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New treatment option for Gastric Adenocarcinoma
Official title A Study of ASP2138 Given by Itself or Given With Other Cancer Treatments in Adults With Stomach Cancer, Gastroesophageal Junction Cancer, or Pancreatic Cancer
ClinicalTrials.gov ID: NCT05365581
What this study is testing
What is ASP2138?
ASP2138 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for gastric adenocarcinoma.
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
- Claudin 18.2 protein, or CLDN18.2 is a protein found on cells in the digestive system. It is also found on some tumors.
- 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
- (IC):
- Participant is considered an adult according to local regulation at the time of signing the informed consent form (ICF).
- Female participant is not pregnant, confirmed by serum pregnancy test \&vmedical evaluation by interview \& at least 1 of the following conditions...
- Not a woman of childbearing potential (WOCBP)
- WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after final study intervention...
You likely can't join if
- (EC):
- Participant has received other investigational agents, or antineoplastic therapy including other immunotherapy or devices concurrently or within 21...
- Participant has any condition which makes the participant unsuitable for study participation.
- Participant has known immediate or delayed hypersensitivity or contraindication to any component of study intervention.
- Participant has had prior severe allergic reaction or intolerance to known ingredients of ASP2138 or other antibodies, including humanized or...
- Participant weighs \< 40 kg.
See the full eligibility criteria
Who can join
- (IC):
- Participant is considered an adult according to local regulation at the time of signing the informed consent form (ICF).
- Female participant is not pregnant, confirmed by serum pregnancy test \&vmedical evaluation by interview \& at least 1 of the following conditions apply:
- Not a woman of childbearing potential (WOCBP)
- WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after final study intervention administration.
- Female participant must agree not to breastfeed starting at screening \& throughout the study period \& for 6 months after the final study intervention administration.
- Female participant must not donate ova starting at screening \& throughout the study period \& for 6 months after the final study intervention administration.
- Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period \& for 6 months after the final study intervention...
- Male participant must not donate sperm during the treatment period \& for 6 months after the final study intervention administration.
- Male participant with pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period \& for 6 months...
- Participant's tumor sample is positive for claudin (CLDN)18.2 expression by central immunohistochemistry (IHC) testing.
- Participant has radiographically-confirmed, locally advanced, unresectable or metastatic disease within 28 days prior to the first dose of study intervention.
- Participant has at least 1 measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 within 28 days prior to the first dose of study intervention. Lesions situated in a previously...
- Participant has QT interval by Fredericia (QTcF) =\< 470 msec.
- Participant agrees not to participate in another treatment study while receiving study Intervention in the present study.
- Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Participant has predicted life expectancy \>= 12 weeks.
- Participant must meet all of criteria based on laboratory tests within 7 days prior to the first dose of study Intervention. In case of multiple laboratory data within this period, the most recent data should be used...
- Participant has histologically confirmed metastatic, locally advanced unresectable gastric/gastroesophageal junction (GEJ) adenocarcinoma.
- Escalation: Participant with gastric/GEJ adenocarcinoma who has progressed, is intolerant, has refused, or for whom there is no standard approved therapies that impart significant clinical benefit (no limit to the...
- Unique to South Korea: Participant with gastric/GEJ adenocarcinoma who has refused standard approved therapies is not allowed.
- Expansion: Participant with gastric/GEJ adenocarcinoma must have received no more than 3 prior lines of systemic chemotherapy treatment.
- Unique to EU: Expansion: Participant with gastric/GEJ adenocarcinoma must have received at least first-line standard therapies in the metastatic setting, must have received ramucirumab treatment if eligible \& where...
- Participant has histologically or cytologically confirmed metastatic pancreatic adenocarcinoma.
- Escalation: Participant with pancreatic adenocarcinoma who has progressed, is intolerant, has refused, or for whom there is no standard approved therapies that impart significant clinical benefit (no limit to the number...
- Unique to South Korea: Participant with pancreatic adenocarcinoma who has refused standard approved therapies is not allowed.
- Expansion: Participants with pancreatic adenocarcinoma must have received no more than 2 prior lines of systemic chemotherapy treatment. Note: Participants with locally advanced unresectable pancreatic adenocarcinoma...
- Unique to EU: Participant with pancreatic adenocarcinoma must have received at least first-line standard therapies in the metastatic setting \& no more than 2 prior lines of systemic chemotherapy treatment. For all...
- If a participant has received a recent blood transfusion, the laboratory tests must be obtained ≥ 1 week after any blood transfusion. Combination Therapy Disease-specific (CTDS) IC: ASP2138 in Combination with...
- Participant has histologically confirmed diagnosis of gastric/GEJ adenocarcinoma.
- Participant has metastatic or locally advanced unresectable gastric/GEJ adenocarcinoma.
- Participant with gastric/GEJ adenocarcinoma has progressed \& must not have been previously treated for metastatic disease with either chemotherapy or prior checkpoint inhibitor therapy.
- Participant has a human epidermal growth factor receptor 2 (HER2)-negative tumor per local testing.
- For CT with oxaliplatin, follow contraception guidelines from time of informed consent through at least 9 months after final study intervention. (Unique to South Korea: For CT with oxaliplatin, follow contraception...
- Participant must have a PD-L1 CPS ≥ 1. CTDS IC: ASP2138 in Combination with Ramucirumab \& Paclitaxel as Second-line Therapy in Gastric/GEJ Cancer
- Participant has histologically confirmed diagnosis of gastric/GEJ adenocarcinoma.
- Participant has metastatic or locally advanced unresectable gastric/GEJ adenocarcinoma.
- Participant with gastric/GEJ adenocarcinoma must have previously received 1 line of systemic chemotherapy treatment (i.e., documented objective radiological or clinical disease progression after first line platinum \&...
- For combination therapy with paclitaxel, female participant must follow contraception guidelines from time of informed consent through at least 7 months after final study intervention. CTDS IC: ASP2138 in Combination...
- Participant has histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma.
- Participant has confirmed metastatic or locally advanced unresectable pancreatic adenocarcinoma.
- Participant has pancreatic adenocarcinoma, has progressed \& must not have received prior systemic anticancer therapy for their advanced disease. However, participants may have received either neoadjuvant or adjuvant...
- For CT with oxaliplatin, follow contraception guidelines from time of informed consent through at least 9 months after final study intervention. (Unique to South Korea: For CT with oxaliplatin, follow contraception...
- Participant has histologically confirmed diagnosis of gastric/GEJ adenocarcinoma.
- Participant has metastatic or locally advanced unresectable gastric/GEJ adenocarcinoma.
- Participant with gastric/GEJ adenocarcinoma must not have been previously treated for metastatic disease with either chemotherapy or prior checkpoint inhibitor therapy.
- Participants have a HER2-negative tumor per local testing.
- For CT with oxaliplatin, follow contraception guidelines from time of informed consent through at least 9 months after final study intervention.
What rules you out
- (EC):
- Participant has received other investigational agents, or antineoplastic therapy including other immunotherapy or devices concurrently or within 21 days or 5 times the half-life, whichever is shorter, prior to first...
- Participant has any condition which makes the participant unsuitable for study participation.
- Participant has known immediate or delayed hypersensitivity or contraindication to any component of study intervention.
- Participant has had prior severe allergic reaction or intolerance to known ingredients of ASP2138 or other antibodies, including humanized or chimeric antibodies.
- Participant weighs \< 40 kg.
- Participant has received systemic immunosuppressive therapy, including systemic corticosteroids 14 days prior to first dose of study intervention. Participant using a physiologic replacement dose of hydrocortisone or...
- Participant has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent/recurrent vomiting.
- Participant has significant gastric bleeding \&/or untreated gastric ulcers that exclude the participant from participation.
- Participant has symptomatic CNS metastases or participant has evidence of unstable CNS metastases even if asymptomatic (e.g., progression on scans). Participants with previously treated CNS metastases are eligible, if...
- Participant is known to have HIV infection. However, participants with cluster of differentiation (CD4) + T cell counts \>= 350 cells/µL \& no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic...
- Participant is known to have active hepatitis B (positive hepatitis B surface antigen [HBsAg]) or hepatitis C infection. Testing is required for known history of these infections or as mandated by local requirements.
- For participant who is negative for HBsAg, but hepatitis B core antibody (HBc Ab) positive, a hepatitis B virus deoxyribonucleic acid test will be performed \& if positive the participant will be excluded.
- Participant with positive hepatitis C virus (HCV) serology, but negative HCV ribonucleic acid (RNA) test results are eligible.
- Participant treated for HCV with undetectable viral load results are eligible
- Participant has had within 6 months prior to first dose of study intervention any of the following: unstable angina, myocardial infarction, ventricular arrhythmia requiring intervention or hospitalization for heart...
- Participant has active infection requiring systemic therapy that has not completely resolved within 7 days prior to the start of study intervention.
- Participant has active autoimmune disease that has required systemic immunosuppressive treatment within the past 1 month prior to the start of study intervention.
- Participant has a clinically significant disease or co-morbidity that may adversely affect the safe delivery of treatment within this study or make the participant unsuitable for study participation.
- Participant has psychiatric illness or social situations that would preclude study compliance.
- Participant has had a major surgical procedure 28 days before start of study intervention \& has not fully recovered.
- Participant has received radiotherapy metastatic or for locally advanced unresectable gastric/GEJ or metastatic pancreatic adenocarcinoma 14 days prior to start of study intervention \& has NOT recovered from any...
- Participant has another malignancy for which treatment is required.
- Participant who has received CLDN18.2-targeted therapy (e.g., zolbetuximab or chimeric antigen receptor CLDN18.2-specific T cells) prior to first dose of study intervention administration is not eligible for dose...
- Participant has a history or complication of interstitial lung disease. China Specific: Participant who has received treatment with herbal medications that have known antitumor activity within 28 days prior to first...
- Participant has prior severe allergic reaction; suspected, known immediate or delayed hypersensitivity; or intolerance or contraindication to any study intervention (i.e., pembrolizumab \& mFOLFOX6 [all components]...
- For 5 FU (fluorouracil): Participant has known dihydropyrimidine dehydrogenase (DPD) deficiency.
- Participants who have received systemic immunosuppressive therapy, including systemic corticosteroids 14 days prior to the first dose of study intervention are generally excluded; however, participants using a...
- Participant is known to have HIV infection.
- NOTE: Differing from monotherapy administration, participants with CD4+ T cell counts ≥ 350 cells/µL \& no history of AIDS-defining opportunistic infections within the past 6 months remain ineligible.
- Participant has had uncontrolled high blood pressure within 6 months prior to the first dose of study intervention (Unique to EU: high blood pressure Stage 2 is defined as ≥ 140/90 mmHg).
- Participant has a history of ascites requiring drainage more than twice in the past 7 days. CTDS EC: ASP2138 in Combination with Pembrolizumab \& mFOLFOX6 as First-line Therapy in Gastric/GEJ Cancer:
- Participant has history of (non-infectious) pneumonitis that required steroids, current pneumonitis, or has a history of interstitial lung disease.
- Participant received live-virus vaccination within 30 days prior to the first dose of study intervention.
- Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention or has been diagnosed...
- History of cerebrovascular accident or transient ischemic attack within 6 months prior to study intervention.
- Participant has significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to study intervention.
- Participant has evidence of a bleeding diathesis or significant coagulopathy.
- Participant has initiated new treatment with medications that affect the coagulation cascade with an INR ≥ 2 such as vitamin K antagonists, heparins \& direct thrombin inhibitors or the use of factor Xa inhibitors...
- Participant has prior severe allergic reaction; suspected, known immediate or delayed hypersensitivity; or intolerance or contraindication to any study intervention (i.e., pembrolizumab \& CAPOX [all components]).
- Participants who have received systemic immunosuppressive therapy, including systemic corticosteroids 14 days prior to the first dose of study intervention are generally excluded, however, participants using a...
- Participant is known to have HIV infection.
- NOTE: Differing from monotherapy administration, participants with CD4+ T cell counts ≥ 350 cells/μL \& no history of AIDS-defining opportunistic infections within the past 6 months remain ineligible.
- Participant has had uncontrolled high blood pressure within 6 months prior to the first dose of study intervention.
- Participant has a history of ascites requiring drainage more than twice in the past 7 days.
- Participant has known DPD deficiency. CTDS EC: ASP2138 in Combination with Pembrolizumab \& CAPOX as First-line Therapy in Gastric/GEJ Cancer:
- Participant has history of (noninfectious) pneumonitis that required steroids, current pneumonitis, or has a history of interstitial lung disease.
- Participant received live-virus vaccination within 30 days prior to the first dose of study intervention.
- Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention or has been diagnosed...
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
- Santa Monica, California, United States
- Chicago, Illinois, United States
- Westwood, Kansas, United States
- New Brunswick, New Jersey, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Dallas, Texas, United States
- Seattle, Washington, United States
- Milwaukee, Wisconsin, United States
- Guangzhou, Guangdong, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Shanghai, Shanghai Municipality, China
- Hangzhou, Zhejiang, China
- Vaillant, Villejuif, France
- Lyon, France
- Marseille, France
- Poitiers, France
+ 21 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Orange, California, United States; Santa Monica, California, United States; Chicago, Illinois, United States; Westwood, Kansas, United States; New Brunswick, New Jersey, United States; New York, New York, United States and 35 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.