Tests INCB161734 in adults with advanced solid tumors carrying a KRAS G12D mutation
Tests INCB161734, alone or with other cancer drugs, in adults with advanced solid tumors.
Key facts
- Who runs it
- Incyte Corporation
- Where
- Milan, Rozzano, and Verona, ItalySee the 3 sitesAlso in 7 other countries, 31 sites
- Trial code
- Registry title
- A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 710 people, planned
- Started
- 4 Jan 2024
- Expected to end
- 1 Jan 2027
- Type of study
- Interventional, 6 groups
- Treatments tested
- INCB161734
- Cetuximab
- Retifanlimab
- GEMNabP
- mFOLFIRINOX
- FOLFOX
- FOLFIRI
- INCA33890
- Record updated
- 22 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a solid tumor that has spread or grown locally and carries the KRAS G12D mutation.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Locally advanced or metastatic solid tumor. ECOG performance status of 0 or 1.
- Earlier treatment
- For some parts of the trial: the disease got worse on standard treatment, or the person cannot take or declined standard treatment, or no standard treatment exists. No earlier treatment with a KRAS G12D inhibitor.
- Biomarker or test result
- KRAS G12D mutation in the tumor.
Main reasons for not taking part
- Earlier treatment with any KRAS G12D inhibitor
- Another invasive cancer within 1 year before the first dose
- History of organ transplant, including allogeneic stem cell transplantation
- Serious uncontrolled medical condition
- ECG abnormality, or organs that do not work well enough
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- ≥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
Who cannot take part
- 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
Where in Italy
Also in 7 other countries, 31 sites
- Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, ItalyTaking people
- IRCCS Istituto Clinico HumanitasRozzano, ItalyTaking people
- Centro Ricerche Cliniche Di VeronaVerona, ItalyTaking people
About the trial
What the trial wants to find out
This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.
The 6 groups in the trial
- Part 1a: Dose Escalation monotherapyTreatment being tested
INCB161734 at the protocol-defined dose strength based on cohort assignment.
Treatment: INCB161734
- Part 1b: Dose Expansion monotherapyTreatment being tested
INCB161734 at the protocol-defined dose strength based on cohort assignment.
Treatment: INCB161734
- Part 1c: Pharmacodynamic cohortTreatment being tested
INCB161734 at the protocol-defined dose strength based on cohort assignment.
Treatment: INCB161734
- Part 2a: Dose Escalation combinationTreatment being tested
INCB161734 in combination at the protocol-defined dose strength based on cohort assignment.
Treatment: INCB161734, Cetuximab, Retifanlimab, GEMNabP, mFOLFIRINOX, FOLFOX, FOLFIRI, and INCA33890
- Part 2b: Dose Expansion combinationTreatment being tested
INCB161734 in combination at the protocol-defined dose strength based on cohort assignment.
Treatment: INCB161734, Cetuximab, Retifanlimab, GEMNabP, mFOLFIRINOX, FOLFOX, FOLFIRI, and INCA33890
- Part 1d: Food-EffectTreatment being tested
Evaluate food effect on drug exposure as defined in the protocol.
Treatment: INCB161734
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
- Plain-language title
- Tests INCB161734 in adults with advanced solid tumors carrying a KRAS G12D mutationGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 22 July 2026