A Study of Intravenous VRT106 for Locally Advanced or Metastatic Solid Tumors
ConditionSolid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuangzhou Virotech Pharmaceutical Co., Ltd.
About this trial
A Phase I Study of the Safety and Tolerability of VRT106 Administered Intravenously for Treatment of Patients With Locally Advanced or MetastaticSolid Tumors
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects voluntarily participate in the clinical study; fully understand and be informed about the study and sign the ICF; and are willing to follow and have the ability to complete all trial procedures.
Males and females are aged at 18-75 years (including borderline values) at the time of signing the ICF, male or female.
Subjects are histologically or cytologically confirmed to be intolerable or refractory to the standard systemic treatment.
Subjects have at least one measurable lesion.
Disqualifiers
Subject has received any antitumor therapy within 4 weeks prior to the first dose of IMP.
Subject has previously received oncolytic virus or other gene drug therapy.
Subject has received treatment with other unlisted clinical investigational drugs/devices within 4 weeks prior to the first dose of IMP.
Subject is known to have an allergic reaction to any of the components of IMP.
Trial design
Design model
Single group
Treatments tested in this trial
VRT106
Biological/VaccineIntravenous drip administration
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: VRT106 for injectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate the safety and tolerability of escalating doses of VRT106 in Patients with advanced malignanttumors
To evaluate the safety and tolerability of VRT106 in patients with locally advanced/metastatic solid tumours and to explore the maximum tolerated dose (MTD)/multiple ascending dose (MAD)/optimal biologically active dose (OBD) and/or the recommended phase 2 dose (RP2D), which will provide a recommended dose for subsequent clinical trials.
Time frame
About 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Guangzhou Virotech Pharmaceutical Co., Ltd.
Lead sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Collaborator
Source ClinicalTrials.gov