← Back to Search

Chemotherapy

Part B: LAC, ADX 1200 mg for Pancreatic Cancer

Phase 1
Waitlist Available
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part a: first dose date up to 32 weeks plus 30 days; part b: first dose date up to 181 weeks plus 30 days
Awards & highlights

Summary

The primary objective of the study is to determine the maximum tolerated dose of andecaliximab monotherapy and to evaluate the safety and tolerability of andecaliximab (formerly GS-5745) alone and in combination with chemotherapy. The study consists of 2 parts (Parts A and B). Participants can only qualify for and participate in 1 part. Part A is a sequential dose escalation to determine the maximum tolerated dose of andecaliximab in participants with advanced solid tumors that are refractory to or intolerant to standard therapy or for which no standard therapy exists. In Part A, participants will receive andecaliximab only. Part B is a dose expansion to obtain additional safety and tolerability data for andecaliximab in participants with advanced pancreatic adenocarcinoma, lung adenocarcinoma, lung squamous cell carcinoma, esophagogastric adenocarcinoma, colorectal cancer, or breast cancer. In Part B, participants will receive andecaliximab in combination with standard-of-care chemotherapy.

Eligible Conditions
  • Pancreatic Cancer
  • Non-Small Cell Lung Cancer
  • Esophageal Cancer
  • Colorectal Cancer
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part a: first dose date up to 32 weeks plus 30 days; part b: first dose date up to 181 weeks plus 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and part a: first dose date up to 32 weeks plus 30 days; part b: first dose date up to 181 weeks plus 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Experiencing Laboratory Abnormalities
Percentage of Participants Experiencing Treatment-Emergent Adverse Events

Trial Design

12Treatment groups
Experimental Treatment
Group I: Part B: SL CRC, ADX 800 mg+BEV 5 mg/kgExperimental Treatment5 Interventions
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.
Group II: Part B: SL CRC, ADX 800 mg+BEV 10 mg/kgExperimental Treatment5 Interventions
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.
Group III: Part B: PAC, ADX 800 mgExperimental Treatment3 Interventions
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.
Group IV: Part B: LSC, ADX 1200 mgExperimental Treatment3 Interventions
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.
Group V: Part B: LAC, ADX 1200 mgExperimental Treatment3 Interventions
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.
Group VI: Part B: FL CRC, ADX 800 mg+BEV 5 mg/kgExperimental Treatment5 Interventions
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.
Group VII: Part B: FL CRC, ADX 800 mg+BEV 10 mg/kgExperimental Treatment5 Interventions
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.
Group VIII: Part B: EGC, ADX 800 mgExperimental Treatment4 Interventions
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.
Group IX: Part B: BRCA, ADX 800 mgExperimental Treatment2 Interventions
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.
Group X: Part A: ADX 600 mgExperimental Treatment1 Intervention
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.
Group XI: Part A: ADX 200 mgExperimental Treatment1 Intervention
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.
Group XII: Part A: ADX 1800 mgExperimental Treatment1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
FDA approved
Paclitaxel
FDA approved
Carboplatin
FDA approved
Pemetrexed
FDA approved
Oxaliplatin
FDA approved
5-FU
2014
Completed Phase 3
~3420
Bevacizumab
FDA approved
Leucovorin
FDA approved
Irinotecan
FDA approved
Paclitaxel
FDA approved
GS-5745
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,098 Previous Clinical Trials
860,233 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
351 Previous Clinical Trials
189,124 Total Patients Enrolled
~19 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top