TriangleNCT04840615 · OUTCOME
Recommended Phase 2 Dose (RP2D) of Intratumorally Administered LMB-100 in Participants With Mesothelioma
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- mcg/kg
- Interval / dispersion
- Not reported
- Time frame
- 21 days after first LMB-100 administration
What was measured
RP2D is defined as the highest dose at which fewer than 2 of 6 participants experience a dose-limiting toxicity. A dose-limiting toxicity is defined as any Grade 4 hematological toxicity lasting greater than 5 days. Grade 3 febrile neutropenia, Grade 3 thrombocytopenia associated with bleeding episodes, any Grade 3 or greater, non-hematological toxicity with the following exceptions: tumor lysis syndrome, Grade 3 electrolyte changes associated with clinically significant consequences, Grade 3 nausea and diarrhea which has not received appropriate treatment, isolated Grade 3 fever occurring within 48 hours of LMB-100 infusion and resolving within 48 hours to ≤ Grade 2 and fully resolved within 1 week, alopecia, infusion-related reactions up to and including Grade 3, asymptomatic ≥ Grade 3 lymphopenia, leukopenia, hypoalbuminemia, electrolyte abnormalities resolving within 24 hours, and increase in alkaline phosphatase.
Groups in this outcome
All Participants in Dose Level 1: 400 mcg LMB-100
All participants that received at least one dose of both LMB-100 and Ipilimumab. Dose Level 1: 400 mcg LMB-100 administered per dose, dose administered on days 1 and 4 of 21-day cycle, cycle 1 in participants with pleural or peritoneal mesothelioma. Those with pleural or peritoneal mesothelioma receiving intra-tumoral administration of LMB-100 + Ipilimumab for up to 4 cycles. For infusion related reactions precaution, all participants will be premedicated 30-60 minutes (+ 30 minutes) prior to each LMB-100 administration with the following medications: Diphenhydramine 25-50 mg by mouth (PO) or intravenous (IV) (or alternative antihistamine at adequate dose), Famotidine 20 mg by mouth (PO) or intravenous (IV) (or alternative histamine H2- receptor antagonists (H2) blocker at adequate dose), and Acetaminophen 650 mg by mouth (PO) or intravenous (IV). Additional infusion precaution at infusions of LMB-100 after Cycle 1 Day 1 (as appropriate): Dexamethasone 20 mg by mouth (PO), 6-12 hours prior to LMB-100 administration OR 10mg, intravenous (IV), 30-60 minutes prior to LMB-100 administration OR equivalent dose of another corticosteroid as clinically indicated.
| Group | Source count |
|---|---|
| All Participants in Dose Level 1: 400 mcg LMB-100 | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants in Dose Level 1: 400 mcg LMB-100 | NA | Not reported | Not reported | Not reported | The RP2D was not determined because the study closed early due to lack of accrual. |
Complete source fields
- classes
- categories
- measurements
- comment
- The RP2D was not determined because the study closed early due to lack of accrual.
- group Id
- OG000
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 2
- units
- Participants
- description
- RP2D is defined as the highest dose at which fewer than 2 of 6 participants experience a dose-limiting toxicity. A dose-limiting toxicity is defined as any Grade 4 hematological toxicity lasting greater than 5 days. Grade 3 febrile neutropenia, Grade 3 thrombocytopenia associated with bleeding episodes, any Grade 3 or greater, non-hematological toxicity with the following exceptions: tumor lysis syndrome, Grade 3 electrolyte changes associated with clinically significant consequences, Grade 3 nausea and diarrhea which has not received appropriate treatment, isolated Grade 3 fever occurring within 48 hours of LMB-100 infusion and resolving within 48 hours to ≤ Grade 2 and fully resolved within 1 week, alopecia, infusion-related reactions up to and including Grade 3, asymptomatic ≥ Grade 3 lymphopenia, leukopenia, hypoalbuminemia, electrolyte abnormalities resolving within 24 hours, and increase in alkaline phosphatase.
- groups
- description
- All participants that received at least one dose of both LMB-100 and Ipilimumab. Dose Level 1: 400 mcg LMB-100 administered per dose, dose administered on days 1 and 4 of 21-day cycle, cycle 1 in participants with pleural or peritoneal mesothelioma. Those with pleural or peritoneal mesothelioma receiving intra-tumoral administration of LMB-100 + Ipilimumab for up to 4 cycles. For infusion related reactions precaution, all participants will be premedicated 30-60 minutes (+ 30 minutes) prior to each LMB-100 administration with the following medications: Diphenhydramine 25-50 mg by mouth (PO) or intravenous (IV) (or alternative antihistamine at adequate dose), Famotidine 20 mg by mouth (PO) or intravenous (IV) (or alternative histamine H2- receptor antagonists (H2) blocker at adequate dose), and Acetaminophen 650 mg by mouth (PO) or intravenous (IV). Additional infusion precaution at infusions of LMB-100 after Cycle 1 Day 1 (as appropriate): Dexamethasone 20 mg by mouth (PO), 6-12 hours prior to LMB-100 administration OR 10mg, intravenous (IV), 30-60 minutes prior to LMB-100 administration OR equivalent dose of another corticosteroid as clinically indicated.
- id
- OG000
- title
- All Participants in Dose Level 1: 400 mcg LMB-100
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- 21 days after first LMB-100 administration
- title
- Recommended Phase 2 Dose (RP2D) of Intratumorally Administered LMB-100 in Participants With Mesothelioma
- type
- PRIMARY
- unit Of Measure
- mcg/kg
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice