A Study of ASP546C in Adults With Gastroesophageal Cancer, Pancreatic Cancer or Other Solid Tumors

NCT07488676 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 546C-CL-0201
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 9

Brief Summary

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. This study is in 2 parts. In both parts of the study, ASP546C will be given once in 3-week cycles. It will be given slowly through a tube into a vein. This is called an infusion. In Part 1, people with gastric cancer or GEJ cancer can take part. They will receive an infusion of either a higher dose or a lower dose of ASP546C. In Part 2, people with pancreatic cancer or who have one of the other solid tumors can take part. Part 2 doesn't include people with gastric cancer or GEJ cancer. All people in this part of the study will receive an infusion of the higher dose of ASP546C. People will visit the clinic on certain days to receive ASP546C and have health checks. The number of visits and checks done during the study will depend on the health of each person and whether they are still receiving infusions of ASP546C.

Conditions

Pancreatic Adenocarcinoma; Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma

Keywords

Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma; Pancreatic Adenocarcinoma; Cholangiocarcinoma; Colorectal adenocarcinoma; Non-small cell lung cancer (NSCLC) (adenocarcinoma); Small cell lung cancer (SCLC); Ovarian mucinous carcinoma; Invasive breast cancer; ASP546C; Claudin 18.2

Outcome Measures

Primary Outcomes (8)

• Part 1: Objective Response Rate (ORR) per Investigator-assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  ORR is defined as the proportion of participants who have a best overall response (BOR) of complete response (CR) or partial response (PR) as per investigator assessment per RECIST v1.1.

  Up to 36 Months

• Part 1: Pharmacokinetics (PK) of ASP546C Antibody-drug Conjugate (ADC): Serum Concentrations of Antibody-drug Conjugate

  ADC concentrations will be recorded from the PK serum samples collected.

  Up to 39 Months

• Part 1: PK of ASP546C ADC: Maximum Concentration (Cmax)

  Cmax will be recorded from the PK serum samples collected.

  Up to 39 Months

• Part 1: PK of ASP546C ADC: Area Under the Serum Concentration-time Curve from Time Zero to 21Days (AUC0-21d)

  AUC0-21d will be recorded from the PK serum samples collected.

  Up to 39 Months

• Part 1: Number of participants with Adverse events (AEs)

  An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures.

  Up to 39 Months

• Part 1: Number of Participants with Vital Sign Abnormalities and/or AEs

  Number of participants with potentially clinically significant vital sign values.

  Up to 39 Months

• Part 1: Number of Participants with Laboratory Value Abnormalities and/or AEs

  Number of participants with potentially clinically significant laboratory values.

  Up to 39 Months

• Part 1: Number of Participants at Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Scores

  The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.

  Up to 39 Months

Secondary Outcomes (32)

• Part 1 and Part 2: ORR per Investigator-assessed per RECIST v1.1

  Up to 36 Months

• Part 1 and Part 2: Disease Control Rate (DCR) per Investigator-assessed per RECIST v1.1

  Up to 36 Months

• Part 1 and Part 2: Duration of Response (DOR) per Investigator-assessed per RECIST v1.1

  Up to 36 Months

• Part 1 and Part 2: Progression Free Survival (PFS) per Investigator-assessed per RECIST v1.1

  Up to 39 Months

• Part 1 and Part 2: Overall Survival (OS)

  Up to 39 Months

Study Arms (4)

Part 1 - Cohort 1 ASP546C Lower Dose

EXPERIMENTAL

Participants with unresectable locally advanced or metastatic (uLA/m) gastroesophageal adenocarcinoma will receive a lower dose of ASP546C intravenously, once every 3 weeks (Q3W).

Drug: ASP546C

Part 1 - Cohort 2 ASP546C Higher Dose

EXPERIMENTAL

Participants with uLA/m gastroesophageal adenocarcinoma will receive a higher dose of ASP546C intravenously, once Q3W.

Drug: ASP546C

Part 2 - Cohort 3 ASP546C Higher Dose

EXPERIMENTAL

Participants with uLA/m pancreatic adenocarcinoma will receive a higher dose of ASP546C intravenously, once Q3W.

Drug: ASP546C

Part 2 - Cohort 4 ASP546C Higher Dose

EXPERIMENTAL

Participants with pan-tumor (cholangiocarcinoma, colorectal adenocarcinoma, NSCLC, SCLC, ovarian mucinous carcinoma or invasive breast cancer) will receive a higher dose of ASP546C intravenously, once Q3W.

Drug: ASP546C

Interventions

ASP546C DRUG

Intravenous administration

Also known as: XNW27011

Part 1 - Cohort 1 ASP546C Lower Dose; Part 1 - Cohort 2 ASP546C Higher Dose; Part 2 - Cohort 3 ASP546C Higher Dose; Part 2 - Cohort 4 ASP546C Higher Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has a histologically confirmed diagnosis of gastroesophageal (gastric/GEJ/esophageal) adenocarcinoma, pancreatic adenocarcinoma, or pan-tumor (cholangiocarcinoma, colorectal adenocarcinoma, NSCLC \[adenocarcinoma\], SCLC, ovarian mucinous carcinoma or invasive breast cancer \[ER/PR+HER2-; ER/PR-HER2+; ER/PR+HER2+ (triple positive); ER/PR-HER2- (triple negative)\].
• 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 lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy.
• 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 evaluable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy.
• 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 half-lives (45 days) plus 6 months after final investigational study intervention administration.
• 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 administration.
• 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 intervention administration.
• 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 final investigational study intervention administration.
• 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 investigational study intervention administration.

You may not qualify 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 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 that would preclude the participant from participation.
• 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 without need of steroids for \>= 2 weeks prior to the first dose of study intervention is eligible.
• 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 glucocorticoids within 6 months prior to the first dose of study intervention.
• 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 these infections should be conducted if indicated per local requirements.
• 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 be excluded.
• 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.

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead

Study Sites (9)

START Los Angeles

Los Angeles, California, 90025, United States

RECRUITING

START Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

START New York

Lake Success, New York, 10042, United States

RECRUITING

Duke Cancer Center Durham

Durham, North Carolina, 27710, United States

RECRUITING

Next Oncology - Austin

Austin, Texas, 78758, United States

RECRUITING

Next Oncology - Houston

Houston, Texas, 77054, United States

RECRUITING

Next Oncology - Dallas

Irving, Texas, 75039, United States

RECRUITING

START San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

START Mountain Region

West Valley City, Utah, 84119, United States

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma; Cholangiocarcinoma; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Study Physician

  Astellas Pharma Global Development, Inc.

  STUDY DIRECTOR

Central Study Contacts

Astellas Pharma Global Development, Inc

CONTACT

800-888-7704; Astellas.registration@astellas.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 23, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
• Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

Locations

US (9)