CVL006 Combination Therapy in Advanced Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorConvalife (Shanghai) Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
CVL006 combined with pemetrexed and carboplatin
DrugCVL006 combined with pemetrexed and carboplatin
CVL006 in combination with SKB264
DrugCVL006 in combination with SKB264
CVL006 in combination with DS-8201
DrugCVL006 in combination with DS-8201
CVL006 in combination with Enfortumab Vedotin
DrugCVL006 in combination with Enfortumab Vedotin
Treatment groups
318 Participants
are divided into 13 treatment groups13
Treatment groupsSee each treatment group below.
Group A: Arm 1.1Experimental treatment 1 intervention
Group B: Arm 1.2Experimental treatment 1 intervention
Group C: Arm 1.3Experimental treatment 1 intervention
Group D: Arm1.4Experimental treatment 1 intervention
Group E: Arm2.1Experimental treatment 1 intervention
Group F: Arm2.2Experimental treatment 1 intervention
Group G: Arm2.3Experimental treatment 1 intervention
Group H: Arm2.4Experimental treatment 1 intervention
Group I: Arm2.5Experimental treatment 1 intervention
Group J: Arm2.6Experimental treatment 1 intervention
Group K: Arm2.7Experimental treatment 1 intervention
Group L: Arm2.8Experimental treatment 1 intervention
Group M: Arm2.9Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
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
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 administration2
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
Time frame
Imaging examinations should be conducted every 8 weeks (±7 days) after the initiation of administration3
Safety endpoints for phase I and Phase II
Number of participants with adverse events (AE)/serious adverse events (SAE)
Time frame
From date of randomization until the date of first documented progression, assessed up to 36 monthsSecondary outcomes
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
Time frame
From date of randomization until the date of first documented progression, assessed up to 36 months2
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
Time frame
From date of randomization until the date of first documented progression, assessed up to 36 months3
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)
Time frame
From date of randomization until the date of first documented progression, assessed up to 36 months4
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)
Time frame
From date of randomization until the date of first documented progression, assessed up to 36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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