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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within approximately 30 months
Awards & highlights
Study 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 belowSelect...
My breast cancer is advanced and tests show low HER2 levels.
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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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within approximately 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within approximately 30 months
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 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
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%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
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
392 Previous Clinical Trials
411,250 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
415,182 Total Patients Enrolled
27 Trials studying Breast Cancer
19,487 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I still have side effects from past cancer treatments.Your heart's electrical activity (QT interval) is longer than usual, which can be risky for your health.You have at least one identifiable and measurable tumor according to a specific set of guidelines.I have been treated with drugs targeting PD-1 or PD-L1.I am fully active or restricted in physically strenuous activity but can do light work.My breast cancer is advanced or has spread, and tests show it's HER2 positive.I stopped a cancer treatment due to a severe immune reaction.My heart's pumping ability is normal or near normal.My breast cancer is advanced and tests show low HER2 levels.I do not have active brain metastases or spinal cord compression.I have an autoimmune disease.I have not taken high-dose steroids or immunosuppressants in the last 14 days.I have not received a live vaccine in the last 30 days.My lung cancer is advanced or has spread and tests show a HER2 mutation.I have severe lung problems due to other lung diseases.My cancer progressed after receiving T-DM1 therapy.I have not had anti-HER2 therapy for my low HER2 breast cancer or NSCLC.I have been treated with pembrolizumab or DS-8201a before.I haven't had a heart attack or severe heart failure in the last 6 months.You have a current infection with hepatitis B or C virus.I have tried all treatments that could significantly help my condition.I have or had lung inflammation that needed steroids, or it might still be present.My cancer progressed after treatment targeting specific gene changes, or I couldn't tolerate the treatment.My advanced lung cancer is HER2 positive.I haven't had cancer treatment or experimental drugs in the last 2-6 weeks.I haven't had any cancer except skin cancer or treated early-stage cancers in the last 3 years.You have had strong allergic reactions to other similar medicines or any components of the study drug.You have been diagnosed with mental health or substance abuse disorders.I am currently being treated for an infection.I have had an organ or stem cell transplant.I am 18 years old or older.I am willing to undergo tumor biopsies.My breast or lung cancer is advanced and tests show it's HER2 positive.I do not have an infection needing IV drugs.My organs are working well.My cancer progressed after treatment targeting specific gene changes, or I couldn't tolerate the treatment.I have been diagnosed with HIV.
Research Study Groups:
This trial has the following groups:- Group 1: HER2-positive breast cancer (Part 2 Dose Expansion)
- Group 2: HER2-low breast cancer (Part 2 Dose Expansion)
- Group 3: Part 1 (Dose Escalation)
- Group 4: HER2-expressing NSCLC (Part 2 Dose Expansion)
- Group 5: HER2-mutant NSCLC (Part 2 Dose Expansion)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacancies in this research project for participants?
"Affirmative. Data hosted on clinicaltrials.gov indicates that this research endeavour, first posted in February of 2020, is currently recruiting patients for participation. 115 participants from 6 distinct sites are needed to complete the study's objectives."
Answered by AI
Are any Canadian medical facilities engaged with this research initiative?
"This trial is being conducted in 6 locations, including Philadelphia, Tampa and San Francisco. To minimize travel commitments during the study period, it's preferable to join a site closest to your home."
Answered by AI
Are there any reports of Pembrolizumab being tested in prior scientific research?
"First explored in 2010, pembrolizumab has had 256 trials completed to date. Currently 994 active studies are being conducted around the world; many of these studies take place within Philadelphia's City of Hope."
Answered by AI
Has Pembrolizumab been granted the nod of approval from the FDA?
"Due to a scarcity of clinical evidence, our team at Power gave Pembrolizumab a safety score of 1. This experimental drug is currently being tested in phase 1 trials with limited data on efficacy and safety."
Answered by AI
What is the current scale of enrollment in this experiment?
"To fully engage in this study, 115 participants that meet the established criteria are necessary. Those looking to join can do so at either Fox Chase Cancer Center located in Philadelphia or Moffit Cancer Centre based out of Tampa."
Answered by AI
What conditions is Pembrolizumab regularly prescribed to treat?
"Pembrolizumab is frequently prescribed to treat malignant neoplasms, but it can also be beneficial for those suffering from advanced melanoma cases that are inoperable, microsatellite instability high as well as cancer progression post-chemotherapy."
Answered by AI
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