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Clinical Trials in Belgium / NCT06179160
Recruiting Phase 1

A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

NCT06179160 · tracked via the Priya Life Science Belgium tracker
Sponsor
Incyte Corporation
Phase
Phase 1
Started
2024-01-04
Last updated
2026-07-22

Condition(s) studied

Solid Tumors

Investigational drug(s) / intervention(s)

INCB161734 →Cetuximab →Retifanlimab →GEMNabP →mFOLFIRINOX →FOLFOX →FOLFIRI →INCA33890 →

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.

Study summary

This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * ≥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. Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (34)

FacilityCityRegionStatus
Mayo Clinic Hospital Phoenix Arizona Recruiting
Stanford University Palo Alto California Recruiting
UCLA Healthcare Hematology-Oncology Santa Monica California Recruiting
Sarah Cannon Research Institue At Healthone Denver Colorado Recruiting
Florida Cancer Specialists Sarasota Florida Recruiting
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins Baltimore Maryland Recruiting
Dana Farber Cancer Institute Boston Massachusetts Recruiting
Hackensack University Medical Center Hackensack New Jersey Recruiting
Weill Cornell Medicine New York New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Jefferson University Hospitals Philadelphia Pennsylvania Recruiting
Scri Oncology Partners Nashville Tennessee Recruiting
Md Anderson Cancer Center Houston Texas Recruiting
Chris Obrien Lifehouse Camperdown New South Wales Recruiting
St Vincent'S Hospital Sydney Darlinghurst New South Wales Recruiting
Peter Maccallum Cancer Centre Melbourne Victoria Recruiting
The Alfred Hospital Melbourne Victoria Recruiting
Linear Clinical Research Nedlands Western Australia Recruiting
Cliniques Universitaires Ucl Saint-Luc Brussels Belgium Recruiting
Universitair Ziekenhuis Antwerpen (Uza) Edegem Belgium Recruiting
Universitair Ziekenhuis (Uz) Leuven Leuven Belgium Recruiting
The Ottawa Hospital Cancer Center Ottawa Ontario Recruiting
Princess Margaret Cancer Center Toronto Ontario Recruiting
Centre Leon Berard Lyon France Recruiting
Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole Toulouse France Recruiting
Institut Gustave Roussy Villejuif France Recruiting
Fondazione Irccs Istituto Nazionale Dei Tumori Milan Italy Recruiting
Irccs Istituto Clinico Humanitas Rozzano Italy Recruiting
Centro Ricerche Cliniche Di Verona Verona Italy Recruiting
National Cancer Center Hospital East Chiba Japan Recruiting
The Cancer Institute Hospital of Jfcr Tokyo Japan Recruiting
Hospital General Universitario Vall D Hebron Barcelona Spain Recruiting
Fundacion Jimenez Diaz Madrid Spain Recruiting
Hospital Universitario Quironsalud Madrid Madrid Spain Recruiting

More Incyte Corporation trials in Belgium

Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression Recruiting
A Phase 3 Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia Recruiting
A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2) Active, not recruiting
A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer Recruiting
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental Vitiligo Recruiting

Other trials for the same condition

A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers Active, not recruiting
A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies Recruiting
A Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Clinical Activity of Mocertatug Rezetecan for Injection in Participants With Advanced Solid Tumors (BEHOLD-1) Recruiting
A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma Recruiting
A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06179160 on ClinicalTrials.gov ↗ ← All trials in Belgium