Clinical Study of CVL006 Combination With 9MW2821

NCT07615660 | Not Yet Recruiting Phase 1

• 1 other identifier: CVL006-T1003
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Advanced Solid Tumor

Keywords

Advanced Solid Tumor; Combination medication; DLT; RP2D

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure

  DLT（Dose-Limiting Toxicity and RP2D（ Recommended Phase 2 Dose）of phase I in patients with advanced solid tumors

  From date of randomization until the date of first documented progression, assessed up to 36 months

Secondary Outcomes (1)

• Secondary Outcome Measure

  From date of randomization until the date of first documented progression, assessed up to 36 months

Study Arms (3)

Arm 1：

EXPERIMENTAL

Arm 1：CVL006 10 mg/kg +9MW2821 1.5mg/kg D1/D15 Q4W，

Drug: CVL006 in combination with 9MW2821

Arm 2：

EXPERIMENTAL

Arm 2：CVL006 20 mg/kg +9MW2821 1.5mg/kg D1/D15 Q4W，

Drug: CVL006 in combination with 9MW2821

Arm3：

EXPERIMENTAL

Arm3： CVL006 20 mg/kg D1/D15 +9MW2821 1.25mg/kg D1/D8/D15 Q4W。

Drug: CVL006 in combination with 9MW2821

Interventions

CVL006 in combination with 9MW2821 DRUG

CVL006 in combination with 9MW2821

Arm 1：; Arm 2：

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• \. 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).
• 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:

Sponsors & Collaborators

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

Central Study Contacts

Qiong Wang

CONTACT

（021）6877 3638; qiong.wang@convalife.com

Chunhui Shi

CONTACT

（021）6877 3638; chunhui.shi@convalife.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 29, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share