|
gptkbp:instance_of
|
gptkb:Clinical_Trials
|
|
gptkbp:adverse_events_monitoring
|
gptkb:Yes
|
|
gptkbp:advocacy
|
Informed consent required
|
|
gptkbp:analysis
|
Statistical analysis
|
|
gptkbp:biomarkers_evaluated
|
gptkb:Yes
|
|
gptkbp:business_model
|
gptkb:Yes
Complied with ethical standards
|
|
gptkbp:case_analysis
|
Clinical evaluation
|
|
gptkbp:clinical_trial
|
1 year
Phase 1
Not yet available
NCT04287480
|
|
gptkbp:clinical_trial_phase_description
|
First-in-human study
|
|
gptkbp:clinical_trial_phase_type
|
Early phase trial
|
|
gptkbp:collaborations
|
gptkb:Yes
With academic institutions
|
|
gptkbp:collaborator
|
Various research institutions
|
|
gptkbp:collection
|
Clinical assessments
|
|
gptkbp:committee
|
gptkb:Yes
|
|
gptkbp:criteria
|
Autoimmune diseases
Adult patients with solid tumors
|
|
gptkbp:developed_by
|
gptkb:Cure_Vac_AG
|
|
gptkbp:dose_escalation
|
gptkb:Yes
|
|
gptkbp:duration
|
Varies by patient
|
|
gptkbp:eligibility
|
Solid tumor types
|
|
gptkbp:end_date
|
gptkb:2021
|
|
gptkbp:events
|
6 months
|
|
gptkbp:feedback
|
Collected during trial
|
|
gptkbp:funding
|
gptkb:Cure_Vac_AG
|
|
https://www.w3.org/2000/01/rdf-schema#label
|
CV8102 Phase 1
|
|
gptkbp:investigator_initiated
|
No
|
|
gptkbp:investigator_role
|
Principal investigator
|
|
gptkbp:is_located_in
|
Multiple sites in Germany
|
|
gptkbp:is_monitored_by
|
Regular follow-ups
|
|
gptkbp:is_studied_in
|
Open-label, single-arm
|
|
gptkbp:is_tested_for
|
Phase 1
|
|
gptkbp:location
|
gptkb:Germany
|
|
gptkbp:mechanism_of_action
|
Stimulates immune response against tumors
|
|
gptkbp:participant_count
|
50
|
|
gptkbp:participants
|
Immune response
Safety and tolerability
|
|
gptkbp:patient_recruitment_goal
|
Achieve target enrollment
|
|
gptkbp:patient_recruitment_status
|
Ongoing
|
|
gptkbp:prevention
|
Single group assignment
|
|
gptkbp:provides_guidance_on
|
Multiple doses
|
|
gptkbp:provides_information_on
|
gptkb:Yes
|
|
gptkbp:regulatory_compliance
|
Not yet approved
|
|
gptkbp:related_products
|
gptkb:CV8102
|
|
gptkbp:research_focus
|
gptkb:Oncology
|
|
gptkbp:research_output
|
Pending
Safety profile assessment
|
|
gptkbp:result
|
No
|
|
gptkbp:route_of_administration
|
Intratumoral
|
|
gptkbp:safety_measures
|
Regular assessments
|
|
gptkbp:sponsor
|
gptkb:Cure_Vac_AG
|
|
gptkbp:start_date
|
gptkb:2020
|
|
gptkbp:status
|
ongoing
|
|
gptkbp:study_completion_status
|
Not completed yet
|
|
gptkbp:study_protocol
|
Approved by ethics committee
|
|
gptkbp:study_results_publication
|
Planned
|
|
gptkbp:targets
|
gptkb:Oncology
|
|
gptkbp:treatment
|
To be determined
m RNA therapy
|
|
gptkbp:trial_completion_date
|
Expected in 2021
|
|
gptkbp:bfsParent
|
gptkb:Cure_Vac
|
|
gptkbp:bfsLayer
|
4
|