IA Trial Radar | ||
|---|---|---|
L'essai clinique NCT06179160 pour Tumeurs solides est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
Un essai clinique correspond aux filtres sélectionnés
Vue en carte
Retour à la recherche
IncyteA Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'essai clinique NCT06179160 est conçu pour étudier le treatment de Tumeurs solides. Il s'agit d'un essai interventionnel en Phase I. Son statut actuel est : en recrutement. L'essai a débuté le 4 janvier 2024 et vise à recruter 710 participants. Dirigé par Incyte, l'essai devrait être terminé d'ici le 1 janvier 2027. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 20 novembre 2025.
Résumé succinct
This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.
Titre officiel
A Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
Conditions
Tumeurs solidesAutres identifiants de l'essai
- INCB161734-101
- 2023-507091-47-00 (Identifiant de registre) (EU CT Number)
Numéro NCT
Date de début (réel)
2024-01-04
Dernière mise à jour publiée
2025-11-20
Date de fin (estimée)
2027-01-01
Inscription (estimée)
710
Type d'essai
Interventionnel
PHASE
Phase I
Statut
En recrutement
Mots clés
INCB161734
KRASG12D Mutation
pancreatic ductal adenocarcinoma (PDAC)
colorectal cancer (CRC)
non-small cell lung cancer (NSCLC)
KRASG12D Mutation
pancreatic ductal adenocarcinoma (PDAC)
colorectal cancer (CRC)
non-small cell lung cancer (NSCLC)
Objectif principal
Traitement
Plan d'attribution
Non aléatoire
Modèle d'intervention
Séquentiel
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalPart 1a: Dose Escalation monotherapy INCB161734 at the protocol-defined dose strength based on cohort assignment. | INCB161734 INCB161734 will be administered at protocol defined dose. |
ExpérimentalPart 1b: Dose Expansion monotherapy INCB161734 at the protocol-defined dose strength based on cohort assignment. | INCB161734 INCB161734 will be administered at protocol defined dose. |
ExpérimentalPart 1c: Pharmacodynamic cohort INCB161734 at the protocol-defined dose strength based on cohort assignment. | INCB161734 INCB161734 will be administered at protocol defined dose. |
ExpérimentalPart 2a: Dose Escalation combination INCB161734 in combination at the protocol-defined dose strength based on cohort assignment. | INCB161734 INCB161734 will be administered at protocol defined dose. Cetuximab Cetuximab will be administered at protocol defined dose. Retifanlimab Retifanlimab will be administered at protocol defined dose. GEMNABP GEMNabP will be administered at protocol defined dose. Mfolfirinox mFOLFIRINOX will be administered at protocol defined dose. FOLFOX FOLFOX will be administered at protocol defined dose. FOLFIRI FOLFIRI will be administered at protocol defined dose. INCA33890 INCA33890 will be administered at protocol defined dose. |
ExpérimentalPart 2b: Dose Expansion combination INCB161734 in combination at the protocol-defined dose strength based on cohort assignment. | INCB161734 INCB161734 will be administered at protocol defined dose. Cetuximab Cetuximab will be administered at protocol defined dose. Retifanlimab Retifanlimab will be administered at protocol defined dose. GEMNABP GEMNabP will be administered at protocol defined dose. Mfolfirinox mFOLFIRINOX will be administered at protocol defined dose. FOLFOX FOLFOX will be administered at protocol defined dose. FOLFIRI FOLFIRI will be administered at protocol defined dose. INCA33890 INCA33890 will be administered at protocol defined dose. |
ExpérimentalPart 1d: Food-Effect Evaluate food effect on drug exposure as defined in the protocol. | INCB161734 INCB161734 will be administered at protocol defined dose. |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Number of participants with Dose Limiting Toxicities (DLTs) | Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol. | Up to 28 days |
Number of participants with Treatment-emergent Adverse Events (TEAEs) | Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug monotherapy and in combination with cetuximab and retifanlimab. | Up to 2 years and 90 days |
Number of participants with TEAEs leading to dose modification or discontinuation | Number of participants with TEAEs leading to dose modification or discontinuation. | Up to 2 years and 90 days |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
INCB161734 pharmacokinetic (PK) in Plasma | INCB161734 concentration in plasma. | Up to approximately 90 days |
Objective Response Rate (ORR) | Defined as having a best overall Complete Response (CR) or Partial Response (PR), as determined by the investigator by radiographic disease assessment according to RECIST v1.1. | Up to 2 years |
Disease Control Response (DCR) | Defined as having a best overall response of CR, PR, or Stable Disease (SD) as determined by the investigator by radiographic disease assessment according to RECIST v1.1. | Up to 2 years |
Duration of Response (DOR) | Defined as the time from earliest date of disease response (Completed Response or Partial Response) until earliest date of disease progression as determined by the investigator by radiographic disease assessment according to RECIST v1.1 or death due to any cause if occurring sooner than progression. | Up to 2 years |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- ≥18 years old.
- Locally advanced or metastatic solid tumor with KRAS G12D mutation.
- For Part 1a and Part 2 Combination Groups 1, 2, and 7: Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, declined available therapies that are known to confer clinical benefit, or no standard available treatment to improve the disease outcome.
- Cohort specific requirements aas defined in the protocol.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Prior treatment with any KRAS G12D inhibitor
- Known additional invasive malignancy within 1 year of the first dose of study drug
- History of organ transplant, including allogeneic stem cell transplantation
- Significant, uncontrolled medical condition
- History or presence of an ECG abnormality
- Inadequate organ function
Other protocol-defined Inclusion/Exclusion Criteria may apply
Contact central de l'essai
Contact: Incyte Corporation Call Center (US), 1.855.463.3463, [email protected]
Contact: Incyte Corporation Call Center (ex-US), +800 00027423, [email protected]
34 Centres de l'essai dans 8 pays
Centre Leon Berard, Lyon, 69373, France
En recrutement
Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole, Toulouse, 31059, France
En recrutement
Institut Gustave Roussy, Villejuif, 94805, France
En recrutement
Cliniques Universitaires Ucl Saint-Luc, Brussels, 01200, Belgium
En recrutement
Universitair Ziekenhuis Antwerpen (Uza), Edegem, 02650, Belgium
En recrutement
Universitair Ziekenhuis (Uz) Leuven, Leuven, 03000, Belgium
En recrutement
Ontario
The Ottawa Hospital Cancer Center, Ottawa, Ontario, K1H 8L6, Canada
En recrutement
Princess Margaret Cancer Center, Toronto, Ontario, M5G 2M9, Canada
En recrutement
Arizona
Mayo Clinic Hospital, Phoenix, Arizona, 85054, United States
En recrutement
California
Stanford University, Palo Alto, California, 94305, United States
En recrutement
UCLA Healthcare Hematology-Oncology, Santa Monica, California, 90404, United States
En recrutement
Colorado
Sarah Cannon Research Institue At Healthone, Denver, Colorado, 80218, United States
En recrutement
Florida
Florida Cancer Specialists, Sarasota, Florida, 34232, United States
Pas encore en recrutement
Maryland
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins, Baltimore, Maryland, 21287, United States
En recrutement
Massachusetts
Dana Farber Cancer Institute, Boston, Massachusetts, 02215, United States
En recrutement
New Jersey
Hackensack University Medical Center, Hackensack, New Jersey, 07601, United States
En recrutement
New York
Weill Cornell Medicine, New York, New York, 10021, United States
En recrutement
Memorial Sloan Kettering Cancer Center, New York, New York, 10022, United States
En recrutement
Pennsylvania
Jefferson University Hospitals, Philadelphia, Pennsylvania, 19107, United States
Pas encore en recrutement
Tennessee
Scri Oncology Partners, Nashville, Tennessee, 37203, United States
En recrutement
Texas
Md Anderson Cancer Center, Houston, Texas, 77030, United States
En recrutement
New South Wales
Chris Obrien Lifehouse, Camperdown, New South Wales, 02050, Australia
En recrutement
St Vincent'S Hospital Sydney, Darlinghurst, New South Wales, 02010, Australia
En recrutement
Victoria
The Alfred Hospital, Melbourne, Victoria, 03004, Australia
En recrutement
Peter Maccallum Cancer Centre, North Melbourne, Victoria, 3051, Australia
En recrutement
Western Australia
Linear Clinical Research, Nedlands, Western Australia, 06009, Australia
En recrutement
Fondazione Irccs Istituto Nazionale Dei Tumori, Milan, 20133, Italy
En recrutement
Irccs Istituto Clinico Humanitas, Rozzano, 20089, Italy
En recrutement
Centro Ricerche Cliniche Di Verona, Verona, 37134, Italy
En recrutement
National Cancer Center Hospital East, Chiba, 277-8577, Japan
En recrutement
The Cancer Institute Hospital of Jfcr, Tokyo, 135-8550, Japan
En recrutement
Hospital General Universitario Vall D Hebron, Barcelona, 08035, Spain
En recrutement
Fundacion Jimenez Diaz, Madrid, 28040, Spain
En recrutement
Hospital Universitario Quironsalud Madrid, Madrid, 28223, Spain
En recrutement