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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
No Placebo-Only Group

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 below
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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.
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My breast cancer is advanced or has spread, and tests show it's HER2 positive.
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My heart's pumping ability is normal or near normal.
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I have tried all treatments that could significantly help my condition.
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My cancer progressed after treatment targeting specific gene changes, or I couldn't tolerate the treatment.
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My advanced lung cancer is HER2 positive.
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I am 18 years old or older.
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My breast or lung cancer is advanced and tests show it's HER2 positive.
Select...
I am willing to undergo tumor biopsies.
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My organs are working well.
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My lung cancer is advanced or has spread and tests show a HER2 mutation.
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My cancer progressed after treatment targeting specific gene changes, or I couldn't tolerate the treatment.

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 2021 Phase 3 trial • 453 Patients • NCT03066778
54%
Neutropenia
45%
Anaemia
38%
Nausea
34%
Alopecia
31%
Decreased appetite
29%
Constipation
27%
Fatigue
26%
Thrombocytopenia
22%
Leukopenia
21%
Diarrhoea
20%
Cough
17%
Asthenia
17%
Dyspnoea
16%
Vomiting
14%
Pyrexia
14%
Dizziness
13%
Headache
13%
Arthralgia
13%
Rash
12%
Hypothyroidism
11%
Pruritus
11%
Insomnia
11%
Back pain
10%
Weight decreased
9%
Hyponatraemia
9%
Aspartate aminotransferase increased
8%
Upper respiratory tract infection
8%
Pneumonia
8%
Oedema peripheral
8%
Alanine aminotransferase increased
7%
Hypokalaemia
7%
Febrile neutropenia
7%
Abdominal pain
7%
Blood creatinine increased
6%
Abdominal pain upper
6%
Stomatitis
6%
Dry skin
6%
Erythema
6%
Dysgeusia
5%
Nasopharyngitis
5%
Hyperthyroidism
5%
Dyspepsia
5%
Dysphagia
5%
Blood alkaline phosphatase increased
5%
Pain in extremity
5%
Musculoskeletal chest pain
5%
Musculoskeletal pain
5%
Chest pain
5%
Hypertension
4%
Hypotension
4%
Urinary tract infection
2%
Atrial fibrillation
2%
Pulmonary embolism
2%
Death
2%
Acute kidney injury
2%
Pneumonitis
1%
Hemiparesis
1%
Clostridium difficile colitis
1%
Neutropenic sepsis
1%
Pleural infection
1%
Sepsis
1%
Infusion related reaction
1%
Diabetes mellitus
1%
Aortic aneurysm
1%
Inappropriate antidiuretic hormone secretion
1%
Pneumothorax
1%
Transient ischaemic attack
1%
Gastritis
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab+EP
Placebo+EP
Pembrolizumab Second Course

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 3
~2070

Find a Location

Who is running the clinical trial?

Daiichi SankyoLead Sponsor
385 Previous Clinical Trials
408,900 Total Patients Enrolled
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
414,992 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,847 Previous Clinical Trials
5,045,749 Total Patients Enrolled

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04042701 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: HER2-positive breast cancer (Part 2 Dose Expansion), HER2-mutant NSCLC (Part 2 Dose Expansion), Part 1 (Dose Escalation), HER2-low breast cancer (Part 2 Dose Expansion), HER2-expressing NSCLC (Part 2 Dose Expansion)
Non-Small Cell Lung 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

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
~0 spots leftby Feb 2024