Recruiting PHASE1, PHASE2 Pancreatic Adenocarcinoma Metastatic

New treatment option for Pancreatic Adenocarcinoma Metastatic

Official title XNW27011 Study of Advanced Solid Tumor Subjects Who Failed Standard Therapies.

ClinicalTrials.gov ID: NCT06792435

What this study is testing

What is XNW27011?

XNW27011 is an investigational medicine, being studied as a potential treatment for pancreatic adenocarcinoma metastatic.

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 is a global, multi-center, open-label, Phase I/II first-in-human study of XNW27011 monotherapy as an investigational product (IP) in patients with locally advanced and/or metastatic solid tumors who have failed or are intolerant to standard therapies. XNW27011 is an antibody-drug conjugate (ADC) targeting Claudin 18.2 (CLDN18.2), a transmembrane protein important to tight junctions.

Phase 2: a mid-size study of how well it works

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

Phase I (Dose Escalation)：
Patients are willing and able to provide written informed consent or where consent is provided by legally authorized representatives.
Age ≥18 years old when signing the informed consent form.
Patients with a histologically or cytologically-confirmed, locally advanced or metastatic solid tumor, which has failed on standard therapy or is...
The enrollment is not restricted to patients with tumor expressing CLDN18.2. However patients are required to provide tumor tissue sections for...

You likely can't join if

PHASE I (DOSE ESCALATION)：
Prior severe allergic reaction or intolerance to a monoclonal antibody, including humanized or chimeric antibodies.
Prior severe allergic reaction or intolerance to the Topoisomerase I Inhibitor or Topoisomerase Inhibitor-Based ADC (e.g: Fam-trastuzumab...
Having any of the following medical conditions in the past or at present:
Acquired or congenital immunodeficiency diseases or organ transplantation.
Past myocardial infarction (within 6 months before the first administration), hospitalization for congestive heart failure within 12 months before...

See the full eligibility criteria

Who can join

Phase I (Dose Escalation)：
Patients are willing and able to provide written informed consent or where consent is provided by legally authorized representatives.
Age ≥18 years old when signing the informed consent form.
Patients with a histologically or cytologically-confirmed, locally advanced or metastatic solid tumor, which has failed on standard therapy or is intolerable to available standard therapy, or there is no available...
The enrollment is not restricted to patients with tumor expressing CLDN18.2. However patients are required to provide tumor tissue sections for CLDN18.2 expression confirmation.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Estimated life expectancy \> 12 weeks.
At least one measurable cancer lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
Adequate organ function, evidenced by the following laboratory results:
Absolute neutrophil count (ANC) ≥ 1.5 × 109/L.
Platelet count ≥ 100 × 109/L.
Hemoglobin ≥ 9.0 g/dL.
Total bilirubin ≤ 1.5 × the upper limit of normal (ULN).
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 × ULN (if liver metastases are present, ≤ 3 × ULN).
Creatinine clearance (Ccr) ≥60 mL/minute as calculated using themodified Cockcroft-Gault equation.
QTc prolongation to ≤480 milliseconds (ms) (based on the average of 3 screening electrocardiograms) (QTc interval corrected by Fridericia's Correction Formula, QTcF = QT/(RR0.33).
Echocardiographic LVEF (left ventricular ejection fraction) ≥ 50%.
Female patients of childbearing potential, who are willing to use a highly effective method of birth control during the study, and for at least 180 days after the last dose of study medication.
Childbearing potential is defined as any female who has experienced menarche and does not meet the criteria for postmenopausal, which is defined as the past 12 months with no menses without an alternative medical cause...
A highly effective method of birth control is defined as one that results in a low failure rate (i.e., \<1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives...
Male patients with female sexual partners of childbearing potential are eligible for inclusion if they agree to use medically acceptable birth control during the study, and for 180 days after the last dose of study...
people are willing and able to provide written informed consent or where consent is provided by legally authorized representatives.
Age ≥18 years old when signing the informed consent form.
Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumors, which have failed on standard therapy, or are intolerable to available standard therapy, or for which there is no...
Only patients with tumor expressing CLDN 18.2 will be enrolled. The most recently available tumor samples of patients will be examined by IHC at a central laboratory. If no archived tumor samples are available or the...
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Estimated life expectancy \> 12 weeks.
At least one measurable cancer lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
Adequate organ function, evidenced by the following laboratory results:
Absolute neutrophil count (ANC) ≥ 1.5 × 109/L.
Platelet count ≥ 100 × 109/L.
Hemoglobin ≥ 9.0 g/dL.
Total bilirubin ≤ 1.5 × the upper limit of normal (ULN).
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5× ULN (if liver metastases are present, ≤ 3 × ULN).
Creatinine clearance (Ccr) ≥50 mL/minute as calculated using the modified Cockcroft-Gault equation.
QTc prolongation to ≤ 480 millisecond (ms) (based on the average of 3 screening electrocardiograms) (QTc interval corrected by Fridericia's Correction Formula, QTcF = QT/(RR0.33).
Echocardiographic LVEF (left ventricular ejection fraction) ≥ 50%.
Female patients of childbearing potential, who are willing to use a highly effective method of birth control during the study and for at least 180 days following the last dose of study medication.
Childbearing potential is defined as any female who has experienced menarche and does not meet the criteria for postmenopausal, which is defined as the past 12 months with no menses without an alternative medical cause...
A highly effective method of birth control is defined as one that results in a low failure rate (i.e., \<1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives...
Male patients with female sexual partners of childbearing potential are eligible for inclusion if they agree to use medically acceptable birth control for 180 days following the last dose of study medication. Sexual...

What rules you out

PHASE I (DOSE ESCALATION)：
Prior severe allergic reaction or intolerance to a monoclonal antibody, including humanized or chimeric antibodies.
Prior severe allergic reaction or intolerance to the Topoisomerase I Inhibitor or Topoisomerase Inhibitor-Based ADC (e.g: Fam-trastuzumab deruxtecan-nxki, Sacituzumab govitecan-hziy, Irinotecan, Topotecan) or any...
Having any of the following medical conditions in the past or at present:
Acquired or congenital immunodeficiency diseases or organ transplantation.
Past myocardial infarction (within 6 months before the first administration), hospitalization for congestive heart failure within 12 months before the first administration, severe or unstable angina, coronary or...
Concomitant diseases that will seriously endanger the safety of the subject or affect the completion of the tests, such as active gastrointestinal bleeding, active peptic ulcer, intestinal obstruction, intestinal...
History of or currently suffering from uncontrolled primary or metastasized brain tumors, except that the investigator believes that the disease has been stabilized in patients, or whose local treatment has ended.
History of significant cerebrovascular disease/event, including stroke or intracranial hemorrhage, within 6 months before the first dose of the XNW27011.
Past or current mental illness that is difficult to control.
Human immunodeficiency virus (HIV) infection, syphilis infection, or active hepatitis B or C infection. Note: Syphilis infection refers to active syphilis or latent syphilis that requires treatment.
Patients who have active infections that required systemic treatment within 2 weeks prior to the first dose of XNW27011.
Clinically significant third spacing (large amount of pleural fluid or ascites, judged by treating physician) that is uncontrollable by drainage or other methods.
Having any adverse event from prior anti-tumor treatments that have not yet recovered to Grade 0 or 1 per NCI-CTCAE v5.0 (except alopecia).
History of treatment:
Patients who have previously participated in clinical trials of other drugs within 4 weeks before the first dose of XNW27011.
Received anti-tumor therapy (chemotherapy, radiotherapy, immunologic therapy or biological therapy,) within 3 weeks, prior to the first dose of XNW27011, or received small molecular targeted therapy, anti-tumor...
Received major surgical or treatment treatment within 4 weeks prior to the first dose of XNW27011, with the exception of tumor biopsy, puncture, etc.
Received systemic steroid therapy for a long period of time (≥20 mg of prednisone/day or equivalent for \>7 days). (Short-term use of no more than 7 days or steroid therapy withdrawal longer than 2 weeks prior to the...
Received live vaccines within 4 weeks prior to the first dose of XNW27011 or plan to take any live vaccine during the study period.
Received strong inhibitors or inducers of CYP3A4, or strong inhibitors of CYP2D6 within 2 weeks or five half-lives (whichever is shorter) of the inhibitor or inducer prior to the first dose of XNW27011.
Women who are pregnant or breastfeeding, or women whose serum pregnancy test results are positive during the screening period (female patients who are infertile do not need to undergo a pregnancy test, e.g., female...
Patients who have poor compliance and are not expected to cooperate to complete the study procedures, or who are deemed unsuitable to participate in the clinical research by the investigator. PHASE Ⅱ (DOSE EXTENSION)：
Prior severe allergic reaction or intolerance to a monoclonal antibody, including humanized or chimeric antibodies.
Prior severe allergic reaction or intolerance to the Topoisomerase I Inhibitor or Topoisomerase Inhibitor-Based ADC (e.g: Fam-trastuzumab deruxtecan-nxki, Sacituzumab govitecan-hziy, Irinotecan, Topotecan) or any...
Having any of the following medical conditions in the past or present:
Acquired or congenital immunodeficiency diseases or organ transplantation.
Past myocardial infarction (within 6 months before the first administration), hospitalization for congestive heart failure within 12 months before the first administration, severe or unstable angina, coronary or...
Concomitant diseases that will seriously endanger the safety of the subject or affect the completion of the study, such as active gastrointestinal bleeding, active peptic ulcer, intestinal obstruction, intestinal...
Previously or currently suffering from uncontrollable primary or metastasized brain tumors, except that the investigator believes that the disease has been stabilized in patients, or whose local treatment has ended.
History of significant cerebrovascular disease/event, including stroke or intracranial hemorrhage, within 6 months before the first dose of XNW27011.
Past or current mental illness that is difficult to control.
Human immunodeficiency virus (HIV) infection, syphilis infection, or active hepatitis B or C infection. Note: Syphilis infection refers to active syphilis or latent syphilis that requires treatment.
Patients who have active infections that required systemic treatment within 2 weeks prior to the first dose of XNW27011.
Has multiple primary malignancies within 5 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, and other solid tumors curatively treated.
Clinically significant third spacing (large amount of pleural fluid or ascites, judged by treating physician) that is uncontrollable by drainage or other methods.
Having any adverse event from prior anti-tumor treatments that have not yet recovered to Grade 0 or 1 per NCI-CTCAE v5.0 (except alopecia).
History of treatment:
Patients who have previously been treated with ADCs or CAR-T targeting CLDN18.2, or participated in clinical trials of other drugs within 4 weeks before the first dose of XNW27011.
Received anti-tumor therapy (chemotherapy, radiotherapy, immunologic therapyor biological therapy) within 3 weeks, prior to the first dose of XNW27011, or received small molecular targeted therapy, anti-tumor medicinal...
Have received major surgical or treatment treatment within 4 weeks prior to the first dose of XNW27011, with the exception for tumor biopsy, puncture, etc.
Received systemic steroid therapy for a long period of time (≥20 mg of prednisone/day or equivalent for \>7 days). (Short-term use of no more than 7 days or steroid therapy withdrawal longer than 2 weeks prior to the...
Received live vaccines within 4 weeks prior to the first dose of XNW27011or planned to take any live vaccine during the study period.
Received strong inhibitors or inducers of CYP3A4, or strong inhibitors of CYP2D6 within 2 weeks or five half-lives (whichever is shorter) of the inhibitor or inducer prior to the first dose of XNW27011.
Women who are pregnant or breastfeeding, or women whose serum pregnancy test results are positive during the screening period (female patients who are infertile do not need to undergo a pregnancy test, e.g., female...
Patients who have poor compliance and are not expected to cooperate to complete the study procedures, or who are deemed unsuitable to participate in the clinical research by the investigator.

The study team makes the final eligibility decision.

Where it's taking place

Jinan, Shandong, China

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 Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.

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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.