A Study of ASP2138 Given by Itself or Given With Other Cancer Treatments in Adults With Stomach Cancer, Gastroesophageal Junction Cancer, or Pancreatic Cancer

Part of paid clinical trials in Orange, California.

Sponsor
Astellas Pharma Global Development, Inc.
Study ID
NCT05365581
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ASP2138 — DRUG
    Intravenously or Subcutaneously
  • Pembrolizumab — DRUG
    Intravenously
  • Oxaliplatin — DRUG
    Intravenously
  • Leucovorin — DRUG
    Intravenously
  • Fluorouracil — DRUG
    Intravenously
  • Ramucirumab — DRUG
    Intravenously
  • Paclitaxel — DRUG
    Intravenously
  • Irinotecan — DRUG
    Intravenously
  • Capecitabine — DRUG
    Oral Administration

Study Details

Claudin 18.2 protein, or CLDN18.2 is a protein found on cells in the digestive system. It is also found on some tumors. Researchers are looking at ways to attack CLDN18.2 to help control tumors. ASP2138 is thought to bind to CLDN18.2 and a protein on a type of immune cell called a T-cell. This "tells" the immune system to attack the tumor. ASP2138 is a potential treatment for people with stomach cancer, gastroesophageal junction cancer (GEJ cancer) or pancreatic cancer. GEJ is where the tube that carries food (esophagus) joins the stomach. Before ASP2138 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. In this study, ASP2138 will either be given by itself, or given together with standard treatments for gastric, GEJ and pancreatic cancer. Pembrolizumab and mFOLFOX6, and ramucirumab and paclitaxel are standard treatments for gastric and GEJ cancer. mFOLFIRINOX is a standard treatment for pancreatic cancer. This information will help find a suitable dose of ASP2138 given by itself and together with the standard cancer treatments and to check for potential medical problems from the treatments. The main aims of the study are: * To check the safety of ASP2138 and how well people can tolerate medical problems during the study. * To find a suitable dose of ASP2138 to be used later in the study. * These are done for ASP2138 given by itself and when given together with the standard cancer treatments. Adults 18 years or older with stomach cancer, GEJ cancer, or pancreatic cancer can take part. Their cancer is locally advanced unresectable or metastatic. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. There should also be the CLDN18.2 marker in a tumor sample. People cannot take part if they need to take medicines to suppress their immune system, have blockages or bleeding in their gut, have specific uncontrollable cancers, have specific infections, have a condition such as hemophagocytic lymphohistiocytosis (HLH) which is when the body over-reacts to a "trigger" such as infection, or have a specific heart condition ("New York Heart Association Class III or IV"). Phase 1: Lower to higher doses of ASP2138 * ASP2138 is either given through a vein (intravenous infusion) or just under the skin (subcutaneous injection). * Different small groups are given lower to higher doses of ASAP2138. * ASP2138 is either given by itself, or given with 1 of 3 standard treatments: * Pembrolizumab and mFOLFOX6 (first treatment for gastric GEJ cancer) * Ramacirumab and paclitaxel (Second treatment for gastric or GEJ cancer) * ASP2138 with mFOLFIRINOX (first treatment for pancreatic cancer) Phase 1b: doses of ASP2138 worked out from Phase 1 * ASP2138 is either given through a vein or just under the skin. This depends on the findings from Phase 1. * People with gastric cancer, GEJ cancer or pancreatic cancer are given doses of ASP2138, worked out from Phase 1. * This includes doses of ASP2138 given by itself and ASP2138 given with the standard cancer treatments. * The standard cancer treatments given depends on the type of cancer they have. End of treatment visit: This is 7 days after final dose of study treatment or if the study doctor decides to stop the person's treatment. People who have locally advanced unresectable pancreatic cancer will not receive ASP2138 by itself.

Key Dates

Start date
Jun 7, 2022
Status verified
Jun 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
398 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Monotherapy Dose Escalation (Phase 1)
    A dose escalation design will be used to determine the Maximum Tolerated Dose (MTD) and/ or the Recommended Phase 2 Dose (RP2D) regimens to be further evaluated in the Monotherapy Dose Expansion arms. Monotherapy Dose escalation part consists of six parts (Part A, B, C, D, E, and F), and approximately 86 patients would be enrolled in total. Participants will be assigned to sequentially escalating dose cohorts of ASP2138 in each part. The study will open with the Part A dosing schedule, while subsequent cohorts will be opened sequentially or in parallel based upon sponsor review of emerging data.
  • Experimental: Monotherapy Dose Expansion (Phase 1b) Gastric/GEJ cancer
    Participants will receive ASP2138 at the candidate RP2D regimens determined in Monotherapy Dose Escalation arm.
  • Experimental: Monotherapy Dose Expansion (Phase 1b) Pancreatic cancer
    Participants will receive ASP2138 at the candidate RP2D regimens determined in Monotherapy Dose Escalation arm.
  • Experimental: Combination Therapy Dose Escalation (Phase 1) Part G - First-line Gastric/GEJ Cancer
    A dose escalation design will be used to determine the MTD and/ or the RP2D regimens to be further evaluated in the Combination Dose Expansion arms. In combination dose escalation part G approximately 24 patients would be enrolled in total. Participants will be assigned to sequentially escalating dose cohorts of ASP2138 in combination with pembrolizumab and mFOLFOX6 as first line therapy.
  • Experimental: Combination Therapy Dose Escalation (Phase 1) Part H - Second-line Gastric/GEJ Cancer
    A dose escalation design will be used to determine the MTD and/ or the RP2D regimens to be further evaluated in the Combination Dose Expansion arms. Participants will be assigned to sequentially escalating dose cohorts of ASP2138 in combination with ramucirumab and paclitaxel as second line therapy.
  • Experimental: Combination Therapy Dose Escalation (Phase 1) Part I - First line Pancreatic Cancer
    A dose escalation design will be used to determine the MTD and/ or the RP2D regimens to be further evaluated in the Combination Dose Expansion arms. Participants will be assigned to sequentially escalating dose cohorts of ASP2138 in combination with mFOLFIRINOX as first line therapy.
  • Experimental: ASP2138 + Pembrolizumab & mFOLFOX6 Combination Therapy Dose Expansion (Phase 1b) Gastric/GEJ Cancer
    Participants will receive candidate RP2D regimens of ASP2138 in combination with pembrolizumab \& mFOLFOX6 as first line therapy determined in Combination Therapy Dose Escalation arm.
  • Experimental: ASP2138 + Ramucirumab & Paclitaxel Combination Therapy Dose Expansion (Phase 1b) Gastric/GEJ Cancer
    Participants will receive candidate RP2D regimens of ASP2138 in combination with ramucirumab and paclitaxel as second line therapy determined in Combination Therapy Dose Escalation arm.
  • Experimental: ASP2138 + mFOLFIRINOX Combination Therapy Dose Expansion (Phase 1b) Pancreatic Cancer
    Participants will receive candidate RP2D regimens of ASP2138 in combination with mFOLFIRINOX as first line therapy in pancreatic cancer determined in Combination Therapy Dose Escalation arm in combination with mFOLFIRINOX as first line therapy in pancreatic cancer.
  • Experimental: ASP2138 + Pembrolizumab & CAPOX CTDE Exploratory Cohort (Phase1b) Gastric/GEJ Cancer - Japan & Korea
    Participants will receive candidate RP2D regimens of ASP2138 in combination with pembrolizumab \& CAPOX as first line therapy determined in Combination Therapy Dose Escalation arm. CTDE: Combination Therapy Dose Expansion

Primary Outcome Measure

Incidence of Dose Limiting Toxicities (DLTs) (Phase 1 Dose Escalation) [ Time Frame: Up to 28 days ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
University of California Irvine Medical CenterOrangeCalifornia92868-
UCLA Dept of Medicine - Hematology/Oncology, Santa MonicaSanta MonicaCalifornia90404-
Northwestern UniversityChicagoIllinois60611-
University of Kansas Cancer CenterWestwoodKansas66205-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901-
Columbia UniversityNew YorkNew York10032-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
NYU Langone Medical Center - NYU Medical Oncology AssociatesNew YorkNew York10016-
Duke Children's Hospital and Health CenterDurhamNorth Carolina27710-
Wake Forest University Baptist HealthWinston-SalemNorth Carolina27103-
UT Southwestern Medical CenterDallasTexas75390-
Virginia Mason Medical CenterSeattleWashington98101-
Froedtert Hospital and the Medical College of WisconsinMilwaukeeWisconsin53226-

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