Trial · NCT02723955
Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1)
NCT02723955, Phase 1, Completed, GlaxoSmithKline; results first posted 2024-12-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1). Trials, record NCT02723955. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02723955
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1)
- NCT number
- NCT02723955
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 829 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Neoplasms
- Interventions
feladilimab (GSK3359609), GSK3174998, Pembrolizumab, Docetaxel, Pemetrexed, Paclitaxel plus Carboplatin, Gemcitabine plus Carboplatin, Fluorouracil (5-FU) plus carboplatin or cisplatin, Dostarlimab, Cobolimab, Bintrafusp alfa
- First posted
- 2016-03-31
- Last updated
- 2024-12-27
- Other registries' IDs
- eudract:2016-000148-32
- Results first posted
- 2024-12-27
Source ClinicalTrials.gov
Registered outcomes80
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1A: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs) | Up to approximately 367 weeks | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. A summary of number of participants with any AEs and SAEs is presented. AEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary). |
| Primary | Part 1A: Number of Participants With Dose Limiting Toxicity (DLT) | Up to 28 days | DLT is an AE that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 28-day DLT period and meets at least one of the DLT criteria: Febrile neutropenia; Grade 4 neutropenia of \>7 days in duration or requiring Granulocyte Colony-stimulating Factor (G-CSF), anemia, thrombocytopenia, non-hematologic toxicity; Grade 3 thrombocytopenia with bleeding, pneumonitis, toxicity that does not resolve to Grade 1 or baseline within 3 days; Grade 2 ocular toxicity; Toxicity that results in permanent discontinuation of feladilimab during the first four weeks of treatment; any other event which in the judgment of the investigator and GSK Medical Monitor is considered to be a DLT. |
| Primary | Part 1A: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Baseline (Day 1) and up to approximately 367 weeks | Blood samples were collected for analysis of clinical chemistry parameters. Laboratory parameters were graded according to CTCAE v4.03. Grade (G) 0: None; G1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Only grade change data is presented for Baseline (B) and Worst-Case Post-Baseline (WCPB) as G0, G1, G2, G3, G4, and missing (M) here as "Parameter name, B GX, WCPB GX" where X=grade digit. |
| Primary | Part 1A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to approximately 367 weeks | Normal ranges were 0.1 to 0.3 micromoles (umol)/liter (L) (direct bilirubin); 6 to 8.3 grams/L (protein); 100 to 250 international units (IU)/L (Lactate Dehydrogenase(LDH)); 2.3 - 4.1 picomoles/L (Free Triiodothyronine(T3)); 4.6 to 11.2 picomoles/L (Free Thyroxine(T4)); 0 and 0.04 microgram (ug)/L (Troponin I); 0 - 0.01 ug/L (Troponin T); 0.45 to 4.5 milliunits (Mu)/L (Thyrotropin(TSH)); and 6 to 24 millimoles/L (Urea). Participants were counted in worst case category that their value changes to low, normal or no change \[NC\] or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g. High to High) or whose value became normal, were recorded in "To Normal or No Change" category. Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%. |
| Primary | Part 1A: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Baseline (Day 1) and up to approximately 367 weeks | Blood samples were collected for analysis of hematology parameters. Laboratory parameters were graded according to CTCAE v4.03. Grade (G) 0: None; G1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Only grade change data is presented for Baseline (B) and Worst-Case Post-Baseline (WCPB) as G0, G1, G2, G3, G4, and missing (M) here as "Parameter name, B GX, WCPB GX" where X=grade digit. |
| Primary | Part 1A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to approximately 367 weeks | Normal ranges were 0.01 to 0.3\*10\^9 cells/L (basophils), 0 to 500 cells /L (eosinophils), 41 to 50 percentage of red blood cells (RBC) in blood (hematocrit), 1,000 - 4,800 lymphocytes per microliter (µL) of blood (lymphocytes), 80-100 femtoliters (fl) (erythrocytes, mean corpuscular volume), 2 to 8 percentage of WBC (monocytes), 40 to 60 cells/mcL (neutrophils) and Women: 4.2 to 5.4 million RBC/ microliter (mcL) of blood and Men: 4.7 to 6.1 million RBC/ mcL (erythrocytes count). Participants were counted in worst case category that their value changes to low, normal or no change \[NC\] or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g. High to High) or whose value became normal, were recorded in "To Normal or No Change" category. Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%. |
| Primary | Part 1A: Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Up to approximately 367 weeks | Urine samples were collected to assess urine glucose, ketones and occult blood using dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline (Day 1) was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Result for urinalysis parameters were recorded as no change/decreased and any increase. |
| Primary | Part 1A: Number of Participants With Dose Modifications of Feladilimab | Up to approximately 367 weeks | Number of participants with dose modifications (including dose delays, dose escalations and infusion interruptions) were reported for Feladilimab. |
| Primary | Part 2A: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs) | Up to approximately 367 weeks | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent disability/incapacity or Is a congenital anomaly/birth defect, Other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. A summary of number of participants with any AEs and SAEs is presented. AEs were coded using the MedDRA dictionary. |
| Primary | Part 2A: Number of Participants With Dose Limiting Toxicity (DLT) | Up to 28 days | DLT is an AE that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 28-day DLT period and meets at least one of the DLT criteria: Febrile neutropenia; Grade 4 neutropenia of \>7 days in duration or requiring Granulocyte Colony-stimulating Factor (G-CSF), anemia, thrombocytopenia, non-hematologic toxicity; Grade 3 thrombocytopenia with bleeding, pneumonitis, toxicity that does not resolve to Grade 1 or baseline within 3 days; Grade 2 ocular toxicity; Toxicity that results in permanent discontinuation of feladilimab monotherapy or in combination during the first four weeks of treatment; any other event which in the judgment of the investigator and GSK Medical Monitor is considered to be a DLT. |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 registered outcomesOutcomes80
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1A: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs) | Up to approximately 367 weeks | All Treated population included all participants who received at least one dose of feladilimab. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1A: Number of Participants With Dose Limiting Toxicity (DLT) | Up to 28 days | DLT Evaluable Population included All Treated Population in the dose escalation phase or PK/PD cohorts, who completed the 28-day DLT observation period or experienced a DLT during the determinative period (28 days). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1A: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Baseline (Day 1) and up to approximately 367 weeks | All Treated Population. Only those participants with data available at specified categories have been analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to approximately 367 weeks | All Treated Population. Only those participants with data available at specified categories have been analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1A: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Baseline (Day 1) and up to approximately 367 weeks | All Treated Population. Only those participants with data available at specified categories have been analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to approximately 367 weeks | All Treated Population. Only those participants with data available at specified categories have been analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1A: Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Up to approximately 367 weeks | All treated population. Only those participants with data available at specified categories have been analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1A: Number of Participants With Dose Modifications of Feladilimab | Up to approximately 367 weeks | All treated population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 2A: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs) | Up to approximately 367 weeks | All Treated population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 2A: Number of Participants With Dose Limiting Toxicity (DLT) | Up to 28 days | DLT Evaluable Population. As pre-specified in the protocol, only specified treatment arms were planned and hence there are 0 participants analyzed for rest of the arms. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 outcomesResults by group19,265
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1A: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs) | Part 1A: Feladilimab (Fela) 0.001 Milligram/Kilogram (mg/kg) | Any AEs | 1 | Participants | |
| Part 1A: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs) | Part 1A: Fela 0.003 mg/kg | Any AEs | 1 | Participants | |
| Part 1A: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs) | Part 1A: Fela 0.010 mg/kg | Any AEs | 2 | Participants | |
| Part 1A: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs) | Part 1A: Fela 0.030 mg/kg | Any AEs | 7 | Participants | |
| Part 1A: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs) | Part 1A: Fela 0.100 mg/kg | Any AEs | 22 | Participants | |
| Part 1A: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs) | Part 1A: Fela 0.300 mg/kg | Any AEs | 24 | Participants | |
| Part 1A: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs) | Part 1A: Fela 1.000 mg/kg | Any AEs | 13 | Participants | |
| Part 1A: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs) | Part 1A: Fela 3.000 mg/kg | Any AEs | 21 | Participants | |
| Part 1A: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs) | Part 1A: Fela 10.000 mg/kg | Any AEs | 6 | Participants | |
| Part 1A: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs) | Part 1A: Feladilimab (Fela) 0.001 Milligram/Kilogram (mg/kg) | Any SAEs | 0 | Participants |
1 to 10 of 19,265Source ClinicalTrials.gov
See all 19,265 results by groupParticipant flow387
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Escalation Phase | STARTED | Part 1A: Feladilimab (Fela) 0.001 Milligram/Kilogram (mg/kg) | 1 | |
| Escalation Phase | STARTED | Part 1A: Fela 0.003 mg/kg | 1 | |
| Escalation Phase | STARTED | Part 1A: Fela 0.010 mg/kg | 2 | |
| Escalation Phase | STARTED | Part 1A: Fela 0.030 mg/kg | 7 | |
| Escalation Phase | STARTED | Part 1A: Fela 0.100 mg/kg | 24 | |
| Escalation Phase | STARTED | Part 1A: Fela 0.300 mg/kg | 25 | |
| Escalation Phase | STARTED | Part 1A: Fela 1.000 mg/kg | 15 | |
| Escalation Phase | STARTED | Part 1A: Fela 3.000 mg/kg | 27 | |
| Escalation Phase | STARTED | Part 1A: Fela 10.000 mg/kg | 7 | |
| Escalation Phase | STARTED | Part 1B: Fela 0.300 mg/kg | 0 |
1 to 10 of 387Source ClinicalTrials.gov
See all 387 participant flowAdverse events21,629
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Part 1A: Feladilimab (Fela) 0.001 Milligram/Kilogram (mg/kg) | 0 | 1 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Part 1A: Fela 0.003 mg/kg | 0 | 1 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Part 1A: Fela 0.010 mg/kg | 0 | 2 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Part 1A: Fela 0.030 mg/kg | 1 | 7 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Part 1A: Fela 0.100 mg/kg | 7 | 24 | 7 |
| other | Anaemia | Blood and lymphatic system disorders | Part 1A: Fela 0.300 mg/kg | 5 | 25 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | Part 1A: Fela 1.000 mg/kg | 4 | 15 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | Part 1A: Fela 3.000 mg/kg | 2 | 27 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Part 1A: Fela 10.000 mg/kg | 2 | 7 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Part 1B: Fela 0.300 mg/kg | 7 | 39 | 7 |
1 to 10 of 21,629Source ClinicalTrials.gov
See all 21,629 adverse eventsAdverse event totals129
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1A: Feladilimab (Fela) 0.001 Milligram/Kilogram (mg/kg) | 1 | 1 |
| Total, all-cause mortality | Part 1A: Fela 0.003 mg/kg | 1 | 1 |
| Total, all-cause mortality | Part 1A: Fela 0.010 mg/kg | 2 | 2 |
| Total, all-cause mortality | Part 1A: Fela 0.030 mg/kg | 7 | 7 |
| Total, all-cause mortality | Part 1A: Fela 0.100 mg/kg | 18 | 24 |
| Total, all-cause mortality | Part 1A: Fela 0.300 mg/kg | 17 | 25 |
| Total, all-cause mortality | Part 1A: Fela 1.000 mg/kg | 11 | 15 |
| Total, all-cause mortality | Part 1A: Fela 3.000 mg/kg | 21 | 27 |
| Total, all-cause mortality | Part 1A: Fela 10.000 mg/kg | 3 | 7 |
| Total, all-cause mortality | Part 1B: Fela 0.300 mg/kg | 25 | 39 |
1 to 10 of 129Source ClinicalTrials.gov
See all 129 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02723955
GET https://conductscience.org/api/trials/v1/NCT02723955/registered?page=2