Clinical trial for Borderline Resectable Pancreatic Ductal Adenocarcinoma
Official title AB801 in Combination With Chemotherapy and Immunotherapy for the Treatment of Patients With Borderline Resectable, Locally Advanced or Metastatic Cholangiocarcinoma or Pancreatic Cancer
ClinicalTrials.gov ID: NCT07619313
What this study is testing
What is Cisplatin?
Cisplatin is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for borderline resectable pancreatic ductal adenocarcinoma.
Also referred to as Abiplatin, Blastolem.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female ≥ 18 years of age and willing and able to provide informed consent
- Previously untreated cytologically or histologically confirmed, at least one measurable lesion via Response Evaluation Criteria in Solid Tumors...
- Cholangiocarcinoma
- Borderline resectable/locally advanced cholangiocarcinoma: to be defined as unresectable disease on evaluation by a hepatobiliary multi-disciplinary...
- Metastatic cholangiocarcinoma: Patients with metastatic cholangiocarcinoma patient who have not received prior systemic therapy
You likely can't join if
- Previous treatment with any of planned study drugs in cholangiocarcinoma, though patients with one cycle of gemcitabine/cisplatin/durvalumab will be...
- Previous treatment with any of planned study drugs in pancreatic adenocarcinoma, though patients with one cycle of FOLFIRINOX will be considered...
- Peripheral neuropathy \> grade 2
- Known status of HIV which is not well-controlled (CD4 \< 300) at the time of study eligibility. Patients with controlled and treated HIV/hepatitis C...
- Untreated hepatitis B infection; Patient has known active hepatitis B virus (HBV) or hepatitis C virus (HCV), or human immunodeficiency virus (HIV)...
- Participants with resolved or treated HCV (ie, HCV antibody positive but undetectable HCV ribonucleic acid [RNA]) will not be excluded from this study
See the full eligibility criteria
Who can join
- Male or female ≥ 18 years of age and willing and able to provide informed consent
- Previously untreated cytologically or histologically confirmed, at least one measurable lesion via Response Evaluation Criteria in Solid Tumors (RECIST 1.1) of cholangiocarcinoma or pancreatic adenocarcinoma meeting...
- Cholangiocarcinoma
- Borderline resectable/locally advanced cholangiocarcinoma: to be defined as unresectable disease on evaluation by a hepatobiliary multi-disciplinary tumor board/surgeon based on tumor size/location, vascular...
- Metastatic cholangiocarcinoma: Patients with metastatic cholangiocarcinoma patient who have not received prior systemic therapy
- Pancreatic adenocarcinoma
- Borderline resectable pancreatic adenocarcinoma: There are multiple definitions of borderline resectable pancreatic ductal adenocarcinoma (PDAC). For the purposes of this study, borderline resectable disease will be...
- An interface between the tumor and superior mesenteric artery (SMA) or celiac axis (CA) measuring \< 180º of the circumference of the vessel wall.
- An interface between the tumor with the common hepatic artery without extension into the celiac axis or hepatic artery bifurcation allowing for safe and complete resection and reconstruction.
- An interface between the primary tumor and the superior mesenteric vein or portal vein (SMV-PV) measuring ≥ 180° of the circumference of the vessel wall
- Short-segment occlusion of the SMV-PV with normal vein above and below the level of obstruction that is amenable to resection and venous reconstruction
- An interface between the primary tumor and the inferior vena cava (IVC)
- Locally advanced pancreatic adenocarcinoma: Multiple guidelines defining locally advanced PDAC have been developed. For the purposes of this study, locally advanced PDAC cases will be identified per the definition...
- Interface between the tumor and SMA or CV measuring \> 180º of the circumference of the vessel wall or solid tumor contact with the CA and aortic involvement.
- Occlusion of the SMV-PV that is not amenable to resection and venous reconstruction
- Metastatic pancreatic adenocarcinoma: Patients with metastatic pancreatic adenocarcinoma who have not received prior systemic therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Absolute neutrophil count (ANC) ≥ 1.5x10\^9/L
- Platelets ≥ 100x10\^9/L
- Hemoglobin ≥ 9 g/dL
- Creatinine clearance (Ccr) ≥ 50 mL/min (as calculated by Modified Cockcroft-Gault formula)
- Serum total bilirubin ≤ 2x upper limit of normal (ULN) or \< 3x ULN if Gilbert's syndrome
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase [SGPT]) ≤ 2.5 X ULN; \< 5x ULN in patients with liver metastases
- Women with no childbearing potential because of surgery or who are at least 1 year postmenopausal (ie, 12 months post last menstrual period) or with menopause confirmed by follicle-stimulating hormone testing, OR
- Women of childbearing potential (defined as any female who has experienced menarche and is not permanently sterile or post-menopausal) must use an effective nonhormonal method of contraception (intrauterine device or...
- Male participants must use an effective method of contraception (condom or occlusive cap [diaphragm or cervical or vault caps] with spermicidal foam or gel or film or cream or suppository; or vasectomy) or practice true...
- 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 study...
- Products with known potential to prolong the corrected QT (QTc) interval should be avoided when possible. When able will replace non-prolonging QTc acting drug when available and if medically necessary
- Major surgery as defined by the Investigator must be completed at least 4 weeks before study treatment administration. Participants should have recovered from the surgical procedure prior to the first dose being...
- Adequate baseline tumor tissue sample for correlative studies
What rules you out
- Previous treatment with any of planned study drugs in cholangiocarcinoma, though patients with one cycle of gemcitabine/cisplatin/durvalumab will be considered eligible
- Previous treatment with any of planned study drugs in pancreatic adenocarcinoma, though patients with one cycle of FOLFIRINOX will be considered eligible
- Peripheral neuropathy \> grade 2
- Known status of HIV which is not well-controlled (CD4 \< 300) at the time of study eligibility. Patients with controlled and treated HIV/hepatitis C virus (HCV) and an undetectable viral load are allowed
- Untreated hepatitis B infection; Patient has known active hepatitis B virus (HBV) or hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection (testing is not mandatory, unless known active or known...
- Participants with resolved or treated HCV (ie, HCV antibody positive but undetectable HCV ribonucleic acid [RNA]) will not be excluded from this study
- Underlying medical conditions that, in the Investigator's opinion, will make the administration of investigational product (IP)(s) hazardous, including but not limited to:
- Interstitial lung disease, including history of interstitial lung disease or non-infectious pneumonitis
- Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of the initiation of the IP,
- Active infection or antibiotics within 48 hours prior to study screening;
- A condition or unresolved adverse event (AE) from a prior investigational drug that may obscure the interpretation of toxicity determination or AEs,
- History of prior solid-organ transplantation
- Any history of malignancy less than 5 years prior to the time of study eligibility (Patients with history of skin cancers excluding melanoma and cancers with a very low risk of recurrence i.e., low grade prostate...
- Serious medical comorbidities such as New York Heart Association Class III/IV cardiac disease, uncontrolled cardiac arrhythmias, myocardial infarction over the past 12 months
- Known family history or personal history of long QTc syndrome or previous drug-induced QTc prolongation of at least grade 3 (QTc \> 500 ms)
- Screening 12-lead electrocardiogram (ECG), in triplicate, with a measurable QTc interval of \> 450ms
- Known, existing uncontrolled coagulopathy. Patients who have had a venous thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring anticoagulation are eligible IF: they are appropriately...
- Known pregnancy, nursing women or positive pregnancy test. Requirement for women of childbearing potential (WOCBP): Negative serum pregnancy test at screening and serum or urine prior to dosing on cycle 1 day 1, within...
- Any condition (concurrent disease, infection, or comorbidity) that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of safety data, in the opinion of the...
- History of trauma or major surgery within 28 days prior to the first dose of IP
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
- Any active or documented history of autoimmune disease, including but not limited to inflammatory bowel disease, celiac disease, Wegner syndrome, Hashimoto syndrome, systemic lupus erythematosus, scleroderma...
- Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders such as vitiligo, or alopecia not requiring systemic therapy, or conditions not expected to recur in the absence of an external...
- Endocrinopathies where the participant is stable on hormone replacement therapy
- History of Hashimoto syndrome within 3 years of the first of study treatment that resolved to hypothyroidism alone
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.