Study of Intratumorally Administered Stimulator of Interferon Genes (STING) Agonist E7766 in Participants With Advanced Solid Tumors or Lymphomas - INSTAL-101
TerminatedPhase 1Results postedLast updated 7 March 2024
What this trial tests
Phase 1 trial testing E7766 in Lymphoma in 24 participants. Terminated before completion.
18 and older, any sex, with Lymphoma or Advanced Solid Tumors. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Dose Escalation Part: Number of Participants With Dose-limiting Toxicities (DLTs)Primary· Cycle 1 (Cycle length= 21 days)
DLTs were predefined as any of the following toxicities occurring during Cycle 1 and were assessed by the investigator according to National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version (v) 5.0. as related to E7766. Nonhematologic toxicity greater than or equal to (\>=) Grade 3 (NCI CTCAE v. 5.0), except Grade 3 fatigue less than (\<) 5 days. Asymptomatic Grade 3 or 4 laboratory abnormalities that were corrected within 72 hours. \>=Grade 3 nausea, vomiting, and diarrhea unless lasting greater than (\>) 48 hours despite optimal supportive care. Hemat
Group
Value
95% CI
Dose Escalation Part: E7766 75 mcg
0
Dose Escalation Part: E7766 150 mcg
0
Dose Escalation Part: E7766 300 mcg
0
Dose Escalation Part: E7766 600 mcg
2
Dose Escalation Part: E7766 780 mcg
1
Number of Participants With Any Treatment-emergent Adverse Events (TEAEs)Primary· From the first dose of the study drug up to 90 days after the last dose (up to 9 months and 14 days)
A TEAE was defined as an adverse event (AE) that emerges during treatment (on or after the first dose of study drug up to 90 days after the participant's last dose) or start day of another anticancer therapy, whichever is earlier; or in case participant has initiated new anticancer therapy within 30 days, then AEs occurring for 30 days following the last dose of E7766, having been absent at pretreatment (Baseline) or reemerges during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state
Group
Value
95% CI
Dose Escalation Part: E7766 75 mcg
2
Dose Escalation Part: E7766 150 mcg
2
Dose Escalation Part: E7766 300 mcg
2
Dose Escalation Part: E7766 600 mcg
11
Dose Escalation Part: E7766 780 mcg
6
Dose Escalation Part: E7766 1000 mcg
1
Dose Escalation Part: ORR Based on iRECISTSecondary· From date of first dose of study drug until confirmed iCR or iPR (up to 6 months and 18 days)
ORR was defined as the percentage of participants whose BOR was iCR or iPR according to iRECIST as per investigator assessment. iCR: immune complete response achieved with disappearance of all target lesions iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions iSD: immune stable disease in the absence of iCR or iPD iUPD: immune unconfirmed progressive disease when iPD is unconfirmed NE: not evaluable.
Group
Value
95% CI
Dose Escalation Part: E7766 75 mcg
0
Dose Escalation Part: E7766 150 mcg
0
Dose Escalation Part: E7766 300 mcg
0
Dose Escalation Part: E7766 600 mcg
0
Dose Escalation Part: E7766 780 mcg
0
Dose Escalation Part: E7766 1000 mcg
0
Dose Escalation Part: ORR Based on mRECIST v1.1Secondary· From date of first dose of study drug until confirmed CR or PR (up to 6 months and 18 days)
ORR was defined as the percentage of participants with a BOR of CR or PR for target and non-target lesions. CR was defined as the disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in the short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The tumor assessment was done using number of lesions based on modified RECIST 1.1 as per investigator assessment for assessing tumor burden up to 10 target lesions w
Group
Value
95% CI
Dose Escalation Part: E7766 75 mcg
0
Dose Escalation Part: E7766 150 mcg
0
Dose Escalation Part: E7766 300 mcg
0
Dose Escalation Part: E7766 600 mcg
0
Dose Escalation Part: E7766 780 mcg
0
Dose Escalation Part: E7766 1000 mcg
0
Dose Escalation Part: DCR Based on iRECISTSecondary· From first dose of study drug until confirmed iCR or iPR or >=5 weeks after first dose for iSD (up to 6 months and 18 days)
DCR: percentage of participants with a confirmed iCR, iPR, or i-SD (duration of iSD \>=5 weeks). DCR was assessed on iRECIST v1.1 as per investigator assessment. iCR: immune complete response achieved with disappearance of all target lesions iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions iSD: immune stable disease in the absence of iCR or iPD iUPD: immune unconfirmed progressive disease when iPD is unconfirmed NE: not evaluable.
Group
Value
95% CI
Dose Escalation Part: E7766 75 mcg
100.0
Dose Escalation Part: E7766 150 mcg
0.0
Dose Escalation Part: E7766 300 mcg
50.0
Dose Escalation Part: E7766 600 mcg
36.4
Dose Escalation Part: E7766 780 mcg
16.7
Dose Escalation Part: E7766 1000 mcg
0.0
Dose Escalation Part: DCR Based on mRECIST v1.1Secondary· From first dose of study drug until confirmed CR or PR or >=5 weeks after first dose for SD (up to 6 months and 18 days)
DCR was defined as the percentage of participants with a best overall response of CR or PR, or SD based on mRECIST 1.1 as per investigator assessment. Best overall response of SD must have been \>=7 weeks after randomization. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference the baseline sum of the diameters of target lesions. SD was when a case does not qualify for either PR or PD and was new non-target les
Group
Value
95% CI
Dose Escalation Part: E7766 75 mcg
100.0
Dose Escalation Part: E7766 150 mcg
0.0
Dose Escalation Part: E7766 300 mcg
50.0
Dose Escalation Part: E7766 600 mcg
36.4
Dose Escalation Part: E7766 780 mcg
16.7
Dose Escalation Part: E7766 1000 mcg
0.0
Cmax: Maximum Observed Plasma Concentration for E7766Secondary· Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose; Dose Expansion: Cycle 1 Days 1 and 15: predose up to 2 hours postdose (Cycle length=21 days)
Cmax was quantified using liquid chromatography tandem mass spectrometry (LC-MS/MS) methods.
Cycle 1 Day 1
Group
Value
95% CI
Dose Escalation Part: E7766 75 mcg
4.23
± 87.4
Dose Escalation Part: E7766 150 mcg
2.77
± 7.16
Dose Escalation Part: E7766 300 mcg
2.95
± 9.85
Dose Escalation Part: E7766 600 mcg
8.03
± 95.8
Dose Escalation Part: E7766 780 mcg
11.3
± 30.6
Dose Escalation Part: E7766 1000 mcg
9.99
± NA
Cycle 1 Day 15
Group
Value
95% CI
Dose Escalation Part: E7766 75 mcg
1.29
± 22.7
Dose Escalation Part: E7766 150 mcg
2.23
± 58.1
Dose Escalation Part: E7766 300 mcg
4.53
± NA
Dose Escalation Part: E7766 600 mcg
2.72
± 168
Dose Escalation Part: E7766 780 mcg
9.33
± 34.8
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7766Secondary· Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose; Dose Expansion: Cycle 1 Days 1 and 15: predose up to 2 hours postdose (Cycle length=21 days)
Tmax was quantified using validated liquid LC-MS/MS methods.
Cycle 1 Day 1
Group
Value
95% CI
Dose Escalation Part: E7766 75 mcg
0.275
0.25 – 0.3
Dose Escalation Part: E7766 150 mcg
0.31
0.27 – 0.35
Dose Escalation Part: E7766 300 mcg
0.275
0.25 – 0.3
Dose Escalation Part: E7766 600 mcg
0.25
0.2 – 0.52
Dose Escalation Part: E7766 780 mcg
0.25
0.2 – 0.28
Dose Escalation Part: E7766 1000 mcg
0.28
0.28 – 0.28
Cycle 1 Day 15
Group
Value
95% CI
Dose Escalation Part: E7766 75 mcg
0.215
0.18 – 0.25
Dose Escalation Part: E7766 150 mcg
0.385
0.27 – 0.5
Dose Escalation Part: E7766 300 mcg
0.25
0.25 – 0.25
Dose Escalation Part: E7766 600 mcg
0.25
0.17 – 23.4
Dose Escalation Part: E7766 780 mcg
0.21
0.2 – 0.25
Part: AUC(0-t): Area Under the Plasma Concentration From Time Zero to Last Curve for E7766Secondary· Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose; Dose Expansion: Cycle 1 Days 1 and 15: predose up to 2 hours postdose (Cycle length=21 days)
AUC was quantified using validated liquid LC-MS/MS methods.
Cycle 1 Day 1
Group
Value
95% CI
Dose Escalation Part: E7766 75 mcg
2.71
± 114.0
Dose Escalation Part: E7766 150 mcg
3.42
± 64.7
Dose Escalation Part: E7766 300 mcg
4.25
± 26.6
Dose Escalation Part: E7766 600 mcg
7.7
± 35.9
Dose Escalation Part: E7766 780 mcg
8.29
± 44.2
Dose Escalation Part: E7766 1000 mcg
10.3
± NA
Cycle 1 Day 15
Group
Value
95% CI
Dose Escalation Part: E7766 75 mcg
0.536
± 17.0
Dose Escalation Part: E7766 150 mcg
1.95
± 29.4
Dose Escalation Part: E7766 300 mcg
5.51
± NA
Dose Escalation Part: E7766 600 mcg
4.06
± 101.0
Dose Escalation Part: E7766 780 mcg
6.89
± 76.9
AUC(0-inf): Area Under the Plasma Concentration From Time Zero to Infinity Curve for E7766Secondary· Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose; Dose Expansion: Cycle 1 Days 1 and 15: predose up to 2 hours postdose (Cycle length=21 days)
AUC(0-inf) was quantified using liquid chromatography tandem mass spectrometry (LC-MS/MS) methods.
Cycle 1 Day 1
Group
Value
95% CI
Dose Escalation Part: E7766 150 mcg
5.58
± NA
Dose Escalation Part: E7766 300 mcg
4.64
± 25.1
Dose Escalation Part: E7766 600 mcg
8.07
± 38.5
Dose Escalation Part: E7766 780 mcg
8.93
± 54.9
Dose Escalation Part: E7766 1000 mcg
10.4
± NA
Cycle 1 Day 15
Group
Value
95% CI
Dose Escalation Part: E7766 150 mcg
2.18
± 35.4
Dose Escalation Part: E7766 300 mcg
5.79
± NA
Dose Escalation Part: E7766 600 mcg
5.16
± 83.6
Dose Escalation Part: E7766 780 mcg
7.07
± 75.7
t1/2: Terminal Elimination Half-life for E7766Secondary· Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose; Dose Expansion: Cycle 1 Days 1 and 15: predose up to 2 hours postdose (Cycle length=21 days)
t1/2 was quantified using validated liquid LC-MS/MS methods.
Cycle 1 Day 1
Group
Value
95% CI
Dose Escalation Part: E7766 150 mcg
1.56
± NA
Dose Escalation Part: E7766 300 mcg
1.07
± 4.61
Dose Escalation Part: E7766 600 mcg
1.18
± 36.9
Dose Escalation Part: E7766 780 mcg
1.15
± 17.5
Dose Escalation Part: E7766 1000 mcg
1
± NA
Cycle 1 Day 15
Group
Value
95% CI
Dose Escalation Part: E7766 150 mcg
0.956
± 58.1
Dose Escalation Part: E7766 300 mcg
0.917
± NA
Dose Escalation Part: E7766 600 mcg
1.34
± 66.7
Dose Escalation Part: E7766 780 mcg
0.723
± 59.5
Dose Escalation Part: CL/F: Apparent Total Body Clearance for E7766Secondary· Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose (Cycle length=21 days)
CL/F was quantified using validated liquid LC-MS/MS methods.
Cycle 1 Day 1
Group
Value
95% CI
Dose Escalation Part: E7766 150 mcg
26.9
± NA
Dose Escalation Part: E7766 300 mcg
64.6
± 25.2
Dose Escalation Part: E7766 600 mcg
74.4
± 38.5
Dose Escalation Part: E7766 780 mcg
87.3
± 54.8
Dose Escalation Part: E7766 1000 mcg
90.3
± NA
Cycle 1 Day 15
Group
Value
95% CI
Dose Escalation Part: E7766 150 mcg
68.7
± 35.3
Dose Escalation Part: E7766 300 mcg
51.8
± NA
Dose Escalation Part: E7766 600 mcg
116.0
± 83.7
Dose Escalation Part: E7766 780 mcg
110.0
± 75.9
Adverse events — posted to ClinicalTrials.gov
Time frame: Dose Escalation Part: From the first dose of the study drug up to 90 days after the last dose (up to 9 months and 14 days).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Dose Escalation Part: E7766 75 mcg
Serious: 0/2 (0%)
Deaths: 1/2
Dose Escalation Part: E7766 150 mcg
Serious: 0/2 (0%)
Deaths: 1/2
Dose Escalation Part: E7766 300 mcg
Serious: 1/2 (50%)
Deaths: 1/2
Dose Escalation Part: E7766 600 mcg
Serious: 3/11 (27%)
Deaths: 4/11
Dose Escalation Part: E7766 780 mcg
Serious: 3/6 (50%)
Deaths: 5/6
Dose Escalation Part: E7766 1000 mcg
Serious: 1/1 (100%)
Deaths: 1/1
Serious adverse events (10 terms)
Reaction
System
Dose Escalation Part: E776…
Dose Escalation Part: E776…
Dose Escalation Part: E776…
Dose Escalation Part: E776…
Dose Escalation Part: E776…
Dose Escalation Part: E776…
Small intestinal obstruction
Gastrointestinal disorders
—
—
—
—
—
—
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
—
—
—
—
—
—
Vomiting
Gastrointestinal disorders
—
—
—
—
—
—
Injection site pain
General disorders
—
—
—
—
—
—
Localised oedema
General disorders
—
—
—
—
—
—
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
—
—
—
Cerebral venous sinus thrombosis
Nervous system disorders
—
—
—
—
—
—
Confusional state
Psychiatric disorders
—
—
—
—
—
—
Hypertension
Vascular disorders
—
—
—
—
—
—
Hypotension
Vascular disorders
—
—
—
—
—
—
Other adverse events (98 terms — click to expand)
Reaction
System
Dose Escalation Part: E776…
Dose Escalation Part: E776…
Dose Escalation Part: E776…
Dose Escalation Part: E776…
Dose Escalation Part: E776…
Dose Escalation Part: E776…
Chills
General disorders
—
—
—
—
—
—
Pyrexia
General disorders
—
—
—
—
—
—
Anaemia
Blood and lymphatic system disorders
—
—
—
—
—
—
Nausea
Gastrointestinal disorders
—
—
—
—
—
—
Fatigue
General disorders
—
—
—
—
—
—
Gamma-glutamyltransferase increased
Investigations
—
—
—
—
—
—
Blood alkaline phosphatase increased
Investigations
—
—
—
—
—
—
Decreased appetite
Metabolism and nutrition disorders
—
—
—
—
—
—
Headache
Nervous system disorders
—
—
—
—
—
—
Tachycardia
Cardiac disorders
—
—
—
—
—
—
Vomiting
Gastrointestinal disorders
—
—
—
—
—
—
Alanine aminotransferase increased
Investigations
—
—
—
—
—
—
Weight decreased
Investigations
—
—
—
—
—
—
Hypotension
Vascular disorders
—
—
—
—
—
—
Constipation
Gastrointestinal disorders
—
—
—
—
—
—
Diarrhoea
Gastrointestinal disorders
—
—
—
—
—
—
Dry mouth
Gastrointestinal disorders
—
—
—
—
—
—
Injection site pain
General disorders
—
—
—
—
—
—
Injection site reaction
General disorders
—
—
—
—
—
—
Aspartate aminotransferase increased
Investigations
—
—
—
—
—
—
Blood creatine phosphokinase increased
Investigations
—
—
—
—
—
—
Hypoalbuminaemia
Metabolism and nutrition disorders
—
—
—
—
—
—
Hypomagnesaemia
Metabolism and nutrition disorders
—
—
—
—
—
—
Hyponatraemia
Metabolism and nutrition disorders
—
—
—
—
—
—
Arthralgia
Musculoskeletal and connective tissue disorders
—
—
—
—
—
—
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This is an open label, multicenter, phase 1/1b study to assess safety/tolerability and preliminary clinical activity of E7766 as a single agent administered intratumorally in participants with advanced solid tumors or lymphomas.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04109092 — A Study of Stimulator of Interferon Genes (STING) Agonist E7766 in Non-muscle Invasive Bladder Cancer (NMIBC) Including
· Phase 1
· withdrawn
Other recruiting trials for Lymphoma
Currently open trials in the same condition.
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· Phase 1, PHASE2
· recruiting
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· recruiting
NCT07138547 — GSL Synthetase Inhibitor Eliglustat Combined With CD30 Target Immunotherapy for the Treatment of of CD30+ Lymphoma
· Phase 1, PHASE2
· recruiting
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Trials by the same sponsor.
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· recruiting
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NCT06744673 — A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control P
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NCT06602258 — A Study of E2814 With Concurrent Lecanemab Treatment in Participants With Early Alzheimer's Disease
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· active not recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eisai Inc.
Last refreshed: 7 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04144140.