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Anti-tumor Antibiotic
DS-8201a for Solid Cancers
Phase 1
Waitlist Available
Research Sponsored by Daiichi Sankyo Co., Ltd.
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 from 6 months postdose of last participant up to 3 years 5 months
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see if it is safe and effective.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with cancer drugs like DS-8201a may include nausea, fatigue, hair loss, increased risk of infection due to low blood cell counts, diarrhea, and potential heart problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from 6 months postdose of last participant up to 3 years 5 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 6 months postdose of last participant up to 3 years 5 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases)
Secondary outcome measures
Best Overall Response Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases)
Disease Control Rate (DCR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases)
Duration of Response (DoR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases)
+8 moreSide effects data
From 2023 Phase 1 trial • 292 Patients • NCT0256490086%
Nausea
56%
Vomiting
48%
Fatigue
46%
Decreased appetite
46%
Anaemia
38%
Alopecia
36%
Diarrhoea
36%
Constipation
30%
Platelet count decreased
28%
Cough
24%
Neutrophil count decreased
20%
Pyrexia
20%
Oedema peripheral
18%
Upper respiratory tract infection
18%
White blood cell count decreased
18%
Aspartate aminotransferase increased
18%
Hypokalaemia
16%
Dizziness
16%
Headache
16%
Epistaxis
14%
Alanine aminotransferase increased
14%
Dyspnoea
14%
Stomatitis
14%
Abdominal pain
14%
Dyspepsia
12%
Chills
12%
Dry eye
12%
Rash
12%
Malaise
10%
Nasopharyngitis
10%
Dry skin
10%
Back pain
10%
Hypoalbuminaemia
10%
Cystitis
10%
Weight decreased
10%
Blood alkaline phosphatase increased
10%
Electrocardiogram QT prolonged
8%
Neuropathy peripheral
8%
Abdominal discomfort
8%
Dysgeusia
8%
Hypertension
8%
Lymphoedema
8%
Respiratory failure
8%
Pneumonia
8%
Skin hyperpigmentation
8%
Asthenia
8%
Fall
6%
Abdominal distension
6%
Keratitis
6%
Conjunctivitis
6%
Oedema
6%
Gastroenteritis
6%
Gastrooesophageal reflux disease
6%
Insomnia
6%
Tinnitus
6%
Pneumonitis
6%
Influenza
6%
Dehydration
6%
Anxiety
6%
Pleural effusion
6%
Dysphonia
6%
Organising pneumonia
6%
Gingival bleeding
6%
Rash maculo-papular
6%
Myalgia
6%
Arthralgia
6%
Musculoskeletal chest pain
6%
Pain
6%
Weight increased
6%
Blood lactate dehydrogenase increased
4%
Haemorrhage subcutaneous
4%
Hypercalcaemia
4%
Urinary tract infection
4%
Hyponatraemia
4%
Muscle spasms
4%
Conjunctival haemorrhage
4%
Ascites
4%
Hot flush
4%
Hypoxia
4%
Hypotension
4%
Flatulence
4%
Lung infection
4%
Bronchitis
4%
Hypomagnesaemia
4%
Abdominal pain upper
4%
Dry mouth
4%
Dermatitis acneiform
4%
Muscular weakness
4%
Musculoskeletal pain
4%
Blood bilirubin increased
4%
Protein total decreased
4%
Corneal disorder
4%
Vitreous floaters
2%
Rhinitis allergic
2%
Peroneal nerve palsy
2%
Sinusitis
2%
Pneumonia aspiration
2%
Diarrhoea haemorrhagic
2%
Vision blurred
2%
Soft tissue infection
2%
Mucosal infection
2%
Cancer pain
2%
Eructation
2%
Urticaria
2%
Tachycardia
2%
Contrast media allergy
2%
Seizure
2%
Febrile neutropenia
2%
Upper-airway cough syndrome
2%
Erythema
2%
Retinal haemorrhage
2%
Dental caries
2%
Nail discolouration
2%
Palmar-plantar erythrodysaesthesia syndrome
2%
Palpitations
2%
Pulmonary oedema
2%
Peritonitis
2%
Pneumocystis jirovecii pneumonia
2%
Hypophosphataemia
2%
Disease progression
2%
Troponin increased
2%
Spinal compression fracture
2%
Hyperkalaemia
2%
Vitamin D deficiency
2%
Peripheral sensory neuropathy
2%
Cataract
2%
Interstitial lung disease
2%
Nasal congestion
2%
Oropharyngeal pain
2%
Gastritis
2%
Pruritus
2%
Herpes zoster
2%
Onychoclasis
2%
Blood creatinine increased
2%
Paronychia
2%
Thermal burn
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
Dose Escalation: Cohort 6, 8.0 mg/kg
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
Dose Escalation: Cohort 1, 0.8 mg/kg
Dose Escalation: Cohort 2, 1.6 mg/kg
Dose Escalation: Cohort 3, 3.2 mg/kg
Dose Escalation: Cohort 4, 5.4 mg/kg
Dose Escalation: Cohort 5, 6.4 mg/kg
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
Dose Expansion: HER2-expressing Other Solid Tumors
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab deruxtecan
FDA approved
Trastuzumab deruxtecan
FDA approved
Trastuzumab deruxtecan
FDA approved
Find a Location
Who is running the clinical trial?
Daiichi SankyoIndustry Sponsor
393 Previous Clinical Trials
416,009 Total Patients Enrolled
Daiichi Sankyo Co., Ltd.Lead Sponsor
115 Previous Clinical Trials
48,794 Total Patients Enrolled
Daiichi Sankyo, Inc.Industry Sponsor
389 Previous Clinical Trials
419,866 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have advanced breast cancer with low levels of HER2 and have either not responded to standard treatment or cannot tolerate it. There is also no other approved treatment available for your condition.You have a history of serious lung diseases.You have advanced or spreading breast cancer, stomach cancer, or cancer in the area where the stomach and esophagus meet. The cancer is not responding to standard treatments, or there are no standard treatments available.You have a type of cancer that has spread or cannot be surgically removed. It has a specific protein called HER2, and you have tried standard treatments that haven't worked or cannot be tolerated.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1 Dose escalation
- Group 2: Part 2 Dose expansion
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Has the FDA approved DS-8201a (DP) for use?
"Though there is limited data available for DS-8201a (DP), its safety was assessed with a score of 1. This evaluation reflects the fact that this treatment is currently undergoing Phase 1 clinical trials, which assesses initial efficacy and safety."
Answered by AI
What is the aggregate figure of participants involved in this research?
"At this time, enrollment for the study is closed. The initial posting date was September 1st 2015, and it's last update occurred October 4th 2022. If looking for other studies, there are presently 2503 clinical trials targeting cancer that have open registration slots along with 36 studies regarding DS-8201a (DP)."
Answered by AI
Are there any openings left for participants in this clinical investigation?
"This clinical trial has concluded its recruitment process. Originally posted on September 1st 2015 and last updated on October 4th 2022, it is no longer searching for participants. However, there are currently 2503 open trials recruiting patients with cancer and 36 studies that are accepting enrolments related to DS-8201a (DP)."
Answered by AI
Is this research pioneering within its field?
"Since 2015, Daiichi Sankyo Inc. has sponsored extensive research into DS-8201a (DP). After a 292 participant initial trial in 2015, the drug was approved for Phase 1 trials and is currently being tested in 36 studies across 44 countries and 483 cities."
Answered by AI
What other investigations have been done concerning DS-8201a (DP)?
"At this time, there are 36 ongoing clinical trials associated with DS-8201a (DP). Of those studies, 10 are in Phase 3. While many of the experiments for this treatment take place in Xi'an and New york City, across the globe there exists a total of 3277 locations that have been used to run these tests."
Answered by AI
Is the clinical trial being conducted in numerous locales across the United States?
"Mayo Clinic in Jacksonville, Florida, University of Texas M. D. Anderson Cancer Center in Houston, Texas, and Sharp Memorial Hospital in San Diego are all recruiting patients for this trial while 8 more locations also accept participants."
Answered by AI
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