Trial Outcomes & Findings for Phase 1/2a Study of VK-2019 in Patients With Epstein-Barr Virus (EBV)-Positive Nasopharyngeal Carcinoma (NPC) (NCT NCT03682055)
NCT ID: NCT03682055
Last Updated: 2023-08-15
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
14 participants
Primary outcome timeframe
24 months
Results posted on
2023-08-15
Participant Flow
Participant milestones
| Measure |
Cohort 1 (Phase 1 Accelerated Titration)
60 mg QD
|
Cohort 2 (Phase 1 Accelerated Titration)
120 mg QD
|
Cohort 3 (Phase 1 Accelerated Titration)
230 mg QD
|
Cohort 4 (Phase 1 Accelerated Titration)
460 mg QD
|
Cohort 5 (Phase 1 Accelerated Titration)
920 mg QD
|
Cohort 6 (Phase 1 Rolling 6)
1800 mg QD
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
1
|
2
|
1
|
7
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
2
|
1
|
7
|
Reasons for withdrawal
| Measure |
Cohort 1 (Phase 1 Accelerated Titration)
60 mg QD
|
Cohort 2 (Phase 1 Accelerated Titration)
120 mg QD
|
Cohort 3 (Phase 1 Accelerated Titration)
230 mg QD
|
Cohort 4 (Phase 1 Accelerated Titration)
460 mg QD
|
Cohort 5 (Phase 1 Accelerated Titration)
920 mg QD
|
Cohort 6 (Phase 1 Rolling 6)
1800 mg QD
|
|---|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
1
|
2
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Termination of Study by Sponsor
|
0
|
0
|
0
|
0
|
0
|
3
|
Baseline Characteristics
Phase 1/2a Study of VK-2019 in Patients With Epstein-Barr Virus (EBV)-Positive Nasopharyngeal Carcinoma (NPC)
Baseline characteristics by cohort
| Measure |
Cohort 1 (Phase 1 Accelerated Titration)
n=1 Participants
60 mg QD
|
Cohort 2 (Phase 1 Accelerated Titration)
n=2 Participants
120 mg QD
|
Cohort 3 (Phase 1 Accelerated Titration)
n=1 Participants
230 mg QD
|
Cohort 4 (Phase 1 Accelerated Titration)
n=2 Participants
460 mg QD
|
Cohort 5 (Phase 1 Accelerated Titration)
n=1 Participants
920 mg QD
|
Cohort 6 (Phase 1 Accelerated Titration)
n=7 Participants
1800 mg QD
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
7 Participants
n=19 Participants
|
12 Participants
n=147 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
2 Participants
n=147 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
1 Participants
n=19 Participants
|
3 Participants
n=147 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
6 Participants
n=19 Participants
|
11 Participants
n=147 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
3 Participants
n=19 Participants
|
9 Participants
n=147 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=147 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
1 Participants
n=19 Participants
|
1 Participants
n=147 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
3 Participants
n=19 Participants
|
3 Participants
n=147 Participants
|
|
Region of Enrollment
Hong Kong
|
0 participants
n=39 Participants
|
0 participants
n=41 Participants
|
0 participants
n=35 Participants
|
0 participants
n=31 Participants
|
1 participants
n=146 Participants
|
2 participants
n=19 Participants
|
3 participants
n=147 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=39 Participants
|
2 participants
n=41 Participants
|
1 participants
n=35 Participants
|
2 participants
n=31 Participants
|
0 participants
n=146 Participants
|
2 participants
n=19 Participants
|
8 participants
n=147 Participants
|
|
Region of Enrollment
France
|
0 participants
n=39 Participants
|
0 participants
n=41 Participants
|
0 participants
n=35 Participants
|
0 participants
n=31 Participants
|
0 participants
n=146 Participants
|
3 participants
n=19 Participants
|
3 participants
n=147 Participants
|
PRIMARY outcome
Timeframe: 24 monthsOutcome measures
| Measure |
Cohort 1 (Phase 1 Accelerated Titration)
n=1 Participants
60 mg QD
|
Cohort 2 (Phase 1 Accelerated Titration)
n=2 Participants
120 mg QD
|
Cohort 3 (Phase 1 Accelerated Titration)
n=1 Participants
230 mg QD
|
Cohort 4 (Phase 1 Accelerated Titration)
n=2 Participants
460 mg QD
|
Cohort 5 (Phase 1 Accelerated Titration)
n=1 Participants
920 mg QD
|
Cohort 6 (Phase 1 Rolling 6)
n=7 Participants
1800 mg QD
|
|---|---|---|---|---|---|---|
|
All Cohorts: The Frequency, Severity, and Duration of AEs and DLTs, AEs Leading to Discontinuation, and AEs Leading to Death.
Experienced a DLT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
All Cohorts: The Frequency, Severity, and Duration of AEs and DLTs, AEs Leading to Discontinuation, and AEs Leading to Death.
Experienced a treatment related AE leading to discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
All Cohorts: The Frequency, Severity, and Duration of AEs and DLTs, AEs Leading to Discontinuation, and AEs Leading to Death.
Experienced a treatment-related AE leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
All Cohorts: The Frequency, Severity, and Duration of AEs and DLTs, AEs Leading to Discontinuation, and AEs Leading to Death.
Experienced an AE
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 24 monthsOutcome measures
| Measure |
Cohort 1 (Phase 1 Accelerated Titration)
n=1 Participants
60 mg QD
|
Cohort 2 (Phase 1 Accelerated Titration)
n=1 Participants
120 mg QD
|
Cohort 3 (Phase 1 Accelerated Titration)
n=1 Participants
230 mg QD
|
Cohort 4 (Phase 1 Accelerated Titration)
n=2 Participants
460 mg QD
|
Cohort 5 (Phase 1 Accelerated Titration)
n=1 Participants
920 mg QD
|
Cohort 6 (Phase 1 Rolling 6)
n=3 Participants
1800 mg QD
|
|---|---|---|---|---|---|---|
|
Phase 1 Dose Escalation and Dose Expansion Cohorts: ORR
Stable Disease
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Phase 1 Dose Escalation and Dose Expansion Cohorts: ORR
Progressive Disease
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Phase 1 Dose Escalation and Dose Expansion Cohorts: ORR
Partial Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1 Dose Escalation and Dose Expansion Cohorts: ORR
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1 Dose Escalation and Dose Expansion Cohorts: ORR
Missing / Not Evaluable
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort 1 (Phase 1 Accelerated Titration)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2 (Phase 1 Accelerated Titration)
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
Cohort 3 (Phase 1 Accelerated Titration)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 4 (Phase 1 Accelerated Titration)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 5 (Phase 1 Accelerated Titration)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 6 (Phase 1 Rolling 6)
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 (Phase 1 Accelerated Titration)
n=1 participants at risk
60 mg QD
|
Cohort 2 (Phase 1 Accelerated Titration)
n=2 participants at risk
120 mg QD
|
Cohort 3 (Phase 1 Accelerated Titration)
n=1 participants at risk
230 mg QD
|
Cohort 4 (Phase 1 Accelerated Titration)
n=2 participants at risk
460 mg QD
|
Cohort 5 (Phase 1 Accelerated Titration)
n=1 participants at risk
920 mg QD
|
Cohort 6 (Phase 1 Rolling 6)
n=7 participants at risk
1800 mg QD
|
|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/1 • 1 year, 8 months
|
50.0%
1/2 • Number of events 1 • 1 year, 8 months
|
0.00%
0/1 • 1 year, 8 months
|
0.00%
0/2 • 1 year, 8 months
|
0.00%
0/1 • 1 year, 8 months
|
0.00%
0/7 • 1 year, 8 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Pain
|
0.00%
0/1 • 1 year, 8 months
|
0.00%
0/2 • 1 year, 8 months
|
0.00%
0/1 • 1 year, 8 months
|
0.00%
0/2 • 1 year, 8 months
|
0.00%
0/1 • 1 year, 8 months
|
14.3%
1/7 • Number of events 1 • 1 year, 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • 1 year, 8 months
|
0.00%
0/2 • 1 year, 8 months
|
0.00%
0/1 • 1 year, 8 months
|
0.00%
0/2 • 1 year, 8 months
|
0.00%
0/1 • 1 year, 8 months
|
14.3%
1/7 • Number of events 1 • 1 year, 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/1 • 1 year, 8 months
|
50.0%
1/2 • Number of events 1 • 1 year, 8 months
|
0.00%
0/1 • 1 year, 8 months
|
0.00%
0/2 • 1 year, 8 months
|
0.00%
0/1 • 1 year, 8 months
|
0.00%
0/7 • 1 year, 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal Stenosis
|
0.00%
0/1 • 1 year, 8 months
|
0.00%
0/2 • 1 year, 8 months
|
0.00%
0/1 • 1 year, 8 months
|
0.00%
0/2 • 1 year, 8 months
|
0.00%
0/1 • 1 year, 8 months
|
14.3%
1/7 • Number of events 1 • 1 year, 8 months
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/1 • 1 year, 8 months
|
0.00%
0/2 • 1 year, 8 months
|
0.00%
0/1 • 1 year, 8 months
|
0.00%
0/2 • 1 year, 8 months
|
100.0%
1/1 • Number of events 1 • 1 year, 8 months
|
0.00%
0/7 • 1 year, 8 months
|
|
Injury, poisoning and procedural complications
Gastrostomy tube site complication
|
0.00%
0/1 • 1 year, 8 months
|
0.00%
0/2 • 1 year, 8 months
|
0.00%
0/1 • 1 year, 8 months
|
0.00%
0/2 • 1 year, 8 months
|
0.00%
0/1 • 1 year, 8 months
|
14.3%
1/7 • Number of events 1 • 1 year, 8 months
|
Other adverse events
| Measure |
Cohort 1 (Phase 1 Accelerated Titration)
n=1 participants at risk
60 mg QD
|
Cohort 2 (Phase 1 Accelerated Titration)
n=2 participants at risk
120 mg QD
|
Cohort 3 (Phase 1 Accelerated Titration)
n=1 participants at risk
230 mg QD
|
Cohort 4 (Phase 1 Accelerated Titration)
n=2 participants at risk
460 mg QD
|
Cohort 5 (Phase 1 Accelerated Titration)
n=1 participants at risk
920 mg QD
|
Cohort 6 (Phase 1 Rolling 6)
n=7 participants at risk
1800 mg QD
|
|---|---|---|---|---|---|---|
|
Social circumstances
Not Reported
|
100.0%
1/1 • Number of events 1 • 1 year, 8 months
|
100.0%
2/2 • Number of events 2 • 1 year, 8 months
|
100.0%
1/1 • Number of events 1 • 1 year, 8 months
|
100.0%
2/2 • Number of events 2 • 1 year, 8 months
|
100.0%
1/1 • Number of events 1 • 1 year, 8 months
|
100.0%
7/7 • Number of events 7 • 1 year, 8 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place