A Study of Dazostinag as Single Agent and Dazostinag in Combination With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors

NCT04420884 | Completed Phase 1 FDA Drug

• 4 other identifiers: TAK-676-1002U1111-1241-44272023-505627-30-00jRCT2031230532
• Study Type: interventional
• Target: 248
• Locations: 11 countries
• Sites: 62

Brief Summary

The main aim of this study is to check if people with advanced solid tumors have side effects from dazostinag, and to check how much dazostinag they can receive without getting significant side effects from it when given alone and in combination with pembrolizumab. The study will be conducted in two phases including a dose escalation phase and a dose expansion phase. In the dose escalation phase, escalating doses of dazostinag are being tested alone and in combination with pembrolizumab to treat participants who have advanced or metastatic solid tumors. In the dose expansion phase, dazostinag will be studied with pembrolizumab with or without chemotherapy in participants with untreated metastatic or recurrent, unresectable squamous cell carcinoma of head and neck (SCCHN) and in combination with pembrolizumab in third-line or later recurrent locally advanced or metastatic microsatellite instability-high/mismatch repair deficient (MSI-H/dMMR) and third-line recurrent locally advanced or metastatic microsatellite stable/mismatch repair proficient (MSS/pMMR) colorectal cancer (CRC).

Conditions

Solid Neoplasms

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (4)

• Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Based on TEAEs Severity

  A severity grade is defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. Grade 1 scales as Mild (asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 scales as Moderate (minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living \[ADL\]); Grade 3 scales as Severe (severe or medically significant but not immediately life threatening hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4 scales as Life-threatening consequences, urgent intervention indicated, and Grade 5 scales as Death related to Adverse Event (AE).

  Up to approximately 68 months

• Number of Participants with Dose-Limiting Toxicities (DLTs)

  A DLT will be defined as any of the TEAEs, but not limited to, those that occur during Cycle 1 and are considered by the investigator to be at least possibly related to dazostinag as a SA or in combination with pembrolizumab. TEAEs meeting DLT definitions occurring in Cycle 2 or later will be considered in the determination of the RDE of dazostinag, both in the dazostinag SA and the combination with pembrolizumab arms. Toxicity will be evaluated according to NCI CTCAE version 5.0.

  Up to approximately 68 months

• Number of Participants Reporting One or More Treatment Emergent Serious Adverse Event (SAEs)

  Up to approximately 68 months

• Number of Participants With one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations

  Up to approximately 68 months

Secondary Outcomes (8)

• Dose Escalation, Japan Safety Lead-in, and Expansion Phases: Overall Response Rate (ORR)

  Up to approximately 68 months

• Dose Escalation, Japan Safety Lead-in, and Expansion Phases: Disease Control Rate (DCR)

  Up to approximately 68 months

• Dose Escalation, Japan Safety Lead-in, and Expansion Phases: Duration of Response (DOR)

  Up to approximately 68 months

• Dose Escalation, Japan Safety Lead-in, and Expansion Phases: Time to Response (TTR)

  Up to approximately 68 months

• Expansion Phase Only: Progression-Free Survival (PFS)

  Up to approximately 29 months

Study Arms (8)

Part 1 (Monotherapy Dose Escalation Phase): Dazostinag Safety Lead-in + Dazostinag SA [Part 1A]

EXPERIMENTAL

Safety Lead-in: Dazostinag 0.1 mg, infusion, intravenously (IV), once weekly, on Days 1, 8 and 15 in 21-day treatment cycles. Dazostinag SA Dose Escalation (Part 1A): Dazostinag single agent (SA), infusion, IV, once weekly on Days 1, 8 and 15 in each 21-day treatment cycles with escalating doses (0.2 mg and above). The dosing will be initiated in the Dazostinag SA Dose Escalation Phase based on the available safety and tolerability data from the Safety Lead-in.

Drug: Dazostinag

Part 1B (Combination Dose Escalation Phase): Dazostinag + Pembrolizumab

EXPERIMENTAL

Dazostinag escalating doses (0.2 mg and above) in combination with pembrolizumab 200 mg, infusion, IV, once weekly on Days 1, 8 and 15 in each 21-day treatment cycle. Pembrolizumab 200 mg will be administered 1 hour prior to Dazostinag once every 3 weeks (Q3W). The dosing will be initiated when at least two dose levels (DLs) of Part 1A have been evaluated.

Drug: Dazostinag; Drug: Pembrolizumab

Arm A: Japan Safety Lead-in Dazostinag + Pembrolizumab

EXPERIMENTAL

Dazostinag 5.0 mg, infusion, IV, in Japanese participants with advanced or metastatic solid tumors on Days 1, 8, and 15 in each 21-day cycle in combination with pembrolizumab 200 mg administered Q3W, IV, on Day 1 in each 21-day cycle. Additional dose levels of Dazostinag (such as 14.0 mg) in combination with pembrolizumab (200 mg, Q3W) may be explored in the Safety Lead-in.

Drug: Dazostinag; Drug: Pembrolizumab

Arm B: Japan Safety Lead-in Dazostinag Transitioned to Pembrolizumab

EXPERIMENTAL

Dazostinag 5.0 mg, infusion, IV, as an SA once on Day 1 in Cycle 0 (cycle length=7 days) in Japanese participants with advanced or metastatic solid tumors based on confirmation of tolerability in Arm A. Following Cycle 0 (7 days), participants will be transitioned to the same dose level of dazostinag on Days 1, 8, and 15 of each 21-day cycle in combination with pembrolizumab administered Q3W, IV, on Day 1 in each 21-day cycle. Additional dose levels of dazostinag (such as ≥ 7.0 mg) in combination with pembrolizumab (200 mg, Q3W) may be explored in the Safety Lead-in.

Drug: Dazostinag; Drug: Pembrolizumab

Part 2A (SCCHN CPS ≥ 1 Dose Expansion and Optimization Phase): Dazostinag + Pembrolizumab

EXPERIMENTAL

Dazostinag 5.0 mg, infusion, IV, will be administered in participants with squamous cell carcinoma of head and neck (SCCHN) at the identified dose level from Part 1 on Days 1, 8, and 15 in a 21-day cycle along with pembrolizumab 200 mg infusion, IV, Q3W. Dose optimization may be performed in this phase.

Drug: Dazostinag; Drug: Pembrolizumab

Part 2B (SCCHN Dose Expansion Phase): Dazostinag + Pembrolizumab + Chemotherapy

EXPERIMENTAL

Dazostinag 5.0 mg, infusion, IV, will be administered in participants with SCCHN at the identified dose level from Part 1 on Days 1, 8, and 15 in a 21-day cycle. Pembrolizumab infusion, IV will be administered at 200 mg Q3W. Platinum-based chemotherapy comprising the combination of carboplatin (target area under the curve of 5 milligrams per milli Liters per minute (mg/mL/minute) \[AUC 5\]) or cisplatin (100 milligrams per square meter \[mg/m\^2\] Day 1 of each treatment cycle), and 5-fluorouracil (\[5-FU\]; 1000 mg/m\^2 per day for 4 consecutive days) Q3W for up to 6 cycles.

Drug: Dazostinag; Drug: Pembrolizumab; Drug: Platinum; Drug: 5-fluorouracil

Part 3A (Expansion Phase in CRC): Dazostinag + Pembrolizumab in MSI-H/dMMR CRC

EXPERIMENTAL

Dazostinag 5.0 mg, infusion, IV, will be administered in participants with microsatellite instability-high /mismatch repair deficient (MSI-H/dMMR) colorectal cancer (CRC) at the identified dose level from Part 1 on Days 1, 8, and 15 in a 21-day cycle along with pembrolizumab 200 mg infusion, IV, Q3W.

Drug: Dazostinag; Drug: Pembrolizumab

Part 3B (Expansion Phase in CRC): Dazostinag + Pembrolizumab in MSS/pMMR CRC

EXPERIMENTAL

Dazostinag 5.0 mg, infusion, IV, will be administered in participants with microsatellite stable/mismatch repair proficient (MSS/pMMR) CRC at the identified dose level from Part 1 on Days 1, 8, and 15 in a 21-day cycle. along with pembrolizumab 200 mg infusion, IV, Q3W.

Drug: Dazostinag; Drug: Pembrolizumab

Interventions

Dazostinag DRUG

Dazostinag intravenous infusion.

Also known as: TAK-676

Arm A: Japan Safety Lead-in Dazostinag + Pembrolizumab; Arm B: Japan Safety Lead-in Dazostinag Transitioned to Pembrolizumab; Part 1 (Monotherapy Dose Escalation Phase): Dazostinag Safety Lead-in + Dazostinag SA [Part 1A]; Part 1B (Combination Dose Escalation Phase): Dazostinag + Pembrolizumab; Part 2A (SCCHN CPS ≥ 1 Dose Expansion and Optimization Phase): Dazostinag + Pembrolizumab; Part 2B (SCCHN Dose Expansion Phase): Dazostinag + Pembrolizumab + Chemotherapy; Part 3A (Expansion Phase in CRC): Dazostinag + Pembrolizumab in MSI-H/dMMR CRC; Part 3B (Expansion Phase in CRC): Dazostinag + Pembrolizumab in MSS/pMMR CRC

Pembrolizumab DRUG

Pembrolizumab intravenous infusion.

Arm A: Japan Safety Lead-in Dazostinag + Pembrolizumab; Arm B: Japan Safety Lead-in Dazostinag Transitioned to Pembrolizumab; Part 1B (Combination Dose Escalation Phase): Dazostinag + Pembrolizumab; Part 2A (SCCHN CPS ≥ 1 Dose Expansion and Optimization Phase): Dazostinag + Pembrolizumab; Part 2B (SCCHN Dose Expansion Phase): Dazostinag + Pembrolizumab + Chemotherapy; Part 3A (Expansion Phase in CRC): Dazostinag + Pembrolizumab in MSI-H/dMMR CRC; Part 3B (Expansion Phase in CRC): Dazostinag + Pembrolizumab in MSS/pMMR CRC

Platinum DRUG

Carboplatin or Cisplatin intravenous infusion

Part 2B (SCCHN Dose Expansion Phase): Dazostinag + Pembrolizumab + Chemotherapy

5-fluorouracil DRUG

5-fluorouracil intravenous infusion

Part 2B (SCCHN Dose Expansion Phase): Dazostinag + Pembrolizumab + Chemotherapy

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.
• Dazostinag SA (dose escalation Part 1A):
• o With histologically confirmed (cytological diagnosis is acceptable) advanced or metastatic solid tumors that have no standard therapeutic options or are intolerant to these therapies.
• Dazostinag in combination with pembrolizumab (dose escalation Parts 1B and Japan safety lead-in):
• With histologically confirmed (cytological diagnosis is acceptable) advanced or metastatic solid tumors that have no standard therapeutic options or are intolerant to them, including:
• Tumors that have relapsed or are refractory to anti-programmed cell death ligand protein 1 (anti PD-(L)-1) therapy.
• Tumors that are naive to anti-PD-(L)-1 therapy.
• For expansion phase only:
• SCCHN (Part 2):
• Participants with histologically confirmed (cytological diagnosis is acceptable) metastatic or recurrent, unresectable SCCHN that is considered incurable by local therapies. Participants should not have had prior systemic therapy administered in the recurrent or metastatic setting. Systemic therapy which was completed more than 6 months before signing consent if given as part of multimodal treatment of locally advanced disease is allowed.
• Anatomic subsites to be included are oral cavity, oropharynx, hypopharynx, larynx, nasal cavity, and paranasal sinuses (maxillary, ethmoid, sphenoid, and frontal). The exception to this is nasopharyngeal cancer and salivary gland tumors, which will not be included.
• Participants with oropharyngeal cancer or tumors arising in the paranasal sinuses (maxillary, ethmoid, sphenoid, and frontal) must agree to provide archival tissue for human papilloma virus (HPV) testing or if known, HPV testing results (using CINtec® p16 Histology assay is preferred but not required) and a 70% cutoff point must be provided. Alternatively, archival tissue or a fresh excisional or core needle biopsy (≥ 2 cores) is required for the determination of HPV status. If HPV status was previously tested using this method (CINtec® p16 Histology assay is preferred but not required), no additional testing is required. Archival tissue can be obtained up to 90 days prior to screening. Samples that are older than 90 days at screening may be used after consultation with the sponsor.
• For Part 2A, tumors must have a PD-L1 CPS ≥ 1. Participants must agree to provide fresh tumor biopsy for analysis from a core or excisional biopsy (fine needle aspirate is not sufficient) at screening for PD-L1 CPS assessment by a central laboratory. This specimen may be the diagnostic sample for participants with a new diagnosis of metastatic SCCHN. Participants for whom newly obtained samples cannot be obtained (eg, inaccessible or participant safety concern) may submit an archived specimen only upon agreement from the Sponsor. Archival tissue can be obtained up to 90 days prior to screening provided there was no other treatment from the time of biopsy until the start of study treatment. For Part 2B, any CPS is eligible but fresh or archival tissue is required for confirmation of CPS status. Collection of the tissue samples for PD-L1 assessments for Part 2B can be discontinued by the sponsor if sufficient data has been collected or dazostinag activity does not justify further collection.
• For Part 2B, participants must be eligible to receive treatment with either cisplatin or carboplatin in combination with 5-fluorouracil (5-FU) per the treating physician.
• CRC (Part 3):

You may not qualify if:

• Corrected QT interval by Fredericia (QTcF) greater than (\>) 450 milliseconds (men) or \> 475 milliseconds (women) on a 12-lead electrocardiogram (ECG) during the screening period.
• Grade greater than or equal to (≥) 2 hypotension (that is, hypotension for which nonurgent intervention is required) at screening or during Cycle 0 Day 1 (C0D1) \[for Japan safety lead-in only\] and Cycle 1 Day 1 (C1D1) predose assessment.
• Oxygen saturation less than (\<) 92 percent (%) on room air at screening or during C0D1 (for Japan safety lead-in only) and C1D1 predose assessment.
• Treated with other STING agonists/antagonist and toll-like receptors agonists within the past 6 months.
• Current history 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 or ascites not controlled by tap or requiring indwelling catheters.
• History of brain and leptomeningeal metastasis unless:
• Brain metastases are clinically and radiologically stable or improved (that is, ≥ 4 weeks) following surgery, whole-brain radiation, or stereotactic radiosurgery, AND
• Off corticosteroids.
• Ongoing Grade ≥ 2 infection or participants with Grade ≥ 2 fever of malignant origin.
• Chronic, active hepatitis (example: participants with known hepatitis B surface antigen seropositive and/or detectable hepatitis C virus \[HCV\]- ribonucleic acid \[RNA\]).
• For participants in the dose escalation SA Part 1A only: refusal of standard therapeutic options.
• For participants receiving pembrolizumab only: contraindication and/or intolerance to the administration of pembrolizumab.
• For participants receiving chemotherapy in Part 2B: contraindication and/or intolerance to the administration of both platinum agents (cisplatin and carboplatin) and/or 5-FU.
• Participant has had any other prior or concurrent malignancy within 2 years prior to enrollment with the following exceptions: adequately treated localized basal cell or squamous cell carcinoma, or curatively treated in situ carcinoma of the cervix or breast. Other exceptions may be considered upon sponsor consultation.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (62)

University of California San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

Norris Comprehensive Cancer Center

Los Angeles, California, 90089-1019, United States

Location

UCI Health - Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

University of California Los Angeles - Jonsson Comprehensive Cancer Center

Santa Monica, California, 90404-2023, United States

Location

SCRI - HealthOne Denver

Denver, Colorado, 80218-1238, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06519, United States

Location

Memorial Cancer Institute at Memorial Hospital West - Cancer Institute/Radiology Oncology

Gainesville, Florida, 32610, United States

Location

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Barbara Ann Karmanos Cancer Institute - Lawrence and Idell Weisberg Cancer Treatment Center

Detroit, Michigan, 48201, United States

Location

Siteman Cancer Center - St. Peters

City of Saint Peters, Missouri, 63376, United States

Location

Siteman Cancer Center - West County

Creve Coeur, Missouri, 63141, United States

Location

Siteman Cancer Center - North County

Florissant, Missouri, 63031, United States

Location

Washington University School of Medicine Siteman Cancer Center

St Louis, Missouri, 63110-1032, United States

Location

Siteman Cancer Center - South County

St Louis, Missouri, 63129, United States

Location

University of Cincinnati Health Barrett Cancer Center

Cincinnati, Ohio, 45019, United States

Location

University of Cincinnati Health Barrett Cancer Center

Cincinnati, Ohio, 45219-2354, United States

Location

West Chester Hospital

West Chester, Ohio, 45069, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Sarah Cannon Research Institute (SCRI)

Nashville, Tennessee, 37203, United States

Location

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

Location

Virginia Cancer Specialists, P.C. - Fairfax

Fairfax, Virginia, 22031-2171, United States

Location

Klinikum Wels-Grieskirchen

Wels, Upper Austria, 4600, Austria

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Beijing Cancer Hospital

Beijing, Beijing Sheng, 100142, China

Location

Sixth Affiliated Hospital of Sun Yat-Sen University/Guangdong Gastrointestinal Hospital

Guangzhou, Guangzhou Sheng, 510655, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200025, China

Location

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200123, China

Location

West China Hospital

Chengdu, Sichuan, 610041, China

Location

West China School of Medicine - West China Hospital of Sichuan University

Chengdu, Sichuan, 610610, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz

Besançon, 25000, France

Location

Hopital Saint-Andre

Bordeaux, 33000, France

Location

Centre Georges Francois Leclerc

Dijon, 21079, France

Location

Centre de Lutte contre le Cancer - Centre Oscar Lambret

Lille, 59000, France

Location

Centre Leon Berard

Lyon, 69008, France

Location

Hopital de la Timone

Marseille, 13385, France

Location

Hopital Saint-Antoine

Paris, 75012, France

Location

Institut de Cancerologie de lOuest - Saint-Herblain - Site Rene Gauducheau

Saint-Herblain, 44805, France

Location

Gustave Roussy

Villejuif, 94805, France

Location

Hopital Foch

Suresnes, Île-de-France Region, 92150, France

Location

Soroka Medical Center

Beersheba, 9457108, Israel

Location

Hadassah University Hospital Ein Kerem

Jerusalem, 9112001, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

The Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

National Cancer Center Hospital

Chuo-Ku, Tokyo, 104-0045, Japan

Location

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

Warsaw, Masovian Voivodeship, 02-034, Poland

Location

PanOncology Trials: Universidad de Puerto Rico - Centro Comprensivo de Cancer

San Juan, 00936, Puerto Rico

Location

Kantonsspital Sankt Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

Inselspital Universitatsspital Bern

Bern, 3010, Switzerland

Location

Hopitaux Universitaires de Geneve

Geneva, 1205, Switzerland

Location

Centre Hospitalier Universitaire Vaudois Lausanne

Lausanne, 1011, Switzerland

Location

Queen's University Belfast

Belfast, Northern Ireland, BT9 7BL, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

Location

University College London Hospitals NHS Foundation Trust

London, NW1 2BU, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, Ox1 2JD, United Kingdom

Location

Related Publications (2)

• Saravanakumar A, Deng R, Dong L, Haridas S, Xia CQ, Appleman VA, Abu-Yousif AO, Piatkov K, Wang H. Population-Based Modeling to Predict Human PK/PD of TAK-500, an Anti-CCR2 Antibody-Drug Conjugate for First-in-Human Study in Cancer Patients. Clin Transl Sci. 2026 Apr;19(4):e70522. doi: 10.1111/cts.70522.

  PMID: 41888610 DERIVED

• Carideo Cunniff E, Sato Y, Mai D, Appleman VA, Iwasaki S, Kolev V, Matsuda A, Shi J, Mochizuki M, Yoshikawa M, Huang J, Shen L, Haridas S, Shinde V, Gemski C, Roberts ER, Ghasemi O, Bazzazi H, Menon S, Traore T, Shi P, Thelen TD, Conlon J, Abu-Yousif AO, Arendt C, Shaw MH, Okaniwa M. TAK-676: A Novel Stimulator of Interferon Genes (STING) Agonist Promoting Durable IFN-dependent Antitumor Immunity in Preclinical Studies. Cancer Res Commun. 2022 Jun 23;2(6):489-502. doi: 10.1158/2767-9764.CRC-21-0161. eCollection 2022 Jun.

  PMID: 36923556 DERIVED

Related Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
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MeSH Terms

Interventions

pembrolizumab; Platinum; Fluorouracil

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

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: June 4, 2020
• First Posted: June 9, 2020
• Study Start: July 22, 2020
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

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

CN (7); CH (4); IL (4); CA (3); FR (10); PR (1); US (26); PL (1); AU (1); JP (1); GB (4)