Trial Outcomes & Findings for Study of BO-112 With Pembrolizumab for Colorectal or Gastric/GEJ Cancer With Liver Metastasis (NCT NCT04508140)
NCT ID: NCT04508140
Last Updated: 2024-11-29
Results Overview
ORR based on the best objective response (BOR) using RECIST 1.1 of repeated IT administrations of BO-112 in metastatic liver lesions in combination with IV pembrolizumab
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
from baseline to approximately 8 months
Results posted on
2024-11-29
Participant Flow
Participant milestones
| Measure |
Cohort A
Cohort A consisted of 11 patients with CRC (microsatellite stable \[MSS\]) with nonresectable liver metastases suitable for IT injection and who had received at least 2 prior standard of care systemic anticancer therapies for advanced/metastatic disease. Patients who had resection of hepatic metastases and had hepatic recurrence, needed to have 1 or more prior standard of care systemic anticancer therapies in order to be eligible for this study.
|
Cohort B
Cohort B consisted of 7 patients with gastric or GC/GEJ with nonresectable liver metastases suitable for IT injection and who had received at least 1 prior standard of care systemic anticancer therapy for advanced/metastatic disease.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
7
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
11
|
7
|
Reasons for withdrawal
| Measure |
Cohort A
Cohort A consisted of 11 patients with CRC (microsatellite stable \[MSS\]) with nonresectable liver metastases suitable for IT injection and who had received at least 2 prior standard of care systemic anticancer therapies for advanced/metastatic disease. Patients who had resection of hepatic metastases and had hepatic recurrence, needed to have 1 or more prior standard of care systemic anticancer therapies in order to be eligible for this study.
|
Cohort B
Cohort B consisted of 7 patients with gastric or GC/GEJ with nonresectable liver metastases suitable for IT injection and who had received at least 1 prior standard of care systemic anticancer therapy for advanced/metastatic disease.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
progressive disease
|
9
|
3
|
Baseline Characteristics
Study of BO-112 With Pembrolizumab for Colorectal or Gastric/GEJ Cancer With Liver Metastasis
Baseline characteristics by cohort
| Measure |
Cohort A
n=11 Participants
Cohort A consisted of 11 patients with CRC (microsatellite stable \[MSS\]) with nonresectable liver metastases suitable for IT injection and who had received at least 2 prior standard of care systemic anticancer therapies for advanced/metastatic disease. Patients who had resection of hepatic metastases and had hepatic recurrence, needed to have 1 or more prior standard of care systemic anticancer therapies in order to be eligible for this study.
|
Cohort B
n=7 Participants
Cohort B consisted of 7 patients with gastric or GC/GEJ with nonresectable liver metastases suitable for IT injection and who had received at least 1 prior standard of care systemic anticancer therapy for advanced/metastatic disease.
|
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
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
55.6 years
n=5 Participants
|
56.1 years
n=7 Participants
|
55.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 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
Belgium
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
9 participants
n=5 Participants
|
6 participants
n=7 Participants
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from baseline to approximately 8 monthsPopulation: Cohort B: only 5 patients were evaluable for efficacy with one baseline and at least one on treatment efficacy assessment.
ORR based on the best objective response (BOR) using RECIST 1.1 of repeated IT administrations of BO-112 in metastatic liver lesions in combination with IV pembrolizumab
Outcome measures
| Measure |
Cohort A
n=11 Participants
Cohort A consisted of 11 patients with CRC (microsatellite stable \[MSS\]) with nonresectable liver metastases suitable for IT injection and who had received at least 2 prior standard of care systemic anticancer therapies for advanced/metastatic disease. Patients who had resection of hepatic metastases and had hepatic recurrence, needed to have 1 or more prior standard of care systemic anticancer therapies in order to be eligible for this study. BO-112 was administered in the liver metastasis at the dose of 1mg (1.2 mL) in combination with intravenous pembrolizumab given at the fixed dose of 200 mg, every 3 weeks for up to 35 cycles (2 years). During the first cycle, BO-112 was administered on D1 and D8.
Hepatic Biopsy: In this trial a biopsy from the hepatic lesion to be injected will be mandatory on C1D1 and C2D1, prior to the BO-112 administration. On the same timepoints, a biopsy from a non-hepatic, non-injected lesion will be optional.
BO-112 with pembrolizumab: BO-112 was administered in the liver metastasis at the dose of 1mg (1.2 mL) in combination with intravenous pembrolizumab given at the fixed dose of 200 mg, every 3 weeks for up to 35 cycles (2 years). During the first cycle, BO-112 was administered on D1 and D8.
|
Cohort B
n=5 Participants
Cohort B consisted of 7 patients with gastric or GC/GEJ with nonresectable liver metastases suitable for IT injection and who had received at least 1 prior standard of care systemic anticancer therapy for advanced/metastatic disease. Only 5 patients were evaluable for efficacy with baseline and at least one on treatment efficacy assessment. BO-112 was administered in the liver metastasis at the dose of 1 mg (1.2 mL) in combination with intravenous pembrolizumab given at the fixed dose of 200 mg, every 3 weeks for up to 35 cycles (2 years). During the first cycle, BO-112 was administered on D1 and D8.
Hepatic Biopsy: In this trial a biopsy from the hepatic lesion to be injected will be mandatory on C1D1 and C2D1, prior to the BO-112 administration. On the same timepoints, a biopsy from a non-hepatic, non-injected lesion will be optional.
BO-112 with pembrolizumab: BO-112 was administered in the liver metastasis at the dose of 1mg (1.2 mL) in combination with intravenous pembrolizumab given at the fixed dose of 200 mg, every 3 weeks for up to 35 cycles (2 years). During the first cycle, BO-112 was administered on D1 and D8.
|
|---|---|---|
|
Anti-tumour Efficacy:Overall Response Rate (ORR) Based on RECIST 1.1
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: from baseline to approximately 8 monthsNumber and proportion of subjects with study treatment-related TEAEs with severity Grade 3 and higher (NCI-CTCAE v 5.0)
Outcome measures
| Measure |
Cohort A
n=11 Participants
Cohort A consisted of 11 patients with CRC (microsatellite stable \[MSS\]) with nonresectable liver metastases suitable for IT injection and who had received at least 2 prior standard of care systemic anticancer therapies for advanced/metastatic disease. Patients who had resection of hepatic metastases and had hepatic recurrence, needed to have 1 or more prior standard of care systemic anticancer therapies in order to be eligible for this study. BO-112 was administered in the liver metastasis at the dose of 1mg (1.2 mL) in combination with intravenous pembrolizumab given at the fixed dose of 200 mg, every 3 weeks for up to 35 cycles (2 years). During the first cycle, BO-112 was administered on D1 and D8.
Hepatic Biopsy: In this trial a biopsy from the hepatic lesion to be injected will be mandatory on C1D1 and C2D1, prior to the BO-112 administration. On the same timepoints, a biopsy from a non-hepatic, non-injected lesion will be optional.
BO-112 with pembrolizumab: BO-112 was administered in the liver metastasis at the dose of 1mg (1.2 mL) in combination with intravenous pembrolizumab given at the fixed dose of 200 mg, every 3 weeks for up to 35 cycles (2 years). During the first cycle, BO-112 was administered on D1 and D8.
|
Cohort B
n=7 Participants
Cohort B consisted of 7 patients with gastric or GC/GEJ with nonresectable liver metastases suitable for IT injection and who had received at least 1 prior standard of care systemic anticancer therapy for advanced/metastatic disease. Only 5 patients were evaluable for efficacy with baseline and at least one on treatment efficacy assessment. BO-112 was administered in the liver metastasis at the dose of 1 mg (1.2 mL) in combination with intravenous pembrolizumab given at the fixed dose of 200 mg, every 3 weeks for up to 35 cycles (2 years). During the first cycle, BO-112 was administered on D1 and D8.
Hepatic Biopsy: In this trial a biopsy from the hepatic lesion to be injected will be mandatory on C1D1 and C2D1, prior to the BO-112 administration. On the same timepoints, a biopsy from a non-hepatic, non-injected lesion will be optional.
BO-112 with pembrolizumab: BO-112 was administered in the liver metastasis at the dose of 1mg (1.2 mL) in combination with intravenous pembrolizumab given at the fixed dose of 200 mg, every 3 weeks for up to 35 cycles (2 years). During the first cycle, BO-112 was administered on D1 and D8.
|
|---|---|---|
|
Safety: Adverse Events
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: from baseline to approximately 8 monthsPopulation: Cohort B: only 5 patients were valid for efficacy with one baseline and at least one on-treatment efficacy assessment
Best response for CR, PR as well as stable disease (SD) using RECIST 1.1
Outcome measures
| Measure |
Cohort A
n=11 Participants
Cohort A consisted of 11 patients with CRC (microsatellite stable \[MSS\]) with nonresectable liver metastases suitable for IT injection and who had received at least 2 prior standard of care systemic anticancer therapies for advanced/metastatic disease. Patients who had resection of hepatic metastases and had hepatic recurrence, needed to have 1 or more prior standard of care systemic anticancer therapies in order to be eligible for this study. BO-112 was administered in the liver metastasis at the dose of 1mg (1.2 mL) in combination with intravenous pembrolizumab given at the fixed dose of 200 mg, every 3 weeks for up to 35 cycles (2 years). During the first cycle, BO-112 was administered on D1 and D8.
Hepatic Biopsy: In this trial a biopsy from the hepatic lesion to be injected will be mandatory on C1D1 and C2D1, prior to the BO-112 administration. On the same timepoints, a biopsy from a non-hepatic, non-injected lesion will be optional.
BO-112 with pembrolizumab: BO-112 was administered in the liver metastasis at the dose of 1mg (1.2 mL) in combination with intravenous pembrolizumab given at the fixed dose of 200 mg, every 3 weeks for up to 35 cycles (2 years). During the first cycle, BO-112 was administered on D1 and D8.
|
Cohort B
n=5 Participants
Cohort B consisted of 7 patients with gastric or GC/GEJ with nonresectable liver metastases suitable for IT injection and who had received at least 1 prior standard of care systemic anticancer therapy for advanced/metastatic disease. Only 5 patients were evaluable for efficacy with baseline and at least one on treatment efficacy assessment. BO-112 was administered in the liver metastasis at the dose of 1 mg (1.2 mL) in combination with intravenous pembrolizumab given at the fixed dose of 200 mg, every 3 weeks for up to 35 cycles (2 years). During the first cycle, BO-112 was administered on D1 and D8.
Hepatic Biopsy: In this trial a biopsy from the hepatic lesion to be injected will be mandatory on C1D1 and C2D1, prior to the BO-112 administration. On the same timepoints, a biopsy from a non-hepatic, non-injected lesion will be optional.
BO-112 with pembrolizumab: BO-112 was administered in the liver metastasis at the dose of 1mg (1.2 mL) in combination with intravenous pembrolizumab given at the fixed dose of 200 mg, every 3 weeks for up to 35 cycles (2 years). During the first cycle, BO-112 was administered on D1 and D8.
|
|---|---|---|
|
Disease Control Rate Based on RECIST 1.1
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: from baseline to approximately 8 monthsBased on best overall response using RECIST modified for immune-based therapies (iRECIST)
Outcome measures
| Measure |
Cohort A
n=11 Participants
Cohort A consisted of 11 patients with CRC (microsatellite stable \[MSS\]) with nonresectable liver metastases suitable for IT injection and who had received at least 2 prior standard of care systemic anticancer therapies for advanced/metastatic disease. Patients who had resection of hepatic metastases and had hepatic recurrence, needed to have 1 or more prior standard of care systemic anticancer therapies in order to be eligible for this study. BO-112 was administered in the liver metastasis at the dose of 1mg (1.2 mL) in combination with intravenous pembrolizumab given at the fixed dose of 200 mg, every 3 weeks for up to 35 cycles (2 years). During the first cycle, BO-112 was administered on D1 and D8.
Hepatic Biopsy: In this trial a biopsy from the hepatic lesion to be injected will be mandatory on C1D1 and C2D1, prior to the BO-112 administration. On the same timepoints, a biopsy from a non-hepatic, non-injected lesion will be optional.
BO-112 with pembrolizumab: BO-112 was administered in the liver metastasis at the dose of 1mg (1.2 mL) in combination with intravenous pembrolizumab given at the fixed dose of 200 mg, every 3 weeks for up to 35 cycles (2 years). During the first cycle, BO-112 was administered on D1 and D8.
|
Cohort B
n=5 Participants
Cohort B consisted of 7 patients with gastric or GC/GEJ with nonresectable liver metastases suitable for IT injection and who had received at least 1 prior standard of care systemic anticancer therapy for advanced/metastatic disease. Only 5 patients were evaluable for efficacy with baseline and at least one on treatment efficacy assessment. BO-112 was administered in the liver metastasis at the dose of 1 mg (1.2 mL) in combination with intravenous pembrolizumab given at the fixed dose of 200 mg, every 3 weeks for up to 35 cycles (2 years). During the first cycle, BO-112 was administered on D1 and D8.
Hepatic Biopsy: In this trial a biopsy from the hepatic lesion to be injected will be mandatory on C1D1 and C2D1, prior to the BO-112 administration. On the same timepoints, a biopsy from a non-hepatic, non-injected lesion will be optional.
BO-112 with pembrolizumab: BO-112 was administered in the liver metastasis at the dose of 1mg (1.2 mL) in combination with intravenous pembrolizumab given at the fixed dose of 200 mg, every 3 weeks for up to 35 cycles (2 years). During the first cycle, BO-112 was administered on D1 and D8.
|
|---|---|---|
|
Objective Response Rate Based iRECIST
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: from baseline to approximately 8 monthsPopulation: Cohort B: only 5 patients were evaluable for efficacy with one baseline and at least one on-treatment efficacy assessment
Comprising best response for CR, PR as well as SD using iRECIST
Outcome measures
| Measure |
Cohort A
n=11 Participants
Cohort A consisted of 11 patients with CRC (microsatellite stable \[MSS\]) with nonresectable liver metastases suitable for IT injection and who had received at least 2 prior standard of care systemic anticancer therapies for advanced/metastatic disease. Patients who had resection of hepatic metastases and had hepatic recurrence, needed to have 1 or more prior standard of care systemic anticancer therapies in order to be eligible for this study. BO-112 was administered in the liver metastasis at the dose of 1mg (1.2 mL) in combination with intravenous pembrolizumab given at the fixed dose of 200 mg, every 3 weeks for up to 35 cycles (2 years). During the first cycle, BO-112 was administered on D1 and D8.
Hepatic Biopsy: In this trial a biopsy from the hepatic lesion to be injected will be mandatory on C1D1 and C2D1, prior to the BO-112 administration. On the same timepoints, a biopsy from a non-hepatic, non-injected lesion will be optional.
BO-112 with pembrolizumab: BO-112 was administered in the liver metastasis at the dose of 1mg (1.2 mL) in combination with intravenous pembrolizumab given at the fixed dose of 200 mg, every 3 weeks for up to 35 cycles (2 years). During the first cycle, BO-112 was administered on D1 and D8.
|
Cohort B
n=5 Participants
Cohort B consisted of 7 patients with gastric or GC/GEJ with nonresectable liver metastases suitable for IT injection and who had received at least 1 prior standard of care systemic anticancer therapy for advanced/metastatic disease. Only 5 patients were evaluable for efficacy with baseline and at least one on treatment efficacy assessment. BO-112 was administered in the liver metastasis at the dose of 1 mg (1.2 mL) in combination with intravenous pembrolizumab given at the fixed dose of 200 mg, every 3 weeks for up to 35 cycles (2 years). During the first cycle, BO-112 was administered on D1 and D8.
Hepatic Biopsy: In this trial a biopsy from the hepatic lesion to be injected will be mandatory on C1D1 and C2D1, prior to the BO-112 administration. On the same timepoints, a biopsy from a non-hepatic, non-injected lesion will be optional.
BO-112 with pembrolizumab: BO-112 was administered in the liver metastasis at the dose of 1mg (1.2 mL) in combination with intravenous pembrolizumab given at the fixed dose of 200 mg, every 3 weeks for up to 35 cycles (2 years). During the first cycle, BO-112 was administered on D1 and D8.
|
|---|---|---|
|
Disease Control Rate Based on iRECIST
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: from baseline to approximately 8 monthsPopulation: Cohort B: only 5 patients were evaluable for efficacy with one baseline and at least one on-treatment assessment
Progression-free survival (PFS)
Outcome measures
| Measure |
Cohort A
n=11 Participants
Cohort A consisted of 11 patients with CRC (microsatellite stable \[MSS\]) with nonresectable liver metastases suitable for IT injection and who had received at least 2 prior standard of care systemic anticancer therapies for advanced/metastatic disease. Patients who had resection of hepatic metastases and had hepatic recurrence, needed to have 1 or more prior standard of care systemic anticancer therapies in order to be eligible for this study. BO-112 was administered in the liver metastasis at the dose of 1mg (1.2 mL) in combination with intravenous pembrolizumab given at the fixed dose of 200 mg, every 3 weeks for up to 35 cycles (2 years). During the first cycle, BO-112 was administered on D1 and D8.
Hepatic Biopsy: In this trial a biopsy from the hepatic lesion to be injected will be mandatory on C1D1 and C2D1, prior to the BO-112 administration. On the same timepoints, a biopsy from a non-hepatic, non-injected lesion will be optional.
BO-112 with pembrolizumab: BO-112 was administered in the liver metastasis at the dose of 1mg (1.2 mL) in combination with intravenous pembrolizumab given at the fixed dose of 200 mg, every 3 weeks for up to 35 cycles (2 years). During the first cycle, BO-112 was administered on D1 and D8.
|
Cohort B
n=5 Participants
Cohort B consisted of 7 patients with gastric or GC/GEJ with nonresectable liver metastases suitable for IT injection and who had received at least 1 prior standard of care systemic anticancer therapy for advanced/metastatic disease. Only 5 patients were evaluable for efficacy with baseline and at least one on treatment efficacy assessment. BO-112 was administered in the liver metastasis at the dose of 1 mg (1.2 mL) in combination with intravenous pembrolizumab given at the fixed dose of 200 mg, every 3 weeks for up to 35 cycles (2 years). During the first cycle, BO-112 was administered on D1 and D8.
Hepatic Biopsy: In this trial a biopsy from the hepatic lesion to be injected will be mandatory on C1D1 and C2D1, prior to the BO-112 administration. On the same timepoints, a biopsy from a non-hepatic, non-injected lesion will be optional.
BO-112 with pembrolizumab: BO-112 was administered in the liver metastasis at the dose of 1mg (1.2 mL) in combination with intravenous pembrolizumab given at the fixed dose of 200 mg, every 3 weeks for up to 35 cycles (2 years). During the first cycle, BO-112 was administered on D1 and D8.
|
|---|---|---|
|
Progression-free Survival
|
1.35 months
Interval 1.02 to 1.41
|
1.38 months
Interval 0.95 to 2.56
|
SECONDARY outcome
Timeframe: at 6 months from enrolmentPopulation: only 5 patients were evaluable for efficacy with both baseline and at least one post-baseline imaging
Number of subjects alive at 6 months
Outcome measures
| Measure |
Cohort A
n=11 Participants
Cohort A consisted of 11 patients with CRC (microsatellite stable \[MSS\]) with nonresectable liver metastases suitable for IT injection and who had received at least 2 prior standard of care systemic anticancer therapies for advanced/metastatic disease. Patients who had resection of hepatic metastases and had hepatic recurrence, needed to have 1 or more prior standard of care systemic anticancer therapies in order to be eligible for this study. BO-112 was administered in the liver metastasis at the dose of 1mg (1.2 mL) in combination with intravenous pembrolizumab given at the fixed dose of 200 mg, every 3 weeks for up to 35 cycles (2 years). During the first cycle, BO-112 was administered on D1 and D8.
Hepatic Biopsy: In this trial a biopsy from the hepatic lesion to be injected will be mandatory on C1D1 and C2D1, prior to the BO-112 administration. On the same timepoints, a biopsy from a non-hepatic, non-injected lesion will be optional.
BO-112 with pembrolizumab: BO-112 was administered in the liver metastasis at the dose of 1mg (1.2 mL) in combination with intravenous pembrolizumab given at the fixed dose of 200 mg, every 3 weeks for up to 35 cycles (2 years). During the first cycle, BO-112 was administered on D1 and D8.
|
Cohort B
n=5 Participants
Cohort B consisted of 7 patients with gastric or GC/GEJ with nonresectable liver metastases suitable for IT injection and who had received at least 1 prior standard of care systemic anticancer therapy for advanced/metastatic disease. Only 5 patients were evaluable for efficacy with baseline and at least one on treatment efficacy assessment. BO-112 was administered in the liver metastasis at the dose of 1 mg (1.2 mL) in combination with intravenous pembrolizumab given at the fixed dose of 200 mg, every 3 weeks for up to 35 cycles (2 years). During the first cycle, BO-112 was administered on D1 and D8.
Hepatic Biopsy: In this trial a biopsy from the hepatic lesion to be injected will be mandatory on C1D1 and C2D1, prior to the BO-112 administration. On the same timepoints, a biopsy from a non-hepatic, non-injected lesion will be optional.
BO-112 with pembrolizumab: BO-112 was administered in the liver metastasis at the dose of 1mg (1.2 mL) in combination with intravenous pembrolizumab given at the fixed dose of 200 mg, every 3 weeks for up to 35 cycles (2 years). During the first cycle, BO-112 was administered on D1 and D8.
|
|---|---|---|
|
Overall Survival Rate
|
9 Participants
|
3 Participants
|
Adverse Events
Cohort A
Serious events: 5 serious events
Other events: 11 other events
Deaths: 2 deaths
Cohort B
Serious events: 2 serious events
Other events: 7 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cohort A
n=11 participants at risk
Cohort A consisted of 11 patients with CRC (microsatellite stable \[MSS\]) with nonresectable liver metastases suitable for IT injection and who had received at least 2 prior standard of care systemic anticancer therapies for advanced/metastatic disease. Patients who had resection of hepatic metastases and had hepatic recurrence, needed to have 1 or more prior standard of care systemic anticancer therapies in order to be eligible for this study.
|
Cohort B
n=7 participants at risk
Cohort B consisted of 7 patients with gastric or GC/GEJ with nonresectable liver metastases suitable for IT injection and who had received at least 1 prior standard of care systemic anticancer therapy for advanced/metastatic disease.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
back pain
|
18.2%
2/11 • Number of events 2 • from baseline to approximately 8 months
|
0.00%
0/7 • from baseline to approximately 8 months
|
|
Gastrointestinal disorders
pyrexia
|
27.3%
3/11 • Number of events 3 • from baseline to approximately 8 months
|
0.00%
0/7 • from baseline to approximately 8 months
|
|
Infections and infestations
alpha hemolytic streptococcal infection
|
9.1%
1/11 • Number of events 1 • from baseline to approximately 8 months
|
0.00%
0/7 • from baseline to approximately 8 months
|
|
Infections and infestations
COVID 19 pneumonia
|
9.1%
1/11 • Number of events 1 • from baseline to approximately 8 months
|
0.00%
0/7 • from baseline to approximately 8 months
|
|
Infections and infestations
bacteriemia
|
0.00%
0/11 • from baseline to approximately 8 months
|
14.3%
1/7 • Number of events 1 • from baseline to approximately 8 months
|
|
Nervous system disorders
syncope
|
0.00%
0/11 • from baseline to approximately 8 months
|
14.3%
1/7 • Number of events 1 • from baseline to approximately 8 months
|
Other adverse events
| Measure |
Cohort A
n=11 participants at risk
Cohort A consisted of 11 patients with CRC (microsatellite stable \[MSS\]) with nonresectable liver metastases suitable for IT injection and who had received at least 2 prior standard of care systemic anticancer therapies for advanced/metastatic disease. Patients who had resection of hepatic metastases and had hepatic recurrence, needed to have 1 or more prior standard of care systemic anticancer therapies in order to be eligible for this study.
|
Cohort B
n=7 participants at risk
Cohort B consisted of 7 patients with gastric or GC/GEJ with nonresectable liver metastases suitable for IT injection and who had received at least 1 prior standard of care systemic anticancer therapy for advanced/metastatic disease.
|
|---|---|---|
|
General disorders
pyrexia
|
72.7%
8/11 • Number of events 20 • from baseline to approximately 8 months
|
57.1%
4/7 • Number of events 8 • from baseline to approximately 8 months
|
|
Vascular disorders
Hypertension
|
9.1%
1/11 • Number of events 2 • from baseline to approximately 8 months
|
0.00%
0/7 • from baseline to approximately 8 months
|
|
Vascular disorders
Hypotension
|
18.2%
2/11 • Number of events 2 • from baseline to approximately 8 months
|
0.00%
0/7 • from baseline to approximately 8 months
|
|
General disorders
Asthenia
|
27.3%
3/11 • Number of events 6 • from baseline to approximately 8 months
|
28.6%
2/7 • Number of events 2 • from baseline to approximately 8 months
|
|
General disorders
Chills
|
45.5%
5/11 • Number of events 9 • from baseline to approximately 8 months
|
0.00%
0/7 • from baseline to approximately 8 months
|
|
General disorders
Fatigue
|
18.2%
2/11 • Number of events 2 • from baseline to approximately 8 months
|
14.3%
1/7 • Number of events 2 • from baseline to approximately 8 months
|
|
General disorders
Injection site pain
|
0.00%
0/11 • from baseline to approximately 8 months
|
28.6%
2/7 • Number of events 5 • from baseline to approximately 8 months
|
|
Immune system disorders
Cytokine release syndrome
|
18.2%
2/11 • Number of events 4 • from baseline to approximately 8 months
|
14.3%
1/7 • Number of events 3 • from baseline to approximately 8 months
|
|
Investigations
Alanine aminotransferase increased
|
9.1%
1/11 • Number of events 1 • from baseline to approximately 8 months
|
14.3%
1/7 • Number of events 1 • from baseline to approximately 8 months
|
|
Investigations
Aspartate aminotransferase increased
|
18.2%
2/11 • Number of events 2 • from baseline to approximately 8 months
|
28.6%
2/7 • Number of events 2 • from baseline to approximately 8 months
|
|
Investigations
Blood alkaline phosphatase increased
|
9.1%
1/11 • Number of events 1 • from baseline to approximately 8 months
|
14.3%
1/7 • Number of events 1 • from baseline to approximately 8 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
9.1%
1/11 • Number of events 1 • from baseline to approximately 8 months
|
14.3%
1/7 • Number of events 1 • from baseline to approximately 8 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
18.2%
2/11 • Number of events 2 • from baseline to approximately 8 months
|
14.3%
1/7 • Number of events 1 • from baseline to approximately 8 months
|
|
Nervous system disorders
Headache
|
18.2%
2/11 • Number of events 2 • from baseline to approximately 8 months
|
0.00%
0/7 • from baseline to approximately 8 months
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/11 • from baseline to approximately 8 months
|
14.3%
1/7 • Number of events 1 • from baseline to approximately 8 months
|
|
Nervous system disorders
Presyncope
|
9.1%
1/11 • Number of events 1 • from baseline to approximately 8 months
|
0.00%
0/7 • from baseline to approximately 8 months
|
|
Nervous system disorders
Tremor
|
9.1%
1/11 • Number of events 1 • from baseline to approximately 8 months
|
0.00%
0/7 • from baseline to approximately 8 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/11 • from baseline to approximately 8 months
|
14.3%
1/7 • Number of events 1 • from baseline to approximately 8 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/11 • from baseline to approximately 8 months
|
14.3%
1/7 • Number of events 1 • from baseline to approximately 8 months
|
|
Eye disorders
Eczema eyelids
|
9.1%
1/11 • Number of events 1 • from baseline to approximately 8 months
|
0.00%
0/7 • from baseline to approximately 8 months
|
|
Gastrointestinal disorders
Abdominal pain
|
36.4%
4/11 • Number of events 5 • from baseline to approximately 8 months
|
14.3%
1/7 • Number of events 1 • from baseline to approximately 8 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/11 • from baseline to approximately 8 months
|
14.3%
1/7 • Number of events 2 • from baseline to approximately 8 months
|
|
Gastrointestinal disorders
Constipation
|
18.2%
2/11 • Number of events 2 • from baseline to approximately 8 months
|
0.00%
0/7 • from baseline to approximately 8 months
|
|
Gastrointestinal disorders
Diarrhea
|
9.1%
1/11 • Number of events 2 • from baseline to approximately 8 months
|
28.6%
2/7 • Number of events 2 • from baseline to approximately 8 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/11 • from baseline to approximately 8 months
|
14.3%
1/7 • Number of events 1 • from baseline to approximately 8 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/11 • from baseline to approximately 8 months
|
14.3%
1/7 • Number of events 1 • from baseline to approximately 8 months
|
|
Gastrointestinal disorders
Nausea
|
36.4%
4/11 • Number of events 12 • from baseline to approximately 8 months
|
14.3%
1/7 • Number of events 1 • from baseline to approximately 8 months
|
|
Gastrointestinal disorders
Vomiting
|
18.2%
2/11 • Number of events 7 • from baseline to approximately 8 months
|
28.6%
2/7 • Number of events 3 • from baseline to approximately 8 months
|
|
Hepatobiliary disorders
Hepatic pain
|
9.1%
1/11 • Number of events 1 • from baseline to approximately 8 months
|
14.3%
1/7 • Number of events 1 • from baseline to approximately 8 months
|
|
Hepatobiliary disorders
Hepatomegaly
|
9.1%
1/11 • Number of events 1 • from baseline to approximately 8 months
|
0.00%
0/7 • from baseline to approximately 8 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.1%
1/11 • Number of events 1 • from baseline to approximately 8 months
|
0.00%
0/7 • from baseline to approximately 8 months
|
|
Renal and urinary disorders
Disuria
|
9.1%
1/11 • Number of events 1 • from baseline to approximately 8 months
|
0.00%
0/7 • from baseline to approximately 8 months
|
|
Renal and urinary disorders
Hematuria
|
9.1%
1/11 • Number of events 1 • from baseline to approximately 8 months
|
0.00%
0/7 • from baseline to approximately 8 months
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/11 • from baseline to approximately 8 months
|
28.6%
2/7 • Number of events 2 • from baseline to approximately 8 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
1/11 • Number of events 1 • from baseline to approximately 8 months
|
14.3%
1/7 • Number of events 1 • from baseline to approximately 8 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
1/11 • Number of events 2 • from baseline to approximately 8 months
|
14.3%
1/7 • Number of events 1 • from baseline to approximately 8 months
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
9.1%
1/11 • Number of events 1 • from baseline to approximately 8 months
|
0.00%
0/7 • from baseline to approximately 8 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/11 • from baseline to approximately 8 months
|
14.3%
1/7 • Number of events 1 • from baseline to approximately 8 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
9.1%
1/11 • Number of events 1 • from baseline to approximately 8 months
|
0.00%
0/7 • from baseline to approximately 8 months
|
|
Infections and infestations
Asymptomatic COVID-19
|
9.1%
1/11 • Number of events 1 • from baseline to approximately 8 months
|
0.00%
0/7 • from baseline to approximately 8 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place