New hope for pancreatic cancer? early trial combines novel drug with chemo and immunotherapy
NCT ID NCT04104672
First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 3 times
Summary
This early-phase study tests a new drug called AB680, combined with immunotherapy (zimberelimab) and two chemotherapy drugs (nab-paclitaxel and gemcitabine), in people with advanced pancreatic cancer that has spread. The main goals are to check safety and find the right dose. About 196 participants who have not had prior treatment for metastatic disease will be enrolled.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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196 people
The number who actually took part.
- Started
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Nov 2019
- Finished
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Jul 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: * 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 * 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 Key Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Site
Santa Monica, California, 90404, United States
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Research Site
St Louis, Missouri, 63110, United States
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Research Site
New York, New York, 10032, United States
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Research Site
New York, New York, 10065, United States
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Research Site
Philadelphia, Pennsylvania, 19104, United States
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Research Site
Pittsburgh, Pennsylvania, 15232, United States
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Research Site
Houston, Texas, 77030, United States
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Research Site
San Antonio, Texas, 78229, United States
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Research Site
Madison, Wisconsin, 53792, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Personalized drug matching put to the test in pancreatic cancer
- Can engineered immune cells tackle Hard-to-Treat KRAS cancers?
- Can a new injection boost chemotherapy against pancreatic cancer?
- Can a Two-Drug immune attack shrink Hard-to-Treat pancreatic tumors?
- Can a targeted antibody give pancreatic cancer chemo a boost?
- Can a targeted antibody slow advanced pancreatic cancer?