A Study of TAK-500 With or Without Pembrolizumab in Adults With Select Locally Advanced or Metastatic Solid Tumors

NCT05070247 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: TAK-500-1001
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 12

Brief Summary

This study is about TAK-500, given either alone or with pembrolizumab, in adults with select locally advanced or metastatic solid tumors. The aims of the study are:

• to assess the safety profile of TAK-500 when given alone and when given with pembrolizumab.
• to assess the anti-tumor effects of TAK-500, when given alone and when given with pembrolizumab, in adults with locally advanced or metastatic solid tumors. Participants may receive TAK-500 for up to 1 year. Participants may continue with their treatment if they have continuing benefit and if this is approved by their study doctor. Participants who are receiving TAK-500 either alone or with pembrolizumab will continue with their treatment until their disease progresses or until they or their study doctor decide they should stop this treatment.

Conditions

Pancreatic Cancer; Mesothelioma; Gastric Cancer; Esophageal Cancer; Nasopharyngeal Cancer; Kidney Cancer; Squamous Cell Cancer of Head and Neck (SCCHN); Non-small Cell Lung Cancer (NSCLC), Non-squamous; Hepatocellular Cancer; Breast Cancer

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (6)

• Dose Escalation: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)

  Adverse event (AE) means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs).

  Up to approximately 32.8 months

• Dose Escalation: Number of Participants With Grade 3 or Higher TEAEs

  AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs). TEAE Grades was evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.

  Up to approximately 32.8 months

• Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)

  DLT was defined as any of the TEAEs that occur during Cycle 1 and are considered by the investigator to be at least possibly related to TAK-500 as a SA or in combination with pembrolizumab. Toxicity will be evaluated according to NCI CTCAE version 5.0.

  Up to Cycle 1 (1 cycle = 21 days)

• Dose Escalation: Number of Participants Reporting One or More Treatment-emergent Serious Adverse Events (SAEs)

  A TEAE is an AE for which the date of onset was on or after the first dose of any study drug and on or before 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs). Treatment-emergent SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.

  Up to approximately 32.8 months

• Dose Escalation: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuations

  AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs).

  Up to approximately 32.8 months

• Dose Expansion: Overall Response Rate (ORR)

  ORR is defined as the percentage of participants who achieve confirmed partial response (cPR) or confirmed complete response (cCR) (determined by the investigator) during the study in the response-evaluable population. ORR will be assessed as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Complete response (CR): defined as disappearance of all target and non- target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than \<10 mm. Partial response (PR): defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. cPR or cCR is defined as a PR or CR that is confirmed with additional imaging 6 weeks after initial response.

  Up to approximately 32.8 months

Secondary Outcomes (20)

• Dose Escalation: Cmax: Maximum Serum Concentration for TAK-500

  Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days)

• Dose Escalation: Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAK-500

  Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days)

• Dose Escalation: AUCt: Area Under the Serum Concentration-time Curve From Time 0 to Time t for TAK-500

  Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days)

• Dose Escalation: AUCinf: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAK-500

  Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days)

• Dose Escalation: t1/2: Terminal Disposition Phase Half-life for TAK-500

  Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days)

Study Arms (15)

Single Agent Dose Escalation: TAK-500 8 µg/kg

EXPERIMENTAL

Participants received TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) for up to 1 year.

Drug: TAK-500

Single Agent Dose Escalation: TAK-500 8 µg/kg + 1 TOCI

EXPERIMENTAL

Participants received premedication with 8 mg/kg tocilizumab (TOCI) followed by TAK-500, 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.

Drug: TAK-500; Drug: Tocilizumab

Single Agent Dose Escalation: TAK-500 16 µg/kg

EXPERIMENTAL

Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.

Drug: TAK-500

Single Agent Dose Escalation: TAK-500 16 µg/kg + 1 DEX

EXPERIMENTAL

Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.

Drug: TAK-500; Drug: Dexamethasone

Single Agent Dose Escalation: TAK-500 16 µg/kg + 2 DEX

EXPERIMENTAL

Participants received premedication with dexamethasone 10 mg tablets orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.

Drug: TAK-500; Drug: Dexamethasone

Single Agent Dose Escalation: TAK-500 16 µg/kg + 1 TOCI

EXPERIMENTAL

Participants received premedication with 8 mg/kg tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W , for up to 1 year.

Drug: TAK-500; Drug: Tocilizumab

Single Agent Dose Escalation: TAK-500 24 µg/kg + 2 DEX

EXPERIMENTAL

Participants received premedication with dexamethasone 10 mg tablets orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.

Drug: TAK-500; Drug: Dexamethasone

Single Agent Dose Escalation: TAK-500 24 µg/kg + 1 TOCI

EXPERIMENTAL

Participants received premedication with 8 mg/kg tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W , for up to 1 year.

Drug: TAK-500; Drug: Tocilizumab

Single Agent Dose Escalation: TAK-500 40 µg/kg + 2 DEX

EXPERIMENTAL

Participants received premedication with dexamethasone 10 mg tablet orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.

Drug: TAK-500; Drug: Dexamethasone

Single Agent Dose Escalation: TAK-500 60 µg/kg + 2 DEX

EXPERIMENTAL

Participants received premedication with dexamethasone 10 mg tablet orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W for up to 1 year.

Drug: TAK-500; Drug: Dexamethasone

Combination Dose Escalation: TAK-500 8 µg/kg + 1 TOCI + Pembrolizumab

EXPERIMENTAL

Participants received premedication with 8 mg/kg tocilizumab followed by TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W , for up to 1 year, along with pembrolizumab 200 mg IV infusion, 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.

Drug: TAK-500; Drug: Pembrolizumab; Drug: Tocilizumab

Combination Dose Escalation: TAK-500 16 µg/kg + Pembrolizumab + 1 TOCI

EXPERIMENTAL

Participants received premedication with 8 mg/kg tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W , for up to 1 year, along with pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle Q3W for up to 1 year.

Drug: TAK-500; Drug: Pembrolizumab; Drug: Tocilizumab

Combination Dose Escalation: TAK 500 24 µg/kg + Pembrolizumab + 2 DEX

EXPERIMENTAL

Participants received premedication with dexamethasone 10 mg tablet orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W , for up to 1 year along with pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle Q3W for up to 1 year.

Drug: TAK-500; Drug: Pembrolizumab; Drug: Dexamethasone

Combination Dose Escalation: TAK-500 40 µg/kg + Pembrolizumab + 2 DEX

EXPERIMENTAL

Participants received premedication with dexamethasone 10 mg tablet orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W , for up to 1 year along with pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle Q3W for up to 1 year.

Drug: TAK-500; Drug: Pembrolizumab; Drug: Dexamethasone

Dose Expansion: TAK-500

EXPERIMENTAL

Participants were planned to receive TAK-500 at recommended doses based on dose escalation cohorts. No participants were enrolled in the expansion phase due to early termination of the study before initiating this phase.

Drug: TAK-500

Interventions

TAK-500 DRUG

TAK-500 IV infusion.

Combination Dose Escalation: TAK 500 24 µg/kg + Pembrolizumab + 2 DEX; Combination Dose Escalation: TAK-500 16 µg/kg + Pembrolizumab + 1 TOCI; Combination Dose Escalation: TAK-500 40 µg/kg + Pembrolizumab + 2 DEX; Combination Dose Escalation: TAK-500 8 µg/kg + 1 TOCI + Pembrolizumab; Dose Expansion: TAK-500; Single Agent Dose Escalation: TAK-500 16 µg/kg; Single Agent Dose Escalation: TAK-500 16 µg/kg + 1 DEX; Single Agent Dose Escalation: TAK-500 16 µg/kg + 1 TOCI; Single Agent Dose Escalation: TAK-500 16 µg/kg + 2 DEX; Single Agent Dose Escalation: TAK-500 24 µg/kg + 1 TOCI; Single Agent Dose Escalation: TAK-500 24 µg/kg + 2 DEX; Single Agent Dose Escalation: TAK-500 40 µg/kg + 2 DEX; Single Agent Dose Escalation: TAK-500 60 µg/kg + 2 DEX; Single Agent Dose Escalation: TAK-500 8 µg/kg; Single Agent Dose Escalation: TAK-500 8 µg/kg + 1 TOCI

Pembrolizumab DRUG

Pembrolizumab IV infusion.

Combination Dose Escalation: TAK 500 24 µg/kg + Pembrolizumab + 2 DEX; Combination Dose Escalation: TAK-500 16 µg/kg + Pembrolizumab + 1 TOCI; Combination Dose Escalation: TAK-500 40 µg/kg + Pembrolizumab + 2 DEX; Combination Dose Escalation: TAK-500 8 µg/kg + 1 TOCI + Pembrolizumab

Tocilizumab DRUG

Tocilizumab IV infusion.

Combination Dose Escalation: TAK-500 16 µg/kg + Pembrolizumab + 1 TOCI; Combination Dose Escalation: TAK-500 8 µg/kg + 1 TOCI + Pembrolizumab; Single Agent Dose Escalation: TAK-500 16 µg/kg + 1 TOCI; Single Agent Dose Escalation: TAK-500 24 µg/kg + 1 TOCI; Single Agent Dose Escalation: TAK-500 8 µg/kg + 1 TOCI

Dexamethasone DRUG

Dexamethasone IV infusion.

Combination Dose Escalation: TAK 500 24 µg/kg + Pembrolizumab + 2 DEX; Combination Dose Escalation: TAK-500 40 µg/kg + Pembrolizumab + 2 DEX; Single Agent Dose Escalation: TAK-500 16 µg/kg + 1 DEX; Single Agent Dose Escalation: TAK-500 16 µg/kg + 2 DEX; Single Agent Dose Escalation: TAK-500 24 µg/kg + 2 DEX; Single Agent Dose Escalation: TAK-500 40 µg/kg + 2 DEX; Single Agent Dose Escalation: TAK-500 60 µg/kg + 2 DEX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.
• For dose expansion in 2L nonsquamous NSCLC (TAK-500 plus pembrolizumab):
• Participants with pathologically confirmed (cytological diagnosis is adequate) locally advanced or metastatic nonsquamous NSCLC.
• Participants may not have a known targetable driver mutation, rearrangement or amplification (eg, EGFR, ALK, MET, ROS1, BRAF, KRASG12C, etc.).
• Must have had disease progression while on or following 1 prior line of therapy:
• \- Disease progression while on or following at least 6 weeks of 1 prior anti-PD-(L)1 therapy in the recurrent locally advanced or metastatic setting. OR Disease progression/recurrence within 6 months of the completion of anti-PD-(L)1 therapy if administered in the adjuvant/neoadjuvant setting. Prior anti-PD-(L)1 therapy may have been given with or without an anti-CTLA4 antibody and/or chemotherapy (eg, carboplatin and pemetrexed).
• Participants are eligible regardless of PD-L1 status.
• For dose expansion in 3L nonsquamous NSCLC (TAK-500 SA):
• Participants with pathologically confirmed (cytological diagnosis is adequate) locally advanced or metastatic nonsquamous NSCLC.
• Participants may not have a known targetable driver mutation, rearrangement or amplification (eg, EGFR, ALK, MET, ROS1, BRAF, KRASG12C, etc.).
• Must have had disease progression while on or following 2 prior lines of therapy:
• Disease progression while on or following at least 6 weeks of 1 prior anti-PD-(L)1 therapy in the recurrent locally advanced or metastatic setting OR Disease progression/recurrence within 6 months of the completion of 1 prior anti-PD-(L)1 therapy if administered in the adjuvant/neoadjuvant setting. Prior anti-PD-(L)1 therapy may have been given with or without an anti-CTLA4 antibody and/or chemotherapy (eg, carboplatin and pemetrexed).
• Participants must have had disease progression while on or after 1 or 2 lines of chemotherapy in the recurrent locally advanced or metastatic setting. If the anti-PD-(L)1 therapy is given in combination with chemotherapy, participant must have progressed on an additional line of chemotherapy.

You may not qualify if:

• History of any of the following \<=6 months before first dose of study drug(s): congestive heart failure New York Heart Association Grade III or IV, unstable angina, myocardial infarction, persistent hypertension \>=160/100 millimeters of mercury (mmHg) despite optimal medical therapy, ongoing cardiac arrhythmias of Grade \>2 (including atrial flutter/ fibrillation or intermittent ventricular tachycardia), other ongoing serious cardiac conditions (example, Grade 3 pericardial effusion or Grade 3 restrictive cardiomyopathy), or symptomatic cerebrovascular events. Chronic, stable atrial fibrillation on stable anticoagulation therapy, including low molecular-weight heparin, is allowed.
• QT interval with Fridericia correction method \>450 milliseconds (men) or \>475 milliseconds (women) on a 12- lead ECG during the screening period.
• Grade \>=2 hypotension (that is, hypotension for which nonurgent intervention is required) at screening or during C1D1 predose assessment.
• Oxygen saturation \<92% on room air at screening or during C1D1 predose assessment.
• Treatment with other STING agonists/antagonists, Toll-like receptor agonists or CCR2 agonist/antagonist within the past 6 months.
• Active diagnosis of pneumonitis, interstitial lung disease, severe chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, other restrictive lung diseases, acute pulmonary embolism, or Grade \>=2 pleural effusion not controlled by tap or requiring indwelling catheters.
• Grade \>=2 fever of malignant origin.
• Chronic, active hepatitis (example, participants with known hepatitis B surface antigen seropositive and/or detectable hepatitis C virus \[HCV\] RNA).
• History of hepatic encephalopathy.
• Prior or current clinically significant ascites, as measured by physical examination, that requires active paracentesis for control.
• Treatment with any investigational products or other anticancer therapy (including chemotherapy, targeted agents, and immunotherapy), within 14 days or 5 half-lives, whichever is shorter, before C1D1 of study drug(s).
• Radiation therapy within 14 days (42 days for radiation to the lungs) and/ or systemic treatment with radionuclides within 42 days before C1D1 of study drug(s). Participants with clinically relevant ongoing pulmonary complications from prior radiation therapy are not eligible.
• Use of systemic corticosteroids or other immunosuppressive therapy, concurrently or within 14 days of C1D1 of study drug(s), with the following exceptions:
• Topical, intranasal, inhaled, ocular, intra-articular, and/or other nonsystemic corticosteroids.
• Physiological doses of replacement steroid therapy (example, for adrenal insufficiency), not to exceed the equivalent of 10 mg prednisone daily.

Sponsors & Collaborators

• Takeda: lead

Study Sites (12)

Univeristy of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

University of California San Diego

La Jolla, California, 92093, United States

Location

University of Colorado - Anschutz Medical Campus - PPDS

Aurora, Colorado, 80045, United States

Location

Sarah Cannon Research Institute

Denver, Colorado, 80218, United States

Location

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Northwestern

Chicago, Illinois, 60611, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

New York University

New York, New York, 10016-4744, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Sarah Cannon Cancer Institute

Nashville, Tennessee, 37203, United States

Location

START South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

Related Links

• To obtain more information on the study, click here/on this link

MeSH Terms

Conditions

Pancreatic Neoplasms; Liver Neoplasms; Mesothelioma; Breast Neoplasms; Stomach Neoplasms; Esophageal Neoplasms; Nasopharyngeal Neoplasms; Kidney Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab; tocilizumab; Dexamethasone

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Liver Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: October 7, 2021
• Study Start: April 14, 2022
• Primary Completion: January 6, 2025
• Study Completion: January 6, 2025
• Last Updated: January 22, 2026
• Results First Posted: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

US (12)