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Advanced Solid TumorPhase 1/2CVL006-T1002NCT07157956

CVL006 Combination Therapy in Advanced Solid Tumors

A Phase 1/2 study testing CVL006 combined with pemetrexed and carboplatin, CVL006 in combination with SKB264 and CVL006 in combination with DS-8201 in people with Advanced Solid Tumor, run by Convalife (Shanghai) Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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 pemetrexed + carboplatin/SKB264/ DS-8201a/ Enfortumab Vedotin in patients with advanced… 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 combined with pemetrexed and carboplatin, CVL006 in combination with SKB264 and CVL006 in combination with DS-8201
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
318 participants
Where
1 siteChina
Study dates
10 Sep 2025to 30 Dec 2028
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 to 75 years old (including both ends), gender not limited;
  • Stage I Arm1.1, Arm1.2, Arm1.3 and Arm1.4: Locally advanced, recurrent or metastatic solid tumors confirmed by histology or cytology, with previous treatment failure.
  • Phase II Arm2.1, Arm2.2, Arm2.5 and Arm2.7: For NSCLC Arm2.1: Non-squamous, wild-type NSCLC Arm2.2: EGFRm nsqNSCLC Arm2.3: Malignant pleural mesothelioma Arm2.4: triple-negative breast cancer Arm2.5: EGFRm nsqNSCLC Arm2.6: breast cancer Arm2.7: NSCLC Arm2.8: adenocarcinoma of the stomach or gastroesophageal junction Arm2.9: urothelial carcinoma
  • All subjects must provide tumor tissue samples for PD-L1 testing: Tumor tissue samples should preferably be newly obtained tumor tissues. For subjects who cannot provide newly obtained tissues, tumor tissue samples archived within 3 years prior to the first study treatment can be provided. The sample type should be neutral formalin-fixed and paraffin-embedded [FFPE] tissue wax blocks or at least 6 unstained tumor tissue sections. If the number is less than 6 pieces, it is necessary to negotiate with the sponsor and only allow enrollment after obtaining consent.
  • ECOG overall performance status (PS) 0-1 point;
  • Predicted survival period ≥ 3 months;
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  • According to the efficacy evaluation criteria for solid tumors (RECISTv 1.1), there is at least one measurable lesion;
  • Have sufficient bone marrow and organ function (no blood components and/or cell growth factors have been used within 14 days prior to the start of the study treatment) :
  • Hemoglobin (HB) ≥ 90 g/L;
  • Neutrophil count (ANC) ≥1.5×109/L;
  • Platelet count (PLT) ≥ 90×109/L;
  • Total bilirubin < 1.5×ULN (for subjects diagnosed with Gilbert syndrome, total bilirubin ≤ 3×ULN);
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3×ULN (for patients with liver metastasis, ALT and/or AST≤ 5×ULN);
  • Serum creatinine ≤ 1.5×ULN or creatinine clearance ≥ 60 mL/min (calculated according to the Cockcroft-Gault formula);
  • International normalized ratio (INR) and activated partial thromboplastin (APTT) time ≤1.5×ULN;
  • Qualitative urine protein ≤1+; Or the qualitative urine protein is ≥2+, and the 24-hour urine protein should be less than 1g
  • Fertile women must agree to abstain from sexual activity (avoiding heterosexual intercourse) or use effective contraceptive methods for at least six months from the date of signing the informed consent form until the last administration of the study drug. Moreover, the blood HCG test must be negative within 7 days before the start of the study treatment, and the patient must not be in the lactation period (if the serum pregnancy test is positive, pregnancy must be excluded and confirmed after discussion with the sponsor for enrollment).
  • For male patients whose partners are women of childbearing age, they must agree to abstain from sexual activity for at least six months from the date of signing the informed consent form until the last administration of the study drug, or use effective contraceptive methods. Male patients must also agree not to donate sperm during the same period of time.
  • The patients voluntarily joined this study, signed the informed consent form and had good compliance.

Who cannot join

  • Accompanied by untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or those currently having meningeal metastasis.
  • Patients with other malignant tumors, excluding fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, ductal carcinoma in situ after radical resection, papillary thyroid carcinoma after radical resection, or those with other malignant tumors, must have at least a 3-year tumor-free period.
  • For those whose tumor lesions are judged by researchers to have a bleeding tendency, such as those whose imaging examinations during the screening period show that the subjects have: imaging evidence of tumor invasion or encirclement of large blood vessels;
  • Exclude subjects who have previously used VEGF/PD-1 (PD-L1) bispecific antibodies; Subjects who have previously received targeted therapy with TROP2, HER2 or Nectin-4, ADC, or any study drugs containing MMAE and whose treatment duration is less than 6 months should also be excluded. Subjects who had previously used bevacizumab were excluded.
  • Previously used immune checkpoint agonist therapy (such as CD137 agonists), anti-CD73 inhibitors, immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), and immune cell therapy (such as CAR-T) And other treatments targeting the tumor immune mechanism are not allowed to be enrolled.
  • It is known that there is an allergic reaction to CVL006, SKB264, T-DXd, Enfortumab Vedotin, pemetrexel or platinum-based or any excipient component of the study drug (including histidine, trehalose and polysorbide 20), or there is a history of severe allergic reaction to other monoclonal antibodies;
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  • Have serious cardiovascular and cerebrovascular diseases, including but not limited to:
  • Severe cardiac rhythm or conduction abnormalities within 6 months prior to the first use of the study drug, such as ventricular arrhythmias requiring clinical intervention, II-III degree atrioventricular block, etc.
  • Acute coronary syndrome, congestive heart failure (New York Heart Association (NYHA) cardiac function classification ≥ grade II), and aortic dissection occurred within 6 months prior to the first use of the study drug;
  • There have been arteriovenous thrombotic events such as cerebrovascular accidents (transient ischemic attack, cerebral hemorrhage, stroke), deep vein thrombosis and pulmonary embolism, etc. within 6 months before the first use of the study drug;
  • The left ventricular ejection fraction (LVEF) was less than 50% within 28 days prior to the first use of the study drug;
  • The mean value of QTcF obtained from three electrocardiogram examinations at baseline 12 (or above) in the resting state, with QTcF> 470 ms (for females) or QTcF> 450 ms (for males);
  • There is uncontrollable pleural effusion, peritoneal effusion or pericardial effusion;
  • Patients with known or suspected interstitial pneumonia; Within three months prior to the first administration, there are other severe pulmonary diseases that seriously affect respiratory function, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia/obliterative bronchiolitis; Non-infectious pulmonary inflammation that currently requires steroid treatment;
  • Patients who have previously received immunotherapy and have developed grade ≥3 irAE or grade ≥2 immune-related myocarditis;
  • Patients with active or previous autoimmune diseases that may recur (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.) are excluded, except for those with clinically stable autoimmune thyroid diseases and type 1 diabetes.
  • Had received systemic glucocorticoids (prednisone > 10mg/ day or equivalent doses of similar drugs) or other immunosuppressants within 14 days prior to the first use of the study drug; Except for the following situations: treatment with topical, ocular, intra-articular, intranasal and inhaled glucocorticoids; Short-term use of glucocorticoids for preventive treatment (such as to prevent contrast agent allergy).
  • Within 6 months prior to the first administration, there was a history of esophageal and gastric varices, severe ulcers, unhealed wounds, abdominal fistulas, abdominal abscesses or acute gastrointestinal bleeding; A history of gastrointestinal perforation and/or fistula within 6 months prior to the first administration, severe gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), and extensive intestinal resection (partial colectomy or extensive small intestine resection);
  • Arm2.3 Exclude primary peritoneal, pericardial and testicular sheath mesothelioma.
  • Patients with Arm2.9 urothelial carcinoma, except for those with eye diseases or symptoms that may increase the risk of corneal epithelial damage before the first treatment with the study drug and are not suitable for participation in this study; Patients with a history of grade ≥2 peripheral neuropathy are excluded. Patients with baseline HbA1c≥8% were excluded.
  • There was a severe infection within 4 weeks before the start of the study treatment, including but not limited to bacteremia, severe pneumonia or other serious infectious complications that require hospitalization, etc. There is an active infection of CTCAE grade ≥ 2 that requires intravenous anti-infective treatment within 2 weeks before the first administration.
  • Have a history of immune deficiency, including a positive HIV test; There is active hepatitis B (HBV DNA higher than the upper limit of the normal value of the testing center) or hepatitis C (anti-HCV positive and HCV RNA higher than the detection limit of the analytical method);
  • Those who were found to have had active pulmonary tuberculosis infection within one year prior to enrollment through medical history or CT examination, or those with a history of active pulmonary tuberculosis infection more than one year ago but have not received regular treatment;
  • 19. The adverse reactions of previous anti-tumor treatment have not yet recovered to CTCAE v 5.0 grade evaluation ≤1 (alopecia, grade 2 peripheral neurotoxicity (Arm2.9 requirement ≤1), except for the numerical requirements in the inclusion criteria or other situations determined by the investigator that do not affect the treatment of the study drug);
  • 20) Those who have received chemotherapy within 3 weeks before the first use of the study drug, or have received anti-tumor treatments such as macromolecular biological therapy (including immunotherapy) or other unmarketed clinical research drugs within 4 weeks before the first use; Excluding the following items:
  • For oral fluorouracil and small molecule targeted drugs, it is within two weeks before the first use of the study drug or within five half-lives of the drug, whichever is shorter.
  • For traditional Chinese medicines with anti-tumor indications, it is two weeks before the first use of the study drug;
  • Radical radiotherapy is 4 weeks before the first use of the study drug, and palliative radiotherapy is 2 weeks before the first use of the study drug.
  • 21) Having undergone major organ surgery, experienced significant trauma, or required elective surgery during the trial period within 4 weeks prior to the first use of the study drug; Perform a coarse needle biopsy or other minor surgery (excluding central venous intubation and port implantation) within 7 days before the first administration of the drug;
  • 22. There is a history of bleeding tendency or coagulation disorder and/or clinically significant bleeding symptoms or risks within 4 weeks prior to the first administration, including but not limited to: a. Gastrointestinal bleeding b. Hemoptysis (coughing up ≥15ml of fresh blood or blood clots); c. Epistaxis/nosebleeds d. Receive therapeutic anticoagulant therapy before the first administration;
  • 23) A history of hypertensive crisis or hypertensive encephalopathy in the past; There was hypertension within one month before the first administration and the systolic blood pressure was ≥150mmHg or the diastolic blood pressure was ≥100mmHg after oral antihypertensive drugs.
  • 24) Active or with a previous history of inflammatory bowel disease (such as Crohn's disease, ulcerative colitis or chronic diarrhea);
  • 25) There is a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
  • 26) Those who need to use strong suppressors or inducers of cytochrome P450 3A4 (CYP3A4) within 2 weeks before the first administration and during the study period (the use of strong suppressors or inducers of CYP3A4 is not allowed. The representative drugs of strong suppressors or inducers of CYP3A4 are listed in the attachment);
  • 27) Receive a live virus vaccine 30 days before the first administration, or plan to receive a live vaccine during the study period;
  • 28) As determined by the researchers, the subjects have other factors that may affect the research results or lead to the forced termination of this study, such as alcohol abuse, drug abuse, suffering from other serious diseases (including mental disorders) requiring concurrent treatment, severely abnormal laboratory test values, family or social factors, and other circumstances that may affect the safety of the subjects or the collection of experimental data, etc.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dong Wang contact

18064082990

dong.wang@convalife.com

Qiong Wang contact

18062000521

qiong.wang@convalife.com

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Su Li, 020-87343565, lisu@sysucc.org.cn

Other trials in China

About this study

Official title: Phase I/II Clinical Study of CVL006 Combination Therapy 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 pemetrexed + carboplatin/SKB264/ DS-8201a/ Enfortumab Vedotin in patients with advanced solid tumors.

Read the detailed description
  1. Phase I Arm1.1 - Arm1.4: Dose escalation of CVL006 combined with pemetrexed + carboplatin/SKB264/ DS-8201a/ Enfortumab Vedotin: Dose escalation studies of CVL006 combined with pemetrexed + carboplatin/SKB264/DS-8201a/ Enfortumab Vedotin can be conducted simultaneously, with two dose groups preset for each combination: The starting Dose (Dose Level1 [DL1]) of CVL006 is 3mg/kg or more (the investigator and the sponsor can discuss and decide on a dose of 3mg or more based on more data from the Phase I monotherapy study), Q2W or Q3W administration, and DL2 (one dose group higher than DL1) dose. Arm1.1 to Arm1.4 Each cohort is expected to increase to 6 to 12 subjects. Based on the data such as safety, tolerability, efficacy and PK characteristics observed during the dose escalation process of each cohort, the researcher and the sponsor jointly decided whether to adopt the Backfill design, that is, to enroll additional patients in the confirmed safe low-dose group during the dose escalation process. And decide whether to explore other administration doses or frequencies (such as Q3W).
  2. Phase II Dose optimization study In order to further evaluate the PK characteristics, safety and preliminary anti-tumor activity of CVL006 combined with pemetrexed + carboplatin/SKB264/ DS-8201a/ Enfortumab Vedotin, while the dose escalation trial of phase I was being conducted, Several dose groups that have passed the safety assessment during the DLT observation period will be selected to conduct the Phase II dose expansion study simultaneously. If, based on the obtained safety, tolerability, PK and efficacy information, the investigator and the sponsor discuss and decide on the choice of dose expansion and the specific number of cases to be increased. And whether a new dose needs to be added for dose expansion. Similarly, for each cohort with a new dose or a new administration frequency, the number of subjects in each group should be increased to 8-30 (subjects who previously used the same dose can be included).
Being tested
CVL006 combined with pemetrexed and carboplatin, CVL006 in combination with SKB264, CVL006 in combination with DS-8201, CVL006 in combination with Enfortumab Vedotin
Keywords
Advanced Solid Tumor, DLT, RP2D

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CVL006 combined with pemetrexed and carboplatinDrug

    Also called CVL006（B006 Injection）、pemetrexed（Pemetrexed Disodium for Injection）、carboplatin（Carboplatin Injection）

    CVL006 combined with pemetrexed and carboplatin

  • CVL006 in combination with SKB264Drug

    Also called CVL006（B006 Injection）、SKB264（Sacituzumab tirumotecan）

    CVL006 in combination with SKB264

  • CVL006 in combination with DS-8201Drug

    Also called CVL006（B006 Injection）、DS-8201a（Trastuzumab deruxtecan）

    CVL006 in combination with DS-8201

  • CVL006 in combination with Enfortumab VedotinDrug

    Also called CVL006（B006 Injection）、Enfortumab Vedotin（Padcev）

    CVL006 in combination with Enfortumab Vedotin

Study groups in NCT07157956
Study groupRoleWhat they receive
Arm 1.1ExperimentalPatients with advanced solid tumors were enrolled in Arm1.1. The medication used was CVL006 combined with pemetrexed and carboplatin. Two dose groups were preset. The starting dose of CVL006 for DL1 was 10mg/kg (administered at Q2W or Q3W), and for DL2 (one dose higher than DL1). Pemetrexed + carboplatin was a fixed dose. Each dose group enrolled 3 to 6 patients, and Arm1.1 enrolled a total of 6 to 12 patients.
Receives: Drug: CVL006 combined with pemetrexed and carboplatin
Arm 1.2ExperimentalPatients with advanced solid tumors were enrolled in Arm1.2, and the medication used was CVL006 combined with SKB264. Two dose groups were preset. The starting dose of CVL006 for DL1 was 10mg/kg (administered at Q2W or Q3W), and for DL2 (one dose group higher than DL1). SKB264 was a fixed dose. Each dose group enrolled 3 to 6 patients, and Arm1.2 enrolled a total of 6 to 12 patients.
Receives: Drug: CVL006 in combination with SKB264
Arm 1.3ExperimentalPatients with advanced solid tumors were enrolled in Arm1.3, and the medication used was CVL006 combined with DS-8201a. Two dose groups were preset. The starting dose of CVL006 for DL1 was 10mg/kg (administered at Q2W or Q3W), and the dose for DL2 (one dose group higher than DL1). DS-8201a was a fixed dose. Each dose group enrolled 3 to 6 patients respectively, and Arm1.3 enrolled a total of 6 to 12 patients.
Receives: Drug: CVL006 in combination with DS-8201
Arm1.4ExperimentalPatients with advanced solid tumors were enrolled in Arm1.4 and treated with CVL006 combined with Enfortumab Vedotin. Two dose groups were preset. The starting dose of CVL006 for DL1 was 10mg/kg (administered at Q2W or Q3W), and the dose of DL2 (one dose group higher than DL1). Enfortumab Vedotin was a fixed dose. 3 to 6 patients were enrolled in each dose group, and 6 to 12 patients were enrolled in Arm1.4.
Receives: Drug: CVL006 in combination with Enfortumab Vedotin
Arm2.1ExperimentalNSCLC patients were enrolled in Arm2.1. The medication used was CVL006 combined with pemetrexed and carboplatin. 8 to 30 patients were enrolled.
Receives: Drug: CVL006 combined with pemetrexed and carboplatin
Arm2.2ExperimentalPatients with EGFRm nsqNSCLC were enrolled in Arm2.2. The medication used was CVL006 combined with pemetrexed and carboplatin. 8 to 30 patients were enrolled.
Receives: Drug: CVL006 combined with pemetrexed and carboplatin
Arm2.3ExperimentalPatients with malignant pleural mesothelioma were enrolled in Arm2.3. The medication used was CVL006 combined with pemetrexed and carboplatin. 8 to 30 patients were enrolled.
Receives: Drug: CVL006 combined with pemetrexed and carboplatin
Arm2.4ExperimentalBreast cancer patients were enrolled in Arm2.4, and the medication used was CVL006 combined with SKB264. 8 to 30 patients were enrolled.
Receives: Drug: CVL006 in combination with SKB264
Arm2.5ExperimentalPatients with EGFRm nsqNSCLC were enrolled under Arm2.5, with the medication being CVL006 combined with SKB264. 8 to 30 patients were enrolled.
Receives: Drug: CVL006 in combination with SKB264
Arm2.6ExperimentalBreast cancer patients were enrolled in Arm2.6, and the medication used was CVL006 combined with DS-8201a. 8 to 30 patients were enrolled.
Receives: Drug: CVL006 in combination with DS-8201
Arm2.7ExperimentalNSCLC patients were enrolled in Arm2.7. The medication used was CVL006 combined with DS-8201a. 8 to 30 patients were enrolled.
Receives: Drug: CVL006 in combination with DS-8201
Arm2.8ExperimentalPatients with adenocarcinoma of the stomach or gastroesophageal junction were enrolled under Arm2.8. The medication used was CVL006 combined with DS-8201a. 8 to 30 patients were enrolled.
Receives: Drug: CVL006 in combination with DS-8201
Arm2.9ExperimentalPatients with urothelial carcinoma were enrolled under Arm2.9. The medication used was CVL006 combined with Enfortumab Vedotin. 8t to 30 patients were enrolled.
Receives: Drug: CVL006 in combination with Enfortumab Vedotin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DLT and RP2D of phase I

    DLT and RP2D of phase I (Arm1.1, Arm1.2, Arm1.3 and Arm1.4) CVL006 combined with pemetrexed + carboplatin/SKB264/ DS-8201a/ Enfortumab Vedotin in patients with advanced solid tumors

    Measured: 28 days after the first medication; If the second administration is delayed, the DLT observation period will be extended to 14 days after the second administration

  2. Phase II, progression-free survival (PFS) according to RECISTv1.1 criteria

    The efficacy of phase II CVL006 combined with pemetrexed + carboplatin /SKB264/ DS-8201a/ Enfortumab Vedotin in the treatment of advanced solid tumors: progression-free survival (PFS) according to RECISTv1.1 criteria

    Measured: Imaging examinations should be conducted every 8 weeks (±7 days) after the initiation of administration

  3. Safety endpoints for phase I and Phase II

    Number of participants with adverse events (AE)/serious adverse events (SAE)

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

Secondary outcomes (6)

  1. Pharmacokinetic (PK) parameters of CVL006 in Phase I and Phase II

    The pharmacokinetic (PK) parameters of CVL006 in phase I and Phase II, including but not limited to: Cmax

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

  2. Pharmacokinetic (PK) parameters of CVL006 in Phase I and Phase II

    The pharmacokinetic (PK) parameters of CVL006 in phase I and Phase II, including but not limited to: Tmax

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

  3. Efficacy endpoints for Phase I and Phase II

    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

  4. Efficacy endpoints for Phase I and Phase II

    Efficacy endpoints for Phase I and Phase II: Evaluated by the investigators based on RECISTv1.1 criteria, including Overall survival (OS)

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

  5. ADA&Nab

    The levels of anti-drug antibody (ADA) and neutralizing antibody (Nab) of CVL006

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

  6. PD-L1 expression

    The correlation between PD-L1 expression and response in the tumor tissues of the subjects

    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.

  1. First posted5 Sep 2025
  2. Study start10 Sep 2025 (estimated)
  3. Primary completion12 Aug 2028 (estimated)
  4. Study completion30 Dec 2028 (estimated)

Resources

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 pemetrexed + carboplatin/SKB264/ DS-8201a/ Enfortumab Vedotin in patients with advanced solid tumors.
Masking
None (open label)
Enrolment
318 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07157956
Sponsor's protocol ID
CVL006-T1002
Acronym
CVL006-T1002
Status last verified
Aug 2025
First submitted
22 Aug 2025
Last updated
5 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CVL006 combined with pemetrexed and carboplatin, CVL006 in combination with SKB264 and CVL006 in combination with DS-8201 in people with Advanced Solid Tumor, 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 36 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 5 Sep 2025. 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 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 Dong Wang (18064082990, dong.wang@convalife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT and RP2D of phase I (time frame: 28 days after the first medication; If the second administration is delayed, the DLT observation period will be extended to 14 days after the second administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07157956.

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 5 Sep 2025.

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