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Combination Therapy for Pancreatic Cancer (ARC-8 Trial)

Phase 1
Waitlist Available
Research Sponsored by Arcus Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The measurable lesion must be outside of a radiation field if the participant received prior radiation
Naïve to any prior treatment, including chemotherapy, biological therapy, or targeted therapy for metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first dose date to date of death, up to 1 year
Awards & highlights

ARC-8 Trial Summary

This trial is testing a new combination of drugs to treat advanced pancreatic cancer. The goal is to see if it is safe and works better than existing treatments.

Who is the study for?
This trial is for adults with advanced pancreatic cancer who haven't had treatment for metastatic disease. They must be able to consent, not pregnant, and have adequate organ function. Prior therapy is okay if it was over 6 months ago. Participants can't join if they've recently used certain steroids, had live vaccines, or have active infections or autoimmune diseases.Check my eligibility
What is being tested?
The study tests AB680 combined with Zimberelimab, Nab-paclitaxel, and Gemcitabine in patients with advanced pancreatic cancer. It's a Phase 1 trial focusing on safety and how the body processes the drugs (pharmacokinetics), as well as their effects on the body (pharmacodynamics) and early signs of effectiveness.See study design
What are the potential side effects?
Potential side effects may include reactions at the infusion site, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, allergic responses, liver inflammation, nausea and vomiting due to chemotherapy agents like Nab-paclitaxel and Gemcitabine.

ARC-8 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have at least one tumor that can be measured and it's not in an area treated with radiation.
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I have not received any treatment for my metastatic disease.
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer is a type of pancreatic cancer confirmed by lab tests.
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I stopped taking high doses of steroids or similar medicines more than 2 weeks ago.

ARC-8 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first dose date to date of death, up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose date to date of death, up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Dose Limiting Toxicities
Therapeutic procedure
Number of participants with clinically significant changes in vital signs and clinical laboratory parameters
Secondary outcome measures
AB680 area under the plasma concentration versus time curve (AUC)
AB680 peak plasma concentration (Cmax)
AB680 time of peak concentration (Tmax)
+9 more
Other outcome measures
Cytokine
AB680 gene expression
AB680 immunophenotyping
+1 more

ARC-8 Trial Design

5Treatment groups
Experimental Treatment
Group I: Dose Expansion(AB680+Zimberelimab+nab-paclitaxel(NP) & gemcitabine (Gem):Cohort A1 (front-line/1L)Experimental Treatment4 Interventions
Participants with advance pancreatic cancer, naïve to any prior treatment will receive AB680 (at the RP2D identified during dose escalation) combined with Zimberelimab and the standard nab-paclitaxel (NP) and gemcitabine (Gem) (NP/Gem) chemotherapy regimen
Group II: Dose Expansion (AB680 + Zimberelimab + NP/Gem): Cohort C (front-line/1L)Experimental Treatment4 Interventions
Participants with advance pancreatic cancer naïve to any prior treatment will receive AB680 combined with Zimberelimab and NP-Gem chemotherapy regimen.
Group III: Dose Expansion (AB680 + Zimberelimab + NP/Gem): Cohort B (second-line/2L)Experimental Treatment4 Interventions
Participants with advance pancreatic cancer who have received 1 prior line of treatment will receive AB680 (at the RP2D identified during dose escalation) combined with Zimberelimab and NP-Gem chemotherapy regimen.
Group IV: Dose Expansion (AB680 + NP/Gem): Cohort A2 (front-line/1L)Experimental Treatment3 Interventions
Participants with advance pancreatic cancer who are naïve to any prior treatment will receive AB680 (at the RP2D identified during dose escalation) and the standard NP/Gem chemotherapy regimen.
Group V: Dose EscalationExperimental Treatment4 Interventions
Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period. The dose expansion dose level will be determined in this part with escalating doses of AB680 in combination with Zimberelimab at the recommended phase 2 dose (RP2D) and the standard nab-paclitaxel and gemcitabine chemotherapy regimen in participants with advanced pancreatic cancer.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AB680
2018
Completed Phase 1
~100
Zimberelimab
2018
Completed Phase 1
~50
Nab-paclitaxel
2014
Completed Phase 3
~2030
Gemcitabine
2017
Completed Phase 3
~2070

Find a Location

Who is running the clinical trial?

Arcus Biosciences, Inc.Lead Sponsor
41 Previous Clinical Trials
5,901 Total Patients Enrolled
Medical DirectorStudy DirectorArcus Biosciences, Inc.
2,777 Previous Clinical Trials
8,063,319 Total Patients Enrolled

Media Library

AB680 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04104672 — Phase 1
Pancreatic Cancer Research Study Groups: Dose Escalation, Dose Expansion(AB680+Zimberelimab+nab-paclitaxel(NP) & gemcitabine (Gem):Cohort A1 (front-line/1L), Dose Expansion (AB680 + NP/Gem): Cohort A2 (front-line/1L), Dose Expansion (AB680 + Zimberelimab + NP/Gem): Cohort B (second-line/2L), Dose Expansion (AB680 + Zimberelimab + NP/Gem): Cohort C (front-line/1L)
Pancreatic Cancer Clinical Trial 2023: AB680 Highlights & Side Effects. Trial Name: NCT04104672 — Phase 1
AB680 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04104672 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots for prospective participants in this study?

"Affirmative. According to information posted on clinicaltrials.gov, this medical study was initially published in November 2019 and recently updated in November 2022. The researchers need 211 participants from 24 different sites for the trial to be successful."

Answered by AI

What precedent exists for AB680 in terms of prior clinical trials?

"As of this moment, 1114 clinical trials for AB680 are active and actively recruiting participants with 321 occurring in the final stage. While most research is taking place within Shanghai proper, there are 59453 stations across the world examining various aspects of AB680."

Answered by AI

Have any federal regulatory bodies granted approval of AB680?

"Given that AB680 is in its initial stage of testing, our team at Power has evaluated the drug's safety as a score of 1 due to limited clinical evidence related to efficacy and safety."

Answered by AI

In what geographic locations is this research endeavor being conducted?

"At the current moment, 24 medical sites are running this experiment. Locations span from Plantation to Spokane and Houston with an additional 21 locations in between. It may be prudent to select a location close by oneself if they choose to take part so as to reduce travel-related burdens."

Answered by AI

What medical conditions does AB680 typically treat?

"AB680 is a popular therapeutic agent for treating neoplasm metastasis and other ailments, such as locally advanced non-small cell lung cancer, bladder cancer that has spread elsewhere in the body, and urinary tract malignancies."

Answered by AI

What is the cumulative amount of participants enrolled in this trial?

"Affirmative. Clinicaltrials.gov demonstrates that this clinical trial is currently recruiting participants, which began on November 6th 2019 and was last updated on the 7th of November 2022. This study requires 211 individuals to be enrolled at 24 separate medical sites."

Answered by AI

What objectives are researchers looking to accomplish with this trial?

"This 12-month clinical trial will assess the Treatment Emergent Adverse Events (TEAEs) of a given medication. Secondary objectives involve monitoring Overall Survival, Zimberelimab peak plasma concentration (Cmax), and Progression Free Survival per RECIST v1.1 guidelines."

Answered by AI
~67 spots leftby May 2027