Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pegilodecakin · 5 trials · 11 indications
Overall survival is defined as the time from date of randomization to the date of death (due to any cause). For participants whose last known status is alive at the data cutoff date for the analysis, time will be censored as the last contact date prior to the data cutoff date.
Pharmacokinetic (PK): maximum drug concentration (Cmax) of Pegilodecakin.
Time of maximum serum concentration (Tmax) of Pegilodecakin.
PK: Area Under the Serum Concentration Versus Time Curve From Time Zero to Infinity AUC\[0-inf\] of Pegilodecakin.
Maximal serum concentration (Cmax) of pegilodecakin is reported.
AUC from time 0 to the time of the last quantifiable concentration \[AUC(0-tlast)\], AUC from time 0 to 72 hours \[AUC(0-72)\] and AUC from time 0 to infinity \[AUC(0-inf)\] of pegilodecakin is reported.
Apparent total body clearance ((CL/F) is the volume of serum from which the drug is completely removed in a given time period.
maximal plasma concentration (Cmax)
maximal concentration (Tmax)
area under the plasma concentration curve (AUC)
clearance (CL/F).
The number of participants who experienced treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) during the study.
Serum concentration of Pegilodecakin is reported.
| Arm | Type | Description |
|---|---|---|
| Pegilodecakin + FOLFOX | EXPERIMENTAL | Pegilodecakin 5 microgram per kilogram (μg/kg) dosed as one of the following 2 fixed doses: 0.4 milligram (mg) for participants weighing ≤80 kg or 0.8 mg for participants weighing\>80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX \[dl-Leucovorin (dl-LV) 400 milligram per meter square (mg/m2) and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2\] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression \[that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity\], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing\>80 kg. |
| FOLFOX | ACTIVE_COMPARATOR | FOLFOX (dl-LV 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-FU 400 mg/m2 and a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. |
| Pegilodecakin Vial | EXPERIMENTAL | Participants received Pegilodecakin subcutaneous (SQ) doses of 0.8 milligrams (mg) at 4 milligrams per milliliter (mg/mL) administered as 0.2 mL injections from a vial drawn into a conventional syringe |
| Pegilodecakin Pre-filled syringe (PFS) | EXPERIMENTAL | Participants received Pegilodecakin SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections from a pre-filled syringe. |
| Pegilodecakin: Treatment A | EXPERIMENTAL | Participants received AM0010 (pegilodecakin) subcutaneous (SQ) doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 1.6 mg at 4 mg/mL administered as 0.4 mL injections for body weight \>80 kg. |
| Pegilodecakin: Treatment B | EXPERIMENTAL | Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 4 mg/mL administered as 0.1 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight \>80 kg. |
| Pegilodecakin: Treatment C | EXPERIMENTAL | Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 2 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 2 mg/mL administered as 0.4 mL injections for body weight \>80 kg. |
| 1 | ACTIVE_COMPARATOR | Pegilodecakin (5 μg/kg) dosed on Day 1, and Days 4-9 SQ |
| 2 | ACTIVE_COMPARATOR | Pegilodecakin (10 μg/kg) dosed on Day 1, and Days 4-9 SQ |
| Part A: Pegilodecakin 0.08/0.1 mg | EXPERIMENTAL | Participants received 0.08 or 0.1 mg of Pegilodecakin once daily (QD) administered subcutaneously (SC). Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part A: Pegilodecakin 0.2/0.25 mg | EXPERIMENTAL | Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part A: Pegilodecakin 0.4/0.5 mg | EXPERIMENTAL | Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part A: Pegilodecakin 0.8/1 mg | EXPERIMENTAL | Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part A: Pegilodecakin 1.6/2 mg | EXPERIMENTAL | Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part A: Pegilodecakin 3.2/4 mg | EXPERIMENTAL | Participants received 3.2 or 4 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part B: Pegilodecakin 0.2/0.25 mg + Platinum/Taxane | EXPERIMENTAL | Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part B: Pegilodecakin 0.4/0.5 mg + Platinum/Taxane | EXPERIMENTAL | Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part B: Pegilodecakin 0.8/1 mg + Platinum/Taxane | EXPERIMENTAL | Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part C: Pegilodecakin 0.2/0.25 mg + FOLFOX | EXPERIMENTAL | Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-Fluorouracil (FU) 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part C: Pegilodecakin 0.4/0.5 mg + FOLFOX | EXPERIMENTAL | Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part C: Pegilodecakin 0.8/1 mg + FOLFOX | EXPERIMENTAL | Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part D: Pegilodecakin 0.4/ 0.5 mg + Gemcitabine/Nab-Paclitaxel | EXPERIMENTAL | Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC with Gemcitabine 1000 mg/m2 IV over 30 minutes plus nab-paclitaxel 125 mg/m2 IV over 30 to 40 minutes on Days 1, 8, and 15 of every 28-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part E: Pegilodecakin 0.8/1 mg + Capecitabine | EXPERIMENTAL | Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Capecitabine 1000 mg/m² orally twice daily (BID) on Days 1 through 14 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part F: Pegilodecakin 0.8/ 1 mg + Paclitaxel | EXPERIMENTAL | Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Paclitaxel 80 mg/m2 IV over 3 hours on Days 1, 8, and 15 of every 28-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part G: Pegilodecakin 0.8/1 mg + Pazopanib | EXPERIMENTAL | Participants received a 0.8 or 1 mg of Pegilodecakin QD administered SC with Pazopanib 800 mg orally QD. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part H: Pegilodecakin 0.8/1 mg + Pembrolizumab | EXPERIMENTAL | Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part H: Pegilodecakin 1.6/2 mg + Pembrolizumab | EXPERIMENTAL | Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part H: Pegilodecakin 3.2/4 mg + Pembrolizumab | EXPERIMENTAL | Participants received 3.2 or 4 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part J: Pegilodecakin 0.8/1 mg + Gemcitabine/Carboplatin | EXPERIMENTAL | Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with gemcitabine 500 mg/m2 IV over 30 minutes followed by carboplatin targeting an Area Under the Curve of 2 mg/mL x min (AUC2) IV over 60 minutes on Days 1 and 8 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part I: Pegilodecakin 1.6/2 mg + Nivolumab | EXPERIMENTAL | Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC with Nivolumab 3 mg/kg IV infusion over 60 minutes on Day 1 of each 14-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part I: Pegilodecakin 0.8/1 mg + Nivolumab | EXPERIMENTAL | Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Nivolumab 3 mg/kg IV infusion over 60 minutes on Day 1 of each 14-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Part J: Pegilodecakin 0.4/0.5 mg + Gemcitabine/Carboplatin | EXPERIMENTAL | Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC with gemcitabine 500 mg/m2 IV over 30 minutes followed by carboplatin targeting an AUC2 IV over 60 minutes on Days 1 and 8 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
| Name | Type | Description |
|---|---|---|
| Pegilodecakin | BIOLOGICAL | Pegilodecakin plus FOLFOX |
| FOLFOX | DRUG | FOLFOX Alone |
| Paclitaxel or Docetaxel and Carboplatin or Cisplatin | DRUG | Platinum/ Taxane administered IV on Day 1 of every 21 day cycle |
| FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil) | DRUG | FOLFOX administered IV on Day 1 and 2 of every 14 day cycle |
| gemcitabine/nab-paclitaxel | DRUG | Gemcitabine/nab-paclitaxel administered IV on Day 1, 8 and 15 of each 28 day treatment cycle. |
| Capecitabine | DRUG | Capecitabine administered orally twice daily for 14 days out of every 21 days. |
| Pazopanib | DRUG | Pazopanib administered orally daily continuously |
| Pembrolizumab | DRUG | Pembrolizumab administered IV on Day 1 of every 21 day cycle. |
| Paclitaxel | DRUG | Paclitaxel administered IV on Days 1, 8, 15 of each cycle (28 days= 1 cycle) |
| nivolumab | DRUG | Nivolumab administered IV on Day 1 of each cycle (14 days = 1 cycle) |
| Gemcitabine/carboplatin | DRUG | Gemcitabine and carboplatin administered IV on Days 1, 8 of each cycle (21 days = 1 cycle) |
Inclusion Criteria: 1. The presence of metastatic pancreatic adenocarcinoma 2. Measurable disease per RECIST v.1.1 3. Participant must have documented tumor progression during or following a gemcitabine containing regimen to treat metastatic disease as established by CT or MRI scan 4. Eastern Coope...
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Pegilodecakin is an investigational monoclonal antibody being studied for use in healthy adult subjects, melanoma, and pancreatic cancer. It is developed by Eli Lilly and Company (LLY). The drug is currently in Phase 1 clinical development, and all completed trials have focused on pharmacokinetics in healthy volunteers or treatment of pancreatic cancer.
Pegilodecakin is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. The drug is being investigated for its effects in conditions such as pancreatic cancer and melanoma, though its mechanism of action is not publicly detailed.
Pegilodecakin is developed by Eli Lilly and Company, a pharmaceutical company traded on the stock exchange under the ticker symbol LLY. The drug is currently in Phase 1 clinical trials, with all studies completed as of the latest data.
Pegilodecakin is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All three clinical trials associated with the drug have been completed, with no active trials currently ongoing.
Pegilodecakin has been studied in three completed clinical trials. NCT02923921 was a Phase 3 study in metastatic pancreatic cancer with 567 participants. NCT03267732, NCT03381547, and NCT04194892 were Phase 1 pharmacokinetic studies in healthy adults, each with 12 to 24 participants.
Yes, Pegilodecakin is also known as LY3500518. Clinical trial records refer to the drug by both names, such as in the study titled 'Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer.'