← Back to Search

Monoclonal Antibodies

DS-8201a + Pembrolizumab for Breast and Lung 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
Pathologically documented, locally advanced/metastatic breast cancer that has centrally determined HER2-low expression (immunohistochemistry [IHC] 1+ or IHC 2+/in situ hybridization [ISH-])
Received prior trastuzumab emtansine (T-DM1) therapy with documented progression
Must not have
Unresolved toxicities from previous anticancer therapy
Prior therapy with an anti-PD-1 or anti-PD-L1 agent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within approximately 30 months
Awards & highlights

Summary

This trial will test a new cancer treatment combining two drugs, one of which is a new experimental drug. The first part will determine how much of the new experimental drug is safe to use. The second part will test how well the combination of the two drugs works, how safe it is, and how well tolerated it is.

Who is the study for?
Adults (≥18 years) with advanced/metastatic breast cancer that is HER2-positive or HER2-low, and those with similar stages of NSCLC. Participants must have tried all other beneficial treatments or be unable to tolerate them. They should not have had prior treatment with pembrolizumab/DS-8201a, severe heart issues within the last 6 months, active hepatitis B/C, certain lung conditions, autoimmune diseases requiring steroids/immunosuppressants, or a history of severe allergic reactions to similar drugs.Check my eligibility
What is being tested?
The trial tests DS8201a combined with Pembrolizumab in two parts: first to find the best dose and then to check how well it works and its safety. It's for people whose breast or lung cancer has spread and expresses a protein called HER2. The study aims to see if this drug combo can help when other treatments haven't worked.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the medication components, potential heart problems like QT interval prolongation which affects heartbeat rhythm, liver issues due to hepatitis infection risks, lung complications such as pneumonitis from inflammation, immune system disorders that could worsen due to immunosuppressive medications needed for treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My breast cancer is advanced and tests show low HER2 levels.
Select...
My cancer progressed after receiving T-DM1 therapy.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My breast cancer is advanced or has spread, and tests show it's HER2 positive.
Select...
My advanced lung cancer is HER2 positive.
Select...
I am 18 years old or older.
Select...
My breast or lung cancer is advanced and tests show it's HER2 positive.
Select...
I am willing to undergo tumor biopsies.
Select...
My lung cancer is advanced or has spread and tests show a HER2 mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I still have side effects from past cancer treatments.
Select...
I have been treated with drugs targeting PD-1 or PD-L1.
Select...
I stopped a cancer treatment due to a severe immune reaction.
Select...
I have been treated with pembrolizumab or DS-8201a before.
Select...
I have not taken high-dose steroids or immunosuppressants in the last 14 days.
Select...
I do not have active brain metastases or spinal cord compression.
Select...
I have an autoimmune disease.
Select...
I am currently being treated for an infection.
Select...
I have had an organ or stem cell transplant.
Select...
I do not have an infection needing IV drugs.
Select...
I have severe lung problems due to other lung diseases.
Select...
I have been diagnosed with HIV.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within approximately 30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and within approximately 30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose-limiting toxicities (DLTs), Part 1
Objective Response Rate (ORR), Confirmed by Independent Central Review, Part 2
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DoR)
Overall survival (OS)
+5 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

5Treatment groups
Experimental Treatment
Group I: Part 1 (Dose Escalation)Experimental Treatment2 Interventions
HER2-positive breast cancer, HER2-low expressing breast cancer, HER2-expressing NSCLC, and HER2-mutant NSCLC participants who received escalating doses of DS8201a (initial dose 3.2 mg/kg Q3W) and pembrolizumab 200 mg.
Group II: HER2-positive breast cancer (Part 2 Dose Expansion)Experimental Treatment2 Interventions
HER2-positive breast cancer participants with prior ado-trastuzumab emtansine (T-DM1) with disease progression and who received DS8201a at the RDE in combination with pembrolizumab 200 mg.
Group III: HER2-mutant NSCLC (Part 2 Dose Expansion)Experimental Treatment2 Interventions
HER2-mutant NSCLC participants who had not received any prior treatment with anti-PD-1, anti-PD-L1, or HER2 agents and received DS8201a at the RDE in combination with pembrolizumab 200 mg.
Group IV: HER2-low breast cancer (Part 2 Dose Expansion)Experimental Treatment2 Interventions
HER2 low breast cancer participants with prior failed standard treatments who received DS8201a at the RDE in combination with pembrolizumab 200 mg.
Group V: HER2-expressing NSCLC (Part 2 Dose Expansion)Experimental Treatment2 Interventions
HER2-expressing NSCLC participants who had not received any prior treatment with anti-PD-1, anti-PD-L1, or HER2 agents and received DS8201a at the RDE in combination with pembrolizumab 200 mg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Daiichi SankyoLead Sponsor
396 Previous Clinical Trials
419,873 Total Patients Enrolled
25 Trials studying Breast Cancer
17,512 Patients Enrolled for Breast Cancer
AstraZeneca UK LimitedUNKNOWN
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
421,350 Total Patients Enrolled
27 Trials studying Breast Cancer
19,487 Patients Enrolled for Breast Cancer

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04042701 — Phase 1
Breast Cancer Research Study Groups: HER2-positive breast cancer (Part 2 Dose Expansion), HER2-low breast cancer (Part 2 Dose Expansion), Part 1 (Dose Escalation), HER2-expressing NSCLC (Part 2 Dose Expansion), HER2-mutant NSCLC (Part 2 Dose Expansion)
Breast Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04042701 — Phase 1
Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04042701 — Phase 1
~8 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top