Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Pamrevlumab, Recombinant human monoclonal antibody, Gemzar, Abraxane, Eloxitan, Leucovorin, Camptosar, 5-Fluracil
FG-3019 · 8 trials · 6 indications
Overall survival was defined as the time from date of randomization to date of death due to any cause. Overall survival was calculated using the Kaplan-Meier method.
FVC in liters was measured during the spirometry assessments at screening and during the randomized treatment period at Day 1 and every 12 weeks. The FVC (% predicted) was calculated for the corresponding gender-race-age group. The least squares (LS) mean change from Baseline to Week 48 (end of the randomized treatment period) in FVC (% predicted) is presented. Baseline was defined as the mean of the last screening visit and the Day 1 visit values. Other statistical analysis data is reported in the statistical analysis section. Observed data from all visits were included in the model.
An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A TEAE was defined as a new or worsening AE that occurred in the window of first infusion of any study drug (Day 1) and within 28 days of the last infusion of study drug or the day before surgery, whichever occurred first. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.
Number of participants who had surgical complications (for example; surgical site infection, intra-abdominal abscess, or perioperative leak during surgery) has been reported
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX |
| Arm B | PLACEBO_COMPARATOR | Placebo + Gemcitabine + Nab-paclitaxel or Placebo + FOLFIRINOX |
| Pamrevlumab | EXPERIMENTAL | Participants will receive pamrevlumab 30 milligram/kilogram (mg/kg) by intravenous (IV) infusion every 3 weeks for a total of 16 infusions over 45 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks. |
| Sub-Study: Pamrevlumab+Pirfenidone or Nintedanib | ACTIVE_COMPARATOR | Participants will receive pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with pamrevlumab in all active comparator participants will be administered at a dose of 15 mg/kg for the first 2 dose administrations. If these are well tolerated, all following study drug administrations will be at 30 mg/kg. Pirfenidone or nintedanib will be dosed according to the instructions in their respective labels and the prescribing physician. |
| Sub-Study: Placebo+Pirfenidone or Nintedanib | PLACEBO_COMPARATOR | Participants will receive placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with placebo in all active comparator participants will be administered at a dose of 15 mg/kg for the first 2 dose administrations. If these are well tolerated, all following study drug administrations will be at 30 mg/kg. Pirfenidone or nintedanib will be dosed according to the instructions in their respective labels and the prescribing physician. |
| Cohort 1/1-EX | EXPERIMENTAL | Subjects with moderate to severe idiopathic pulmonary fibrosis (IPF) who have evidence of disease progression |
| Cohort 2/2-EX | EXPERIMENTAL | Subjects with mild to moderate idiopathic pulmonary fibrosis (IPF) who have evidence of disease progression |
| FG-3019 + Gemcitabine + Nab-paclitaxel | EXPERIMENTAL | Participants will receive FG-3019 35 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion on Days 1 and 15 of each treatment cycle and on Day 8 of the first cycle, gemcitabine 1000 mg/square meter (m\^2) and nab-paclitaxel 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each treatment cycle. Treatment will be administered over a 28-day cycle, for up to 6 cycles. |
| Gemcitabine + Nab-paclitaxel | ACTIVE_COMPARATOR | Participants will receive gemcitabine 1000 mg/ meter squared (m\^2) and nab-paclitaxel 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each treatment cycle. Treatment will be administered over a 28-day cycle, for up to 6 cycles. |
| FG-3019 | EXPERIMENTAL | All subjects are treated with FG-3019 |
| A | PLACEBO_COMPARATOR | Placebo |
| B | EXPERIMENTAL | FG-3019 5 mg/kg |
| C | EXPERIMENTAL | FG-3019 10 mg/kg |
| FG-3019 Low Dose | EXPERIMENTAL | Participants will receive a single intravenous (IV) infusion of FG-3019 low dose on Day 0. |
| FG-3019 Medium Dose | EXPERIMENTAL | Participants will receive a single IV infusion of FG-3019 medium dose on Day 0. |
| FG-3019 High Dose | EXPERIMENTAL | Participants will receive a single IV infusion of FG-3019 high dose on Day 0. |
| Name | Type | Description |
|---|---|---|
| Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX | DRUG | Drug: Pamrevlumab is administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion. Drug: Gemcitabine is administered on Days 1, 8 and 15 of each 28 day treatment cycle via IV infusion. Drug: Nab-paclitaxel is administered on Days 1, 8 and 15 of each 28 day treatment cycle via IV infusion. Drug: FOLFIRINOX is a combination of several agents administered on Days 1 and 15 of each 28 day treatment cycle via IV infusion. The specific agents are Oxaliplatin, Folinic Acid, Irinotecan, and Fluorouracil. |
| Placebo + Gemcitabine + Nab-paclitaxel or Placebo + FOLFIRINOX | DRUG | Drug: Placebo is administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion. Drug: Gemcitabine is administered on Days 1, 8 and 15 of each 28 day treatment cycle via IV infusion. Drug: Nab-paclitaxel is administered on Days 1, 8 and 15 of each 28 day treatment cycle via IV infusion. Drug: FOLFIRINOX is a combination of several agents administered on Days 1 and 15 of each 28 day treatment cycle via IV infusion. The specific agents are Oxaliplatin, Folinic Acid, Irinotecan, and Fluorouracil. |
| Pamrevlumab | DRUG | Solution for infusion |
| Placebo | DRUG | Solution for infusion |
| Sub-Study: Pirfenidone | DRUG | Pirfenidone concomitant therapy will not be provided by the Sponsor. |
| Sub-Study: Nintedanib | DRUG | Nintedanib concomitant therapy will not be provided by the Sponsor. |
| FG-3019 | DRUG | Cohort 1 and Cohort 1-EX: 15 mg/kg by infusion every 3 weeks for 45 weeks in the target population (first treatment year and first extended treatment year and every 3 weeks thereafter for three additional extended treatment years). |
| Gemcitabine | DRUG | Gemcitabine will be administered per dose and schedule specified in the arm group description. |
| Nab-paclitaxel | DRUG | Nab-paclitaxel will be administered per dose and schedule specified in the arm group description. |
Inclusion Criteria: 1. Understand and sign informed consent; be willing to comply with study procedures, including surgery 2. Age ≥ 18 years 3. Be a male, or non-pregnant and non-lactating female 4. Negative serum B-hCG pregnancy test at screening for women of childbearing potential 5. Male partici...
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FG-3019 is an investigational monoclonal antibody developed by Kyntra Bio, Inc. (ticker KYNB). It has been studied in clinical trials for diabetes mellitus with diabetic nephropathy, idiopathic pulmonary fibrosis, and pancreatic cancer, including locally advanced or metastatic and unresectable disease. It is not approved and remains in clinical development.
FG-3019 has been studied as a potential treatment for idiopathic pulmonary fibrosis. A completed Phase 2 trial, NCT01262001, evaluated its safety, tolerability, and efficacy in 90 participants with the condition. FG-3019 is investigational and has not been approved for idiopathic pulmonary fibrosis or any other indication.
FG-3019 targets CTGF, connective tissue growth factor, a protein involved in fibrosis and tissue remodeling. By binding CTGF, the monoclonal antibody is designed to interfere with this signaling. This mechanism underlies its study in fibrotic and metabolic conditions such as idiopathic pulmonary fibrosis and diabetic nephropathy.
FG-3019 is developed by Kyntra Bio, Inc., which trades under the ticker KYNB. The company has sponsored clinical trials of the monoclonal antibody across metabolic, fibrotic, and oncology indications. FG-3019 remains an investigational agent and is not commercially available.
FG-3019 is in Phase 1 development overall, with completed Phase 1 trials in diabetes mellitus with diabetic nephropathy and in pancreatic cancer. One completed Phase 2 trial in idiopathic pulmonary fibrosis is also recorded. FG-3019 is investigational and has not been approved by the FDA for any indication.
FG-3019 has been evaluated in completed trials including NCT02210559 in unresectable pancreatic cancer, NCT01262001 in idiopathic pulmonary fibrosis, NCT01181245 in locally advanced or metastatic pancreatic cancer, and NCT00754143 in diabetes mellitus with diabetic nephropathy. These studies enrolled a total of 215 participants across the four trials.