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NCT07619313 · ClinicalTrials.gov registry record · Phase 1
AB801 in Combination With Chemotherapy and Immunotherapy for the Treatment of Patients With Borderline Resectable, Locally Advanced or Metastatic Cholangiocarcinoma or Pancreatic Cancer
A Phase 1 study, sponsored by Jonsson Comprehensive Cancer Center.
- Not yet
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
NCT07619313: Clinical Trial Phase 1 study, sponsored by Jonsson Comprehensive Cancer Center.
NCT07619313 is a Phase 1 study that has not yet begun recruiting, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 46 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07619313, a Phase 1 study, has not yet begun recruiting, sponsored by Jonsson Comprehensive Cancer Center.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
Study Summary
This phase I trial tests the safety, side effects, best dose and effectiveness of AB801 in combination with chemotherapy and immunotherapy in treating patients with cholangiocarcinoma or pancreatic adenocarcinoma that may be removed by surgery (borderline resectable), that has spread to nearby tissue or lymph nodes (locally advanced), or that has spread from where it first started (primary site) to other places in the body (metastatic). AB801 is a drug designed to block a protein called AXL. AXL is found on the surface of certain cancer cells and plays an important role in helping tumors grow, spread to other parts of the body, and avoid the immune system. It is thought to contribute to resistance against common cancer treatments such as chemotherapy, radiation and immunotherapy. In many cancers, including cholangiocarcinoma and pancreatic adenocarcinoma, AXL is overactive and associated with worse outcomes. AB801 inhibits AXL which may make cancer cells more sensitive to chemotherapy and allow immune cells to better recognize and attack the tumor. Chemotherapy drugs, such as gemcitabine, cisplatin, oxaliplatin, irinotecan, leucovrin and fluorouracil, work in different ways to stop the growth of cancer cells either by killing the cells, by stopping them from dividing or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as durvalumab and zimberelimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving AB801 in combination with chemotherapy and immunotherapy may better treat patients with borderline resectable, locally advanced or metastatic cholangiocarcinoma or pancreatic adenocarcinoma.
Primary Outcome
Overall exposure to study drug, the numbers of participants completing each cycle, and the dose intensity will be summarized using descriptive statistics. The number of participants with any dose adjustment will be presented for entire treatment period as well as for each cycle. The number of participants with dose reductions, dose delays, or dose omissions will also be summarized, as will the reasons for dose adjustments. Adverse events and serious adverse events will be reported using Common T
Interventions
- PROCEDURE Computed Tomography
- DRUG Cisplatin
- DRUG Fluorouracil
- PROCEDURE Biopsy Procedure
- BIOLOGICAL Durvalumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2026-06-01 |
| Est. Completion | 2028-06-01 |
| Phase | Phase 1 |
What is known before NCT07619313 opens enrollment
NCT07619313 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 5 interventions - of which Computed Tomography is the first listed.
NCT07619313 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07619313 about?
NCT07619313 is a clinical study titled "AB801 in Combination With Chemotherapy and Immunotherapy for the Treatment of Patients With Borderline Resectable, Locally Advanced or Metastatic Cholangiocarcinoma or Pancreatic Cancer". This phase I trial tests the safety, side effects, best dose and effectiveness of AB801 in combination with chemotherapy and immunotherapy in treating patients with cholangiocarcinoma or pancreatic adenocarcinoma that may be removed by surgery (borderline resectable), that has spread to nearby tissu...
What is the current status of trial NCT07619313?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2026-06-01. Estimated completion is 2028-06-01.
What interventions are being tested in trial NCT07619313?
The interventions under investigation include: Computed Tomography (PROCEDURE), Cisplatin (DRUG), Fluorouracil (DRUG), Biopsy Procedure (PROCEDURE), Durvalumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT07619313?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07619313's enrollment target sits among peer trials
46 1058th of 2000 higher than 935 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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