Trial Outcomes & Findings for Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2 (NCT NCT05980416)
NCT ID: NCT05980416
Last Updated: 2025-11-14
Results Overview
Tumor assessments were evaluated at baseline by computerized tomography (CT) or magnetic resonance imaging (MRI). The primary objective of this study was to determine the overall objective response rate (ORR) per investigator assessment, defined as confirmed complete response (CR; disappearance of all target lesions) + partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions) by RECIST v1.1.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
88 participants
Primary outcome timeframe
Up to 24 months
Results posted on
2025-11-14
Participant Flow
Participant milestones
| Measure |
EO-3021 Monotherapy 1.0 mg/kg
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 1.0 mg/kg every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 Monotherapy 2.0 mg/kg
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.0 mg/kg every 3 weeks to determine MTD/RP2D(s).
In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who had received at least 1 but no more than 3 prior lines of therapy in the advanced metastatic setting were randomized to EO-3021 2.0 mg/kg or 2.5 mg/kg every 3 weeks in a 1:1 fashion.
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 Monotherapy 2.5 mg/kg
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.5 mg/kg every 3 weeks to determine MTD/RP2D(s).
In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who had received at least 1 but no more than 3 prior lines of therapy in the advanced metastatic setting were randomized to EO-3021 2.0 mg/kg or 2.5 mg/kg every 3 weeks in a 1:1 fashion.
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 Monotherapy 2.9 mg/kg
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.9 mg/kg every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 2.0 mg/kg in Combination With Ramucirumab
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 2.0 mg/kg in combination with ramucirumab every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
Ramucirumab (CYRAMZA®): VEGFR2 inhibitor
|
EO-3021 2.0 mg/kg in Combination With Dostarlimab
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma will receive EO-3021 2.0 mg/kg in combination with dostarlimab every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
Dostarlimab: anti-PD-1 antibody
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
42
|
34
|
6
|
2
|
1
|
|
Overall Study
COMPLETED
|
3
|
42
|
34
|
6
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2
Baseline characteristics by cohort
| Measure |
EO-3021 Monotherapy 1.0 mg/kg
n=3 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 1.0 mg/kg every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 Monotherapy 2.0 mg/kg
n=42 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.0 mg/kg every 3 weeks to determine MTD/RP2D(s).
In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who had received at least 1 but no more than 3 prior lines of therapy in the advanced metastatic setting were randomized to EO-3021 2.0 mg/kg or 2.5 mg/kg every 3 weeks in a 1:1 fashion.
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 Monotherapy 2.5 mg/kg
n=34 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.5 mg/kg every 3 weeks to determine MTD/RP2D(s).
In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who had received at least 1 but no more than 3 prior lines of therapy in the advanced metastatic setting were randomized to EO-3021 2.0 mg/kg or 2.5 mg/kg every 3 weeks in a 1:1 fashion.
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 Monotherapy 2.9 mg/kg
n=6 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.9 mg/kg every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 2.0 mg/kg in Combination With Ramucirumab
n=2 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 2.0 mg/kg in combination with ramucirumab every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
Ramucirumab (CYRAMZA®): VEGFR2 inhibitor
|
EO-3021 2.0 mg/kg in Combination With Dostarlimab
n=1 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma will receive EO-3021 2.0 mg/kg in combination with dostarlimab every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
Dostarlimab: anti-PD-1 antibody
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
67.3 years
n=10 Participants
|
60.8 years
n=10 Participants
|
60.7 years
n=20 Participants
|
65.7 years
n=45 Participants
|
46.0 years
n=44 Participants
|
45. years
n=45 Participants
|
60.8 years
n=265 Participants
|
|
Sex: Female, Male
Female
|
2.0 Participants
n=10 Participants
|
15.0 Participants
n=10 Participants
|
8.0 Participants
n=20 Participants
|
1.0 Participants
n=45 Participants
|
1.0 Participants
n=44 Participants
|
1.0 Participants
n=45 Participants
|
28 Participants
n=265 Participants
|
|
Sex: Female, Male
Male
|
1.0 Participants
n=10 Participants
|
27.0 Participants
n=10 Participants
|
26.0 Participants
n=20 Participants
|
5.0 Participants
n=45 Participants
|
1.0 Participants
n=44 Participants
|
0.0 Participants
n=45 Participants
|
60 Participants
n=265 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0.0 Participants
n=10 Participants
|
0.0 Participants
n=10 Participants
|
0.0 Participants
n=20 Participants
|
0.0 Participants
n=45 Participants
|
0.0 Participants
n=44 Participants
|
0.0 Participants
n=45 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Asian
|
0.0 Participants
n=10 Participants
|
17.0 Participants
n=10 Participants
|
16.0 Participants
n=20 Participants
|
3.0 Participants
n=45 Participants
|
0.0 Participants
n=44 Participants
|
0.0 Participants
n=45 Participants
|
36 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0.0 Participants
n=10 Participants
|
0.0 Participants
n=10 Participants
|
0.0 Participants
n=20 Participants
|
0.0 Participants
n=45 Participants
|
0.0 Participants
n=44 Participants
|
0.0 Participants
n=45 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0.0 Participants
n=10 Participants
|
2.0 Participants
n=10 Participants
|
1.0 Participants
n=20 Participants
|
0.0 Participants
n=45 Participants
|
0.0 Participants
n=44 Participants
|
0.0 Participants
n=45 Participants
|
3 Participants
n=265 Participants
|
|
Race (NIH/OMB)
White
|
3.0 Participants
n=10 Participants
|
20.0 Participants
n=10 Participants
|
15.0 Participants
n=20 Participants
|
3.0 Participants
n=45 Participants
|
2.0 Participants
n=44 Participants
|
1.0 Participants
n=45 Participants
|
44 Participants
n=265 Participants
|
|
Race (NIH/OMB)
More than one race
|
0.0 Participants
n=10 Participants
|
0.0 Participants
n=10 Participants
|
0.0 Participants
n=20 Participants
|
0.0 Participants
n=45 Participants
|
0.0 Participants
n=44 Participants
|
0.0 Participants
n=45 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0.0 Participants
n=10 Participants
|
3.0 Participants
n=10 Participants
|
2.0 Participants
n=20 Participants
|
0.0 Participants
n=45 Participants
|
0.0 Participants
n=44 Participants
|
0.0 Participants
n=45 Participants
|
5 Participants
n=265 Participants
|
PRIMARY outcome
Timeframe: From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose)Outcome measures
| Measure |
EO-3021 Monotherapy 1.0 mg/kg
n=3 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 1.0 mg/kg every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 Monotherapy 2.0 mg/kg
n=42 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.0 mg/kg every 3 weeks to determine MTD/RP2D(s).
In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who had received at least 1 but no more than 3 prior lines of therapy in the advanced metastatic setting were randomized to EO-3021 2.0 mg/kg or 2.5 mg/kg every 3 weeks in a 1:1 fashion.
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 Monotherapy 2.5 mg/kg
n=34 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.5 mg/kg every 3 weeks to determine MTD/RP2D(s).
In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who had received at least 1 but no more than 3 prior lines of therapy in the advanced metastatic setting were randomized to EO-3021 2.0 mg/kg or 2.5 mg/kg every 3 weeks in a 1:1 fashion.
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 Monotherapy 2.9 mg/kg
n=6 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.9 mg/kg every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 2.0 mg/kg in Combination With Ramucirumab
n=2 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 2.0 mg/kg in combination with ramucirumab every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
Ramucirumab (CYRAMZA®): VEGFR2 inhibitor
|
EO-3021 2.0 mg/kg in Combination With Dostarlimab
n=1 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma will receive EO-3021 2.0 mg/kg in combination with dostarlimab every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
Dostarlimab: anti-PD-1 antibody
|
|---|---|---|---|---|---|---|
|
Number of Patients With Treatment Emergent Adverse Events When Treated With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab.
|
3.0 Participants
|
42.0 Participants
|
34.0 Participants
|
6.0 Participants
|
2.0 Participants
|
1.0 Participants
|
PRIMARY outcome
Timeframe: The first 21-day treatment cycle for each patient enrolled in the Escalation PhaseOutcome measures
| Measure |
EO-3021 Monotherapy 1.0 mg/kg
n=3 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 1.0 mg/kg every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 Monotherapy 2.0 mg/kg
n=42 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.0 mg/kg every 3 weeks to determine MTD/RP2D(s).
In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who had received at least 1 but no more than 3 prior lines of therapy in the advanced metastatic setting were randomized to EO-3021 2.0 mg/kg or 2.5 mg/kg every 3 weeks in a 1:1 fashion.
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 Monotherapy 2.5 mg/kg
n=34 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.5 mg/kg every 3 weeks to determine MTD/RP2D(s).
In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who had received at least 1 but no more than 3 prior lines of therapy in the advanced metastatic setting were randomized to EO-3021 2.0 mg/kg or 2.5 mg/kg every 3 weeks in a 1:1 fashion.
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 Monotherapy 2.9 mg/kg
n=6 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.9 mg/kg every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 2.0 mg/kg in Combination With Ramucirumab
n=2 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 2.0 mg/kg in combination with ramucirumab every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
Ramucirumab (CYRAMZA®): VEGFR2 inhibitor
|
EO-3021 2.0 mg/kg in Combination With Dostarlimab
n=1 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma will receive EO-3021 2.0 mg/kg in combination with dostarlimab every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
Dostarlimab: anti-PD-1 antibody
|
|---|---|---|---|---|---|---|
|
The Incidence Rate of Dose Limiting Toxicities (DLT) During the First 21-day Cycle of Treatment With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab.
|
0.0 Participants
|
0.0 Participants
|
2.0 Participants
|
5.0 Participants
|
0.0 Participants
|
0.0 Participants
|
PRIMARY outcome
Timeframe: From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose)Outcome measures
| Measure |
EO-3021 Monotherapy 1.0 mg/kg
n=3 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 1.0 mg/kg every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 Monotherapy 2.0 mg/kg
n=42 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.0 mg/kg every 3 weeks to determine MTD/RP2D(s).
In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who had received at least 1 but no more than 3 prior lines of therapy in the advanced metastatic setting were randomized to EO-3021 2.0 mg/kg or 2.5 mg/kg every 3 weeks in a 1:1 fashion.
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 Monotherapy 2.5 mg/kg
n=34 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.5 mg/kg every 3 weeks to determine MTD/RP2D(s).
In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who had received at least 1 but no more than 3 prior lines of therapy in the advanced metastatic setting were randomized to EO-3021 2.0 mg/kg or 2.5 mg/kg every 3 weeks in a 1:1 fashion.
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 Monotherapy 2.9 mg/kg
n=6 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.9 mg/kg every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 2.0 mg/kg in Combination With Ramucirumab
n=2 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 2.0 mg/kg in combination with ramucirumab every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
Ramucirumab (CYRAMZA®): VEGFR2 inhibitor
|
EO-3021 2.0 mg/kg in Combination With Dostarlimab
n=1 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma will receive EO-3021 2.0 mg/kg in combination with dostarlimab every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
Dostarlimab: anti-PD-1 antibody
|
|---|---|---|---|---|---|---|
|
Number of Patients With Serious Adverse Events When Treated With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab.
|
2.0 Participants
|
20.0 Participants
|
15.0 Participants
|
4.0 Participants
|
0.0 Participants
|
0.0 Participants
|
PRIMARY outcome
Timeframe: From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last doseOutcome measures
| Measure |
EO-3021 Monotherapy 1.0 mg/kg
n=3 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 1.0 mg/kg every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 Monotherapy 2.0 mg/kg
n=42 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.0 mg/kg every 3 weeks to determine MTD/RP2D(s).
In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who had received at least 1 but no more than 3 prior lines of therapy in the advanced metastatic setting were randomized to EO-3021 2.0 mg/kg or 2.5 mg/kg every 3 weeks in a 1:1 fashion.
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 Monotherapy 2.5 mg/kg
n=34 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.5 mg/kg every 3 weeks to determine MTD/RP2D(s).
In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who had received at least 1 but no more than 3 prior lines of therapy in the advanced metastatic setting were randomized to EO-3021 2.0 mg/kg or 2.5 mg/kg every 3 weeks in a 1:1 fashion.
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 Monotherapy 2.9 mg/kg
n=6 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.9 mg/kg every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 2.0 mg/kg in Combination With Ramucirumab
n=2 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 2.0 mg/kg in combination with ramucirumab every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
Ramucirumab (CYRAMZA®): VEGFR2 inhibitor
|
EO-3021 2.0 mg/kg in Combination With Dostarlimab
n=1 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma will receive EO-3021 2.0 mg/kg in combination with dostarlimab every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
Dostarlimab: anti-PD-1 antibody
|
|---|---|---|---|---|---|---|
|
Number of Patients With Clinically Significant Changes to Vital Signs When Treated With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab
|
0.0 Participants
|
3.0 Participants
|
2.0 Participants
|
0.0 Participants
|
0.0 Participants
|
0.0 Participants
|
PRIMARY outcome
Timeframe: From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose)Outcome measures
| Measure |
EO-3021 Monotherapy 1.0 mg/kg
n=3 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 1.0 mg/kg every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 Monotherapy 2.0 mg/kg
n=42 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.0 mg/kg every 3 weeks to determine MTD/RP2D(s).
In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who had received at least 1 but no more than 3 prior lines of therapy in the advanced metastatic setting were randomized to EO-3021 2.0 mg/kg or 2.5 mg/kg every 3 weeks in a 1:1 fashion.
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 Monotherapy 2.5 mg/kg
n=34 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.5 mg/kg every 3 weeks to determine MTD/RP2D(s).
In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who had received at least 1 but no more than 3 prior lines of therapy in the advanced metastatic setting were randomized to EO-3021 2.0 mg/kg or 2.5 mg/kg every 3 weeks in a 1:1 fashion.
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 Monotherapy 2.9 mg/kg
n=6 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.9 mg/kg every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 2.0 mg/kg in Combination With Ramucirumab
n=2 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 2.0 mg/kg in combination with ramucirumab every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
Ramucirumab (CYRAMZA®): VEGFR2 inhibitor
|
EO-3021 2.0 mg/kg in Combination With Dostarlimab
n=1 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma will receive EO-3021 2.0 mg/kg in combination with dostarlimab every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
Dostarlimab: anti-PD-1 antibody
|
|---|---|---|---|---|---|---|
|
Number of Patients With Clinically Significant Changes in Laboratory Tests When Treated With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab.
|
0.0 Participants
|
3.0 Participants
|
2.0 Participants
|
0.0 Participants
|
0.0 Participants
|
0.0 Participants
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: The Efficacy Evaluable Population includes all patients who receive at least one dose of EO-3021, have baseline measurable disease and at least one post baseline imaging assessment.
Tumor assessments were evaluated at baseline by computerized tomography (CT) or magnetic resonance imaging (MRI). The primary objective of this study was to determine the overall objective response rate (ORR) per investigator assessment, defined as confirmed complete response (CR; disappearance of all target lesions) + partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions) by RECIST v1.1.
Outcome measures
| Measure |
EO-3021 Monotherapy 1.0 mg/kg
n=3 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 1.0 mg/kg every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 Monotherapy 2.0 mg/kg
n=34 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.0 mg/kg every 3 weeks to determine MTD/RP2D(s).
In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who had received at least 1 but no more than 3 prior lines of therapy in the advanced metastatic setting were randomized to EO-3021 2.0 mg/kg or 2.5 mg/kg every 3 weeks in a 1:1 fashion.
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 Monotherapy 2.5 mg/kg
n=31 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.5 mg/kg every 3 weeks to determine MTD/RP2D(s).
In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who had received at least 1 but no more than 3 prior lines of therapy in the advanced metastatic setting were randomized to EO-3021 2.0 mg/kg or 2.5 mg/kg every 3 weeks in a 1:1 fashion.
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 Monotherapy 2.9 mg/kg
n=4 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.9 mg/kg every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 2.0 mg/kg in Combination With Ramucirumab
n=1 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 2.0 mg/kg in combination with ramucirumab every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
Ramucirumab (CYRAMZA®): VEGFR2 inhibitor
|
EO-3021 2.0 mg/kg in Combination With Dostarlimab
n=1 Participants
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma will receive EO-3021 2.0 mg/kg in combination with dostarlimab every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
Dostarlimab: anti-PD-1 antibody
|
|---|---|---|---|---|---|---|
|
The Estimate of Overall Response Rate (ORR) for the Efficacy Population.
|
1 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
EO-3021 Monotherapy 1.0 mg/kg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
EO-3021 Monotherapy 2.0 mg/kg
Serious events: 20 serious events
Other events: 42 other events
Deaths: 29 deaths
EO-3021 Monotherapy 2.5 mg/kg
Serious events: 15 serious events
Other events: 34 other events
Deaths: 19 deaths
EO-3021 Monotherapy 2.9 mg/kg
Serious events: 4 serious events
Other events: 6 other events
Deaths: 4 deaths
EO-3021 2.0 mg/kg in Combination With Ramucirumab
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
EO-3021 2.0 mg/kg in Combination With Dostarlimab
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EO-3021 Monotherapy 1.0 mg/kg
n=3 participants at risk
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 1.0 mg/kg every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 Monotherapy 2.0 mg/kg
n=42 participants at risk
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.0 mg/kg every 3 weeks to determine MTD/RP2D(s).
In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who had received at least 1 but no more than 3 prior lines of therapy in the advanced metastatic setting were randomized to EO-3021 2.0 mg/kg or 2.5 mg/kg every 3 weeks in a 1:1 fashion.
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 Monotherapy 2.5 mg/kg
n=34 participants at risk
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.5 mg/kg every 3 weeks to determine MTD/RP2D(s).
In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who had received at least 1 but no more than 3 prior lines of therapy in the advanced metastatic setting were randomized to EO-3021 2.0 mg/kg or 2.5 mg/kg every 3 weeks in a 1:1 fashion.
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 Monotherapy 2.9 mg/kg
n=6 participants at risk
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.9 mg/kg every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 2.0 mg/kg in Combination With Ramucirumab
n=2 participants at risk
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 2.0 mg/kg in combination with ramucirumab every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
Ramucirumab (CYRAMZA®): VEGFR2 inhibitor
|
EO-3021 2.0 mg/kg in Combination With Dostarlimab
n=1 participants at risk
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma will receive EO-3021 2.0 mg/kg in combination with dostarlimab every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
Dostarlimab: anti-PD-1 antibody
|
|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasm Progression
|
33.3%
1/3 • 1 year 10 months
|
2.4%
1/42 • 1 year 10 months
|
2.9%
1/34 • 1 year 10 months
|
16.7%
1/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • 1 year 10 months
|
2.4%
1/42 • 1 year 10 months
|
2.9%
1/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • 1 year 10 months
|
2.4%
1/42 • 1 year 10 months
|
0.00%
0/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/3 • 1 year 10 months
|
2.4%
1/42 • 1 year 10 months
|
2.9%
1/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • 1 year 10 months
|
2.4%
1/42 • 1 year 10 months
|
2.9%
1/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Gastrointestinal disorders
Upper Gasterointestinal Haemorrhage
|
0.00%
0/3 • 1 year 10 months
|
0.00%
0/42 • 1 year 10 months
|
5.9%
2/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • 1 year 10 months
|
0.00%
0/42 • 1 year 10 months
|
2.9%
1/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/3 • 1 year 10 months
|
2.4%
1/42 • 1 year 10 months
|
0.00%
0/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Hepatobiliary disorders
Biliary Tract Infection
|
0.00%
0/3 • 1 year 10 months
|
2.4%
1/42 • 1 year 10 months
|
0.00%
0/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Vascular disorders
Cerebral Infarction
|
0.00%
0/3 • 1 year 10 months
|
2.4%
1/42 • 1 year 10 months
|
0.00%
0/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Psychiatric disorders
Completed Suicide
|
0.00%
0/3 • 1 year 10 months
|
2.4%
1/42 • 1 year 10 months
|
0.00%
0/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • 1 year 10 months
|
2.4%
1/42 • 1 year 10 months
|
0.00%
0/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/3 • 1 year 10 months
|
2.4%
1/42 • 1 year 10 months
|
0.00%
0/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • 1 year 10 months
|
2.4%
1/42 • 1 year 10 months
|
0.00%
0/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Gastrointestinal disorders
Duodenal Obstruction
|
0.00%
0/3 • 1 year 10 months
|
2.4%
1/42 • 1 year 10 months
|
0.00%
0/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • 1 year 10 months
|
2.4%
1/42 • 1 year 10 months
|
0.00%
0/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • 1 year 10 months
|
0.00%
0/42 • 1 year 10 months
|
2.9%
1/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Metabolism and nutrition disorders
Failure to Thrive
|
0.00%
0/3 • 1 year 10 months
|
0.00%
0/42 • 1 year 10 months
|
2.9%
1/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • 1 year 10 months
|
0.00%
0/42 • 1 year 10 months
|
2.9%
1/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • 1 year 10 months
|
2.4%
1/42 • 1 year 10 months
|
0.00%
0/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • 1 year 10 months
|
0.00%
0/42 • 1 year 10 months
|
2.9%
1/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Gastrointestinal disorders
Impaired Gastric Temptying
|
0.00%
0/3 • 1 year 10 months
|
2.4%
1/42 • 1 year 10 months
|
0.00%
0/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Hepatobiliary disorders
Jaundice Cholestatic
|
0.00%
0/3 • 1 year 10 months
|
2.4%
1/42 • 1 year 10 months
|
0.00%
0/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • 1 year 10 months
|
9.5%
4/42 • 1 year 10 months
|
0.00%
0/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/3 • 1 year 10 months
|
2.4%
1/42 • 1 year 10 months
|
11.8%
4/34 • 1 year 10 months
|
16.7%
1/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
General disorders
Fatigue
|
0.00%
0/3 • 1 year 10 months
|
0.00%
0/42 • 1 year 10 months
|
0.00%
0/34 • 1 year 10 months
|
33.3%
2/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
Other adverse events
| Measure |
EO-3021 Monotherapy 1.0 mg/kg
n=3 participants at risk
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 1.0 mg/kg every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 Monotherapy 2.0 mg/kg
n=42 participants at risk
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.0 mg/kg every 3 weeks to determine MTD/RP2D(s).
In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who had received at least 1 but no more than 3 prior lines of therapy in the advanced metastatic setting were randomized to EO-3021 2.0 mg/kg or 2.5 mg/kg every 3 weeks in a 1:1 fashion.
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 Monotherapy 2.5 mg/kg
n=34 participants at risk
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.5 mg/kg every 3 weeks to determine MTD/RP2D(s).
In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who had received at least 1 but no more than 3 prior lines of therapy in the advanced metastatic setting were randomized to EO-3021 2.0 mg/kg or 2.5 mg/kg every 3 weeks in a 1:1 fashion.
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 Monotherapy 2.9 mg/kg
n=6 participants at risk
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 monotherapy 2.9 mg/kg every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
|
EO-3021 2.0 mg/kg in Combination With Ramucirumab
n=2 participants at risk
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma received EO-3021 2.0 mg/kg in combination with ramucirumab every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
Ramucirumab (CYRAMZA®): VEGFR2 inhibitor
|
EO-3021 2.0 mg/kg in Combination With Dostarlimab
n=1 participants at risk
In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma will receive EO-3021 2.0 mg/kg in combination with dostarlimab every 3 weeks to determine MTD/RP2D(s).
EO-3021: Anti-Claudin 18.2 antibody drug conjugate
Dostarlimab: anti-PD-1 antibody
|
|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
1/3 • 1 year 10 months
|
7.1%
3/42 • 1 year 10 months
|
5.9%
2/34 • 1 year 10 months
|
16.7%
1/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
General disorders
Pyrexia
|
0.00%
0/3 • 1 year 10 months
|
4.8%
2/42 • 1 year 10 months
|
11.8%
4/34 • 1 year 10 months
|
16.7%
1/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/3 • 1 year 10 months
|
2.4%
1/42 • 1 year 10 months
|
14.7%
5/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Gastrointestinal disorders
Hiccups
|
0.00%
0/3 • 1 year 10 months
|
2.4%
1/42 • 1 year 10 months
|
8.8%
3/34 • 1 year 10 months
|
16.7%
1/6 • 1 year 10 months
|
50.0%
1/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
0.00%
0/3 • 1 year 10 months
|
9.5%
4/42 • 1 year 10 months
|
5.9%
2/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • 1 year 10 months
|
7.1%
3/42 • 1 year 10 months
|
5.9%
2/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • 1 year 10 months
|
4.8%
2/42 • 1 year 10 months
|
8.8%
3/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • 1 year 10 months
|
7.1%
3/42 • 1 year 10 months
|
5.9%
2/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • 1 year 10 months
|
4.8%
2/42 • 1 year 10 months
|
8.8%
3/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
General disorders
Malaise
|
0.00%
0/3 • 1 year 10 months
|
7.1%
3/42 • 1 year 10 months
|
5.9%
2/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/3 • 1 year 10 months
|
7.1%
3/42 • 1 year 10 months
|
5.9%
2/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • 1 year 10 months
|
19.0%
8/42 • 1 year 10 months
|
14.7%
5/34 • 1 year 10 months
|
16.7%
1/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • 1 year 10 months
|
14.3%
6/42 • 1 year 10 months
|
8.8%
3/34 • 1 year 10 months
|
16.7%
1/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • 1 year 10 months
|
11.9%
5/42 • 1 year 10 months
|
14.7%
5/34 • 1 year 10 months
|
16.7%
1/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
100.0%
1/1 • 1 year 10 months
|
|
General disorders
Edema Peripheral
|
33.3%
1/3 • 1 year 10 months
|
7.1%
3/42 • 1 year 10 months
|
14.7%
5/34 • 1 year 10 months
|
16.7%
1/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • 1 year 10 months
|
19.0%
8/42 • 1 year 10 months
|
2.9%
1/34 • 1 year 10 months
|
16.7%
1/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Eye disorders
Dry Eye
|
0.00%
0/3 • 1 year 10 months
|
7.1%
3/42 • 1 year 10 months
|
11.8%
4/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
100.0%
1/1 • 1 year 10 months
|
|
Eye disorders
Vision Blurred
|
0.00%
0/3 • 1 year 10 months
|
4.8%
2/42 • 1 year 10 months
|
14.7%
5/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
100.0%
1/1 • 1 year 10 months
|
|
Metabolism and nutrition disorders
Weight Decreased
|
0.00%
0/3 • 1 year 10 months
|
11.9%
5/42 • 1 year 10 months
|
5.9%
2/34 • 1 year 10 months
|
0.00%
0/6 • 1 year 10 months
|
50.0%
1/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • 1 year 10 months
|
11.9%
5/42 • 1 year 10 months
|
17.6%
6/34 • 1 year 10 months
|
33.3%
2/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
100.0%
1/1 • 1 year 10 months
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • 1 year 10 months
|
59.5%
25/42 • 1 year 10 months
|
58.8%
20/34 • 1 year 10 months
|
83.3%
5/6 • 1 year 10 months
|
100.0%
2/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
66.7%
2/3 • 1 year 10 months
|
42.9%
18/42 • 1 year 10 months
|
58.8%
20/34 • 1 year 10 months
|
83.3%
5/6 • 1 year 10 months
|
100.0%
2/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
General disorders
Fatigue
|
33.3%
1/3 • 1 year 10 months
|
42.9%
18/42 • 1 year 10 months
|
26.5%
9/34 • 1 year 10 months
|
50.0%
3/6 • 1 year 10 months
|
100.0%
2/2 • 1 year 10 months
|
100.0%
1/1 • 1 year 10 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • 1 year 10 months
|
33.3%
14/42 • 1 year 10 months
|
29.4%
10/34 • 1 year 10 months
|
33.3%
2/6 • 1 year 10 months
|
50.0%
1/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Eye disorders
Keratopathy
|
33.3%
1/3 • 1 year 10 months
|
26.2%
11/42 • 1 year 10 months
|
38.2%
13/34 • 1 year 10 months
|
16.7%
1/6 • 1 year 10 months
|
0.00%
0/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • 1 year 10 months
|
19.0%
8/42 • 1 year 10 months
|
17.6%
6/34 • 1 year 10 months
|
50.0%
3/6 • 1 year 10 months
|
50.0%
1/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
33.3%
1/3 • 1 year 10 months
|
16.7%
7/42 • 1 year 10 months
|
17.6%
6/34 • 1 year 10 months
|
50.0%
3/6 • 1 year 10 months
|
50.0%
1/2 • 1 year 10 months
|
0.00%
0/1 • 1 year 10 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place