DS-1103a + T-DXd for Advanced Cancer

Phase 1

Recruiting

Research Sponsored by Daiichi Sankyo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up until documented progressive disease, unacceptable toxicity, death, lost to follow-up, or withdrawal by the participant, up to approximately 44 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a new drug combo is safe & effective for advanced cancer patients.

Who is the study for?

Adults over 18 with advanced solid tumors, specifically HER2-expressing or mutated, who've had prior treatment without success. They must have measurable lesions and be in good health with proper organ function. Women of childbearing age need a negative pregnancy test and agree to birth control; men must also use birth control.

What is being tested?

The trial is testing DS-1103a combined with T-DXd for safety and effectiveness against advanced solid tumors. Participants will receive this combination therapy to see how well it works compared to current treatments.

What are the potential side effects?

Potential side effects may include reactions related to the immune system, infusion-related responses, fatigue, digestive issues like nausea or diarrhea, blood cell count changes leading to increased infection risk, heart problems due to cardiotoxicity, and possible lung issues such as pneumonitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up until documented progressive disease, unacceptable toxicity, death, lost to follow-up, or withdrawal by the participant, up to approximately 44 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up until documented progressive disease, unacceptable toxicity, death, lost to follow-up, or withdrawal by the participant, up to approximately 44 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up until documented progressive disease, unacceptable toxicity, death, lost to follow-up, or withdrawal by the participant, up to approximately 44 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Objective Response Rate Assessed by Blinded Independent Central Review Following DS-1103a Combination Therapy (Dose Expansion)

Secondary study objectives

Clinical Benefit Rate Following DS-1103a Combination Therapy (Dose Escalation and Dose Expansion)

Disease Control Rate Following DS-1103a Combination Therapy Assessed by Investigator (Dose Escalation) or Blinded Independent Central Review (Dose Expansion)

Duration of Response Following DS-1103a Combination Therapy (Dose Escalation and Dose Expansion)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Expansion: DS-1103a + T-DXdExperimental Treatment2 Interventions

Participants with HER2-low expressing breast cancer who will receive an IV infusion of DS-1103a at the recommended dose for expansion (RDE) in combination with T-DXd 5.4 mg/kg Q3W starting on Cycle 1 Day 1.

Group II: Dose Escalation: DS-1103a + T-DXdExperimental Treatment2 Interventions

Participants with HER2-expressing or HER2-mutant advanced metastatic solid tumors who will receive an intravenous (IV) infusion of DS-1103a (starting dose of 100 mg) every 3 weeks (Q3W) starting on Cycle 1 Day 1. Starting on Cycle 2 Day 1 and on Day 1 of each subsequent cycle, participants will also receive T-DXd Q3W at a dose of 5.4 mg/kg.

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