1 secondary outcome
Secondary Outcome Measure
Time frame: From date of randomization until the date of first documented progression, assessed up to 36 months
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 29 May 2026.
- Individual participant dataSharing planned: No
Related trials for Advanced Solid Tumor
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CVL006 in combination with 9MW2821 in people with Advanced Solid Tumor, 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 13 inclusion and 27 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 29 May 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Qiong Wang (（021）6877 3638, qiong.wang@convalife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure (time frame: From date of randomization until the date of first documented progression, assessed up to 36 months). 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 29 May 2026.