Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ended
Participants planned
192
Countries
1
Sites
5
"Ph1: •Locally advanced (LA) or metastatic MTAP-deleted (met.MTAP-del.) solid tumors •MTAP-del.relapsed or refrac. Grade 4 astrocytoma or glioblastoma multiforme (R/R GBM) Ph2: A1:LA or met.MTAP-del. squamous and nonsquamous NSCLC A2:LA or met.MTAP-del. mesothelioma A3:LA or met.MTAP-del. sarcoma A4:LA or met.MTAP-del. pancreatic ductal adenocarcinoma or adenosquamous carcinoma w/predominantly adenocarcinoma histology A5:Other LA or met.MTAP-del. solid tumors A6:MTAP-del. R/R GBM"
"Phase 1: To determine the MTD and RP2D(s) of TNG908 Phase 2: To assess anti-neoplastic activity of TNG908 in patients with MTAP-deleted advanced solid tumors"
Key facts
- Sponsor
- Tango Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 31 Oct 2022 → 30 Dec 2025
- Decision date (initial)
- 2024-10-03
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Tango Therapeutics, Inc.
External identifiers
- EU CT number
- 2024-511976-34-00
- EudraCT number
- 2021-005605-27
- ClinicalTrials.gov
- NCT05275478
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Dose response, Safety, Pharmacokinetic, Pharmacodynamic, Efficacy
"Phase 1: To determine the MTD and RP2D(s) of TNG908
Phase 2: To assess anti-neoplastic activity of TNG908 in patients with MTAP-deleted advanced solid tumors"
Secondary objectives 1
- "Phase 1: To assess preliminary evidence of anti-neoplastic activity of TNG908 in patients with MTAP-deleted advanced solid tumors Phases 1 and 2: To describe the safety and tolerability profile of TNG908 To characterize the plasma PK profile of TNG908 To assess the PD of TNG908 in patients with MTAP-deleted solid tumors"
Conditions and MedDRA coding
"Ph1: •Locally advanced (LA) or metastatic MTAP-deleted (met.MTAP-del.) solid tumors •MTAP-del.relapsed or refrac. Grade 4 astrocytoma or glioblastoma multiforme (R/R GBM) Ph2: A1:LA or met.MTAP-del. squamous and nonsquamous NSCLC A2:LA or met.MTAP-del. mesothelioma A3:LA or met.MTAP-del. sarcoma A4:LA or met.MTAP-del. pancreatic ductal adenocarcinoma or adenosquamous carcinoma w/predominantly adenocarcinoma histology A5:Other LA or met.MTAP-del. solid tumors A6:MTAP-del. R/R GBM"
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Phase 1: Dose Escalation Phase 1 will evaluate escalating doses of TNG908 administered BID, with the potential to explore other dosing schedules based on the observed PK parameters and safety and tolerability data. The starting dose will be 25 mg BID. Additional patients may be enrolled for the purpose of PK/PD, safety, efficacy, and dose schedule determination. Within France, there must be 1 day between dosing of sequential patients at all dose levels during Phase 1.
|
Not Applicable | None | Locally advanced or metastatic MTAP deleted tumors: Solid tumors including GBM | |
| 2 | Phase 2: Dose Expansion "Phase 2 will evaluate TNG908 as a single agent in a Simon 2-stage design in 6 arms at the selected RP2D and schedule following Phase 1.
Multiple dose levels may be studied in the expansion phase based on the safety, PK, and/or PD considerations.
Each arm may enroll approximately 27 patients based on the clinical responses observed. Additional treatment arms may be added based on emerging data as the study progresses. "
|
Not Applicable | None | MTAP-deleted NSCLC: Locally advanced or metastatic MTAP deleted NSCLC MTAP-deleted mesothelioma: Locally advanced or metastatic MTAP deleted mesothelioma MTAP-deleted sarcoma (soft tissue or bone): Locally advanced or metastatic MTAP deleted sarcoma MTAP-deleted pancreatic ductal adenocarcinoma: Locally advanced or metastatic MTAP deleted pancreatic ductal adenocarcinoma MTAP-deleted basket (including esophageal, cholangiocarcinoma, urothelial and unknown primary): Locally advanced or metastatic MTAP deleted tumors MTAP-deleted R/R GBM: Relapse or Refractory MTAP deleted GBM |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- "_Age: ≥18 years-of-age at the time of signature of the main study ICF _Performance status: a)Patients with solid tumors other than R/R GBM: ECOG performance status score of 0 to 1 b) Patients with R/R GBM: Karnofsky performance status score ≥70 _For solid tumors other than R/R GBM, have confirmed histologic or cytologic diagnosis of a locally advanced, metastatic, and/or unresectable solid tumor or for GBM, have R/R GBM _Prior standard therapy, as available _Documented bi-allelic (homozygous) deletion of MTAP in a tumor detected by a validated NGS test, or absence of MTAP protein in a tumor detected by a validated IHC test. _Adequate organ function/reserve per local labs _Adequate liver function per local labs _Adequate renal function per local labs _Negative serum pregnancy test result at screening _Patient must be able to swallow tablets _Written informed consent must be obtained according to local guidelines"
Exclusion criteria 1
- Not have received prior treatment with a PRMT5 inhibitor.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Phase 1: Incidence of DLTs within the first 28 days of treatment with TNG908 monotherapy Phase 2: - ORR (CR + PR) as determined by RECIST v1.1, mRECIST v1.1, or modified RANO criteria per investigator assessment - DOR as determined by RECIST v1.1, mRECIST v1.1, or modified RANO criteria per investigator assessment
- - PFS by investigator assessment - CBR (CR + PR + stable disease) at 16 weeks
Secondary endpoints 1
- "Secondary – Phases 1 and 2 - Type, frequency, severity, timing, and relationship to study treatment of any AEs, SAEs, and changes in vital signs, ECGs, ECOG performance status or Karnofsky performance status, and safety laboratory tests - PK parameters of TNG908 including, but not limited to, Cmax, Tmax, AUC0-t, AUC0-∞, t1/2, λz, CL/F, Vz/F, Rac for Cmax and AUC, and Ctrough - Changes in SDMA levels in tumor after dosing with TNG908 "
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
PRD11143133 · Product
- Active substance
- N-6-AMINO-5-METHYLPYRIDIN-3-YL-2-2R5S-2-BENZODTHIAZOL-5-YL-5-METHYLPIPERIDIN-1-YL-2-OXOACETAMIDE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Authorisation status
- Not Authorised
- MA holder
- TANGO THERAPEUTICS INC
- Paediatric formulation
- No
- Orphan designation
- No
PRD11143132 · Product
- Active substance
- N-6-AMINO-5-METHYLPYRIDIN-3-YL-2-2R5S-2-BENZODTHIAZOL-5-YL-5-METHYLPIPERIDIN-1-YL-2-OXOACETAMIDE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Authorisation status
- Not Authorised
- MA holder
- TANGO THERAPEUTICS INC
- Paediatric formulation
- No
- Orphan designation
- No
PRD10171624 · Product
- Active substance
- N-6-AMINO-5-METHYLPYRIDIN-3-YL-2-2R5S-2-BENZODTHIAZOL-5-YL-5-METHYLPIPERIDIN-1-YL-2-OXOACETAMIDE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Authorisation status
- Not Authorised
- MA holder
- TANGO THERAPEUTICS INC
- Paediatric formulation
- No
- Orphan designation
- No
PRD10171623 · Product
- Active substance
- N-6-AMINO-5-METHYLPYRIDIN-3-YL-2-2R5S-2-BENZODTHIAZOL-5-YL-5-METHYLPIPERIDIN-1-YL-2-OXOACETAMIDE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Authorisation status
- Not Authorised
- MA holder
- TANGO THERAPEUTICS INC
- Paediatric formulation
- No
- Orphan designation
- No
Auxiliary 1
SCP112629113 · ATC
- Active substance
- Dobutamine Hydrochloride
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- N05CD08 — MIDAZOLAM
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Tango Therapeutics Inc.
- Sponsor organisation
- Tango Therapeutics Inc.
- Address
- 201 Brookline Avenue Suite 901
- City
- Boston
- Postcode
- 02215-4159
- Country
- United States
Scientific contact point
- Organisation
- Tango Therapeutics Inc.
- Contact name
- Heather DiBenedetto
Public contact point
- Organisation
- Tango Therapeutics Inc.
- Contact name
- Heather DiBenedetto
Third parties 15
| Organisation | City, country | Duties |
|---|---|---|
| Flagship Biosciences Inc. ORG-100043268
|
Morrisville, United States | Other |
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Other |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| MyData-TRUST ORL-000000898
|
Mons, Belgium | Other |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other |
| Ppd Inc. ORG-100018960
|
Middleton, United States | Other |
| Scout Clinical ORG-100042228
|
Dallas, United States | Other |
| BostonGene ORL-000010037
|
United States | Other |
| Labcorp Early Development Laboratories Inc. ORG-100012865
|
Madison, United States | Other |
| PPD Ireland ORG-100032234
|
Athlone, Ireland | Other |
| Fisher Clinical Services GmbH ORG-100017323
|
Rheinfelden (Baden), Germany | On site monitoring |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Other |
| PPD Italy S.r.l. ORG-100007383
|
Segrate, Italy | On site monitoring, Code 10, Code 11, Code 12, Code 2, Code 5, Data management, Code 8, Code 9 |
| CellCarta ORG-100039881
|
Antwerp, Belgium | Other |
| Foundation Medicine Inc. ORG-100040457
|
Boston, United States | Other |
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 50 | 5 |
| Rest of world
United States
|
— | 142 | — |
Investigational sites
Institut Gustave Roussy
Medical Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Oncopole Claudius Regaud
Medical Oncology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Institut De Cancerologie De L Ouest
Medical Oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Institut Bergonie
Medical Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
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 | 2022-10-31 | 2022-12-15 | 2024-11-25 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Synoptic CSR SUM-124696
|
2026-03-25T09:14:50 | Submitted | Summary of Results |
Documents 13 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D2_Tango_TNG908-C101_Protocol_2024-511976-34-00_Public | 4.0 |
| Protocol (for publication) | D4_Tango_TNG908-C101_Patient Diary_FR_ENG_Public | 4 |
| Protocol (for publication) | D4_Tango_TNG908-C101_Patient Diary_FR_FRN_Public | 4 |
| Recruitment arrangements (for publication) | K1_TNG908-C101_Recruitment-Arrangements_NTF_FRA_Public | N/A |
| Subject information and informed consent form (for publication) | L1_TNG908-C101_ICF_Main study_FRA_French_Public | 9.0 |
| Subject information and informed consent form (for publication) | L1_TNG908-C101_ICF_Molecular Pre-Screening _FRA_French_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_TNG908-C101_ICF_Pregnant Partner_FRA_French_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_TNG908-C101_ICF_Scout procedure_FRA_French_Public | 2.0 |
| Summary of results (for publication) | D1_Tango_TNG908-C101 CSR addendum_2024-511976-34_Public | 1.0 |
| Summary of results (for publication) | D1_Tango_TNG908-C101_Synoptic CSR_2024-511976-34_Public | n/a |
| Summary of results (for publication) | Tango_TNG908-C101_Cover Letter | n/a |
| Synopsis of the protocol (for publication) | D1_Tango_TNG908-C101_Protocol synopsis_2024-511976-34-00_FR_ENG_Public | 4.0 |
| Synopsis of the protocol (for publication) | D1_Tango_TNG908-C101_Protocol synopsis_2024-511976-34-00_FR_FRN_Public | 4.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-12 | France | Acceptable 2024-10-03
|
2024-10-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-20 | France | Acceptable 2025-06-17
|
2025-07-24 |