Trial Outcomes & Findings for QUILT-3.060: NANT Pancreatic Cancer Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy (NCT NCT03329248)
NCT ID: NCT03329248
Last Updated: 2024-12-12
Results Overview
Graded Using the National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
6 participants
Primary outcome timeframe
30 days after last dose, up to 2 years (up to 1 year in each treatment phase) or until they experience confirmed progressive disease or unacceptable toxicity, withdrawn consent, or if the Investigator feels it is no longer in their best interest.
Results posted on
2024-12-12
Participant Flow
Only the Phase 1b portion of the study enrolled participants. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study. Eligible participants could have gone through both induction and maintenance treatment on study.
Participant milestones
| Measure |
NANT Pancreatic Cancer Vaccine
A combination of agents were administered to subjects in this study: ALT-803, ETBX-011, GI-4000, haNK, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, omega-3-acid ethyl esters, oxaliplatin, SBRT ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex ETBX-011: Ad5 \[E1-, E2b-\]-CEA GI-4000: Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins haNK for infusion: NK-92 \[CD16.158V, ER IL-2\] avelumab: Recombinant human anti-PD-L1 IgG1 monoclonal antibody bevacizumab: Recombinant human anti-VEGF IgG1 monoclonal Capecitabine: 5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine Cyclophosphamide: 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate Fluorouracil: 5-fluoro-2,4 (1H,3H)-pyrimidinedione Leucovorin: L-Glutamic acid, N-\[4-\[\[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl\]amino\]benzoyl\]-, calcium salt nab-Paclitaxel: Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin lovaza: Omega-3-acid ethyl esters Oxaliplatin: cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum SBRT: Stereotactic Body Radiation Therapy
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|---|---|
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Overall Study
STARTED
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6
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
NANT Pancreatic Cancer Vaccine
A combination of agents were administered to subjects in this study: ALT-803, ETBX-011, GI-4000, haNK, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, omega-3-acid ethyl esters, oxaliplatin, SBRT ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex ETBX-011: Ad5 \[E1-, E2b-\]-CEA GI-4000: Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins haNK for infusion: NK-92 \[CD16.158V, ER IL-2\] avelumab: Recombinant human anti-PD-L1 IgG1 monoclonal antibody bevacizumab: Recombinant human anti-VEGF IgG1 monoclonal Capecitabine: 5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine Cyclophosphamide: 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate Fluorouracil: 5-fluoro-2,4 (1H,3H)-pyrimidinedione Leucovorin: L-Glutamic acid, N-\[4-\[\[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl\]amino\]benzoyl\]-, calcium salt nab-Paclitaxel: Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin lovaza: Omega-3-acid ethyl esters Oxaliplatin: cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum SBRT: Stereotactic Body Radiation Therapy
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|---|---|
|
Overall Study
Progressive Disease
|
6
|
Baseline Characteristics
QUILT-3.060: NANT Pancreatic Cancer Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy
Baseline characteristics by cohort
| Measure |
NANT Pancreatic Cancer Vaccine
n=6 Participants
A combination of agents will be administered to subjects in this study: ALT-803, ETBX-011, GI-4000, haNK, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, omega-3-acid ethyl esters, oxaliplatin, SBRT ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex ETBX-011: Ad5 \[E1-, E2b-\]-CEA GI-4000: Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins haNK for infusion: NK-92 \[CD16.158V, ER IL-2\] avelumab: Recombinant human anti-PD-L1 IgG1 monoclonal antibody bevacizumab: Recombinant human anti-VEGF IgG1 monoclonal Capecitabine: 5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine Cyclophosphamide: 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate Fluorouracil: 5-fluoro-2,4 (1H,3H)-pyrimidinedione Leucovorin: L-Glutamic acid, N-\[4-\[\[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl\]amino\]benzoyl\]-, calcium salt nab-Paclitaxel: Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin lovaza: Omega-3-acid ethyl esters Oxaliplatin: cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum SBRT: Stereotactic Body Radiation Therapy
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|---|---|
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Age, Continuous
|
51.8 years
STANDARD_DEVIATION 9.02 • n=5 Participants
|
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Sex: Female, Male
Female
|
3 Participants
n=5 Participants
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Sex: Female, Male
Male
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3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Subjects with pancreatic cancer who have progressed on or after previous SoC chemotherapy
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days after last dose, up to 2 years (up to 1 year in each treatment phase) or until they experience confirmed progressive disease or unacceptable toxicity, withdrawn consent, or if the Investigator feels it is no longer in their best interest.Graded Using the National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Outcome measures
| Measure |
NANT Pancreatic Cancer Vaccine
n=6 Participants
A combination of agents will be administered to subjects in this study: ALT-803, ETBX-011, GI-4000, haNK, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, omega-3-acid ethyl esters, oxaliplatin, SBRT ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex ETBX-011: Ad5 \[E1-, E2b-\]-CEA GI-4000: Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins haNK for infusion: NK-92 \[CD16.158V, ER IL-2\] avelumab: Recombinant human anti-PD-L1 IgG1 monoclonal antibody bevacizumab: Recombinant human anti-VEGF IgG1 monoclonal Capecitabine: 5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine Cyclophosphamide: 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate Fluorouracil: 5-fluoro-2,4 (1H,3H)-pyrimidinedione Leucovorin: L-Glutamic acid, N-\[4-\[\[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl\]amino\]benzoyl\]-, calcium salt nab-Paclitaxel: Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin lovaza: Omega-3-acid ethyl esters Oxaliplatin: cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum SBRT: Stereotactic Body Radiation Therapy
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|---|---|
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Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)
Treatment Emergent Adverse Events
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6 Participants
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|
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)
Treatment Emergent Serious Adverse Events
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3 Participants
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SECONDARY outcome
Timeframe: Tumors will be assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression, up to 211 days.Outcome measures
| Measure |
NANT Pancreatic Cancer Vaccine
n=6 Participants
A combination of agents will be administered to subjects in this study: ALT-803, ETBX-011, GI-4000, haNK, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, omega-3-acid ethyl esters, oxaliplatin, SBRT ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex ETBX-011: Ad5 \[E1-, E2b-\]-CEA GI-4000: Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins haNK for infusion: NK-92 \[CD16.158V, ER IL-2\] avelumab: Recombinant human anti-PD-L1 IgG1 monoclonal antibody bevacizumab: Recombinant human anti-VEGF IgG1 monoclonal Capecitabine: 5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine Cyclophosphamide: 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate Fluorouracil: 5-fluoro-2,4 (1H,3H)-pyrimidinedione Leucovorin: L-Glutamic acid, N-\[4-\[\[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl\]amino\]benzoyl\]-, calcium salt nab-Paclitaxel: Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin lovaza: Omega-3-acid ethyl esters Oxaliplatin: cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum SBRT: Stereotactic Body Radiation Therapy
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|---|---|
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Objective Response Rate by RECIST Version 1.1
|
0 Participants
|
SECONDARY outcome
Timeframe: Tumors will be assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression, up to 211 days.Outcome measures
| Measure |
NANT Pancreatic Cancer Vaccine
n=6 Participants
A combination of agents will be administered to subjects in this study: ALT-803, ETBX-011, GI-4000, haNK, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, omega-3-acid ethyl esters, oxaliplatin, SBRT ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex ETBX-011: Ad5 \[E1-, E2b-\]-CEA GI-4000: Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins haNK for infusion: NK-92 \[CD16.158V, ER IL-2\] avelumab: Recombinant human anti-PD-L1 IgG1 monoclonal antibody bevacizumab: Recombinant human anti-VEGF IgG1 monoclonal Capecitabine: 5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine Cyclophosphamide: 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate Fluorouracil: 5-fluoro-2,4 (1H,3H)-pyrimidinedione Leucovorin: L-Glutamic acid, N-\[4-\[\[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl\]amino\]benzoyl\]-, calcium salt nab-Paclitaxel: Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin lovaza: Omega-3-acid ethyl esters Oxaliplatin: cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum SBRT: Stereotactic Body Radiation Therapy
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|---|---|
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Objective Response Rate by irRC
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0 Participants
|
SECONDARY outcome
Timeframe: Tumors will be assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or deathOutcome measures
| Measure |
NANT Pancreatic Cancer Vaccine
n=6 Participants
A combination of agents will be administered to subjects in this study: ALT-803, ETBX-011, GI-4000, haNK, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, omega-3-acid ethyl esters, oxaliplatin, SBRT ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex ETBX-011: Ad5 \[E1-, E2b-\]-CEA GI-4000: Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins haNK for infusion: NK-92 \[CD16.158V, ER IL-2\] avelumab: Recombinant human anti-PD-L1 IgG1 monoclonal antibody bevacizumab: Recombinant human anti-VEGF IgG1 monoclonal Capecitabine: 5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine Cyclophosphamide: 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate Fluorouracil: 5-fluoro-2,4 (1H,3H)-pyrimidinedione Leucovorin: L-Glutamic acid, N-\[4-\[\[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl\]amino\]benzoyl\]-, calcium salt nab-Paclitaxel: Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin lovaza: Omega-3-acid ethyl esters Oxaliplatin: cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum SBRT: Stereotactic Body Radiation Therapy
|
|---|---|
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Progression Free Survival by RECIST Version 1.1.
|
4.8 Months
Interval 1.9 to
Not Achieved
|
SECONDARY outcome
Timeframe: Tumors will be assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression or deathOutcome measures
| Measure |
NANT Pancreatic Cancer Vaccine
n=6 Participants
A combination of agents will be administered to subjects in this study: ALT-803, ETBX-011, GI-4000, haNK, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, omega-3-acid ethyl esters, oxaliplatin, SBRT ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex ETBX-011: Ad5 \[E1-, E2b-\]-CEA GI-4000: Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins haNK for infusion: NK-92 \[CD16.158V, ER IL-2\] avelumab: Recombinant human anti-PD-L1 IgG1 monoclonal antibody bevacizumab: Recombinant human anti-VEGF IgG1 monoclonal Capecitabine: 5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine Cyclophosphamide: 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate Fluorouracil: 5-fluoro-2,4 (1H,3H)-pyrimidinedione Leucovorin: L-Glutamic acid, N-\[4-\[\[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl\]amino\]benzoyl\]-, calcium salt nab-Paclitaxel: Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin lovaza: Omega-3-acid ethyl esters Oxaliplatin: cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum SBRT: Stereotactic Body Radiation Therapy
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|---|---|
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Progression Free Survival by irRC
|
4.8 Months
Interval 1.9 to
Not Achieved
|
SECONDARY outcome
Timeframe: Tumors will be assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until deathOutcome measures
| Measure |
NANT Pancreatic Cancer Vaccine
n=6 Participants
A combination of agents will be administered to subjects in this study: ALT-803, ETBX-011, GI-4000, haNK, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, omega-3-acid ethyl esters, oxaliplatin, SBRT ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex ETBX-011: Ad5 \[E1-, E2b-\]-CEA GI-4000: Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins haNK for infusion: NK-92 \[CD16.158V, ER IL-2\] avelumab: Recombinant human anti-PD-L1 IgG1 monoclonal antibody bevacizumab: Recombinant human anti-VEGF IgG1 monoclonal Capecitabine: 5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine Cyclophosphamide: 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate Fluorouracil: 5-fluoro-2,4 (1H,3H)-pyrimidinedione Leucovorin: L-Glutamic acid, N-\[4-\[\[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl\]amino\]benzoyl\]-, calcium salt nab-Paclitaxel: Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin lovaza: Omega-3-acid ethyl esters Oxaliplatin: cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum SBRT: Stereotactic Body Radiation Therapy
|
|---|---|
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Overall Survival
|
7.3 Months
Interval 5.0 to
Not Achieved
|
SECONDARY outcome
Timeframe: Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression, up to 211 daysPopulation: There were no participants with confirmed CR or PR. Therefore, no participants were included in the DOR analysis.
DOR was be defined as the time from the date of first response (PR or CR) to the date of disease progression or death (any cause) whichever occurs first. Responding subjects completed study follow-up or initiating a new anticancer therapy prior to documented PD were censored in the DOR analysis at the last known date the subject was progression free prior completing follow-up or initiating the new therapy.
Outcome measures
| Measure |
NANT Pancreatic Cancer Vaccine
n=6 Participants
A combination of agents will be administered to subjects in this study: ALT-803, ETBX-011, GI-4000, haNK, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, omega-3-acid ethyl esters, oxaliplatin, SBRT ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex ETBX-011: Ad5 \[E1-, E2b-\]-CEA GI-4000: Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins haNK for infusion: NK-92 \[CD16.158V, ER IL-2\] avelumab: Recombinant human anti-PD-L1 IgG1 monoclonal antibody bevacizumab: Recombinant human anti-VEGF IgG1 monoclonal Capecitabine: 5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine Cyclophosphamide: 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate Fluorouracil: 5-fluoro-2,4 (1H,3H)-pyrimidinedione Leucovorin: L-Glutamic acid, N-\[4-\[\[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl\]amino\]benzoyl\]-, calcium salt nab-Paclitaxel: Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin lovaza: Omega-3-acid ethyl esters Oxaliplatin: cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum SBRT: Stereotactic Body Radiation Therapy
|
|---|---|
|
Duration of Response (DOR) by RECIST Version 1.1 and irRC
|
NA Months
Insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression, up to 211 daysDisease control is defined as subjects with a confirmed CR, PR, or SD lasting for at least 2 months.
Outcome measures
| Measure |
NANT Pancreatic Cancer Vaccine
n=6 Participants
A combination of agents will be administered to subjects in this study: ALT-803, ETBX-011, GI-4000, haNK, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, omega-3-acid ethyl esters, oxaliplatin, SBRT ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex ETBX-011: Ad5 \[E1-, E2b-\]-CEA GI-4000: Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins haNK for infusion: NK-92 \[CD16.158V, ER IL-2\] avelumab: Recombinant human anti-PD-L1 IgG1 monoclonal antibody bevacizumab: Recombinant human anti-VEGF IgG1 monoclonal Capecitabine: 5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine Cyclophosphamide: 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate Fluorouracil: 5-fluoro-2,4 (1H,3H)-pyrimidinedione Leucovorin: L-Glutamic acid, N-\[4-\[\[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl\]amino\]benzoyl\]-, calcium salt nab-Paclitaxel: Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin lovaza: Omega-3-acid ethyl esters Oxaliplatin: cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum SBRT: Stereotactic Body Radiation Therapy
|
|---|---|
|
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1.
Stable Disease
|
5 Participants
|
|
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1.
Confirmed Complete Response
|
0 Participants
|
|
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1.
Confirmed Partial Response
|
0 Participants
|
|
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1.
Unconfirmed Complete Response
|
0 Participants
|
|
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1.
Unconfirmed Partial Response
|
0 Participants
|
|
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1.
Progressive Disease
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 9 monthsPopulation: Not all participants had QOLs collected for analysis.
PROs were assessed using the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. The FACT-Hep is compilation of general questions divided into five QOL subscales: Physical Well-Being - Scores ranging from 0-28 Social/Family Well-Being - Scores ranging from 0-28 Emotional Well-Being - Scores ranging from 0-24 Functional Well-Being - Scores ranging from 0-28 Additional Concerns - Scores ranging from 0-72 It uses 5-point Likert-type response categories ranging from 0 = 'not at all' to 4 = 'very much'. The higher scales and subscales indicate better quality of life. Negatively worded items were reverse scored. If the missing for each subscale was less than 50%, the prorating scores were computed for the subscale.
Outcome measures
| Measure |
NANT Pancreatic Cancer Vaccine
n=6 Participants
A combination of agents will be administered to subjects in this study: ALT-803, ETBX-011, GI-4000, haNK, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, omega-3-acid ethyl esters, oxaliplatin, SBRT ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex ETBX-011: Ad5 \[E1-, E2b-\]-CEA GI-4000: Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins haNK for infusion: NK-92 \[CD16.158V, ER IL-2\] avelumab: Recombinant human anti-PD-L1 IgG1 monoclonal antibody bevacizumab: Recombinant human anti-VEGF IgG1 monoclonal Capecitabine: 5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine Cyclophosphamide: 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate Fluorouracil: 5-fluoro-2,4 (1H,3H)-pyrimidinedione Leucovorin: L-Glutamic acid, N-\[4-\[\[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl\]amino\]benzoyl\]-, calcium salt nab-Paclitaxel: Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin lovaza: Omega-3-acid ethyl esters Oxaliplatin: cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum SBRT: Stereotactic Body Radiation Therapy
|
|---|---|
|
Quality of Life by Patient Reported Outcomes (PRO)
Additional Concerns - Baseline
|
44.0 score on a scale
Interval 39.0 to 65.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Emotional Well-Being - Baseline
|
14.0 score on a scale
Interval 12.0 to 21.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Functional Well-Being - Baseline
|
19.0 score on a scale
Interval 13.0 to 23.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Physical Well-Being - Baseline
|
16.0 score on a scale
Interval 10.0 to 25.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Social/Family Well-Being - Baseline
|
25.0 score on a scale
Interval 18.7 to 28.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Additional Concerns - End of Dosing
|
46.0 score on a scale
Interval 27.0 to 55.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Emotional Well-Being - End of Dosing
|
12.5 score on a scale
Interval 9.0 to 22.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Functional Well-Being - End of Dosing
|
13.0 score on a scale
Interval 8.0 to 22.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Physical Well-Being - End of Dosing
|
15.0 score on a scale
Interval 5.0 to 26.0
|
|
Quality of Life by Patient Reported Outcomes (PRO)
Social/Family Well-Being - End of Dosing
|
22.6 score on a scale
Interval 13.0 to 28.0
|
SECONDARY outcome
Timeframe: Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression, up to 211 daysDisease control is defined as subjects with a confirmed CR, PR, or SD lasting for at least 2 months.
Outcome measures
| Measure |
NANT Pancreatic Cancer Vaccine
n=6 Participants
A combination of agents will be administered to subjects in this study: ALT-803, ETBX-011, GI-4000, haNK, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, omega-3-acid ethyl esters, oxaliplatin, SBRT ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex ETBX-011: Ad5 \[E1-, E2b-\]-CEA GI-4000: Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins haNK for infusion: NK-92 \[CD16.158V, ER IL-2\] avelumab: Recombinant human anti-PD-L1 IgG1 monoclonal antibody bevacizumab: Recombinant human anti-VEGF IgG1 monoclonal Capecitabine: 5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine Cyclophosphamide: 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate Fluorouracil: 5-fluoro-2,4 (1H,3H)-pyrimidinedione Leucovorin: L-Glutamic acid, N-\[4-\[\[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl\]amino\]benzoyl\]-, calcium salt nab-Paclitaxel: Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin lovaza: Omega-3-acid ethyl esters Oxaliplatin: cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum SBRT: Stereotactic Body Radiation Therapy
|
|---|---|
|
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC
Confirmed irCR
|
0 Participants
|
|
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC
Confirmed irPR
|
0 Participants
|
|
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC
Unconfirmed irCR
|
0 Participants
|
|
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC
Unconfirmed irPR
|
0 Participants
|
|
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC
irSD
|
4 Participants
|
|
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC
Unconfirmed irPD
|
0 Participants
|
|
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC
Confirmed irPD
|
2 Participants
|
Adverse Events
NANT Pancreatic Cancer Vaccine
Serious events: 3 serious events
Other events: 6 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
NANT Pancreatic Cancer Vaccine
n=6 participants at risk
A combination of agents were administered to subjects in this study: ALT-803, ETBX-011, GI-4000, haNK, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, omega-3-acid ethyl esters, oxaliplatin, SBRT ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex ETBX-011: Ad5 \[E1-, E2b-\]-CEA GI-4000: Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins haNK for infusion: NK-92 \[CD16.158V, ER IL-2\] avelumab: Recombinant human anti-PD-L1 IgG1 monoclonal antibody bevacizumab: Recombinant human anti-VEGF IgG1 monoclonal Capecitabine: 5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine Cyclophosphamide: 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate Fluorouracil: 5-fluoro-2,4 (1H,3H)-pyrimidinedione Leucovorin: L-Glutamic acid, N-\[4-\[\[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl\]amino\]benzoyl\]-, calcium salt nab-Paclitaxel: Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin lovaza: Omega-3-acid ethyl esters Oxaliplatin: cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum SBRT: Stereotactic Body Radiation Therapy
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
33.3%
2/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Gastrointestinal disorders
Obstruction gastric
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
General disorders
Disease progression
|
33.3%
2/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Infections and infestations
Abdominal abscess
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Infections and infestations
Influenza
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
Other adverse events
| Measure |
NANT Pancreatic Cancer Vaccine
n=6 participants at risk
A combination of agents were administered to subjects in this study: ALT-803, ETBX-011, GI-4000, haNK, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, omega-3-acid ethyl esters, oxaliplatin, SBRT ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex ETBX-011: Ad5 \[E1-, E2b-\]-CEA GI-4000: Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins haNK for infusion: NK-92 \[CD16.158V, ER IL-2\] avelumab: Recombinant human anti-PD-L1 IgG1 monoclonal antibody bevacizumab: Recombinant human anti-VEGF IgG1 monoclonal Capecitabine: 5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine Cyclophosphamide: 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate Fluorouracil: 5-fluoro-2,4 (1H,3H)-pyrimidinedione Leucovorin: L-Glutamic acid, N-\[4-\[\[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl\]amino\]benzoyl\]-, calcium salt nab-Paclitaxel: Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin lovaza: Omega-3-acid ethyl esters Oxaliplatin: cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum SBRT: Stereotactic Body Radiation Therapy
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
83.3%
5/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Blood and lymphatic system disorders
Anaemia
|
66.7%
4/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
66.7%
4/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
6/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Gastrointestinal disorders
Abdominal pain
|
83.3%
5/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Gastrointestinal disorders
Nausea
|
83.3%
5/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
66.7%
4/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
3/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Gastrointestinal disorders
Flatulence
|
50.0%
3/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
50.0%
3/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Gastrointestinal disorders
Abdominal distension
|
33.3%
2/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Gastrointestinal disorders
Colitis
|
33.3%
2/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
33.3%
2/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Gastrointestinal disorders
Ascites
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Gastrointestinal disorders
Gingival bleeding
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Gastrointestinal disorders
Haematochezia
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Gastrointestinal disorders
Haemorrhoids
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Gastrointestinal disorders
Mouth ulceration
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Gastrointestinal disorders
Obstruction gastric
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
General disorders
Fatigue
|
100.0%
6/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
General disorders
Injection site reaction
|
100.0%
6/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
General disorders
Pyrexia
|
83.3%
5/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
General disorders
Injection site erythema
|
66.7%
4/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
General disorders
Injection site pain
|
66.7%
4/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
General disorders
Chills
|
50.0%
3/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
General disorders
Injection site swelling
|
50.0%
3/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
General disorders
Asthenia
|
33.3%
2/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
General disorders
Disease progression
|
33.3%
2/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
General disorders
Influenza like illness
|
33.3%
2/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
General disorders
Mucosal inflammation
|
33.3%
2/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
General disorders
Catheter site irritation
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
General disorders
Chest pain
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
General disorders
Feeling abnormal
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
General disorders
Injection site bruising
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
General disorders
Injection site oedema
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
General disorders
Injection site pruritus
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
General disorders
Injection site warmth
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
General disorders
Oedema
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
General disorders
Pain
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
100.0%
6/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Nervous system disorders
Neuropathy peripheral
|
83.3%
5/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Nervous system disorders
Headache
|
66.7%
4/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Nervous system disorders
Paraesthesia
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Nervous system disorders
Syncope
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
100.0%
6/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
3/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
33.3%
2/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
33.3%
2/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
100.0%
6/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
2/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
2/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Urticaria papular
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Renal and urinary disorders
Dysuria
|
33.3%
2/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Renal and urinary disorders
Haematuria
|
33.3%
2/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Renal and urinary disorders
Urinary retention
|
33.3%
2/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Renal and urinary disorders
Proteinuria
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Renal and urinary disorders
Renal injury
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Vascular disorders
Hypotension
|
33.3%
2/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Vascular disorders
Labile blood pressure
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Vascular disorders
Varicose vein
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
50.0%
3/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Injury, poisoning and procedural complications
Vulvovaginal injury
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Investigations
Weight decreased
|
50.0%
3/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Investigations
White blood cell count decreased
|
50.0%
3/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Investigations
Neutrophil count decreased
|
33.3%
2/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Investigations
Blood alkaline phosphatase increased
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Cardiac disorders
Tachycardia
|
33.3%
2/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Psychiatric disorders
Depression
|
33.3%
2/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Psychiatric disorders
Insomnia
|
33.3%
2/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Ear and labyrinth disorders
Ear discomfort
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Ear and labyrinth disorders
Vertigo
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
2/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Eye disorders
Diplopia
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Hepatobiliary disorders
Cholelithiasis
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Infections and infestations
Abdominal abscess
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Infections and infestations
Bacteraemia
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Infections and infestations
Candida infection
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Infections and infestations
Influenza
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
|
Reproductive system and breast disorders
Breast pain
|
16.7%
1/6 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 2 years. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 2 years. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place