Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GS-5745 SC, Andecaliximab
GS-5745 · 7 trials · 10 indications
OS was defined as the time interval from the date of randomization to death from any cause.
ORR was defined as the percentage of participants with confirmed overall best response of complete response (CR) or partial response (PR) after starting study drug but before starting any new chemotherapy or radiotherapy as assessed by the investigator according to Response Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as the disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
This composite endpoint will measure the safety and tolerability profile of GS-5745.
This composite endpoint will measure the plasma PK profile of GS-5745. The following parameters will be measured, where applicable: * Cmax: maximum observed concentration of drug in plasma * AUClast: concentration of drug from time zero to the last quantifiable concentration * AUC0-inf: area under the plasma concentration versus time curve starting with time zero to infinity
A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline and occurring after the first dose of study drug and within 30 days after last study drug administration. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening) using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. The most severe graded abnormality from all tests was counted for each participant.
The presence of anti-andecaliximab antibodies in serum samples was determined using an electrochemiluminescent (ECL) assay that detects antibodies that bind to andecaliximab.
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. Participants with any laboratory abnormality were reported.
TEAEs are any AEs with an onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug.
Cmax is defined as the maximum concentration of drug.
Cmax is defined as the maximum concentration of drug over the dosing interval. Data for Day 1 was based on the data collected from Day 1 through Day 8. Data for Day 29 was based on the data collected from Day 29 through Day 36.
Ctau is defined as the observed drug concentration at the end of the dosing interval.
AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time.
AUCtau is defined as the area under the plasma concentration versus time curve over the dosing interval. Data for Day 1 was based on the data collected from Day 1 through Day 8. Data for Day 29 was based on the data collected from Day 29 through Day 36.
AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last observable concentration.
| Arm | Type | Description |
|---|---|---|
| Andecaliximab | EXPERIMENTAL | Andecaliximab plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by andecaliximab plus LV+5-FU during subsequent cycles |
| Placebo | PLACEBO_COMPARATOR | Placebo plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by placebo plus LV+5-FU during subsequent cycles |
| Andecaliximab + Nivolumab | EXPERIMENTAL | Andecaliximab 800 mg plus nivolumab 3 mg/kg administered every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis). |
| Nivolumab | ACTIVE_COMPARATOR | Nivolumab 3 mg/kg administered every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis). |
| GS-5745 | EXPERIMENTAL | Participants will receive GS-5745 every 2 weeks for a total of 3 infusions. |
| Placebo to match GS-5745 | PLACEBO_COMPARATOR | Participants will receive placebo to match GS-5745 every 2 weeks for a total of 3 infusions. |
| GS-5745 SC | EXPERIMENTAL | Participants will receive a single dose of GS-5745 by SC injection. |
| GS-5745 IV | EXPERIMENTAL | Participants will receive a single dose of GS-5745 by IV infusion. |
| Placebo to match andecaliximab | PLACEBO_COMPARATOR | Participants will receive placebo to match andecaliximab every 2 weeks for a total of 3 infusions. |
| Part A: ADX 200 mg | EXPERIMENTAL | Participants with advanced solid tumors who fail or are intolerant to standard therapy or for whom no standard therapy exists, will receive 200 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. |
| Part A: ADX 600 mg | EXPERIMENTAL | Participants with advanced solid tumors who fail or are intolerant to standard therapy or for whom no standard therapy exists, will receive 600 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. |
| Part A: ADX 1800 mg | EXPERIMENTAL | Participants with advanced solid tumors who fail or are intolerant to standard therapy or for whom no standard therapy exists, will receive 1800 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug |
| Part B: PAC, ADX 800 mg | EXPERIMENTAL | Participants with PAC will receive ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (gemcitabine and nab paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. |
| Part B: LAC, ADX 1200 mg | EXPERIMENTAL | Participants with lung adenocarcinoma (LAC) will receive ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and pemetrexed, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. |
| Part B: LSC, ADX 1200 mg | EXPERIMENTAL | Participants with lung squamous cell carcinoma (LSC) will receive ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and paclitaxel, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. |
| Part B: EGC, ADX 800 mg | EXPERIMENTAL | Participants with esophagogastric adenocarcinoma (EGC) will receive ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (leucovorin+oxaliplatin+5-fluorouracil {5-FU} \[mFOLFOX6\], on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. |
| Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg | EXPERIMENTAL | Participants with colorectal cancer (CRC) will receive first-line (FL) treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. |
| Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg | EXPERIMENTAL | Participants with CRC will receive FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. |
| Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg | EXPERIMENTAL | Participants with CRC will receive second-line (SL) treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (leucovorin+irinotecan+5-FU \[FOLFIRI\] and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. |
| Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg | EXPERIMENTAL | Participants with CRC will receive SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. |
| Part B: BRCA, ADX 800 mg | EXPERIMENTAL | Participants with breast cancer (BRCA) will receive ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. |
| Andecaliximab 0.3 mg/kg IV single ascending dose (SAD) | EXPERIMENTAL | Participants will receive andecaliximab 0.3 milligrams per kilogram (mg/kg) on Day 1. |
| Andecaliximab 1.0 mg/kg IV (SAD) | EXPERIMENTAL | Participants will receive andecaliximab 1.0 mg/kg on Day 1. |
| Andecaliximab 2.5 mg/kg IV (SAD) | EXPERIMENTAL | Participants will receive andecaliximab 2.5 mg/kg on Day 1. |
| Andecaliximab 5.0 mg/kg IV (SAD) | EXPERIMENTAL | Participants will receive andecaliximab 5.0 mg/kg on Day 1. |
| Placebo Pooled (SAD) | PLACEBO_COMPARATOR | Participants will receive placebo on Day 1. |
| Andecaliximab 0.3 mg/kg IV multiple ascending doses (MAD) | EXPERIMENTAL | Participants will receive andecaliximab 0.3 mg/kg on Days 1, 15, and 29. |
| Andecaliximab 1.0 mg/kg IV (MAD) | EXPERIMENTAL | Participants will receive andecaliximab 1.0 mg/kg on Days 1, 15, and 29. |
| Andecaliximab 2.5 mg/kg IV (MAD) | EXPERIMENTAL | Participants will receive andecaliximab 2.5 mg/kg on Days 1, 15, and 29. |
| Andecaliximab 5.0 mg/kg IV (MAD) | EXPERIMENTAL | Participants will receive andecaliximab 5.0 mg/kg on Days 1, 15, and 29. |
| Andecaliximab 150 mg SC (Adaptive MAD) | EXPERIMENTAL | Participants will receive andecaliximab 150 mg on Days 1, 8, 15, 22, and 29. |
| Placebo Pooled (MAD) | PLACEBO_COMPARATOR | Participants will receive placebo on Days 1, 15, and 29. |
| Name | Type | Description |
|---|---|---|
| Andecaliximab | DRUG | 800 mg administered intravenously on Days 1 and 15 of each 28-day treatment cycle |
| Placebo | DRUG | Administered intravenously on Days 1 and 15 of each treatment cycle |
| Leucovorin | DRUG | Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle |
| 5-fluorouracil | DRUG | Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle |
| Oxaliplatin | DRUG | Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle |
| Nivolumab | DRUG | 3 mg/kg administered via IV infusion |
| GS-5745 | DRUG | GS-5745 400 mg administered intravenously |
| Placebo to match GS-5745 | DRUG | Placebo to match GS-5745 administered intravenously |
| GS-5745 SC | DRUG | GS-5745 150 mg administered by SC injection formulated as a sterile, aqueous buffered solution in a single-use pre-filled syringe |
| GS-5745 IV | DRUG | GS-5745 150 mg administered by IV infusion formulated as a sterile, aqueous buffered solution in single-use glass vials |
| Placebo to match Andecaliximab | DRUG | Placebo to match andecaliximab administered intravenously |
| Gemcitabine | DRUG | Administered intravenously on Days 1, 8, and 15 of each 28-day treatment cycle |
| Nab-paclitaxel | DRUG | Administered intravenously on Days 1, 8, and 15 of each 28-day treatment cycle |
| Carboplatin | DRUG | Administered intravenously on Day 1 of each 21-day treatment cycle |
| Pemetrexed | DRUG | Administered intravenously on Day 1 of each 21-day treatment cycle |
| 5-FU | DRUG | Administered intravenously on Days 1 and 15 of each 28-day treatment cycle |
| Bevacizumab | DRUG | Administered intravenously on Days 1 and 15 of each 28-day treatment cycle |
| Irinotecan | DRUG | Administered intravenously on Days 1 and 15 of each 28-day treatment cycle |
| Paclitaxel | DRUG | Administered intravenously on Days 1, 8 and 15 of each 28-day treatment cycle (Breast cancer) or on Day 1 of each 21-day treatment cycle (NSCLC) |
Key Inclusion Criteria: * Adults with histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction that is inoperable, locally advanced or metastatic and not amenable to curative therapy * Adequate hematologic, liver, coagulation and kidney function * Eastern Cooperative Onco...
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GS-5745 is an investigational small molecule being developed by Gilead Sciences, Inc. (ticker GILD) for immunology indications, specifically rheumatoid arthritis and ulcerative colitis. It has completed Phase 1 clinical testing and is not yet approved for any use.
GS-5745 is being studied as a potential treatment for rheumatoid arthritis and ulcerative colitis. Both are immune-mediated inflammatory conditions. The drug remains investigational and has only completed Phase 1 trials, so it is not available as a marketed therapy for either indication.
GS-5745 is made by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. Gilead is the developer responsible for the clinical program evaluating the drug in rheumatoid arthritis and ulcerative colitis.
GS-5745 is in Phase 1 clinical development. It has completed Phase 1 testing in healthy volunteers and in patients with rheumatoid arthritis. No later-phase trials have been reported, and the drug is not approved for any indication.
GS-5745 has been evaluated in two completed Phase 1 trials. NCT02209987 assessed subcutaneous bioavailability, safety, and tolerability in 28 healthy adults in New Zealand. NCT02176876 evaluated safety, tolerability, and pharmacokinetics in 18 subjects with rheumatoid arthritis in Czechia and Hungary.
Yes, GS-5745 SC is an alternative name for GS-5745. The SC designation refers to the subcutaneous formulation studied in the Phase 1 bioavailability trial NCT02209987. Both names refer to the same investigational small molecule developed by Gilead Sciences.