TAK-500 for Breast Cancer
Phase-Based Progress Estimates
Effectiveness
Safety
Breast Cancer+14 More
TAK-500 - DrugEligibility
18+
All Sexes
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Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary
This trial is studying TAK-500 to find out how well it works in treating adults with certain types of solid tumors that have spread or cannot be removed by surgery. TAK-500 will be given alone or with pembrolizumab and will be compared to standard of care.
Eligible Conditions
- Breast Cancer
- Esophageal Neoplasms Malignant
- Mesothelioma
- Malignant Neoplasm of Pancreas
- Non-Small Cell Lung Carcinoma
- Hepatocellular Cancer (HCC)
- Squamous Epithelial Cells
- Malignant Neoplasm of Stomach
Treatment Effectiveness
Study Objectives
5 Primary · 17 Secondary · Reporting Duration: Up to 30 months
Day 42
Recommended Phase 2 Dose (RP2D) of TAK-500 SA and in Combination With Pembrolizumab
Day 42
Pharmacologically Active Dose (PAD) range of TAK-500 SA and in Combination With Pembrolizumab
Day 21
Cmax: Maximum Observed Serum Concentration for TAK-500
Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAK-500
Day 21
AUCinf: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAK-500
AUCt: Area Under the Serum Concentration-time Curve From Time 0 to Time t for TAK-500
CL: Total Clearance After Intravenous Administration for TAK-500
Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-500
t1/2: Terminal Disposition Phase Half-life for TAK-500
Day 23
Changes in Tumor Immune Cell Activation as Measured by Gene Expression
Changes in Tumor Immune Cell Infiltration and Activation as Measured by Immunohistochemistry or In-Situ Hybridization
Up to 30 months
Disease Control Rate (DCR)
Dose Expansion: Progression Free Survival (PFS)
Duration of Response (DOR)
Number of Participants Reporting one or More Serious Adverse Event (SAEs)
Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs)
Number of Participants With Dose Limiting Toxicities (DLTs)
Number of Participants With Grade 3 or Higher TEAEs
Number of Participants With Positive Anti-drug Antibody (ADA) and Acquired Immunogenicity
Number of Participants With one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations
Overall Response Rate (ORR)
Time to Response (TTR)
Trial Safety
Side Effects for
Pembrolizumab+EP
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%Arthralgia
13%Rash
13%Headache
12%Hypothyroidism
11%Insomnia
11%Pruritus
11%Back pain
10%Weight decreased
9%Hyponatraemia
9%Aspartate aminotransferase increased
8%Oedema peripheral
8%Upper respiratory tract infection
8%Alanine aminotransferase increased
8%Pneumonia
7%Abdominal pain
7%Blood creatinine increased
7%Hypokalaemia
7%Febrile neutropenia
6%Abdominal pain upper
6%Stomatitis
6%Dysgeusia
6%Erythema
6%Dry skin
5%Hyperthyroidism
5%Dyspepsia
5%Dysphagia
5%Chest pain
5%Blood alkaline phosphatase increased
5%Musculoskeletal pain
5%Hypertension
5%Nasopharyngitis
5%Musculoskeletal chest pain
5%Pain in extremity
4%Urinary tract infection
4%Hypotension
2%Death
2%Acute kidney injury
2%Pneumonitis
2%Pulmonary embolism
2%Atrial fibrillation
1%Neutropenic sepsis
1%Inappropriate antidiuretic hormone secretion
1%Diabetes mellitus
1%Hemiparesis
1%Transient ischaemic attack
1%Superior vena cava syndrome
1%Pneumothorax
1%Gastritis
1%Aortic aneurysm
1%Sepsis
1%Pleural infection
1%Infusion related reaction
1%Clostridium difficile colitis
Trial Design
3 Treatment Groups
Dose Expansion: TAK-500 (dosed Q3W and/or Q2W) + Pembrolizumab (dosed Q3W)
1 of 3
Dose Escalation: TAK-500 Single Agent (SA) (dosed Q3W)
1 of 3
Dose Escalation: TAK-500 (dosed Q3W) + Pembrolizumab (dosed Q3W)
1 of 3
Experimental Treatment
106 Total Participants · 3 Treatment Groups
Primary Treatment: TAK-500 · No Placebo Group · Phase 1
Dose Expansion: TAK-500 (dosed Q3W and/or Q2W) + Pembrolizumab (dosed Q3W)Experimental Group · 2 Interventions: TAK-500, Pembrolizumab · Intervention Types: Drug, Drug
Dose Escalation: TAK-500 Single Agent (SA) (dosed Q3W)
Drug
Experimental Group · 1 Intervention: TAK-500 · Intervention Types: DrugDose Escalation: TAK-500 (dosed Q3W) + Pembrolizumab (dosed Q3W)Experimental Group · 2 Interventions: TAK-500, Pembrolizumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 30 months
Who is running the clinical trial?
TakedaLead Sponsor
1,108 Previous Clinical Trials
4,042,749 Total Patients Enrolled
2 Trials studying Breast Cancer
3,467 Patients Enrolled for Breast Cancer
Study DirectorStudy DirectorTakeda
1,055 Previous Clinical Trials
473,435 Total Patients Enrolled
24 Trials studying Breast Cancer
8,554 Patients Enrolled for Breast Cancer
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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