Trial Outcomes & Findings for Treatment of Castration Resistant Prostate Cancer Using Multi-Targeted Recombinant Ad5 PSA/MUC1/Brachyury Based Immunotherapy Vaccines (NCT NCT03481816)
NCT ID: NCT03481816
Last Updated: 2021-05-19
Results Overview
A dose-limiting toxicity is defined as occurring within 28 days after the first vaccine administration and meeting on of these criteria: Any Grade 3 or greater toxicity or any Grade 2 or higher autoimmune reaction as defined by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0; or generalized erythroderma or macular or papular rash.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
4 weeks after receiving the first vaccine dose
Results posted on
2021-05-19
Participant Flow
Participant milestones
| Measure |
Arm 1/Dose De-escalation
Subjects enrolled to dose de-escalation cohorts. We did not need to dose de-escalate since none of patient's had dose limiting toxicity (DLT) so all patients received planned higher starting dose.
ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
|
Arm 2/Dose Expansion
Subjects enrolled at the maximum tolerated dose (MTD) after the MTD is established.
ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
|
|---|---|---|
|
Starting Dose
STARTED
|
6
|
0
|
|
Starting Dose
COMPLETED
|
5
|
0
|
|
Starting Dose
NOT COMPLETED
|
1
|
0
|
|
Dose Expansion
STARTED
|
0
|
12
|
|
Dose Expansion
COMPLETED
|
0
|
0
|
|
Dose Expansion
NOT COMPLETED
|
0
|
12
|
Reasons for withdrawal
| Measure |
Arm 1/Dose De-escalation
Subjects enrolled to dose de-escalation cohorts. We did not need to dose de-escalate since none of patient's had dose limiting toxicity (DLT) so all patients received planned higher starting dose.
ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
|
Arm 2/Dose Expansion
Subjects enrolled at the maximum tolerated dose (MTD) after the MTD is established.
ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
|
|---|---|---|
|
Starting Dose
Refused further vaccines after 1 dose
|
1
|
0
|
|
Dose Expansion
Off treatment due to progressive disease
|
0
|
5
|
|
Dose Expansion
Withdrawal by Subject
|
0
|
2
|
|
Dose Expansion
Physician Decision
|
0
|
5
|
Baseline Characteristics
Treatment of Castration Resistant Prostate Cancer Using Multi-Targeted Recombinant Ad5 PSA/MUC1/Brachyury Based Immunotherapy Vaccines
Baseline characteristics by cohort
| Measure |
Arm 1/Dose De-Escalation
n=6 Participants
Subjects enrolled to dose de-escalation cohorts.
ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
|
Arm 2/Dose Expansion
n=12 Participants
Subjects enrolled at the maximum tolerated dose (MTD) after the MTD is established.
ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
|
Total
n=18 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
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Continuous
|
70.62 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
72.58 years
STANDARD_DEVIATION 9.23 • n=7 Participants
|
71.60 years
STANDARD_DEVIATION 8.91 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
12 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Median Baseline Prostate-Specific Antigen (PSA)
|
46.92 ng/mL
n=5 Participants
|
14.55 ng/mL
n=7 Participants
|
25.58 ng/mL
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks after receiving the first vaccine doseA dose-limiting toxicity is defined as occurring within 28 days after the first vaccine administration and meeting on of these criteria: Any Grade 3 or greater toxicity or any Grade 2 or higher autoimmune reaction as defined by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0; or generalized erythroderma or macular or papular rash.
Outcome measures
| Measure |
Arm 1/Dose De-Escalation
n=6 Participants
Subjects enrolled to dose de-escalation cohorts. We did not need to dose de-escalate since none of patient's had dose limiting toxicity (DLT) so all patients received planned higher starting dose.
ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
|
Arm 2/Dose Expansion
n=12 Participants
Subjects enrolled at the maximum tolerated dose (MTD) after the MTD is established.
ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
|
|---|---|---|
|
Number of Participants With Dose-Limiting Toxicities
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within the first 4 weeks after drug is administered.RP2D is the maximum tolerated dose declared after ≤1 of 6 participants experience a dose-limiting toxicity within the first 4 weeks.
Outcome measures
| Measure |
Arm 1/Dose De-Escalation
n=6 Participants
Subjects enrolled to dose de-escalation cohorts. We did not need to dose de-escalate since none of patient's had dose limiting toxicity (DLT) so all patients received planned higher starting dose.
ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
|
Arm 2/Dose Expansion
Subjects enrolled at the maximum tolerated dose (MTD) after the MTD is established.
ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
|
|---|---|---|
|
Recommended Phase 2 Dose
|
500000000000 viral particles
|
—
|
SECONDARY outcome
Timeframe: Objective response at any time point during treatment on study up to 1 yearORR is the percentage of subjects who experience partial response (PR) or complete response (CR) measured by the Response Evaluation Criteria in Solid Tumors (RECIST) at any time point during the treatment period. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.
Outcome measures
| Measure |
Arm 1/Dose De-Escalation
n=6 Participants
Subjects enrolled to dose de-escalation cohorts. We did not need to dose de-escalate since none of patient's had dose limiting toxicity (DLT) so all patients received planned higher starting dose.
ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
|
Arm 2/Dose Expansion
n=12 Participants
Subjects enrolled at the maximum tolerated dose (MTD) after the MTD is established.
ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
|
|---|---|---|
|
Percentage of Participants With an Objective Response
Partial Response
|
0 percentage of participants
|
8.3 percentage of participants
|
|
Percentage of Participants With an Objective Response
Complete Response
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 6 months post treatmentDCR is the percentage of subjects who experience partial response (PR), complete response (CR), or stable disease (SD) lasting for at least 6 months. Response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST)v1. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of diameters while on study. Progressive disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progressions.
Outcome measures
| Measure |
Arm 1/Dose De-Escalation
n=6 Participants
Subjects enrolled to dose de-escalation cohorts. We did not need to dose de-escalate since none of patient's had dose limiting toxicity (DLT) so all patients received planned higher starting dose.
ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
|
Arm 2/Dose Expansion
n=12 Participants
Subjects enrolled at the maximum tolerated dose (MTD) after the MTD is established.
ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
|
|---|---|---|
|
Percentage of Participants With a Disease Control Rate (DCR) Lasting for at Least 6 Months
Partial Response
|
0 percentage of participants
|
8.3 percentage of participants
|
|
Percentage of Participants With a Disease Control Rate (DCR) Lasting for at Least 6 Months
Complete Response
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With a Disease Control Rate (DCR) Lasting for at Least 6 Months
Stable Disease
|
0 percentage of participants
|
41.6 percentage of participants
|
SECONDARY outcome
Timeframe: Time from recorded partial response until development of progressive disease. This was accessed every 3 weeks for the first 3 doses and then every 8 weeks up to 1 year (Arm 2)Population: Per protocol, this outcome measure was pre-specified to be performed in Arm 2 only.
Duration of response is the time from when measurement criteria for Partial Response (PR) or Complete Response (CR) are met until disease recurrence or progression per dose cohort. Response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST)v1. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progressions.
Outcome measures
| Measure |
Arm 1/Dose De-Escalation
n=1 Participants
Subjects enrolled to dose de-escalation cohorts. We did not need to dose de-escalate since none of patient's had dose limiting toxicity (DLT) so all patients received planned higher starting dose.
ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
|
Arm 2/Dose Expansion
Subjects enrolled at the maximum tolerated dose (MTD) after the MTD is established.
ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
|
|---|---|---|
|
Duration of Response
|
16 Weeks
The full range cannot be calculated because we need at least two values. 1/12 participants had a response and was analyzed.
|
—
|
SECONDARY outcome
Timeframe: This was accessed every 3 weeks for the first 3 doses, then every 8 weeks up to 1 year (Arm 2).Population: Per protocol, this outcome measure was pre-specified to be performed in Arm 2 only.
PFS is the time from the date of first treatment to the date of disease progression or death (any cause) whichever occurs first per dose cohort. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST)v1. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progressions.
Outcome measures
| Measure |
Arm 1/Dose De-Escalation
n=12 Participants
Subjects enrolled to dose de-escalation cohorts. We did not need to dose de-escalate since none of patient's had dose limiting toxicity (DLT) so all patients received planned higher starting dose.
ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
|
Arm 2/Dose Expansion
Subjects enrolled at the maximum tolerated dose (MTD) after the MTD is established.
ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
22 Weeks
Interval 19.1 to 34.0
|
—
|
SECONDARY outcome
Timeframe: Every 3 weeks for the first 3 doses, then every 8 weeks up to 1 year then every 3 months for 12 months and then approximately every 6 months every 6 months for 24 months and then every 12 months thereafter for another 24 months.Population: Median OS not reached. Per protocol we have to assess Overall survival (OS) - the time from the date of first treatment to the date of death (any cause) per dose cohort and overall.
OS is the time from the date of first treatment to the date of death (any cause).
Outcome measures
| Measure |
Arm 1/Dose De-Escalation
n=6 Participants
Subjects enrolled to dose de-escalation cohorts. We did not need to dose de-escalate since none of patient's had dose limiting toxicity (DLT) so all patients received planned higher starting dose.
ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
|
Arm 2/Dose Expansion
n=12 Participants
Subjects enrolled at the maximum tolerated dose (MTD) after the MTD is established.
ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
|
|---|---|---|
|
Overall Survival (OS)
|
12.2 Weeks
Interval 3.3 to
There is no upper end with "not estimable".
|
NA Weeks
Median OS not reached as no events occurred (all patients are alive)
|
SECONDARY outcome
Timeframe: 12 and 24 months after first treatmentProbability of being alive at 12 Months and 24 Months after first vaccine.
Outcome measures
| Measure |
Arm 1/Dose De-Escalation
n=6 Participants
Subjects enrolled to dose de-escalation cohorts. We did not need to dose de-escalate since none of patient's had dose limiting toxicity (DLT) so all patients received planned higher starting dose.
ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
|
Arm 2/Dose Expansion
n=12 Participants
Subjects enrolled at the maximum tolerated dose (MTD) after the MTD is established.
ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
|
|---|---|---|
|
Percentage of Overall Survival (OS) Probability at 12 Months and 24 Months
12 Months
|
50.0 Percentage of probability
Interval 11.1 to 80.4
|
100 Percentage of probability
Interval 100.0 to 100.0
|
|
Percentage of Overall Survival (OS) Probability at 12 Months and 24 Months
24 Months
|
33.3 Percentage of probability
Interval 4.6 to 67.6
|
100 Percentage of probability
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: PSA DT was done once at week 14 and the second time at the end of study (any time point within a year while on study when they met criteria for progression)PSA DT in participants with advanced cancer treated with the ETBX-071, ETBX-061, and ETBX-051 vaccines were determined using a nomogram to find detectable PSA.
Outcome measures
| Measure |
Arm 1/Dose De-Escalation
n=6 Participants
Subjects enrolled to dose de-escalation cohorts. We did not need to dose de-escalate since none of patient's had dose limiting toxicity (DLT) so all patients received planned higher starting dose.
ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
|
Arm 2/Dose Expansion
n=12 Participants
Subjects enrolled at the maximum tolerated dose (MTD) after the MTD is established.
ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
|
|---|---|---|
|
Prostate-Specific Antigen Doubling Time (PSA DT) at Week 14 and End of Study
Week 14
|
NA Months
Standard Deviation NA
The first 6 patients completed study after 6 weeks, therefore we did not calculate PSA DT at end of study treatment).
|
2.4 Months
Standard Deviation 23.9
|
|
Prostate-Specific Antigen Doubling Time (PSA DT) at Week 14 and End of Study
End of Study
|
NA Months
Standard Deviation NA
The first 6 patients completed study after 6 weeks, therefore we did not calculate PSA DT at end of study treatment).
|
4.3 Months
Standard Deviation 4.97
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Arm 1/Dose De-Escalation
n=6 Participants
Subjects enrolled to dose de-escalation cohorts. We did not need to dose de-escalate since none of patient's had dose limiting toxicity (DLT) so all patients received planned higher starting dose.
ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
|
Arm 2/Dose Expansion
n=12 Participants
Subjects enrolled at the maximum tolerated dose (MTD) after the MTD is established.
ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
|
|---|---|---|
|
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
|
6 Participants
|
12 Participants
|
Adverse Events
Arm 1/Dose De-Escalation
Serious events: 1 serious events
Other events: 6 other events
Deaths: 4 deaths
Arm 2/Dose Expansion
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1/Dose De-Escalation
n=6 participants at risk
Subjects enrolled to dose de-escalation cohorts.
ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
|
Arm 2/Dose Expansion
n=12 participants at risk
Subjects enrolled at the maximum tolerated dose (MTD) after the MTD is established.
ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
Other adverse events
| Measure |
Arm 1/Dose De-Escalation
n=6 participants at risk
Subjects enrolled to dose de-escalation cohorts.
ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
|
Arm 2/Dose Expansion
n=12 participants at risk
Subjects enrolled at the maximum tolerated dose (MTD) after the MTD is established.
ETBX-071; adenoviral PSA vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-061; adenoviral MUC1 vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
ETBX-051; adenoviral brachyury vaccine: 5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
3/6 • Number of events 3 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
General disorders
Chills
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
Investigations
Creatinine increased
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
Nervous system disorders
Dizziness
|
50.0%
3/6 • Number of events 3 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
Ear and labyrinth disorders
Ear pain
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
General disorders
Edema limbs
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
General disorders
Fatigue
|
66.7%
4/6 • Number of events 4 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
25.0%
3/12 • Number of events 3 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
General disorders
Fever
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
General disorders
Flu like symptoms
|
50.0%
3/6 • Number of events 3 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
58.3%
7/12 • Number of events 8 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
Injury, poisoning and procedural complications
Injection site reaction
|
100.0%
6/6 • Number of events 7 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
91.7%
11/12 • Number of events 22 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
Investigations
Lymphocyte count decreased
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
General disorders
Malaise
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
General disorders
Pain
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
8.3%
1/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
|
Investigations
Weight loss
|
33.3%
2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place