Trial Outcomes & Findings for A Phase 1 Study of HS130 in Combination With Viagenpumatucel-L (HS110) in Patients With Solid Tumors (NCT NCT04116710)
NCT ID: NCT04116710
Last Updated: 2023-08-23
Results Overview
Number of Patients with Dose Limiting Toxicity (DLT)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
1 month
Results posted on
2023-08-23
Participant Flow
Participant milestones
| Measure |
Cohort 1: HS-130 (150 ng- 600 ng) + HS-110 (150 ng - 300 ng) (Viagenpumatucel-L)
Patients will receive a combination of intradermal HS-130 and HS-110 once every 14 days. The dose levels will be determined by the starting dose and the escalation steps outlined in the protocol.
HS-110 (viagenpumatucel-L): Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
HS-130: Vaccine derived from irradiated human lung cancer cells expressing the co-stimulatory fusion protein OX40L-Ig
|
Cohort 2: HS-130 (600 ng) + HS-110 (600 ng) (Viagenpumatucel-L)
Patients will receive a combination of intradermal HS-130 and HS-110 once every 14 days. The dose levels will be determined by the starting dose and the escalation steps outlined in the protocol.
HS-110 (viagenpumatucel-L): Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
HS-130: Vaccine derived from irradiated human lung cancer cells expressing the co-stimulatory fusion protein OX40L-Ig
|
Cohort 3: HS-130 (1200 ng) + HS-110 (600 ng) (Viagenpumatucel-L)
Patients will receive a combination of intradermal HS-130 and HS-110 once every 14 days. The dose levels will be determined by the starting dose and the escalation steps outlined in the protocol.
HS-110 (viagenpumatucel-L): Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
HS-130: Vaccine derived from irradiated human lung cancer cells expressing the co-stimulatory fusion protein OX40L-Ig
|
Cohort 4: HS-130 (1200 ng) + HS-110 (1200 ng) (Viagenpumatucel-L)
Patients will receive a combination of intradermal HS-130 and HS-110 once every 14 days. The dose levels will be determined by the starting dose and the escalation steps outlined in the protocol.
HS-110 (viagenpumatucel-L): Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
HS-130: Vaccine derived from irradiated human lung cancer cells expressing the co-stimulatory fusion protein OX40L-Ig
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
3
|
2
|
|
Overall Study
Disease Progression
|
4
|
6
|
2
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
3
|
2
|
Reasons for withdrawal
| Measure |
Cohort 1: HS-130 (150 ng- 600 ng) + HS-110 (150 ng - 300 ng) (Viagenpumatucel-L)
Patients will receive a combination of intradermal HS-130 and HS-110 once every 14 days. The dose levels will be determined by the starting dose and the escalation steps outlined in the protocol.
HS-110 (viagenpumatucel-L): Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
HS-130: Vaccine derived from irradiated human lung cancer cells expressing the co-stimulatory fusion protein OX40L-Ig
|
Cohort 2: HS-130 (600 ng) + HS-110 (600 ng) (Viagenpumatucel-L)
Patients will receive a combination of intradermal HS-130 and HS-110 once every 14 days. The dose levels will be determined by the starting dose and the escalation steps outlined in the protocol.
HS-110 (viagenpumatucel-L): Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
HS-130: Vaccine derived from irradiated human lung cancer cells expressing the co-stimulatory fusion protein OX40L-Ig
|
Cohort 3: HS-130 (1200 ng) + HS-110 (600 ng) (Viagenpumatucel-L)
Patients will receive a combination of intradermal HS-130 and HS-110 once every 14 days. The dose levels will be determined by the starting dose and the escalation steps outlined in the protocol.
HS-110 (viagenpumatucel-L): Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
HS-130: Vaccine derived from irradiated human lung cancer cells expressing the co-stimulatory fusion protein OX40L-Ig
|
Cohort 4: HS-130 (1200 ng) + HS-110 (1200 ng) (Viagenpumatucel-L)
Patients will receive a combination of intradermal HS-130 and HS-110 once every 14 days. The dose levels will be determined by the starting dose and the escalation steps outlined in the protocol.
HS-110 (viagenpumatucel-L): Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
HS-130: Vaccine derived from irradiated human lung cancer cells expressing the co-stimulatory fusion protein OX40L-Ig
|
|---|---|---|---|---|
|
Overall Study
Death
|
4
|
6
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Phase 1 Study of HS130 in Combination With Viagenpumatucel-L (HS110) in Patients With Solid Tumors
Baseline characteristics by cohort
| Measure |
Cohort 1: HS-130 (150 ng- 600 ng) + HS-110 (150 ng - 300 ng) (Viagenpumatucel-L)
n=4 Participants
Patients will receive a combination of intradermal HS-130 and HS-110 once every 14 days. The dose levels will be determined by the starting dose and the escalation steps outlined in the protocol.
HS-110 (viagenpumatucel-L): Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
HS-130: Vaccine derived from irradiated human lung cancer cells expressing the co-stimulatory fusion protein OX40L-Ig
|
Cohort 2: HS-130 (600 ng) + HS-110 (600 ng) (Viagenpumatucel-L)
n=6 Participants
Patients will receive a combination of intradermal HS-130 and HS-110 once every 14 days. The dose levels will be determined by the starting dose and the escalation steps outlined in the protocol.
HS-110 (viagenpumatucel-L): Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
HS-130: Vaccine derived from irradiated human lung cancer cells expressing the co-stimulatory fusion protein OX40L-Ig
|
Cohort 3: HS-130 (1200 ng) + HS-110 (600 ng) (Viagenpumatucel-L)
n=3 Participants
Patients will receive a combination of intradermal HS-130 and HS-110 once every 14 days. The dose levels will be determined by the starting dose and the escalation steps outlined in the protocol.
HS-110 (viagenpumatucel-L): Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
HS-130: Vaccine derived from irradiated human lung cancer cells expressing the co-stimulatory fusion protein OX40L-Ig
|
Cohort 4: HS-130 (1200 ng) + HS-110 (1200 ng) (Viagenpumatucel-L)
n=2 Participants
Patients will receive a combination of intradermal HS-130 and HS-110 once every 14 days. The dose levels will be determined by the starting dose and the escalation steps outlined in the protocol.
HS-110 (viagenpumatucel-L): Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
HS-130: Vaccine derived from irradiated human lung cancer cells expressing the co-stimulatory fusion protein OX40L-Ig
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
3 participants
n=5 Participants
|
2 participants
n=4 Participants
|
15 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Continuous
|
73.5 years
STANDARD_DEVIATION 3.51 • n=5 Participants
|
49.8 years
STANDARD_DEVIATION 7.52 • n=7 Participants
|
62.3 years
STANDARD_DEVIATION 7.02 • n=5 Participants
|
69.0 years
STANDARD_DEVIATION 9.90 • n=4 Participants
|
61.2 years
STANDARD_DEVIATION 12.02 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: The safety population includes all patients who received at least one dose of study drug.
Number of Patients with Dose Limiting Toxicity (DLT)
Outcome measures
| Measure |
Cohort 1: HS-130 (150 ng- 600 ng) + HS-110 (150 ng - 300 ng) (Viagenpumatucel-L)
n=4 Participants
Patients will receive a combination of intradermal HS-130 and HS-110 once every 14 days. The dose levels will be determined by the starting dose and the escalation steps outlined in the protocol.
HS-110 (viagenpumatucel-L): Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
HS-130: Vaccine derived from irradiated human lung cancer cells expressing the co-stimulatory fusion protein OX40L-Ig
|
Cohort 2: HS-130 (600 ng) + HS-110 (600 ng) (Viagenpumatucel-L)
n=6 Participants
Patients will receive a combination of intradermal HS-130 and HS-110 once every 14 days. The dose levels will be determined by the starting dose and the escalation steps outlined in the protocol.
HS-110 (viagenpumatucel-L): Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
HS-130: Vaccine derived from irradiated human lung cancer cells expressing the co-stimulatory fusion protein OX40L-Ig
|
Cohort 3: HS-130 (1200 ng) + HS-110 (600 ng) (Viagenpumatucel-L)
n=3 Participants
Patients will receive a combination of intradermal HS-130 and HS-110 once every 14 days. The dose levels will be determined by the starting dose and the escalation steps outlined in the protocol.
HS-110 (viagenpumatucel-L): Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
HS-130: Vaccine derived from irradiated human lung cancer cells expressing the co-stimulatory fusion protein OX40L-Ig
|
Cohort 4: HS-130 (1200 ng) + HS-110 (1200 ng) (Viagenpumatucel-L)
n=2 Participants
Patients will receive a combination of intradermal HS-130 and HS-110 once every 14 days. The dose levels will be determined by the starting dose and the escalation steps outlined in the protocol.
HS-110 (viagenpumatucel-L): Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
HS-130: Vaccine derived from irradiated human lung cancer cells expressing the co-stimulatory fusion protein OX40L-Ig
|
|---|---|---|---|---|
|
Dose Limiting Toxicity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort 1: HS-130 (150 ng- 600 ng) + HS-110 (150 ng - 300 ng) (Viagenpumatucel-L)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 4 deaths
Cohort 2: HS-130 (600 ng) + HS-110 (600 ng) (Viagenpumatucel-L)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 6 deaths
Cohort 3: HS-130 (1200 ng) + HS-110 (600 ng) (Viagenpumatucel-L)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort 4: HS-130 (1200 ng) + HS-110 (1200 ng) (Viagenpumatucel-L)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cohort 1: HS-130 (150 ng- 600 ng) + HS-110 (150 ng - 300 ng) (Viagenpumatucel-L)
n=4 participants at risk
Patients will receive a combination of intradermal HS-130 and HS-110 once every 14 days. The dose levels will be determined by the starting dose and the escalation steps outlined in the protocol.
HS-110 (viagenpumatucel-L): Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
HS-130: Vaccine derived from irradiated human lung cancer cells expressing the co-stimulatory fusion protein OX40L-Ig
|
Cohort 2: HS-130 (600 ng) + HS-110 (600 ng) (Viagenpumatucel-L)
n=6 participants at risk
Patients will receive a combination of intradermal HS-130 and HS-110 once every 14 days. The dose levels will be determined by the starting dose and the escalation steps outlined in the protocol.
HS-110 (viagenpumatucel-L): Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
HS-130: Vaccine derived from irradiated human lung cancer cells expressing the co-stimulatory fusion protein OX40L-Ig
|
Cohort 3: HS-130 (1200 ng) + HS-110 (600 ng) (Viagenpumatucel-L)
n=3 participants at risk
Patients will receive a combination of intradermal HS-130 and HS-110 once every 14 days. The dose levels will be determined by the starting dose and the escalation steps outlined in the protocol.
HS-110 (viagenpumatucel-L): Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
HS-130: Vaccine derived from irradiated human lung cancer cells expressing the co-stimulatory fusion protein OX40L-Ig
|
Cohort 4: HS-130 (1200 ng) + HS-110 (1200 ng) (Viagenpumatucel-L)
n=2 participants at risk
Patients will receive a combination of intradermal HS-130 and HS-110 once every 14 days. The dose levels will be determined by the starting dose and the escalation steps outlined in the protocol.
HS-110 (viagenpumatucel-L): Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
HS-130: Vaccine derived from irradiated human lung cancer cells expressing the co-stimulatory fusion protein OX40L-Ig
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Intestinal Ischaemia
|
0.00%
0/4 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
0.00%
0/6 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
0.00%
0/2 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
|
Infections and infestations
Bacteremia
|
0.00%
0/4 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
16.7%
1/6 • Number of events 1 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
0.00%
0/3 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
0.00%
0/2 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
|
Nervous system disorders
Embolic Stroke
|
0.00%
0/4 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
0.00%
0/6 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
0.00%
0/3 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
50.0%
1/2 • Number of events 1 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
Other adverse events
| Measure |
Cohort 1: HS-130 (150 ng- 600 ng) + HS-110 (150 ng - 300 ng) (Viagenpumatucel-L)
n=4 participants at risk
Patients will receive a combination of intradermal HS-130 and HS-110 once every 14 days. The dose levels will be determined by the starting dose and the escalation steps outlined in the protocol.
HS-110 (viagenpumatucel-L): Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
HS-130: Vaccine derived from irradiated human lung cancer cells expressing the co-stimulatory fusion protein OX40L-Ig
|
Cohort 2: HS-130 (600 ng) + HS-110 (600 ng) (Viagenpumatucel-L)
n=6 participants at risk
Patients will receive a combination of intradermal HS-130 and HS-110 once every 14 days. The dose levels will be determined by the starting dose and the escalation steps outlined in the protocol.
HS-110 (viagenpumatucel-L): Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
HS-130: Vaccine derived from irradiated human lung cancer cells expressing the co-stimulatory fusion protein OX40L-Ig
|
Cohort 3: HS-130 (1200 ng) + HS-110 (600 ng) (Viagenpumatucel-L)
n=3 participants at risk
Patients will receive a combination of intradermal HS-130 and HS-110 once every 14 days. The dose levels will be determined by the starting dose and the escalation steps outlined in the protocol.
HS-110 (viagenpumatucel-L): Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
HS-130: Vaccine derived from irradiated human lung cancer cells expressing the co-stimulatory fusion protein OX40L-Ig
|
Cohort 4: HS-130 (1200 ng) + HS-110 (1200 ng) (Viagenpumatucel-L)
n=2 participants at risk
Patients will receive a combination of intradermal HS-130 and HS-110 once every 14 days. The dose levels will be determined by the starting dose and the escalation steps outlined in the protocol.
HS-110 (viagenpumatucel-L): Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
HS-130: Vaccine derived from irradiated human lung cancer cells expressing the co-stimulatory fusion protein OX40L-Ig
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
75.0%
3/4 • Number of events 3 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
66.7%
4/6 • Number of events 4 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
66.7%
2/3 • Number of events 2 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
50.0%
1/2 • Number of events 1 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
|
General disorders
Injection Site Pruritus
|
50.0%
2/4 • Number of events 2 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
50.0%
3/6 • Number of events 3 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
66.7%
2/3 • Number of events 2 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
50.0%
1/2 • Number of events 1 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
|
General disorders
Injection Site Erythema
|
50.0%
2/4 • Number of events 2 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
33.3%
2/6 • Number of events 2 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
66.7%
2/3 • Number of events 2 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
50.0%
1/2 • Number of events 1 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Number of events 2 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
50.0%
3/6 • Number of events 3 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
0.00%
0/3 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
50.0%
1/2 • Number of events 1 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
2/4 • Number of events 2 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
33.3%
2/6 • Number of events 2 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
33.3%
1/3 • Number of events 1 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
50.0%
1/2 • Number of events 1 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
|
Metabolism and nutrition disorders
Decreased appetite
|
75.0%
3/4 • Number of events 3 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
66.7%
4/6 • Number of events 4 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
0.00%
0/3 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
0.00%
0/2 • AEs and SAEs were collected from Cycle 1 day 1 (first dose) until 30 days after last dose. The study duration was 18 months.
Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
Additional Information
Vice President, Clinical Development
NightHawk Biosciences Inc.
Phone: 9197948950
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60