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Monoclonal Antibodies

TAK-500 + Pembrolizumab for Advanced Solid Cancers

Phase 1 & 2
Recruiting
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
Individuals with the following pathologically confirmed (cytological diagnosis is adequate) select locally advanced or metastatic solid tumors, whose disease has progressed on or are intolerant to all standard therapy: gastroesophageal (esophageal, gastroesophageal junction, and gastric) adenocarcinoma, pancreatic adenocarcinoma, hepatocellular carcinoma (HCC), nonsquamous non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), mesothelioma, triple-negative breast cancer (TNBC), renal clear cell carcinoma (RCC) and nasopharyngeal carcinoma (NPC). Participants who are intolerant to all standard therapies are those who have developed clinical or laboratory abnormalities that prevent continued drug administration as evaluated by the principal investigator at the time of screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 50 months
Awards & highlights

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.

Who is the study for?
Adults with certain advanced or metastatic solid tumors, including various cancers like lung, liver, breast, and stomach cancer. Participants must be in good physical condition (ECOG 0-1), have measurable disease per RECIST criteria, adequate organ function, and no severe side effects from previous treatments. They should not have heart issues or active hepatitis among other exclusions.Check my eligibility
What is being tested?
The trial is testing TAK-500 alone or combined with pembrolizumab to evaluate safety and anti-tumor effects in adults with specific advanced cancers. Treatment can last up to a year but will stop if the disease progresses or at the doctor's discretion.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation of organs, infusion-related reactions which may cause discomfort during treatment administration, fatigue, digestive disturbances like nausea or diarrhea, blood cell count changes that could increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can carry out all my daily activities without help.
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My cancer has worsened or I can't tolerate standard treatments.
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My blood, kidney, and liver tests are within normal ranges.
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My blood counts meet the required levels for treatment.
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My liver function tests are within the required range.
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My kidneys are functioning well enough, based on a specific test.
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My heart pumps well, with an ejection fraction over 50%.
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My liver function is relatively good (Child-Pugh A or B7).
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My side effects from previous treatments have mostly gone away, except for hair loss, mild nerve pain, or hormone issues treated with medication.
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I haven't had certain cancer antibody treatments in the last 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 50 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 50 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 Escalation: Number of Participants Reporting one or More Serious Adverse Event (SAEs)
Dose Escalation: Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs)
Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)
+3 more
Secondary outcome measures
Dose Escalation and Dose Expansion: AUCinf: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAK-500
Dose Escalation and Dose Expansion: AUCt: Area Under the Serum Concentration-time Curve From Time 0 to Time t for TAK-500
Dose Escalation and Dose Expansion: CL: Total Clearance After Intravenous Administration for TAK-500
+17 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

9Treatment groups
Experimental Treatment
Group I: Dose Expansion: 3L RCC: TAK-500 + Pembrolizumab (RDE 1)Experimental Treatment2 Interventions
Participants with 3L renal clear cell carcinoma (RCC) will receive TAK-500, infusion, intravenously, in a 42-day treatment cycle (Q2W or Q3W) with pembrolizumab 200 mg infusion, intravenously, in a 42-day treatment cycle (Q3W) for up to 1 year. The recommended dose (RDE 1) and schedule of TAK-500 for expansion will be based on the results of the TAK-500 in combination with pembrolizumab Dose Escalation arm.
Group II: Dose Expansion: 3L NSCLC: TAK-500 (RDE 2) SAExperimental Treatment1 Intervention
Participants with 3L NSCLC will receive TAK-500, infusion, intravenously, in a 42-day treatment cycle (Q2W or Q3W) for up to 1 year. The recommended dose (RDE 2) and schedule of TAK-500 for expansion will be based on the results of the TAK-500 as single agent in Dose Escalation arm.
Group III: Dose Expansion: 3L NSCLC: TAK-500 (RDE 1) SAExperimental Treatment1 Intervention
Participants with third-line (3L) NSCLC will receive TAK-500, infusion, intravenously, in a 42-day treatment cycle (Q2W or Q3W) for up to 1 year. The recommended dose (RDE 1) and schedule of TAK-500 for expansion will be based on the results of the TAK-500 as single agent in Dose Escalation arm.
Group IV: Dose Expansion: 2L Pancreatic Adenocarcinoma: TAK-500 + Pembrolizumab (RDE 1)Experimental Treatment2 Interventions
Participants with 2L Pancreatic Adenocarcinoma will receive TAK-500, infusion, intravenously, in a 42-day treatment cycle (Q2W or Q3W) with pembrolizumab 200 mg infusion, intravenously, in a 42-day treatment cycle (Q3W) for up to 1 year. The recommended dose (RDE 1) and schedule of TAK-500 for expansion will be based on the results of the TAK-500 in combination with pembrolizumab Dose Escalation arm.
Group V: Dose Expansion: 2L Pancreatic Adeno: TAK-500 (RDE 1) SAExperimental Treatment1 Intervention
Participants with 2L Pancreatic Adenocarcinoma will receive TAK-500, infusion, intravenously, in a 42-day treatment cycle (Q2W or Q3W) for up to 1 year. The recommended dose (RDE 1) and schedule of TAK-500 for expansion will be based on the results of the TAK-500 as single agent in Dose Escalation arm.
Group VI: Dose Expansion: 2L NSCLC: TAK-500 + Pembrolizumab (RDE 2)Experimental Treatment2 Interventions
Participants with 2L NSCLC will receive TAK-500, infusion, intravenously, in a 42-day treatment cycle (Q2W or Q3W) with pembrolizumab 200 mg infusion, intravenously, in a 42-day treatment cycle (Q3W) for up to 1 year. The recommended dose (RDE 2) and schedule of TAK-500 for expansion will be based on the results of the TAK-500 in combination with pembrolizumab Dose Escalation arm.
Group VII: Dose Expansion: 2L NSCLC: TAK-500 + Pembrolizumab (RDE 1)Experimental Treatment2 Interventions
Participants with second-line (2L) non-small cell lung cancer (NSCLC) will receive TAK-500, infusion, intravenously, in a 42-day treatment cycle (Q2W or Q3W) with pembrolizumab 200 mg infusion, intravenously, in a 42-day treatment cycle (Q3W) for up to 1 year. The recommended dose (RDE 1) and schedule of TAK-500 for expansion will be based on the results of the TAK-500 in combination with pembrolizumab Dose Escalation arm.
Group VIII: Dose Escalation: TAK-500 Single Agent (SA)Experimental Treatment1 Intervention
TAK-500 dose escalation starting at 8 microgram per kilogram (mcg/kg), infusion, intravenously, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) or once on Day 1, 15 and 29 of each 42-day treatment cycle (once every 2 weeks, Q2W), for up to 1 year.
Group IX: Dose Escalation: TAK-500 + PembrolizumabExperimental Treatment2 Interventions
TAK-500, infusion, intravenously, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) or once on Day 1, 15 and 29 of each 42-day treatment cycle (once every 2 weeks, Q2W), for up to 1 year, along with pembrolizumab 200 milligram (mg) infusion, intravenously, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year. The exact starting dose of TAK-500 will be determined from the results of the TAK-500 SA arm dose escalation.
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?

TakedaLead Sponsor
1,200 Previous Clinical Trials
4,177,833 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,203 Previous Clinical Trials
489,266 Total Patients Enrolled

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05070247 — Phase 1 & 2
Kidney Cancer Research Study Groups: Dose Expansion: 2L NSCLC: TAK-500 + Pembrolizumab (RDE 2), Dose Expansion: 2L NSCLC: TAK-500 + Pembrolizumab (RDE 1), Dose Expansion: 3L NSCLC: TAK-500 (RDE 1) SA, Dose Escalation: TAK-500 Single Agent (SA), Dose Escalation: TAK-500 + Pembrolizumab, Dose Expansion: 3L NSCLC: TAK-500 (RDE 2) SA, Dose Expansion: 2L Pancreatic Adenocarcinoma: TAK-500 + Pembrolizumab (RDE 1), Dose Expansion: 2L Pancreatic Adeno: TAK-500 (RDE 1) SA, Dose Expansion: 3L RCC: TAK-500 + Pembrolizumab (RDE 1)
Kidney Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05070247 — Phase 1 & 2
Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05070247 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How secure is the application of TAK-500 for human health?

"Due to the limited safety and efficacy data surrounding TAK-500, it received a score of 1."

Answered by AI

In what geographic locations is this trial carrying out its research?

"Besides the University of Colorado - Anschutz Medical Campus - PPDS in Aurora, Dana Farber Cancer Institute in Boston, and Cancer Clinical Trials Office (CCTO) University of Colorado Anschutz Medical Campus in Denver, this trial is also recruiting patients from 8 other medical centres."

Answered by AI

Is there still the opportunity to join this clinical exploration?

"According to clinicaltrials.gov, this medical trial is actively seeking participants after first being posted on April 26th 2022 and most recently updated on August 3rd of the same year."

Answered by AI

For what medical conditions is TAK-500 commonly employed?

"TAK-500 is frequently utilized to treat malignancies. It can also be beneficial in the management of unresectable melanoma, microsatellite instability high, and as a response to chemotherapy failure."

Answered by AI

How extensive is the scope of participants in this particular research study?

"In order to proceed with the clinical trial, a total of 106 qualified participants are required. The sponsor for this study, Takeda Pharmaceuticals, is recruiting patients from two sites - University of Colorado - Anschutz Medical Campus- PPDS in Aurora and Dana Farber Cancer Institute in Boston."

Answered by AI

What other exploratory trials have been conducted with TAK-500?

"At the moment, there are 961 clinical trials for TAK-500. Of those active studies, 122 have progressed to Phase 3. Many of these experiments take place in Houston, Texas; however, it should be noted that 35731 sites around the world offer this medication as part of a research study."

Answered by AI
~172 spots leftby Aug 2026