Clinical Study of CVL006 Injection in Advanced Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorConvalife (Shanghai) Co., Ltd.
About this trial
Evaluate the safety and tolerability of CVL006 monotherapy in patients with advanced solid tumors; Observe the dose limiting toxicity (DLT) of CVL006 monotherapy in patients with advanced solid tumors, evaluate the maximum tolerated dose (MTD), and recommend the dosage for phase II clinical trials (RP2D).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: 18~75 years old (including both ends), gender not limited;
Dose escalation and dose expansion stage: For patients with advanced malignant solid tumors confirmed by histology or cytology, if standard treatment has failed, or if there is no standard treatment plan, or if standard treatment is not applicable at this stage;
All subjects are required to provide tumor tissue samples for PD-L1 testing: tumor tissue samples should preferably be newly obtained. For subjects who cannot provide newly obtained tissue, they can provide tumor tissue samples archived within 3 years before the first study treatment. The sample type should be neutral formalin fixed, paraffin embedded [FFPE] tissue blocks or at least 6 unstained tumor tissue sections; If there are less than 6 pieces, it is necessary to consult with the sponsor and obtain their agreement before being allowed to be included in the group;
ECOG performance status (PS) score 0-1 points;
Disqualifiers
Accompanied by untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis.
Patients with other malignant tumors within the five years prior to the first use of the investigational drug, except for fully treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, local prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, and papillary thyroid carcinoma after radical surgery;
If the researcher determines that the tumor lesion has a tendency to bleed, and the screening imaging examination shows that the subject has imaging evidence of tumor invasion or wrapping around large blood vessels;
Subjects who have previously used VEGF/PD-1 (PD-L1) bispecific antibodies;
Trial design
Design model
Single group
Treatments tested in this trial
CVL006 Injection
Biological/VaccineCVL006 injection, intravenous infusion, administered every 2 weeks. Every 28 days is a cycle. Until the subject cannot tolerate the disease progression or toxicity, or the researcher determines that the medication must be terminated or the sponsor terminates the study. SMC can adjust the dosing frequency based on safety, tolerability, and PK results data. If researchers consider that subjects enrolled in the lower dose group can benefit from the study intervention, they can allow them to continue treatment at a higher dose that has been proven safe based on the researcher's judgment.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: CVL006 monotherapy groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
DLT of CVL006 monotherapy in advanced solid tumor patients.
Safety events that occur during the DLT observation period and are determined by researchers to be related to the investigational drug.
Time frame
In Phase Ia trials, if there is a delay in the second administration 28 days after the first dose, the DLT observation period will be extended to 14 days after the second administration.2
MTD of CVL006 monotherapy in patients with advanced solid tumors.
During the DLT observation period, the highest dose at which ≤ 1 subject experienced DLT and could not continue to increase in dose among at least 6 subjects
Time frame
Phase Ia trial, from the first subject to the end of the DLT observation period for the last subject.3
RP2D of CVL006 monotherapy in patients with advanced solid tumors
RP2D is an extended study conducted through dose escalation stage exploration, recommended by SMC, to obtain sufficient safety, tolerability, PK, and preliminary efficacy results. The dosage selected for subsequent efficacy expansion stage is further discussed and confirmed by SMC. RP2D should not exceed the MTD obtained by dose escalation.
Time frame
From the first subject enrolled in Phase 1a to the last subject removed from Phase Ib.Secondary outcomes
1
Objective response rate (ORR) in patients
ORR by investigator
Time frame
Throughout the study for approximately 5 years.2
Progression-free survival (PFS)
Progression-free survival (PFS), defined as the time from the start of study treatment to any documented tumor progression or death due to any cause, whichever occurs first.
Time frame
Throughout the study for approximately 5 years.3
Overall Survival (OS)
Overall survival (OS), defined as the time from enrollment to death due to any cause. Efficacy of each tumor type will be analyzed independently.
Time frame
Throughout the study for approximately 5 years.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: