Trial Outcomes & Findings for TTX-030 Single Agent and in Combination With Immunotherapy or Chemotherapy for Patients With Advanced Cancers (NCT NCT03884556)
NCT ID: NCT03884556
Last Updated: 2025-07-02
Results Overview
A DLT was defined as any clinically significant AE that occurred during Treatment Cycle 1 that the Investigator or Sponsor considered as possibly or likely related to TTX-030 as a single agent, or the combination of TTX-030 and other agent(s), and met the following criteria: NCI CTCAE Version 5.0 Grade 5 event, Grade 4 hematological or Grade≥3 non-hematological toxicities, or Grade≥3 irAEs. Laboratory abnormalities that were asymptomatic and deemed not clinically significant were not regarded as DLTs. During Dose Escalation, each dosing cohort was completed through the DLT observation window before escalation was allowed within its arm. In each Safety Lead-in cohort, all participants were closely monitored for the occurrence of DLTs.
COMPLETED
PHASE1
56 participants
1 cycle (each cycle is 21-28 days)
2025-07-02
Participant Flow
Participant milestones
| Measure |
Arm 1: TTX-030 0.5 mg/kg
Participants in Arm 1 Escalation were administered IV 0.5 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 1.5 mg/kg
Participants in Arm 1 Escalation were administered IV 1.5 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 3.0 mg/kg
Participants in Arm 1 Escalation were administered IV 3.0 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 6.0 mg/kg
Participants in Arm 1 Escalation were administered IV 6.0 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 10 mg/kg
Participants in Arm 1 Escalation were administered IV 10 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 20 mg/kg
Participants in Arm 1 Escalation were administered IV 20 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 40 mg/kg
Participants in Arm 1 Escalation were administered IV 40 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1 Expansion: TTX-030 40 mg/kg Load, 30 mg/kg Q3W
Participants in Arm 1 Expansion received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W.
|
Arm 2 (Safety Lead-in and Expansion), Combination
Participants in Safety Lead-in portion and Expansion of Arm 2 received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W and pembrolizumab IV at a dose of 200 mg on Day 1 of each 21-day treatment cycle.
|
Arm 4 (Safety Lead-In and Expansion)
Participants in Safety Lead-in and Arm 4 received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W and received gemcitabine 1000 mg/m\^2 + nab-Paclitaxel 125 mg/m\^2 Days 1, 8, and 15 every 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
2
|
4
|
3
|
3
|
6
|
8
|
13
|
14
|
|
Overall Study
COMPLETED
|
1
|
2
|
2
|
4
|
3
|
3
|
6
|
8
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TTX-030 Single Agent and in Combination With Immunotherapy or Chemotherapy for Patients With Advanced Cancers
Baseline characteristics by cohort
| Measure |
Arm 1: TTX-030 0.5 mg/kg
n=1 Participants
Participants in Arm 1 Escalation were administered IV 0.5 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 1.5 mg/kg
n=2 Participants
Participants in Arm 1 Escalation were administered IV 1.5 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 3.0 mg/kg
n=2 Participants
Participants in Arm 1 Escalation were administered IV 3 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 6.0 mg/kg
n=4 Participants
Participants in Arm 1 Escalation were administered IV 6 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 10 mg/kg
n=3 Participants
Participants in Arm 1 Escalation were administered IV 10mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 20 mg/kg
n=3 Participants
Participants in Arm 1 Escalation were administered IV 20 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 40 mg/kg
n=6 Participants
Participants in Arm 1 Escalation were administered IV 40 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1 Expansion: TTX-030 40 mg/kg Load/30 mg/kg Q3W
n=8 Participants
Participants in Expansion received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W.
|
Arm 2 (Safety Lead-in and Expansion), Combination
n=13 Participants
Participants in Safety Lead-in portion and Expansion of Arm 2 received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W and pembrolizumab IV at a dose of 200 mg on Day 1 of each 21-day treatment cycle.
|
Arm 4 (Safety Lead-In and Expansion)
n=14 Participants
Participants in Safety Lead-in and Arm 4 received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W and received gemcitabine 1000 mg/m\^2 + nab-Paclitaxel 125 mg/m\^2 Days 1, 8, and 15 every 28 days.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
9 Participants
n=6 Participants
|
6 Participants
n=64 Participants
|
31 Participants
n=17 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
8 Participants
n=64 Participants
|
25 Participants
n=17 Participants
|
|
Age, Continuous
|
26 years
n=5 Participants
|
73 years
n=7 Participants
|
59.5 years
n=5 Participants
|
63 years
n=4 Participants
|
64 years
n=21 Participants
|
59 years
n=10 Participants
|
61.5 years
n=115 Participants
|
64.5 years
n=6 Participants
|
57 years
n=6 Participants
|
66.5 years
n=64 Participants
|
63.5 years
n=17 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
10 Participants
n=64 Participants
|
34 Participants
n=17 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
4 Participants
n=64 Participants
|
22 Participants
n=17 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
2 Participants
n=17 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
6 Participants
n=17 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
12 Participants
n=6 Participants
|
10 Participants
n=64 Participants
|
45 Participants
n=17 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
2 Participants
n=17 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
3 participants
n=21 Participants
|
3 participants
n=10 Participants
|
6 participants
n=115 Participants
|
8 participants
n=6 Participants
|
13 participants
n=6 Participants
|
14 participants
n=64 Participants
|
56 participants
n=17 Participants
|
PRIMARY outcome
Timeframe: 1 cycle (each cycle is 21-28 days)Population: All participants in the Dose Escalation cohorts who received 1 infusion during the treatment cycle and completed safety evaluations through the end of the DLT period or experienced a DLT before the end of the DLT period (ie, participants started Cycle 2 or experienced a DLT).
A DLT was defined as any clinically significant AE that occurred during Treatment Cycle 1 that the Investigator or Sponsor considered as possibly or likely related to TTX-030 as a single agent, or the combination of TTX-030 and other agent(s), and met the following criteria: NCI CTCAE Version 5.0 Grade 5 event, Grade 4 hematological or Grade≥3 non-hematological toxicities, or Grade≥3 irAEs. Laboratory abnormalities that were asymptomatic and deemed not clinically significant were not regarded as DLTs. During Dose Escalation, each dosing cohort was completed through the DLT observation window before escalation was allowed within its arm. In each Safety Lead-in cohort, all participants were closely monitored for the occurrence of DLTs.
Outcome measures
| Measure |
Arm 1: TTX-030 1.5 mg/kg
n=2 Participants
Participants in Arm 1: TTX-030 was administered IV 1.5 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 3.0 mg/kg
n=2 Participants
Participants in Arm 1: TTX-030 was administered IV 3.0 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 6.0 mg/kg
n=3 Participants
Participants in Arm 1: TTX-030 was administered IV 6.0 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 10 mg/kg
n=3 Participants
Participants in Arm 1: TTX-030 was administered IV 10 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 20 mg/kg
n=3 Participants
Participants in Arm 1: TTX-030 was administered IV 20 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 40 mg/kg
n=6 Participants
Participants in Arm 1: TTX-030 was administered IV 40 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 40 mg/kg
Participants in Arm 1: TTX-030 was administered IV 40 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 4 (Safety Lead-In and Expansion)
Participants in Safety Lead-in and Arm 4 received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W and received gemcitabine 1000 mg/m\^2 + nab-Paclitaxel 125 mg/m\^2 Days 1, 8, and 15 every 28 days.
|
Arm 2 (Safety Lead-in and Expansion), Combination
Participants in Safety Lead-in portion and Expansion of Arm 2 received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W and pembrolizumab IV at a dose of 200 mg on Day 1 of each 21-day treatment cycle.
|
Arm 4 (Safety Lead-In and Expansion)
Participants in Safety Lead-in and Arm 4 received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W and received gemcitabine 1000 mg/m\^2 + nab-Paclitaxel 125 mg/m\^2 Days 1, 8, and 15 every 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: Participants in the Safety Analysis Set who had at least 1 post baseline evaluable tumor assessment unless death or clinical progressive disease (PD) occurred before the first post baseline disease assessment.
Anti-tumor activity in subjects treated with TTX-030 as single agent or in combination with specified regimens
Outcome measures
| Measure |
Arm 1: TTX-030 1.5 mg/kg
n=7 Participants
Participants in Arm 1: TTX-030 was administered IV 1.5 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 3.0 mg/kg
n=11 Participants
Participants in Arm 1: TTX-030 was administered IV 3.0 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 6.0 mg/kg
Participants in Arm 1: TTX-030 was administered IV 6.0 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 10 mg/kg
Participants in Arm 1: TTX-030 was administered IV 10 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 20 mg/kg
Participants in Arm 1: TTX-030 was administered IV 20 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 40 mg/kg
Participants in Arm 1: TTX-030 was administered IV 40 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 40 mg/kg
Participants in Arm 1: TTX-030 was administered IV 40 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 4 (Safety Lead-In and Expansion)
Participants in Safety Lead-in and Arm 4 received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W and received gemcitabine 1000 mg/m\^2 + nab-Paclitaxel 125 mg/m\^2 Days 1, 8, and 15 every 28 days.
|
Arm 2 (Safety Lead-in and Expansion), Combination
Participants in Safety Lead-in portion and Expansion of Arm 2 received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W and pembrolizumab IV at a dose of 200 mg on Day 1 of each 21-day treatment cycle.
|
Arm 4 (Safety Lead-In and Expansion)
Participants in Safety Lead-in and Arm 4 received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W and received gemcitabine 1000 mg/m\^2 + nab-Paclitaxel 125 mg/m\^2 Days 1, 8, and 15 every 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) - Arm 1 and Arm 2 Expansion Cohorts
|
7 percentage of participants
Interval 0.0 to 41.0
|
9.1 percentage of participants
Interval 0.2 to 41.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: Participants in the Safety Analysis Set who had at least 1 post baseline evaluable tumor assessment unless death or clinical progressive disease (PD) occurred before the first post baseline disease assessment.
Anti-tumor activity in subjects treated with TTX-030 as single agent or in combination with specified regimens
Outcome measures
| Measure |
Arm 1: TTX-030 1.5 mg/kg
n=1 Participants
Participants in Arm 1: TTX-030 was administered IV 1.5 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 3.0 mg/kg
n=2 Participants
Participants in Arm 1: TTX-030 was administered IV 3.0 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 6.0 mg/kg
n=1 Participants
Participants in Arm 1: TTX-030 was administered IV 6.0 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 10 mg/kg
n=3 Participants
Participants in Arm 1: TTX-030 was administered IV 10 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 20 mg/kg
n=2 Participants
Participants in Arm 1: TTX-030 was administered IV 20 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 40 mg/kg
n=3 Participants
Participants in Arm 1: TTX-030 was administered IV 40 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 40 mg/kg
n=6 Participants
Participants in Arm 1: TTX-030 was administered IV 40 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 4 (Safety Lead-In and Expansion)
n=13 Participants
Participants in Safety Lead-in and Arm 4 received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W and received gemcitabine 1000 mg/m\^2 + nab-Paclitaxel 125 mg/m\^2 Days 1, 8, and 15 every 28 days.
|
Arm 2 (Safety Lead-in and Expansion), Combination
Participants in Safety Lead-in portion and Expansion of Arm 2 received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W and pembrolizumab IV at a dose of 200 mg on Day 1 of each 21-day treatment cycle.
|
Arm 4 (Safety Lead-In and Expansion)
Participants in Safety Lead-in and Arm 4 received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W and received gemcitabine 1000 mg/m\^2 + nab-Paclitaxel 125 mg/m\^2 Days 1, 8, and 15 every 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) (Except for Arm 1 and 2 Expansion Cohorts, Where ORR Was a Primary Endpoint)
|
1 percentage of participants
Interval 0.0 to 97.5
|
2 percentage of participants
Interval 0.0 to 84.2
|
1 percentage of participants
Interval 0.0 to 97.5
|
3 percentage of participants
Interval 0.0 to 70.8
|
2 percentage of participants
Interval 0.0 to 70.8
|
3 percentage of participants
Interval 0.0 to 70.8
|
6 percentage of participants
Interval 0.0 to 45.9
|
30.8 percentage of participants
Interval 9.1 to 61.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycles 1-3 (each cycle is 21-28 days)Population: Dose-Normalized PK Parameters of Serum TTX-030
PK parameters of serum TTX-030 by Arm and Dose - Cycle 1
Outcome measures
| Measure |
Arm 1: TTX-030 1.5 mg/kg
n=1 Participants
Participants in Arm 1: TTX-030 was administered IV 1.5 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 3.0 mg/kg
n=2 Participants
Participants in Arm 1: TTX-030 was administered IV 3.0 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 6.0 mg/kg
n=2 Participants
Participants in Arm 1: TTX-030 was administered IV 6.0 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 10 mg/kg
n=4 Participants
Participants in Arm 1: TTX-030 was administered IV 10 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 20 mg/kg
n=3 Participants
Participants in Arm 1: TTX-030 was administered IV 20 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 40 mg/kg
n=3 Participants
Participants in Arm 1: TTX-030 was administered IV 40 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 40 mg/kg
n=6 Participants
Participants in Arm 1: TTX-030 was administered IV 40 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 4 (Safety Lead-In and Expansion)
n=8 Participants
Participants in Safety Lead-in and Arm 4 received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W and received gemcitabine 1000 mg/m\^2 + nab-Paclitaxel 125 mg/m\^2 Days 1, 8, and 15 every 28 days.
|
Arm 2 (Safety Lead-in and Expansion), Combination
n=13 Participants
Participants in Safety Lead-in portion and Expansion of Arm 2 received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W and pembrolizumab IV at a dose of 200 mg on Day 1 of each 21-day treatment cycle.
|
Arm 4 (Safety Lead-In and Expansion)
n=13 Participants
Participants in Safety Lead-in and Arm 4 received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W and received gemcitabine 1000 mg/m\^2 + nab-Paclitaxel 125 mg/m\^2 Days 1, 8, and 15 every 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
4.91 Cmax (μg/mL)
Geometric Coefficient of Variation 0
|
25.9 Cmax (μg/mL)
Geometric Coefficient of Variation 8.2
|
35.2 Cmax (μg/mL)
Geometric Coefficient of Variation 6.4
|
79.3 Cmax (μg/mL)
Geometric Coefficient of Variation 49.3
|
188 Cmax (μg/mL)
Geometric Coefficient of Variation 13.8
|
190 Cmax (μg/mL)
Geometric Coefficient of Variation 75.8
|
629 Cmax (μg/mL)
Geometric Coefficient of Variation 47.6
|
694 Cmax (μg/mL)
Geometric Coefficient of Variation 56.8
|
647 Cmax (μg/mL)
Geometric Coefficient of Variation 50.5
|
487 Cmax (μg/mL)
Geometric Coefficient of Variation 27.3
|
Adverse Events
Arm 1: TTX-030 0.5 mg/kg
Arm 1: TTX-030 1.5 mg/kg
Arm 1: TTX-030 3.0 mg/kg
Arm 1: TTX-030 6.0 mg/kg
Arm 1: TTX-030 10 mg/kg
Arm 1: TTX-030 20 mg/kg
Arm 1: TTX-030 40 mg/kg
Arm 1 Expansion: TTX-030 40 mg/kg Load/30 mg/kg Q3W
Arm 2 (Safety Lead-in and Expansion), Combination
Arm 4 (Safety Lead-In and Expansion)
Serious adverse events
| Measure |
Arm 1: TTX-030 0.5 mg/kg
n=1 participants at risk
Participants in Arm 1 Escalation were administered IV 0.5 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 1.5 mg/kg
n=2 participants at risk
Participants in Arm 1 Escalation were administered IV 1.5 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 3.0 mg/kg
n=2 participants at risk
Participants in Arm 1 Escalation were administered IV 3.0 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 6.0 mg/kg
n=4 participants at risk
Participants in Arm 1 Escalation were administered IV 6.0 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 10 mg/kg
n=3 participants at risk
Participants in Arm 1 Escalation were administered IV 10 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 20 mg/kg
n=3 participants at risk
Participants in Arm 1 Escalation were administered IV 20 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 40 mg/kg
n=6 participants at risk
Participants in Arm 1 Escalation were administered IV 40 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1 Expansion: TTX-030 40 mg/kg Load/30 mg/kg Q3W
n=8 participants at risk
Participants in Expansion received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W.
|
Arm 2 (Safety Lead-in and Expansion), Combination
n=13 participants at risk
Participants in Safety Lead-in portion and Expansion of Arm 2 received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W and pembrolizumab IV at a dose of 200 mg on Day 1 of each 21-day treatment cycle.
|
Arm 4 (Safety Lead-In and Expansion)
n=14 participants at risk
Participants in Safety Lead-in and Arm 4 received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W and received gemcitabine 1000 mg/m\^2 + nab-Paclitaxel 125 mg/m\^2 Days 1, 8, and 15 every 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
50.0%
1/2 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
16.7%
1/6 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
7.7%
1/13 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
16.7%
1/6 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/13 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
7.7%
1/13 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
7.7%
1/13 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
7.7%
1/13 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/13 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
7.1%
1/14 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
7.7%
1/13 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
16.7%
1/6 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/13 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
General disorders
Generalized edema
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/13 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
50.0%
1/2 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/13 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
50.0%
1/2 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/13 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Infections and infestations
Septic shock
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
7.7%
1/13 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
7.1%
1/14 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Infections and infestations
Covid-19
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/13 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
7.1%
1/14 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Infections and infestations
Extradural abscess
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
7.7%
1/13 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Infections and infestations
Sepsis
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
25.0%
1/4 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/13 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
7.7%
1/13 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
7.7%
1/13 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
33.3%
1/3 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/13 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
16.7%
1/6 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/13 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
7.7%
1/13 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
16.7%
1/6 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/13 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
16.7%
1/6 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/13 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
7.7%
1/13 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
7.7%
1/13 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
7.1%
1/14 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
7.7%
1/13 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Vascular disorders
Embolism
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/13 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
7.1%
1/14 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
Other adverse events
| Measure |
Arm 1: TTX-030 0.5 mg/kg
n=1 participants at risk
Participants in Arm 1 Escalation were administered IV 0.5 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 1.5 mg/kg
n=2 participants at risk
Participants in Arm 1 Escalation were administered IV 1.5 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 3.0 mg/kg
n=2 participants at risk
Participants in Arm 1 Escalation were administered IV 3.0 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 6.0 mg/kg
n=4 participants at risk
Participants in Arm 1 Escalation were administered IV 6.0 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 10 mg/kg
n=3 participants at risk
Participants in Arm 1 Escalation were administered IV 10 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 20 mg/kg
n=3 participants at risk
Participants in Arm 1 Escalation were administered IV 20 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1: TTX-030 40 mg/kg
n=6 participants at risk
Participants in Arm 1 Escalation were administered IV 40 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle.
|
Arm 1 Expansion: TTX-030 40 mg/kg Load/30 mg/kg Q3W
n=8 participants at risk
Participants in Expansion received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W.
|
Arm 2 (Safety Lead-in and Expansion), Combination
n=13 participants at risk
Participants in Safety Lead-in portion and Expansion of Arm 2 received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W and pembrolizumab IV at a dose of 200 mg on Day 1 of each 21-day treatment cycle.
|
Arm 4 (Safety Lead-In and Expansion)
n=14 participants at risk
Participants in Safety Lead-in and Arm 4 received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W and received gemcitabine 1000 mg/m\^2 + nab-Paclitaxel 125 mg/m\^2 Days 1, 8, and 15 every 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Muscular weakness
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
33.3%
1/3 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
16.7%
1/6 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
25.0%
2/8 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/13 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
50.0%
1/2 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
25.0%
1/4 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
33.3%
1/3 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
15.4%
2/13 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
50.0%
7/14 • Number of events 7 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/13 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
35.7%
5/14 • Number of events 5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
23.1%
3/13 • Number of events 3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
33.3%
1/3 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
16.7%
1/6 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/13 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
100.0%
1/1 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
25.0%
1/4 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
16.7%
1/6 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/13 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Investigations
Weight decreased
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
25.0%
1/4 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
16.7%
1/6 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
15.4%
2/13 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
21.4%
3/14 • Number of events 3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/13 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
28.6%
4/14 • Number of events 4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
50.0%
1/2 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
33.3%
1/3 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
25.0%
2/8 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/13 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
35.7%
5/14 • Number of events 5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
33.3%
1/3 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
33.3%
1/3 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
16.7%
1/6 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/13 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
7.7%
1/13 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
21.4%
3/14 • Number of events 3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/13 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
21.4%
3/14 • Number of events 3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
50.0%
1/2 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
25.0%
1/4 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
16.7%
1/6 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/13 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
50.0%
1/2 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
66.7%
2/3 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
33.3%
2/6 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
50.0%
4/8 • Number of events 4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
46.2%
6/13 • Number of events 6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
71.4%
10/14 • Number of events 10 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
50.0%
1/2 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
50.0%
1/2 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
25.0%
2/8 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
23.1%
3/13 • Number of events 3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
21.4%
3/14 • Number of events 3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
15.4%
2/13 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
21.4%
3/14 • Number of events 3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/13 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
42.9%
6/14 • Number of events 6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
33.3%
2/6 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
38.5%
5/13 • Number of events 5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
28.6%
4/14 • Number of events 4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Injury, poisoning and procedural complications
Back pain
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
23.1%
3/13 • Number of events 3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
14.3%
2/14 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
23.1%
3/13 • Number of events 3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/14 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
30.8%
4/13 • Number of events 4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
35.7%
5/14 • Number of events 5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
25.0%
1/4 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
16.7%
1/6 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/13 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
35.7%
5/14 • Number of events 5 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
66.7%
2/3 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
16.7%
1/6 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
12.5%
1/8 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
7.7%
1/13 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
21.4%
3/14 • Number of events 3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
33.3%
1/3 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
33.3%
1/3 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
25.0%
2/8 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
15.4%
2/13 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
42.9%
6/14 • Number of events 6 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
33.3%
2/6 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
25.0%
2/8 • Number of events 2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
30.8%
4/13 • Number of events 4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
7.1%
1/14 • Number of events 1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
|
Nervous system disorders
Edema peripheral
|
0.00%
0/1 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/2 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
50.0%
3/6 • Number of events 3 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/8 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
0.00%
0/13 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
28.6%
4/14 • Number of events 4 • Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place