RecruitingPhase 1Phase 2NCT07730021

A Study of ASP388B Given by Itself and With Standard Therapies in Participants With Solid Tumors

A Phase 1b/2 Study of ASP388B as Monotherapy and in Combination With Standard Therapies in Participants With Locally Advanced Unresectable or Metastatic Solid Tumors


Sponsor

Astellas Pharma Global Development, Inc.

Enrollment

392 participants

Start Date

Sep 2, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is an early development study of ASP388B in people with solid tumors. In this study, ASP388B will be given to people for the first time. It will be given by itself or together with standard cancer therapies. The main aims of the study are to check the safety of ASP388B and find the most suitable dose. This study will be in 2 parts. In Part 1, different small groups of people with solid tumors will receive lower to higher doses of ASP388B. Some groups will receive ASP388B by itself, and other groups will receive ASP388B with standard cancer therapies. Any medical problems will be recorded for each dose. This is to find suitable doses of ASP388B to use in Part 2 of the study, and to include the tumor types that responded well to ASP388B. In Part 2, other different small groups of people with the specific tumor types (from Part 1) will receive the most suitable doses worked out from Part 1. Some groups will receive ASP388B by itself, and other groups will receive ASP388B with standard cancer therapies. In both parts of the study, ASP388B will be given once in 3-week cycles. The standard cancer therapies will be given according to their approved label. ASP388B and the standard cancer therapies will be given slowly through a tube into a vein. This is called an infusion. In both parts of the study, safety checks will be done at each visit, and the doctors will continue to check for medical problems throughout the study.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 5-fluorouracil, a drug called ASP388B, and others for people with locally advanced or metastatic solid tumors. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGASP388B

Intravenous infusion

DRUGPembrolizumab

Intravenous infusion

DRUGCarboplatin

Intravenous infusion

DRUGOxaliplatin

Intravenous infusion

DRUG5-fluorouracil

Intravenous infusion


Locations(4)

START New York

Lake Success, New York, United States

NEXT Virginia

Fairfax, Virginia, United States

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07730021


Related Trials