Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ended
Participants planned
462
Countries
5
Sites
15
Cholangiocarcinoma (CCA) and Other Advanced Solid Tumors
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
Key facts
- Sponsor
- Elevar Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 10 Sep 2021 → 5 Sep 2025
- Decision date (initial)
- 2024-09-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Relay Therapeutics, Inc.
External identifiers
- EU CT number
- 2024-512622-29-00
- EudraCT number
- 2020-004535-24
- ClinicalTrials.gov
- NCT04526106
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others, Pharmacokinetic, Efficacy, Pharmacodynamic
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
Secondary objectives 1
- Part 1 • Evaluate FGFR2 status in blood and tumor tissue • To define the PK profile of RLY-4008 and its metabolites if appropriate • To assess the pharmacodynamics of RLY-4008 by monitoring blood markers • 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
Conditions and MedDRA coding
Cholangiocarcinoma (CCA) and Other Advanced Solid Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Study design 4 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Part 1 - Dose Escalation Part 1 (dose escalation) evaluates multiple ascending doses of RLY-4008
|
Not Applicable | None | ||
| 2 | Part 2 - Dose Expansion Part 2 (dose expansion) will further evaluate the safety of RP2D and preliminary antitumor activity determined in Part 1
|
Not Applicable | None | Group 1: CCA patients with an FGFR2 fusion previously treated with an FGFRi Group 2: CCA patients with an FGFR2 fusion with prior chemotherapy but not previously treated with an FGFRi Group 3: Non-CCA patients with an FGFR2 fusion and not previously treated with an FGFRi Group 4: Non-CCA patients with an FGFR2 amplification and not previously treated with an FGFRi Group 5: Non-CCA patients with an FGFR2 mutation and not previously treated with an FGFRi Group 6: CCA patients with and FGFR2 fusion with no prior chemotherapry and not previously treated with an FGFRi. Prior adjuvant/neo-adjuvant treatment completed >6 months before enrollment is acceptable. Up to 2 cycles of palliative chemotherapy are allowed during screening. Group 7: CCA patients with an FGFR2 mutation or amplification and not previously treated with and FGFRi.Note: For Group 7, patients with confirmed diagnosis of unresectable or metastatic CCA with an FGFR2 fusion are not eligible. |
|
| 3 | Part 3 - Extension CCA patients with an FGFR2 fusion with prior chemotherapy but not previously treated with an FGFRi
|
Not Applicable | None | ||
| 4 | Part 4 - Rollover Ongoing patients from Parts 1, 2 and 3 receiving RLY-4008
|
Not Applicable | None |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Main inclusion criteria for the study, including specific criteria for Part 1, 2, 3 and 4 can be found in the study protocol (section 5.2).
Exclusion criteria 1
- Main exclusion criteria for the study, including specific criteria for Part 1, 2, 3 and 4 can be found in the study protocol (section 5.3).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 4
- Part 1: MTD and RP2D of RLY-4008
- Part 1: Overall safety profile of RLY-4008
- Parts 2 & 3: Objective response rate (ORR) assessed by Independent Review Committee (IRC) using RECIST v.1.1
- Part 4: Frequency, severity, timing, and relationship to RLY-4008 of any AEs and SAEs. Dose modifications.
Secondary endpoints 5
- Part 1: FGFR2 genotype in blood and tumor tissue
- Part 1: 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
- Part 1: Pharmacodynamic parameters: including, but not limited to blood markers
- Part 1: Overall response rate (ORR), Duration of Response (DOR), and Disease Control Rate (DCR) per RECIST 1.1
- Parts 2 & 3: Duration of response (DOR) by Independent Review Committee (IRC) using RECIST v.1.1
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD9430055 · Product
- Active substance
- RLY-4008
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Authorisation status
- Not Authorised
- MA holder
- RELAY THERAPEUTICS INC.
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EMA/OD/0000099049
PRD9430054 · Product
- Active substance
- RLY-4008
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Authorisation status
- Not Authorised
- MA holder
- RELAY THERAPEUTICS INC.
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EMA/OD/0000099049
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Elevar Therapeutics Inc.
- Sponsor organisation
- Elevar Therapeutics Inc.
- Address
- 1 Bridge Plaza North Suite 850
- City
- Fort Lee
- Postcode
- 07024-7101
- Country
- United States
Scientific contact point
- Organisation
- Elevar Therapeutics Inc.
- Contact name
- Chris Galloway
Public contact point
- Organisation
- Elevar Therapeutics Inc.
- Contact name
- Jenn Florence
Third parties 11
| Organisation | City, country | Duties |
|---|---|---|
| Yprime LLC ORG-100042888
|
Malvern, United States | Other |
| Guardant Health Inc. ORG-100042461
|
Redwood City, United States | Other, Laboratory analysis |
| Icon Development Solutions LLC ORG-100012400
|
Whitesboro, United States | Other, Laboratory analysis |
| Lanterne Dx LLC ORG-100052256
|
Boulder, United States | Other, Laboratory analysis |
| Foundation Medicine Inc. ORG-100040457
|
Cambridge, United States | Other, Laboratory analysis |
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Other |
| PPD Development LP ORG-100011560
|
Wilmington, United States | On site monitoring, Code 10, Code 11, Code 12, Code 13, Code 2, Interactive response technologies (IRT), Laboratory analysis, Code 5, Data management, Code 8, Code 9 |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other, Laboratory analysis |
| Medable Inc. ORG-100043083
|
Palo Alto, United States | Other |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
Locations
5 EU/EEA countries · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 70 | 4 |
| Germany | Ended | 19 | 3 |
| Netherlands | Ended | 10 | 2 |
| Spain | Ended | 54 | 5 |
| Sweden | Ended | 6 | 1 |
| Rest of world
Hong Kong, United States, United Kingdom, Korea, Republic of, Taiwan, Singapore, Australia
|
— | 303 | — |
Investigational sites
Centre Leon Berard
Unité de Phase 1, 28 Rue Laennec, 69008, Lyon
Centr Georges Francois Leclerc
Service d’Oncologie Médicale, 1 Rue Professeur Marion, 21000, Dijon
Institut Gustave Roussy
Drug development department (DITEP) Oncologie Digestive, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Bergonie
Département d’Oncologie Médicale, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Medizinische Hochschule Hannover
Klinik fuer Gastroenterologie, Hepatologie und Endokrinologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Klinikum der Universitaet Muenchen AöR
Campus Grosshadern Medizinische Klinik und Poliklinik III Comprehensive Cancer Center, Marchioninistrasse 15, Hadern, Munich
National Center For Tumor Diseases (NCT) Heidelberg
Medizinische Onkologie Universitaetsklinikum Heidelberg, Im Neuenheimer Feld 460, Neuenheim, Heidelberg
NKI
Clinical Research Unit, Plesmanlaan 121, 1066 CX, Amesterdam
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Medical Oncology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Clinica Universidad De Navarra
Oncology Service, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Clinico Universitario De Valencia
Oncology Department, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitari Vall D Hebron
Oncology Service, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Hm Sanchinarro
Oncology Service, Calle Ona 10, 28050, Madrid
Hospital Universitario Fundacion Jimenez Diaz
Oncology Department, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2021-10-21 | 2025-08-12 | 2021-11-08 | 2024-01-30 | |
| Germany | 2022-10-17 | 2025-05-08 | 2022-11-14 | 2024-01-30 | |
| Netherlands | 2022-02-16 | 2025-08-11 | 2022-03-18 | 2024-01-30 | |
| Spain | 2021-09-10 | 2025-08-20 | 2021-09-13 | 2024-01-30 | |
| Sweden | 2021-09-22 | 2024-09-19 | 2021-09-29 | 2024-01-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 38 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Elevar_RLY-4008-101_Protocol_Memo_2024-512622-29-00_Public | 3.0 |
| Protocol (for publication) | D1_Relay_RLY-4008-101_Protocol_2024-512622-29-00_Public | 10.0 |
| Protocol (for publication) | D4_Relay_RLY-4008-101_Participant Care Product Recommendations_DE_Public | 2.0 |
| Protocol (for publication) | D4_Relay_RLY-4008-101_Participant Care Product Recommendations_EN_Public | 2.0 |
| Protocol (for publication) | D4_Relay_RLY-4008-101_Participant Care Product Recommendations_FR_Public | 2.0 |
| Protocol (for publication) | D4_Relay_RLY-4008-101_Participant Package_DE_Public | 8.0 |
| Protocol (for publication) | D4_Relay_RLY-4008-101_Participant Package_EN_Public | 8.0 |
| Protocol (for publication) | D4_Relay_RLY-4008-101_Participant Package_FR_Public | 8.0 |
| Protocol (for publication) | D4_Relay_RLY-4008-101_Participant_Care_Product_Recommendations_ES_ESP_Public | 2.0 |
| Protocol (for publication) | D4_Relay_RLY-4008-101_Participant_Package_ES_ESP_Public | 8.0 |
| Protocol (for publication) | D4_RLY-4008-101_Participant Care Product Recommendations_NL_Public | 2.0 |
| Protocol (for publication) | D4_RLY-4008-101_Participant Package_NL_Public | 8.0 |
| Recruitment arrangements (for publication) | K1_RLY_4008_101_Recruitment Arrangement_NtF_FR_ | 1 |
| Recruitment arrangements (for publication) | K1_RLY-4008-101_Recruitment arrangements_Non-Mandatory Placeholder_SWE | N/A |
| Recruitment arrangements (for publication) | K1_RLY-4008-101_Recruitment_Arrangement_NtF_DE | 1 |
| Recruitment arrangements (for publication) | K1_RLY-4008-101_Recruitment-Arrangement_ES_Public | 1 |
| Recruitment arrangements (for publication) | K1_RLY-4008-101_Recruitment-arrangments_NTF_NL | 1 |
| Subject information and informed consent form (for publication) | L1_RLY-4008-101_ICF_Travel_DE-German_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_RLY-4008-101_Main_PISICF_FR_FRA_Public | 12.0 |
| Subject information and informed consent form (for publication) | L1_RLY-4008-101_PISICF Add_TBP_DE_German_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_RLY-4008-101_PISICF Addendum_FR_FRA_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_RLY-4008-101_PISICF_Add_TBP_ES_Spanish_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_RLY-4008-101_PISICF_Add_TBP_SE_SWE_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_RLY-4008-101_PISICF_DE-German_Model_Public | 10.0 |
| Subject information and informed consent form (for publication) | L1_RLY-4008-101_PISICF_ES_Spanish_Public | 10.0 |
| Subject information and informed consent form (for publication) | L1_RLY-4008-101_PISICF_SC_ES_Spanish_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_RLY-4008-101_PISICF_SE_SWE_Public | 8.0 |
| Subject information and informed consent form (for publication) | L1_RLY-4008-101_PPISICF_DE_German_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_RLY-4008-101_PPISICF_ES_Spanish_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_RLY-4008-101_PPISICF_FR-FRA_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_RLY-4008-101_PPISICF_SE_SWE_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_RLY-4008-101_SIS-and-ICF-Addendum-Add_TBP_NL_Dutch_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_RLY-4008-101_SIS-and-ICF-adults_NL-Dutch_Public | 10.0 |
| Subject information and informed consent form (for publication) | L1_RLY-4008-101_SIS-and-ICF-pregnant-partner_NL_Dutch_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_RLY-4008-101_Layperson Protocol Synopsis_2024-512622-29-00_ENG_Public | 1.1 |
| Synopsis of the protocol (for publication) | D1_RLY-4008-101_Layperson Protocol Synopsis_2024-512622-29-00_ES_Public | 1.1 |
| Synopsis of the protocol (for publication) | D1_RLY-4008-101_Layperson Protocol Synopsis_2024-512622-29-00_FR_Public | 1.1 |
| Synopsis of the protocol (for publication) | D1_RLY-4008-101_Layperson Protocol Synopsis_2024-512622-29-00_NL_Public | 1.1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-08 | Spain | Acceptable with conditions 2024-09-04
|
2024-09-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-28 | Spain | Acceptable 2025-02-06
|
2025-02-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-14 | Spain | Acceptable 2025-05-21
|
2025-05-21 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-06-27 | Spain | Acceptable 2025-08-29
|
2025-08-29 |