DS-8201a for Solid Cancers

Recruiting in Palo Alto (17 mi)

+13 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Daiichi Sankyo Co., Ltd.

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called DS-8201a. It is aimed at patients with advanced solid tumors. The drug works by targeting cancer cells and delivering medicine directly to them.

Eligibility Criteria

This trial is for adults with advanced solid tumors, particularly those with certain types of breast or stomach cancer that have HER2 overexpression and haven't responded to standard treatments. Participants should be relatively active (ECOG PS 0 or 1) and have a healthy heart function (LVEF ≥ 50%). Those with significant heart issues, arrhythmias, or lung diseases cannot join.

Inclusion Criteria

Eastern Cooperative Oncology Group performance status( PS) of 0 or 1.

Left Ventricular Ejection Fraction (LVEF) ≥ 50%

Advanced breast cancer with HER2 overexpression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available. Treated with ado-trastuzumab emtansine (T-DM1)

+5 more

Exclusion Criteria

Has a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females.

Has a medical history of myocardial infarction or unstable angina.

Has a medical history of symptomatic Congestive Heart Failure (CHF) (NYHA classes II-IV) or serious cardiac arrhythmia.

+1 more

Participant Groups

The study is testing different doses of DS-8201a, an investigational drug for treating various advanced solid malignant tumors. It's an open-label study where all participants know they're receiving the drug; it aims to assess the safety and how well people can tolerate different doses.

2Treatment groups

Experimental Treatment

Group I: Part 2 Dose expansionExperimental Treatment3 Interventions

Part 2 is a dose expansion to examine the safety and efficacy of DS-8201a and it is consist of multiple cohorts: in subjects with trastuzumab emtansine (T-DM1)-treated HER2 overexpressing breast cancer (Part 2a); trastuzumab-treated HER2 overexpressing gastric or gastroesophageal junction adenocarcinoma (Part 2b); HER2 low expressing breast cancer (Part 2c), HER2 expressing other solid malignant tumor (Part 2d); HER2 expressing breast cancer (Japan only; Part 2e)

Group II: Part 1 Dose escalationExperimental Treatment2 Interventions

Part 1 is a dose escalation to identify the Maximum Tolerated dose (MTD) or the recommended phase 2 dose of DS-8201a guided by the modified continuous reassessment method using a Bayesian logistic regression model following escalation with overdose control principal.