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AB680 for Pancreatic Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Pancreatic CancerAB680 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions
  • Pancreatic Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Ipilimumab (Cohort A and B)
1
IDE397
1
Bosentan

Study Objectives

4 Primary · 12 Secondary · Reporting Duration: First dose date to date of death, up to 1 year

Day 421
AB680 area under the plasma concentration versus time curve (AUC)
AB680 peak plasma concentration (Cmax)
AB680 time of peak concentration (Tmax)
Day 421
Zimberelimab area under the plasma concentration versus time curve (AUC)
Zimberelimab peak plasma concentration (Cmax)
Zimberelimab time of peak concentration (Tmax)
Day 421
Immunogenicity indicators: anti-drug antibodies (ADA)
Day 85
Cytokine
AB680 gene expression
AB680 immunophenotyping
Pharmacodynamic effects of AB680
Year 1
Overall survival
Year 1
Disease control rate
Progression free survival
Year 1
Overall response rate
Day 28
Number of Participants With Dose Limiting Toxicities
Year 1
Therapeutic procedure
Number of participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0
Number of participants with clinically significant changes in vital signs and clinical laboratory parameters
Year 1
Duration of response

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Ipilimumab (Cohort A and B)
1
IDE397
1
Bosentan

Trial Design

7 Treatment Groups

Dose Expansion (AB680 + Zimberelimab + NP/Gem): Cohort C (front-line/1L)
1 of 7
Dose Expansion (AB680 + NP/Gem)
1 of 7
Dose Expansion(AB680+Zimberelimab+nab-paclitaxel(NP) & gemcitabine (Gem):Cohort ...
1 of 7
Dose Expansion (AB680 + Zimberelimab + NP/Gem): Cohort B (second-line/2L)
1 of 7
Dose Expansion (AB680 + NP/Gem): Cohort A2 (front-line/1L)
1 of 7
Dose Escalation
1 of 7
Dose Expansion (AB680 + Zimberelimab + NP/Gem)
1 of 7

Experimental Treatment

211 Total Participants · 7 Treatment Groups

Primary Treatment: AB680 · No Placebo Group · Phase 1

Dose Expansion (AB680 + Zimberelimab + NP/Gem): Cohort C (front-line/1L)Experimental Group · 4 Interventions: Nab-paclitaxel, AB680, Zimberelimab, Gemcitabine · Intervention Types: Drug, Drug, Drug, Drug
Dose Expansion (AB680 + NP/Gem)Experimental Group · 3 Interventions: Nab-paclitaxel, AB680, Gemcitabine · Intervention Types: Drug, Drug, Drug
Dose Expansion(AB680+Zimberelimab+nab-paclitaxel(NP) & gemcitabine (Gem):Cohort A1 (front-line/1L)Experimental Group · 4 Interventions: Nab-paclitaxel, AB680, Zimberelimab, Gemcitabine · Intervention Types: Drug, Drug, Drug, Drug
Dose Expansion (AB680 + Zimberelimab + NP/Gem): Cohort B (second-line/2L)Experimental Group · 4 Interventions: Nab-paclitaxel, AB680, Zimberelimab, Gemcitabine · Intervention Types: Drug, Drug, Drug, Drug
Dose Expansion (AB680 + NP/Gem): Cohort A2 (front-line/1L)Experimental Group · 3 Interventions: Nab-paclitaxel, AB680, Gemcitabine · Intervention Types: Drug, Drug, Drug
Dose EscalationExperimental Group · 4 Interventions: Nab-paclitaxel, AB680, Zimberelimab, Gemcitabine · Intervention Types: Drug, Drug, Drug, Drug
Dose Expansion (AB680 + Zimberelimab + NP/Gem)Experimental Group · 4 Interventions: Nab-paclitaxel, AB680, Zimberelimab, Gemcitabine · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
AB680
2018
Completed Phase 1
~100
Zimberelimab
2018
Completed Phase 1
~50
Gemcitabine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: first dose date to date of death, up to 1 year

Who is running the clinical trial?

Arcus Biosciences, Inc.Lead Sponsor
31 Previous Clinical Trials
5,391 Total Patients Enrolled
Medical DirectorStudy DirectorArcus Biosciences, Inc.
2,635 Previous Clinical Trials
7,941,016 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have received prior adjuvant therapy (including chemotherapy and/or radiotherapy) for pancreatic adenocarcinoma.
You have metastatic pancreatic adenocarcinoma.
You have at least 1 measurable lesion per RECIST v1.1
You have a performance status score of 0 or 1.
A tissue sample from the primary tumor is required.
References

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