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    Summary
    EudraCT Number:2020-004535-24
    Sponsor's Protocol Code Number:RLY-4008-101
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-03-31
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2020-004535-24
    A.3Full title of the trial
    A First-in-Human Study of Highly Selective FGFR2 inhibitor, RLY-4008, in Patients with Intrahepatic Cholangiocarcinoma (ICC) and other Advanced Solid Tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the effects of study drug RLY-4008 in patients with Intrahepatic Cholangiocarcinoma and other Advanced Solid Tumors
    A.3.2Name or abbreviated title of the trial where available
    First-in-Human Study of RLY-4008 in patients with ICC and other advanced solid tumors
    A.4.1Sponsor's protocol code numberRLY-4008-101
    A.5.4Other Identifiers
    Name:IND Number:147405
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRelay Therapeutics, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRelay Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRelay Therapeutics, Inc.
    B.5.2Functional name of contact pointClinOps
    B.5.3 Address:
    B.5.3.1Street Address399 Binney Street
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02139
    B.5.3.4CountryUnited States
    B.5.6E-mailStudy-RLY-4008-101@relaytx.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEMA/OD/0000099049
    D.3 Description of the IMP
    D.3.1Product nameRLY-4008
    D.3.2Product code RLY-4008
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number 2688040-45-9
    D.3.9.2Current sponsor code RLY-4008 HCl
    D.3.9.3Other descriptive nameRLY-4008 hydrochloride, RTX-1137216 HCl, REL009-05, RTX-7216
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEMA/OD/0000099049
    D.3 Description of the IMP
    D.3.1Product nameRLY-4008
    D.3.2Product code RLY-4008
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number 2688040-45-9
    D.3.9.2Current sponsor codeRLY-4008 HCl
    D.3.9.3Other descriptive nameRLY-4008 hydrochloride, RTX-1137216 HCl, REL009-05, RTX-7216
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Unresectable or metastatic cholangiocarcinoma (CCA), other advanced solid tumors with an FGFR2-alteration or other potential FGFR2-dependent tumors
    E.1.1.1Medical condition in easily understood language
    Cholangiocarcinoma (CCA) and Other Advanced Solid Tumors
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 27.0
    E.1.2Level LLT
    E.1.2Classification code 10073077
    E.1.2Term Intrahepatic cholangiocarcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10065252
    E.1.2Term Solid tumor
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 27.0
    E.1.2Level LLT
    E.1.2Classification code 10008595
    E.1.2Term Cholangiocarcinoma NOS
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10014735
    E.1.2Term Endometrial cancer NOS
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10017760
    E.1.2Term Gastric cancer NOS
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10006192
    E.1.2Term Breast cancer NOS
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1
    • To determine the MTD and RP2D of RLY-4008
    • To determine the safety and tolerability of RLY-4008
    Part 2 and 3
    • To evaluate the efficacy of RLY-4008 by objective response rate (ORR) assessed by Independent Review Committee (IRC)
    Part 4
    • To assess the safety and tolerability of RLY-4008.
    E.2.2Secondary objectives of the trial
    Part 1
    • To evaluate FGFR2 status in blood and tumor tissue by next generation nucleic acid sequencing
    • To define the PK profile of RLY-4008 and its metabolites if appropriate
    • To assess the pharmacodynamics of RLY-4008 by monitoring blood markers (eg. CA 19-9, CEA, FGF23)
    • To characterize the preliminary anti-tumor activity of RLY-4008 per RECIST 1.1
    Part 2 and 3
    • To determine the duration of response (DOR) by IRC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Main inclusion criteria for the study, including specific criteria for Part 1, 2 and 3 can be found in the study protocol (section 5.2).

    Part 4
    14. Patient is currently receiving RLY-4008 on RLY-4008-101 Study and benefiting from treatment as assessed by the investigator.
    E.4Principal exclusion criteria
    Main exclusion criteria for the study, including specific criteria for Part 1, 2 and 3 can be found in the study protocol (section 5.3).

    Part 4
    21. Patient has permanently discontinued treatment with RLY-4008 for any reason before enrolling into Part 4.
    E.5 End points
    E.5.1Primary end point(s)
    • MTD and RP2D
    • Overall safety profile of RLY-4008 as assessed by the type, frequency, severity, timing and relationship to RLY-4008 of any adverse events (AEs), serious AEs (SAEs), changes in vital signs, electrocardiograms (ECGs) and safety laboratory tests. All AEs and SAEs will be collected and graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
    • To evaluate the efficacy of RLY-4008 by objective response rate (ORR) assessed by Independent Review Committee (IRC) using RECIST v.1.1

    Part 4
    • To assess the safety and tolerability of RLY-4008
    • Frequency, severity, timing, and relationship to RLY-4008 of any AEs and SAEs. All AEs and SAEs will be collected and graded according to
    NCI
    CTCAE, Version 5.0.
    • Dose modification (e.g., dose interruption, dose reduction, dose
    discontinuation)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The minimum duration of participation for a patient is approximately 3 months including a Screening Period up to 28 days, a Treatment Period of up to 1 cycle (28 days), an End of Treatment visit within 14 days of the last dose of RLY-4008, and a Safety Follow-up to document any new AE or resolution of any residual AE, 30 days (±7 days) after the last dose of RLY-4008, or prior to the initiation of a new antineoplastic therapy. All AEs should be followed until they are resolved, or the Investigator assesses them as chronic or stable, the patient’s participation in the study ends, or until a subsequent antineoplastic therapy is initiated.
    E.5.2Secondary end point(s)
    • FGFR2 genotype in blood and tumor tissue
    • PK parameters of RLY-4008 (and its metabolites if appropriate) including, but not limited to Maximum Concentration (Cmax), Time to Maximum Concentration (Tmax), Area Under the Concentration-Time Curve (AUC), effective half-life(T1/2eff), clearance (CL/F), and other relevant parameters
    • Pharmacodynamic parameters: including, but not limited to blood markers (eg. CA 19-9, CEA, FGF23)
    • Overall response rate (ORR), Duration of Response (DOR), and Disease Control Rate (DCR) per RECIST 1.1
    • To determine the duration of response (DOR) by Independent Review Committee (IRC) using RECIST v.1.1
    E.5.2.1Timepoint(s) of evaluation of this end point
    Plasma samples for extensive PK will be collected on Cycle 1 Day 1 (through 24 hours post dose) and Cycle 1 Day 15 (through 8 hours post dose). On Day 1 of Cycles 2, 3, and 4, samples will only be collected pre-dose (within 30 minutes pre-dose).
    ORR is defined as the proportion of patients achieving Complete response (CR) and partial response (PR). Confirmed responses are those that persist on repeat tumor assessments for at least 4 weeks after initial documentation or response. Otherwise, the patient will be counted as a non-responder in the assessment of ORR.
    DOR is defined as the time from first documentation of CR or PR until the time of first documentation of progressive disease (PD) or death due to any cause.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    To define the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) and evaluate the efficacy, safety, and tolerability of RLY-4008
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Singapore
    Hong Kong
    Taiwan
    Australia
    Korea, Republic of
    United Kingdom
    United States
    France
    Germany
    Netherlands
    Spain
    Sweden
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study is defined as the date of the last visit of the last patient for any protocol-related activity. For individual patients, study completion is defined as the time of the patient’s last data collection.
    A patient is considered to have completed the study if he/she has discontinued the study for any of the following reasons: withdrawal of consent by the patient, contact has been adequately attempted, but patients are considered lost to follow-up, death, sponsor decision
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 363
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 187
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 193
    F.4.2.2In the whole clinical trial 550
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    If a patient ends his/her participation in the study, available treatment options, including benefits and risks of each, will be discussed with the patient.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-07
    P. End of Trial
    P.End of Trial StatusOngoing
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