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Recruiting NCT06179160

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

Phase I Interventional Solid Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: INCB161734, Cetuximab, Retifanlimab, GEMNabP.
Who it may be relevant to
Registry conditions: Solid Tumors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Belgium, Canada, France +3
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

Overview

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

Interventions

  • Drug INCB161734
    INCB161734 will be administered at protocol defined dose.
  • Drug Cetuximab
    Cetuximab will be administered at protocol defined dose.
  • Drug Retifanlimab
    Retifanlimab will be administered at protocol defined dose.
  • Drug GEMNabP
    GEMNabP will be administered at protocol defined dose.
  • Drug mFOLFIRINOX
    mFOLFIRINOX will be administered at protocol defined dose.
  • Drug FOLFOX
    FOLFOX will be administered at protocol defined dose.
  • Drug FOLFIRI
    FOLFIRI will be administered at protocol defined dose.
  • Drug INCA33890
    INCA33890 will be administered at protocol defined dose.

Primary outcome measures

  • Number of participants with Dose Limiting Toxicities (DLTs) [Time frame: Up to 28 days]
  • Number of participants with Treatment-emergent Adverse Events (TEAEs) [Time frame: Up to 2 years and 90 days]
  • Number of participants with TEAEs leading to dose modification or discontinuation [Time frame: Up to 2 years and 90 days]
Secondary outcome measures (4)
  • INCB161734 pharmacokinetic (PK) in Plasma [Time frame: Up to approximately 90 days]
  • Objective Response Rate (ORR) [Time frame: Up to 2 years]
  • Disease Control Response (DCR) [Time frame: Up to 2 years]
  • Duration of Response (DOR) [Time frame: Up to 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 13 centers
  • Mayo Clinic Hospital — Phoenix
  • Stanford University — Palo Alto
  • UCLA Healthcare Hematology-Oncology — Santa Monica
  • Sarah Cannon Research Institue At Healthone — Denver
  • Florida Cancer Specialists — Sarasota
  • Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins — Baltimore
  • Dana Farber Cancer Institute — Boston
  • Hackensack University Medical Center — Hackensack
  • … and 5 more centers
Australia · 5 centers
  • Chris Obrien Lifehouse — Camperdown
  • St Vincent'S Hospital Sydney — Darlinghurst
  • Peter Maccallum Cancer Centre — Melbourne
  • The Alfred Hospital — Melbourne
  • Linear Clinical Research — Nedlands
Belgium · 3 centers
  • Cliniques Universitaires Ucl Saint-Luc — Brussels
  • Universitair Ziekenhuis Antwerpen (Uza) — Edegem
  • Universitair Ziekenhuis (Uz) Leuven — Leuven
France · 3 centers
  • Centre Leon Berard — Lyon
  • Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole — Toulouse
  • Institut Gustave Roussy — Villejuif
Italy · 3 centers
  • Fondazione Irccs Istituto Nazionale Dei Tumori — Milan
  • Irccs Istituto Clinico Humanitas — Rozzano
  • Centro Ricerche Cliniche Di Verona — Verona
Spain · 3 centers
  • Hospital General Universitario Vall D Hebron — Barcelona
  • Fundacion Jimenez Diaz — Madrid
  • Hospital Universitario Quironsalud Madrid — Madrid
Canada · 2 centers
  • The Ottawa Hospital Cancer Center — Ottawa
  • Princess Margaret Cancer Center — Toronto
Japan · 2 centers
  • National Cancer Center Hospital East — Chiba
  • The Cancer Institute Hospital of Jfcr — Tokyo

Identifiers

NCT: NCT06179160 · INCB161734-101 · 2023-507091-47-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗