Trial: Safety and Efficacy of EIK1001 in Combo…

Trial Details

Sponsor: Eikon Therapeutics (industry)

Phase: 2/3

Start date: May 22, 2025

Planned enrollment: 740

Trial ID: NCT06697301

More trial details at ClinicalTrials.gov

Show Summary from Sponsor

Investigational Drug AI Analysis

Show for: EIK1001 (BDB001)

Overview

EIK1001, formerly BDB001, is an investigational, intravenously administered small-molecule immunotherapy and dual agonist of Toll-like receptors 7 and 8 (TLR7/8). It is being developed for solid tumors, principally in combination with immune-checkpoint inhibitors and, in non-small-cell lung cancer (NSCLC), chemotherapy. Clinical development includes Phase 2 NSCLC and Phase 2/3 advanced-melanoma studies; no regulatory approval has been reported. (sec.gov)

Mechanism of action

TLR7 activation in plasmacytoid dendritic cells promotes type I interferon signaling and innate immunity, while TLR8 activation stimulates myeloid dendritic cells and antigen presentation, supporting tumor-specific T-cell priming. Systemic intravenous administration is intended to activate immune cells in lymphoid tissues rather than only within injected tumors. Clinical pharmacodynamic studies found increases in interferon-γ, IP-10 and other cytokines consistent with TLR7/8 activation. (eikontx.com)

Efficacy

First-line stage IV NSCLC: In the open-label Phase 2 TeLuRide-005 study, EIK1001 plus pembrolizumab and chemotherapy produced a 61% objective response rate (ORR) and 90% disease-control rate (DCR) among 71 treated patients. ORR was 55.6% in nonsquamous and 68.0% in squamous NSCLC; the respective DCRs were 83.3% and 100%. Because this was a nonrandomized study, the contribution of EIK1001 beyond standard pembrolizumab plus chemotherapy remains uncertain. (ascopubs.org)
Monotherapy, advanced solid tumors: A Phase 1 study reported two partial responses among 32 efficacy-evaluable patients (ORR 6%) and a 62% DCR, including durable responses in renal-cell carcinoma and NSCLC. (jitc.bmj.com)
With pembrolizumab: In Phase 1 dose escalation, four of 14 patients at the two highest dose levels responded (29%), with an overall 57% DCR in that subgroup. (ascopubs.org)
With atezolizumab: A Phase 1 study reported responses in 3/37 patients (ORR 8.1%), a 51.4% DCR, and a median response duration of 13 months. (ascopubs.org)
Pancreatic adenocarcinoma: In the Phase 2 AGADIR study combining BDB001, atezolizumab and stereotactic radiotherapy, central review found partial responses in 2/21 patients (9.5%) and a 38% DCR. (s3.amazonaws.com)

Safety

In TeLuRide-005, 76.1% of patients experienced at least one grade ≥3 treatment-emergent adverse event and 46.5% experienced a serious adverse event; these rates include toxicities from the entire pembrolizumab–chemotherapy combination. Cytokine-release syndrome occurred in seven patients and was limited to grade 1–2. (ascopubs.org)

Earlier Phase 1 monotherapy data showed mostly grade 1–2 events—commonly chills/rigors, fever, fatigue, nausea and pruritus. Grade 3 treatment-related events occurred in 8.3%, including two cases of cytokine-release syndrome; no grade 4–5 treatment-related events were reported. With pembrolizumab, 13% had grade 3 treatment-related events and none had grade 4–5 events. (jitc.bmj.com)

TrialFetch AI Analysis

Goal: Determine whether adding EIK1001 to first-line pembrolizumab improves outcomes in advanced melanoma while evaluating safety and selecting a dose.

Patients: Adults with unresectable stage III or metastatic stage IV melanoma, measurable disease, ECOG performance status 0–1, and eligibility for pembrolizumab. Prior systemic treatment for advanced disease is excluded; prior adjuvant or neoadjuvant therapy may be allowed under specified conditions. Active CNS metastases are excluded, but stable, previously treated brain metastases may be permitted.

Design: Multicenter, randomized, double-blind, active comparator-controlled, adaptive study with dose-optimization and expansion components.

Treatments: Participants receive pembrolizumab with placebo or with one of two selected doses of EIK1001. Pembrolizumab is a standard anti–PD-1 immunotherapy for advanced melanoma. EIK1001 is an investigational intravenous TLR7/8 agonist intended to enhance innate immune activation and tumor-specific T-cell priming. Early studies in advanced solid tumors reported responses with EIK1001 plus pembrolizumab, but its added benefit has not been established in a randomized trial; no efficacy results from this melanoma trial are provided.

Outcomes: Primary outcomes are progression-free survival by blinded independent central review and overall survival, each assessed for up to five years. In dose optimization, primary measures also include investigator-assessed objective response and adverse events or treatment discontinuation due to adverse events. Secondary measures include response, duration of response, investigator-assessed progression-free survival, and safety.

Burden on patient: Likely moderate. Patients receive pembrolizumab plus an additional intravenous investigational treatment or placebo, requiring treatment visits and monitoring for adverse effects. Screening includes imaging, laboratory tests, and BRAF status assessment or testing; follow-up includes scans and survival assessment. The schedule of visits and scans and any research-specific blood draws or biopsies are not specified, so the additional burden beyond standard pembrolizumab care cannot be quantified.

Last updated: Sep 2026

Eligibility

Show Criteria

Inclusion Criteria:

To be eligible for inclusion in this study, participants must:

* Be ≥ 18 years of age on the day of signing of informed consent.

* Have a life expectancy of at least 3 months.

* Have histologically or cytologically confirmed Stage 3 (unresectable) or Stage 4 metastatic melanoma per AJCC 8th ed. and be eligible for standard therapy with pembrolizumab.

* Have at least 1 lesion with measurable disease at Baseline by CT or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by assessment of local site Investigator/radiologist.

* Have known BRAF V600 mutation status or consent to BRAF V600 mutation testing per local institutional standards during the screening period

* Have completed prior radiotherapy at least 2 weeks prior to study treatment administration.

* Have an ECOG Performance Status of 0 to 1.

* Have adequate organ and marrow function as defined by normal CBC, coagulation, serum chemistry and liver function tests on specimens collected within 10 days of treatment start.

* Have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study medication (applies to women of childbearing potential \[WOCBP\]).

* Be willing to use either 2 adequate methods of contraception, 1 adequate method plus a hormonal method of contraception, or be willing to abstain from heterosexual activity throughout the study (Visit 1 to 120 days after the last dose of study therapy; applies to WOCBP who are not menopausal for \> 2 years, post-hysterectomy/oophorectomy, or surgically sterilized).

* Agree to use an approved adequate contraceptive method throughout the study (Visit 1 to 120 days after the last dose of study therapy; applies to sexually active male participants with a partner who is WOCBP).

* Be willing and able to provide written, informed consent for the study.

Exclusion Criteria:

A participant is excluded from the study if any of the following criteria apply:

* Has melanoma of ocular origin.

* Is currently enrolled in or has recently participated in a study of an IMP and received an IMP within 4 weeks or 5 half-lives (whichever is shorter) of administration of EIK1001 or placebo.

* Prior to the 1St dose of EIK1001 or placebo, the prospective participant has received systemic therapy for advanced melanoma.

* Note: prior adjuvant or neoadjuvant melanoma therapies (such as anti-PD-1 or anti CTLA 4 therapies or BRAF/MEK inhibitors) are permitted if all related AEs have either returned to Baseline or stabilized, with a minimum of 6 months between the last dose of prior therapy and documented disease progression.

* Experienced a ≥ Grade 3 AE while receiving prior anti PD 1 therapy.

* Has had major surgery (\< 3 weeks prior to the first dose).

* Has received a live-virus vaccination within 30 days of the first dose of study treatment.

* Has a known history of prior malignancy, unless the participant has undergone potentially curative therapy with no evidence of disease recurrence for 5 years.

* Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate if they are clinically stable for at least 4 weeks with no evidence of new or enlarging brain metastases. There must be no need for immunosuppressive doses of glucocorticoids for at least 2 weeks prior to study treatment administration.

* There is a mean resting QTcF \> 470 ms on triplicate electrocardiograms.

* There is active autoimmune disease that has required systemic treatment in the past 2 years. The following autoimmune conditions are permitted: Type 1 diabetes, hypothyroidism (on hormone replacement), or- vitiligo, psoriasis and alopecia as long as no systemic treatment is required.

* There is either chronic treatment with systemic steroids, other immunosuppressive medication, or either of these has been administered within 14 days of start of study treatment.

* Note: Participants with asthma that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections are eligible. Steroid replacement for adrenal insufficiency is also permitted.

* There is a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/ interstitial lung disease.

* There are any active infections requiring therapy.

* There is uncontrolled human immunodeficiency virus (HIV) infection. HIV-infected participants with well-controlled HIV may enroll.

* There is a positive test result for hepatitis B virus (HBV) or HCV indicating presence of virus (it is expected that all participants will have been serologically tested for hepatitis B in advance of this study, with HBsAG, anti-HBc IgG, and anti-HBs as per ASCO 2020 Provisional Clinical Opinion \[PCO\] on universal Serologic testing for hepatitis B at the onset of anticancer therapy; screening should also include an anti-HCV test prior to start of cancer treatment:

* There is a history or clinical evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study or interfere with the participant's participation for the full duration of the study

* Known psychiatric or substance abuse disorder that would interfere with cooperation with study requirements.

* There is a known history of regular illicit drug use and/or recent history (within the last year) of substance abuse (including alcohol).

* Participant is pregnant, breastfeeding, or planning to conceive or father children within the projected duration of the study.

* Participant is currently receiving medications known to be strong inhibitors or inducers of CYP3A4 and CYP1A2.

Sites (77)

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Cancer Care Wollongong

Wollongong, New South Wales, 2500, Australia

[email protected] / +61 242439708

Status: Recruiting

Icon Cancer Centre Chermside

Chermside, Queensland, 4032, Australia

[email protected] / +07 3737 4539

Status: Recruiting

Southern Adelaide Local Health Network Incorporated Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

[email protected] / 08 8204 4485

Status: Recruiting

Eastern Health

Box Hill, Victoria, 3128, Australia

[email protected] / +61 474 871 676

Status: Recruiting

Universitätsklinikum Graz

Graz, Styria, 8036, Austria

[email protected] / +43 316385 80169

Status: Recruiting

Universitair Ziekenhuis Antwerpen

Edegem, Antwerpen, 2650, Belgium

[email protected] / +3234368354

Status: Recruiting

Cliniques Universitaires Saint-Luc

Brussels, Brussels Capital, 1200, Belgium

[email protected] / +32 2 764 35 13

Status: Recruiting

Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne

Yvoir, Namur, B-5530, Belgium

[email protected] / +32 0 81 42 38 57

Status: Recruiting

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, Vlaams Brabant, 3000, Belgium

[email protected] / +32 16 34 39 44

Status: Recruiting

Algemeen Ziekenhuis Groeninge - Campus Kennedylaan

Kortrijk, West-Vlaanderen, 8500, Belgium

[email protected] / +32 56 63 39 40

Status: Recruiting

Sunnybrook Research Ins<tute

Toronto, Ontario, M4N 3M5, Canada

[email protected] / +1 416-480-5000

Status: Recruiting

Masaryk Memorial Cancer Institute

Brno, Brno, 65653, Czechia

[email protected] / +420 543 136 233

Status: Recruiting

University Hospital Hradec Kralove

Sokolov, Hradce Kralove, 50009, Czechia

[email protected] / +420495832849

Status: Recruiting

Aarhus Universitetshospital

Aarhus, Central Jutland, 8200, Denmark

[email protected] / +45 27512026

Status: Recruiting

Aalborg University Hospital

Aalborg, Nord Jutland, 9000, Denmark

[email protected] / +4599661290

Status: Recruiting

Oulu University Hospital

Oulu, Oulu, 90230, Finland

[email protected] / +358405057872

Status: Recruiting

Tampere University Hospital

Tampere, Pirkanmaa, 33521, Finland

[email protected] / +358444728004

Status: Recruiting

Helsinki University Hospital

Helsinki, Uusimaa, 00029, Finland

[email protected] / +358-50-372 9043

Status: Recruiting

Centre Hospitalier Lyon-Sud

Pierre-Bénite, Auvergne-Rhône-Alpes, 69495, France

[email protected] / +33 04 78 86 33 35

Status: Recruiting

Centre Hospitalier Universitaire Grenoble Alpes

La Tronche, Isère, 38700, France

[email protected] / +33476767081

Status: Recruiting

Hôpital La Timone

Marseille, Marseille, 13385, France

[email protected] / +33 0491 38 88 03

Status: Recruiting

CHU Rouen

Rouen, Rouen, 76031, France

[email protected] / (33) 02 32 88 66 99

Status: Recruiting

Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

[email protected] / 07071 29-80833

Status: Recruiting

Universitätsmedizin Mannheim

Mannheim, Baden-Wurttemberg, 68167, Germany

[email protected] / +49 621 383-3993

Status: Recruiting

Universitat Leipzig

Saxony, Leipzig, 04103, Germany

[email protected] / +493419718750

Status: Recruiting

Elbe Kliniken Stade-Buxtehude

Buxtehude, Lower Saxony, 21614, Germany

[email protected] / +4941617036212

Status: Recruiting

Johannes Wesling Klinikum Minden

Minden, North Rhine-Westphalia, 32429, Germany

[email protected] / +49-(0)571-790-54528

Status: Recruiting

University of Mainz Medical Center

Mainz, RLP, 55131, Germany

[email protected] / +496131175147

Status: Recruiting

Universitätsklinikum Schleswig-Holstein - Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

[email protected] / +49 431 500 21133

Status: Recruiting

Universitätsklinikum Schleswig-Holstein - Campus Lübeck

Lübeck, Schleswig-Holstein, 23538, Germany

[email protected] / +49 451 500 41570

Status: Recruiting

Soroka medical center

Beersheba, Be'er Sheva, 8410101, Israel

[email protected] / 972 8-6403375

Status: Recruiting

Rabin Medical Center

Petah Tikva, Petach Tikva, 4941492, Israel

[email protected] / +97239378077

Status: Recruiting

Ella Lemelbaum Institute for Immuno-Oncology and Melanoma

Ramat Gan, Ramat Gan, 5262100, Israel

[email protected] / +972 35307916

Status: Recruiting

Tel Aviv Medical Center

Tel Aviv, Tel Aviv, 6423906, Israel

[email protected] / 972-52-7360519

Status: Recruiting

Humanitas Gavazzeni Bergamo

Bergamo, Province of Bergamo, 24125, Italy

[email protected] / +39 0354204760

Status: Recruiting

Christchurch Public Hospital

Christchurch, Christchurch, 8011, New Zealand

[email protected] / +64 2740 66867

Status: Recruiting

Auckland City Hospital

Auckland, New Zealand, 1023, New Zealand

[email protected] / +64 9 3074949

Status: Recruiting

Nordland Hospital Trust

Bodø, Bodø, N-8005, Norway

[email protected] / +47 75599133

Status: Recruiting

Oslo University Hospital - The Norwegian Radium Hospital

Oslo, Oslo, 0310, Norway

[email protected] / +47 99293273

Status: Recruiting

Uniwersyteckie Centrum Kliniczne

Gdansk, Gdańsk, 80-952, Poland

[email protected] / +48517331593

Status: Recruiting

Prezychodnia Lekarska KOMED Roman Karaszewski

Konin, Konin, 62-500, Poland

[email protected] / +48632406136

Status: Recruiting

Mazowiecki Szpital Wojewódzki, Siedlckie Centrum Onkologii

Siedlce, Siedlce, 08-110, Poland

[email protected] / +48600173523

Status: Recruiting

Hospital da Luz Lisboa

Lisbon, Lisbon District, 1500-650, Portugal

[email protected] / +351.217.104.544

Status: Recruiting

Military Medical Academy- Department of Oncology

Belgrade, Belgrade, 11000, Serbia

[email protected] / +381641452888

Status: Recruiting

Cancercare Port Elizabeth - Langenhoven Drive Oncology Centre

Port Elizabeth, Eastern Cape, 6045, South Africa

[email protected] / +36 209529 303

Status: Recruiting

The Medical Oncology Centre of Rosebank

Saxonwold, Gauteng, 2196, South Africa

[email protected] / 0027828805944

Status: Recruiting

University of Pretoria, Steve Biko Academic Hospital

Pretoria, Gauteng, 0002, South Africa

[email protected] / +27 12 354 2022

Status: Recruiting

Cape Town Oncology Trials

Cape Town, Western Cape, 7570, South Africa

[email protected] / +27 (0)71 129 1765

Status: Recruiting

TASK Eden

George Central, Western Cape, 6530, South Africa

[email protected] / +27 (0) 82 853 4991

Status: Recruiting

Hospital Universitari Dexeus

Barcelona, Barcelona, 08028, Spain

[email protected] / +34 93 54 60 143

Status: Recruiting

Vall d' Hebron Institute of Oncology

Barcelona, Barcelona, 08035, Spain

[email protected] / (+34) 93 254 34 50

Status: Recruiting

Hospital Universitario Lucus Augusti

Lugo, Galicia, 27003, Spain

[email protected] / +34 982 296459

Status: Recruiting

Institut Català d'Oncologia Girona (ICO Girona)

Girona, Girona, 17007, Spain

[email protected] / +34 972 22 58 28

Status: Recruiting

University Hospital of Jerez

Jerez de La Frontera (Cádiz), Jerez de La Frontera (Cádiz), 11407, Spain

[email protected] / +34 956 03 22 44

Status: Recruiting

GenesisCare Madrid - Hospital San Francisco de Asís

Madrid, Madrid, 28002, Spain

[email protected] / +34 916219256

Status: Recruiting

Hospital 12 de Octubre

Usera, Madrid, 28031, Spain

[email protected] / +34913908547

Status: Recruiting

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, 28007, Spain

[email protected] / 915868161

Status: Recruiting

Hospital Universitario Virgen de la Victoria

Málaga, Málaga, 29010, Spain

[email protected] / +34 951032508

Status: Recruiting

INCLIVA Instituto de Investigación Sanitaria

Valencia, Valencia, 46010, Spain

[email protected] / +34) 96 197 35 00

Status: Recruiting

IVO - Fundacion Instituto Valenciano de Oncologia

Valencia, Valencia, 46009, Spain

[email protected] / 671429340

Status: Recruiting

Gävle Sjukhus

Gävle, Gävleborg County, 801 88, Sweden

[email protected] / +46 722077689

Status: Recruiting

Karolinska University Hospital

Stockholm, Södermanland County, 17176, Sweden

[email protected] / +46 8 12373388

Status: Recruiting

Universitätsspital Zürich

Zurich, Canton of Zurich, 8091, Switzerland

[email protected] / +41 44 255 18 59

Status: Recruiting

Kantonsspital Graubünden

Chur, Chur, 7000, Switzerland

[email protected] / +41812566860

Status: Recruiting

Guy's and St Thomas' NHS Foundation Trust

London, England, SE1 9RT, United Kingdom

[email protected] / 020 7188 7188

Status: Recruiting

Sarah Cannon Research Institute London

London, England, W1G6AD, United Kingdom

[email protected] / +44 203 219 5211

Status: Recruiting

Ironwood Cancer & Research Centers

Chandler, Arizona, 85224, United States

[email protected] / 480-256-1372

Status: Recruiting

Genesis Cancer and Blood Institute

Hot Springs, Arkansas, 71913, United States

[email protected] / 833-886-1725

Status: Recruiting

Helios Clinical Research

Los Angeles, California, 90015, United States

[email protected] / 562-735-3226

Status: Recruiting

Providence Medical Foundation

Santa Rosa, California, 95403, United States

[email protected] / +1 714-992-3000

Status: Recruiting

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, 80909, United States

[email protected] / 719-365-5062

Status: Recruiting

Bioresearch Partner

Hialeah, Florida, 33013, United States

[email protected] / 833-489-4968

Status: Recruiting

The Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

[email protected] / 301-571-2016

Status: Recruiting

MidAmerica Cancer Care

Kansas City, Missouri, 64132, United States

[email protected] / 833-886-1725

Status: Recruiting

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63108, United States

[email protected] / 314-273-0656

Status: Recruiting

Gabrail Cancer Center Research LLC

Canton, Ohio, 44718, United States

[email protected] / 330-417-8231

Status: Recruiting

University of Pittsburgh Medical Center(UPMC)-Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

[email protected] / 412 623-1191

Status: Recruiting

A Multicenter, Randomized, Double-Blind, Active Comparator-Controlled, Adaptive Phase 2/3 Study to Evaluate the Safety and Efficacy of EIK1001 and Pembrolizumab Versus Placebo and Pembrolizumab as First-Line Therapy in Participants With Advanced Melanoma (TeLuRide-006)

Trial Details

Show Summary from Sponsor

More details:

Investigational Drug AI Analysis

Show for: EIK1001 (BDB001)

Overview

Mechanism of action

Efficacy

Safety

Further reading

TrialFetch AI Analysis

Eligibility

Show Criteria

Sites (77)

Cancer Care Wollongong

Icon Cancer Centre Chermside

Southern Adelaide Local Health Network Incorporated Flinders Medical Centre

Eastern Health

Universitätsklinikum Graz

Universitair Ziekenhuis Antwerpen

Cliniques Universitaires Saint-Luc

Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Algemeen Ziekenhuis Groeninge - Campus Kennedylaan

Sunnybrook Research Ins<tute

Masaryk Memorial Cancer Institute

University Hospital Hradec Kralove

Aarhus Universitetshospital

Aalborg University Hospital

Oulu University Hospital

Tampere University Hospital

Helsinki University Hospital

Centre Hospitalier Lyon-Sud

Centre Hospitalier Universitaire Grenoble Alpes

Hôpital La Timone

CHU Rouen

Universitätsklinikum Tübingen

Universitätsmedizin Mannheim

Universitat Leipzig

Elbe Kliniken Stade-Buxtehude

Johannes Wesling Klinikum Minden

University of Mainz Medical Center

Universitätsklinikum Schleswig-Holstein - Campus Kiel

Universitätsklinikum Schleswig-Holstein - Campus Lübeck

Soroka medical center

Rabin Medical Center

Ella Lemelbaum Institute for Immuno-Oncology and Melanoma

Tel Aviv Medical Center

Humanitas Gavazzeni Bergamo

Christchurch Public Hospital

Auckland City Hospital

Nordland Hospital Trust

Oslo University Hospital - The Norwegian Radium Hospital

Uniwersyteckie Centrum Kliniczne

Prezychodnia Lekarska KOMED Roman Karaszewski

Mazowiecki Szpital Wojewódzki, Siedlckie Centrum Onkologii

Hospital da Luz Lisboa

Military Medical Academy- Department of Oncology

Cancercare Port Elizabeth - Langenhoven Drive Oncology Centre

The Medical Oncology Centre of Rosebank

University of Pretoria, Steve Biko Academic Hospital

Cape Town Oncology Trials

TASK Eden

Hospital Universitari Dexeus

Vall d' Hebron Institute of Oncology

Hospital Universitario Lucus Augusti

Institut Català d'Oncologia Girona (ICO Girona)

University Hospital of Jerez

GenesisCare Madrid - Hospital San Francisco de Asís

Hospital 12 de Octubre

Hospital General Universitario Gregorio Marañón

Hospital Universitario Virgen de la Victoria

INCLIVA Instituto de Investigación Sanitaria

IVO - Fundacion Instituto Valenciano de Oncologia

Gävle Sjukhus

Karolinska University Hospital

Universitätsspital Zürich

Kantonsspital Graubünden

Guy's and St Thomas' NHS Foundation Trust