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Advanced Pancreatic CancerPhase 1ARC-8NCT04104672

A Study to Evaluate the Safety and Tolerability of AB680 in Participants With Gastrointestinal Malignancies

A Phase 1 study testing AB680, Zimberelimab and Nab-paclitaxel in people with Advanced Pancreatic Cancer, run by Arcus Biosciences, Inc. at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 1, open-label, dose-escalation, and dose-expansion, with a gated randomization portion, study to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic and clinical activity of AB680 in combination with zimberelimab (AB122), nab-paclitaxel and gemcitabine in participants with advanced… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Pancreatic Cancer
What is being tested?
AB680, Zimberelimab and Nab-paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
196 participants
Where
9 sitesUnited States
Study dates
6 Nov 2019to 21 Jul 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed metastatic pancreatic adenocarcinoma
  • Naïve to any prior treatment, including chemotherapy, biological therapy, or targeted therapy for metastatic disease
  • Prior adjuvant therapy (including chemotherapy and/or radiotherapy) for pancreatic adenocarcinoma is permitted if neoadjuvant or adjuvant therapy was completed at least 6 months prior to study enrollment. Prior adjuvant therapy may include nab- paclitaxel or gemcitabine
  • Participants initially diagnosed with locally advanced pancreatic cancer who have undergone chemotherapy then resection and had no evidence of disease are eligible if relapse of metastatic disease has occurred and if the last dose of chemotherapy was received more than 6 months before study entry
  • 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
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Show all 12Show fewer
  • Confirmation that an archival tissue sample is available; if not, a new biopsy of a tumor must be obtained
  • Prior radiation therapy for metastatic disease must have been completed
  • Immunosuppressive doses of systemic medications, such as corticosteroids or absorbed topical corticosteroids (doses > 10 mg/day prednisone or equivalent) must be discontinued at least 2 weeks (14 days) before investigational product administration. Physiologic doses of corticosteroids (≤ 10 mg/day of prednisone or its equivalent) or short pulses of corticosteroids (≤ 3 days) may be permitted
  • Prior surgery that required general anesthesia or other major surgery as defined by the Investigator must be completed at least 4 weeks before investigational product administration
  • Negative tests for hepatitis B surface antigen, hepatitis C virus antibody (or hepatitis C qualitative ribonucleic acid [RNA; qualitative]), and human immunodeficiency virus (HIV)-1 and HIV-2 antibody at screening
  • Adequate organ and marrow function

Who cannot join

  • Significant cardiovascular disease (NYHA Class III-IV), myocardial infarction or cerebrovascular accident within 12 months of the first dose of investigational agent or history of arterial thromboembolic event, uncontrolled hypertension, unstable arrhythmia, or unstable angina within 3 months or venous thromboses within 1 month of the first dose of investigational agent.
  • Any active autoimmune disease or a documented history of autoimmune disease or history of a syndrome that required systemic steroids or immunosuppressive medications, except for vitiligo or resolved childhood asthma/atopy. Participants with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study
  • History of a syndrome that required systemic steroids or immunosuppressive medications, except for vitiligo or resolved childhood asthma/atopy. Participants with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study
  • Prior malignancy active within the previous year except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer
  • Has not recovered (ie, ≤ Grade 1 or baseline) from a non-hematologic AEs due to a previously administered agent, except ≤ Grade 2 alopecia or ≤ Grade 2 neuropathy.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Research Site

    Houston, Texas, 77030

  • Research Site

    Madison, Wisconsin, 53792

  • Research Site

    New York, New York, 10032

  • Research Site

    New York, New York, 10065

  • Research Site

    Philadelphia, Pennsylvania, 19104

  • Research Site

    Pittsburgh, Pennsylvania, 15232

  • Research Site

    San Antonio, Texas, 78229

  • Research Site

    Santa Monica, California, 90404

  • Research Site

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase 1 Study to Evaluate the Safety and Tolerability of AB680 Combination Therapy in Participants With Gastrointestinal Malignancies

This is a Phase 1, open-label, dose-escalation, and dose-expansion, with a gated randomization portion, study to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic and clinical activity of AB680 in combination with zimberelimab (AB122), nab-paclitaxel and gemcitabine in participants with advanced pancreatic cancer.

Read the detailed description

Dose escalation of AB680 in combination with zimberelimab (AB122), nab-paclitaxel and gemcitabine will be assessed in participants with advanced pancreatic cancer. In this dose escalation combination study, participants with advanced pancreatic cancer will receive escalating doses of AB680 in combination with zimberelimab at the recommended phase 2 dose (RP2D), and nab-paclitaxel and gemcitabine at standard doses. AB680, zimberelimab, nab-paclitaxel and gemcitabine are all administered via IV infusion.

In the dose expansion portion of the study in front-line (1L) pancreatic patients, participants will receive AB680 at the RP2D determined from the dose escalation study in combination with zimberelimab at the RP2D and nab-paclitaxel and gemcitabine at standard doses or AB680 at the RP2D in combination with nab-paclitaxel and gemcitabine at standard doses. In the dose-expansion portion of the study in second-line (2L) pancreatic patients, participants will receive AB680 at the RP2D determined from the dose-escalation study in combination with zimberelimab at the RP2D and nab-paclitaxel and gemcitabine at standard doses.

Being tested
AB680, Zimberelimab, Nab-paclitaxel, Gemcitabine
Keywords
AB680, Zimberelimab, Pancreatic cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AB680Drug

    AB680 is a Cluster of Differentiation (CD)73 Inhibitor.

  • ZimberelimabDrug

    Also called AB122

    Zimberelimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody targeting human PD-1.

  • Nab-paclitaxelDrug

    Also called Abraxane

    Nab-paclitaxel is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.

  • GemcitabineDrug

    Also called Gemzar

    Gemcitabine is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.

Study groups in NCT04104672
Study groupRoleWhat they receive
Dose EscalationExperimentalDose 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.
Receives: Drug: AB680; Drug: Zimberelimab; Drug: Nab-paclitaxel; Drug: Gemcitabine
Dose Expansion (AB680+zimberelimab+ NP/Gem): Cohort A (front-line/1L)ExperimentalParticipants with advanced 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
Receives: Drug: AB680; Drug: Zimberelimab; Drug: Nab-paclitaxel; Drug: Gemcitabine
Dose Expansion (AB680+zimberelimab+NP/Gem):Cohort A1 (front-line/1L)ExperimentalParticipants with advanced 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
Receives: Drug: AB680; Drug: Zimberelimab; Drug: Nab-paclitaxel; Drug: Gemcitabine
Dose Expansion (AB680 + NP/Gem): Cohort A2 (front-line/1L)ExperimentalParticipants with advanced 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.
Receives: Drug: AB680; Drug: Nab-paclitaxel; Drug: Gemcitabine
Dose Expansion (AB680 + zimberelimab + NP/Gem): Cohort B (second-line/2L)ExperimentalParticipants 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.
Receives: Drug: AB680; Drug: Zimberelimab; Drug: Nab-paclitaxel; Drug: Gemcitabine
Dose Expansion (AB680 + zimberelimab + NP/Gem): Cohort C (front-line/1L)ExperimentalParticipants with advanced pancreatic cancer naïve to any prior treatment will receive AB680 combined with zimberelimab and NP-Gem chemotherapy regimen.
Receives: Drug: AB680; Drug: Zimberelimab; Drug: Nab-paclitaxel; Drug: Gemcitabine
Dose Expansion (AB680 + NP/Gem): Cohort D (front-line/1L)ExperimentalParticipants with advanced pancreatic cancer naïve to any prior treatment will receive AB680 combined with NP-Gem chemotherapy regimen.
Receives: Drug: AB680; Drug: Nab-paclitaxel; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with Treatment Emergent Adverse Events (TEAEs)

    Safety will be assessed by monitoring adverse events and clinically relevant changes in 12 lead Electrocardiogram (ECG) and Physical examination findings

    Measured: From first dose date to 90 days after the last dose (approximately 1 year)

  2. Number of Participants With Dose Limiting Toxicities

    Measured: From First dose to day 28

Secondary outcomes (12)

  1. Duration of response

    Time at which response criteria are met for complete response or partial response (whichever occurs first) until the first date of recurrence, progression or death per RECIST v1.1

    Measured: Start date of response to first progression/death, up to 1 year

  2. Disease control rate

    Number of participants with complete response, partial response, or stable disease for greater than 6 months per RECIST v1.1

    Measured: First dose date to first progression/death

  3. Overall survival

    Overall survival rate, defined as time between first dose date and date of death

    Measured: First dose date to date of death, up to 1 year

  4. Progression free survival

    Number of participants without disease progression per RECIST v1.1

    Measured: First dose date to first progression/death

  5. AB680 peak plasma concentration (Cmax)

    Peak plasma concentration (Cmax) of AB680

    Measured: Day 1 (sequential), day 2, day 3, day 8, day 15, day 29, day 36, day 43, day 57, day 85, day 197, day 309, day 421, 30 days after last dose, and 90 days after last dose

  6. Zimberelimab peak plasma concentration (Cmax)

    Peak plasma concentration (Cmax) of zimberelimab

    Measured: Day 1 (sequential), day 2, day 3, day 8, day 15, day 29, day 43, day 57, day 85, day 197, day 309, day 421, 30 days after last dose, and 90 days after last dose

  7. AB680 time of peak concentration (Tmax)

    Time of peak concentration (Tmax) of AB680

    Measured: Day 1 (sequential), day 2, day 3, day 8, day 15, day 29, day 36, day 43, day 57, day 85, day 197, day 309, day 421, 30 days after last dose, and 90 days after last dose

  8. Zimberelimab time of peak concentration (Tmax)

    Time of peak concentration of zimberelimab

    Measured: Day 1 (sequential), day 2, day 3, day 8, day 15, day 29, day 43, day 57, day 85, day 197, day 309, day 421, 30 days after last dose, and 90 days after last dose

  9. AB680 area under the plasma concentration versus time curve (AUC)

    Area under the plasma concentration versus time curve (AUC) of AB680

    Measured: Day 1 (sequential), day 2, day 3, day 8, day 15, day 29, day 36, day 43, day 57, day 85, day 197, day 309, day 421, 30 days after last dose, and 90 days after last dose

  10. Zimberelimab area under the plasma concentration versus time curve (AUC)

    Area under the plasma concentration versus time curve (AUC) of zimberelimab

    Measured: Day 1 (sequential), day 2, day 3, day 8, day 15, day 29, day 43, day 57, day 85, day 197, day 309, day 421, 30 days after last dose, and 90 days after last dose

  11. Immunogenicity indicators: anti-drug antibodies (ADA)

    Number of participants who develop anti-drug antibodies to zimberelimab

    Measured: Day 1, day 15, day 29, day 57, day 85, day 197, day 309, and day 421

  12. Overall response rate

    Number of Participants with Complete or Partial Response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.1

    Measured: First dose date to progression or last tumor assessment, up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2019
  2. Study start6 Nov 2019
  3. Primary completion21 Jul 2026
  4. Study completion21 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
3+3 Dose escalation design
Masking
None (open label)
Enrolment
196 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04104672
Sponsor's protocol ID
ARC-8 (AB680CSP0002)
Acronym
ARC-8
Status last verified
May 2026
First submitted
23 Sep 2019
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan \[SAP\], Clinical Study Report \[CSR\]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. For more information, please visit our website.

Publications

  • Wainberg ZA, Manji GA, Bahary N, Ulahannan SV, Pant S, Spigel DR, Uboha NV, Oberstein PE, Saeed A, Beagle B, Kim JY, Wang N, Weeder B, Shitole S, Mrouj K, Scott JR, Ensign LG, DiRenzo DM, Walters MJ, Wu W, Kaplan A, Cho S, Kabbarah O, O'Reilly EM. Quemliclustat and chemotherapy with or without zimberelimab in metastatic pancreatic adenocarcinoma: a randomized phase 1 trial. Nat Med. 2026 Apr;32(4):1267-1277. doi: 10.1038/s41591-026-04283-z. Epub 2026 Mar 30.

    PubMed 41912809

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AB680, Zimberelimab and Nab-paclitaxel in people with Advanced Pancreatic Cancer, run by Arcus Biosciences, Inc. at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Treatment Emergent Adverse Events (TEAEs) (time frame: From first dose date to 90 days after the last dose (approximately 1 year)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04104672, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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