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New treatment option for Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma
Official title A Study of ASP546C in Adults With Gastroesophageal Cancer, Pancreatic Cancer or Other Solid Tumors
ClinicalTrials.gov ID: NCT07488676
What this study is testing
What is ASP546C?
ASP546C is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastric or gastro-esophageal junction (gej) adenocarcinoma.
Also referred to as XNW27011.
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 study will help find the most suitable dose of ASP546C in people with gastric cancer, gastroesophageal junction (GEJ) cancer, pancreatic cancer, and other specific solid tumors. GEJ is where the food pipe (esophagus) joins the stomach.
- 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
- Participant has a histologically confirmed diagnosis of gastroesophageal (gastric/GEJ/esophageal) adenocarcinoma, pancreatic adenocarcinoma, or...
- Participant has radiologically confirmed uLA/m gastroesophageal (gastric/GEJ/esophageal) adenocarcinoma, pancreatic adenocarcinoma or pan-tumor...
- Cohorts 1 to 3 only: Participant has measurable disease according to RECIST v1.1 within 28 days prior to the first dose of study intervention. For...
- Cohort 4 only: Participant has radiologically evaluable disease (measurable and/or non-measurable) according to RECIST v1.1, within 28 days prior to...
- Participant's tumor expresses CLDN18.2.
You likely can't join if
- Cohorts 1, 2 and 3 only: Participant's disease is of the non-adenocarcinoma histology or mixed histology containing adenocarcinoma.
- Cohorts 1, 2 and 3 only: Participant has received \> 2 prior lines of therapy for uLA/m disease.
- Participants in Cohort 4 (pan-tumor) may enroll regardless of the number of prior lines of therapy, if they are not eligible for, decline, or do not...
- Participant has complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent recurrent vomiting.
- Participant has significant gastric bleeding or had a significant bleeding episode from the gastrointestinal tract within 3 months prior to the first...
- Participant has significant bleeding disorders or has had vasculitis within 3 months prior to the first dose of study intervention.
See the full eligibility criteria
Who can join
- Participant has a histologically confirmed diagnosis of gastroesophageal (gastric/GEJ/esophageal) adenocarcinoma, pancreatic adenocarcinoma, or pan-tumor (cholangiocarcinoma, colorectal adenocarcinoma, NSCLC...
- Participant has radiologically confirmed uLA/m gastroesophageal (gastric/GEJ/esophageal) adenocarcinoma, pancreatic adenocarcinoma or pan-tumor within 28 days prior to the first dose of study intervention.
- Cohorts 1 to 3 only: Participant has measurable disease according to RECIST v1.1 within 28 days prior to the first dose of study intervention. For participants with only 1 measurable lesion and prior radiotherapy, the...
- Cohort 4 only: Participant has radiologically evaluable disease (measurable and/or non-measurable) according to RECIST v1.1, within 28 days prior to the first dose of study intervention. For participants with only 1...
- Participant's tumor expresses CLDN18.2.
- Participant has received at least 1 line of therapy for uLA/m disease.
- Participant has an ECOG performance status of 0 or 1.
- Participant has a predicted life expectancy \>= 12 weeks.
- Female participant is not pregnant and at least 1 of the following conditions apply:
- Not a women of childbearing potential (WOCBP)
- WOCBP who has a negative urine or serum pregnancy test at screening (Specific to Japan: with a medical interview), and agrees to follow the contraceptive guidance from the time of informed consent through at least 5...
- Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 5 half-lives (45 days) plus 6 months after final investigational study intervention...
- Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period and for 5 half-lives (45 days) plus 6 months after final investigational study...
- Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 5 half-lives (45 days) plus 3 months after...
- Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 5 half-lives (45 days) plus 3 months after final...
- Male participant must not donate sperm during the treatment period and for 5 half-lives (45 days) plus 3 months after final investigational study intervention administration.
- Participant must meet all of the criteria based on the locally analyzed laboratory tests collected within 14 days prior to the first dose of study intervention. In case of multiple local laboratory tests within this...
- Participant is willing to provide or has sufficient tumor tissue for central biomarker assessment.
- Participant agrees not to participate in another treatment study while receiving study intervention in the present study.
What rules you out
- Cohorts 1, 2 and 3 only: Participant's disease is of the non-adenocarcinoma histology or mixed histology containing adenocarcinoma.
- Cohorts 1, 2 and 3 only: Participant has received \> 2 prior lines of therapy for uLA/m disease.
- Participants in Cohort 4 (pan-tumor) may enroll regardless of the number of prior lines of therapy, if they are not eligible for, decline, or do not have any available standard of care treatment options.
- Participant has complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent recurrent vomiting.
- Participant has significant gastric bleeding or had a significant bleeding episode from the gastrointestinal tract within 3 months prior to the first dose of study intervention and/or an untreated peptic ulcer disease...
- Participant has significant bleeding disorders or has had vasculitis within 3 months prior to the first dose of study intervention.
- Participant has a history of gastrointestinal perforation and/or fistula within 6 months prior to the first dose of study intervention.
- Participant has symptomatic, untreated brain metastases or meningeal carcinomatosis (carcinomatous meningitis) from the primary malignancy. A participant with stable central nervous system metastases for \> 3 months...
- Participant has a past or current mental illness that is difficult to control.
- Participant has unresolved pneumonitis or a history of non-infectious pneumonitis such as immune-related pneumonitis or radiation-induced pneumonitis for which the participant is taking glucocorticoids or needed...
- Participant has a known history of a positive test for human immunodeficiency virus (HIV) infection or known active hepatitis B (positive hepatitis B surface antigen [HBsAg]) or hepatitis C infection. Screening for...
- If participant is negative for HBsAg, but hepatitis B core antibody (HBcAb) and/or hepatitis B surface antibody (HBsAb) positive, a hepatitis B DNA test will be performed; if the test is positive, the participant will...
- Participant with positive hepatitis C virus (HCV) serology, but negative HCV RNA test results, is eligible.
- Participant treated for HCV with undetectable viral load results is eligible.
- Participant has an active infection requiring systemic therapy that has not completely resolved within 7 days prior to the first dose of study intervention.
- Participant has a malignancy for which treatment is required, has a history of another malignancy within the past 5 years, except malignancies for which participant received curative therapy without recurrence for the...
- Participant has clinically significant third spacing (large amount of pleural fluid or ascites) that requires frequent percutaneous draining or requires placement of a drainage catheter for adequate control.
- Participant has any AE from prior antitumor treatments that has not yet recovered to grade 0 or 1 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v6.0 (except alopecia).
- Participant has an active autoimmune disease or other medical condition that has required high dose systemic steroids at the time of screening.
- Participant has known peripheral neuropathy \> grade 1 (except when the sole neurological abnormality is absence of deep tendon reflexes).
- Participant has sinusoidal obstruction syndrome, formerly known as veno-occlusive disease; if present, should be stable or improving.
- Participant has significant cardiovascular disease, including any of the following:
- Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, cerebrovascular accident...
- History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes), cardiac arrhythmias requiring anti-arrhythmic medications (a...
- QTc interval \> 470 msec
- Documented history or family history of congenital long QT syndrome.
- Participant has ongoing or previous interstitial lung disease, active diverticulitis or solid organ or stem cell transplant.
- Participant has a serious non-healing wound or bone fracture within 28 days prior to study intervention.
- Participant has had a major surgical procedure within 28 days prior to the first dose of study intervention and has not completely recovered from the surgical procedure \<= 14 days prior to the first dose of study...
- Participant has received chemotherapy, immunotherapy or investigational therapy \ 14 days prior to the first dose of study intervention.
- Participant has received prior CLDN18.2 ADC. Prior treatment with CLDN18.2 monoclonal antibody or bi-specific T-cell engager is allowed.
- Participant has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.
- Participant has a known or suspected hypersensitivity to ASP546C or any components of the formulation used.
- Participant has a clinically significant disease or comorbidity that in the opinion of the investigator may adversely affect the safe delivery of treatment within this study or make the participant unsuitable for study...
- Cohorts 1 and 2 (gastroesophageal adenocarcinoma) only: Participant has known HER2 positive status defined as immunohistochemistry (IHC) 3+ or IHC 2+/ in situ hybridization (ISH) +. ISH positive is defined as HER2/...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Los Angeles, California, United States
- Indianapolis, Indiana, United States
- Grand Rapids, Michigan, United States
- Lake Success, New York, United States
- Durham, North Carolina, United States
- Austin, Texas, United States
- Houston, Texas, United States
- Irving, Texas, United States
- San Antonio, Texas, United States
- West Valley City, Utah, United States
- Kashiwa-shi, Chiba, Japan
- Chuo-ku, Tokyo, Japan
- Koto-ku, Tokyo, Japan
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 Birmingham, Alabama, United States; Los Angeles, California, United States; Indianapolis, Indiana, United States; Grand Rapids, Michigan, United States; Lake Success, New York, United States; Durham, North Carolina, United States and 8 more location(s). 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.