TAK-500 for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Breast Cancer+14 More
TAK-500 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

Effectiveness Progress

1 of 3

Other trials for Breast Cancer

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

Safety Progress

1 of 3

Other trials for Breast Cancer

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
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab+EP ARM group. Side effects include: Neutropenia with 54%, Anaemia with 45%, Nausea with 38%, Alopecia with 34%, Decreased appetite with 31%.

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: Drug
Dose 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

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 7th, 2021

Last Reviewed: October 4th, 2022

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.