Solid TumorsPhase 1NCT06179160
A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
A Phase 1 study testing INCB161734, Cetuximab and Retifanlimab in people with Solid Tumors, run by Incyte Corporation at 34 sites in 8 countries.
Trial summary
This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- INCB161734, Cetuximab and Retifanlimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 710 participants
- Where
- 34 sitesin 8 countries
- Study dates
- 4 Jan 2024to 1 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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 join
- 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
Trial locations and contacts
34 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
34 sites in 8 countries
United States13 sites, 13 recruiting
- Recruiting
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, 21287
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
Sarah Cannon Research Institue At Healthone
Denver, Colorado, 80218
- Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
- Recruiting
Md Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Scri Oncology Partners
Nashville, Tennessee, 37203
- Recruiting
Weill Cornell Medicine
New York, New York, 10021
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10022
- Recruiting
Stanford University
Palo Alto, California, 94305
- Recruiting
Jefferson University Hospitals
Philadelphia, Pennsylvania, 19107
- Recruiting
Mayo Clinic Hospital
Phoenix, Arizona, 85054
- Recruiting
UCLA Healthcare Hematology-Oncology
Santa Monica, California, 90404
- Recruiting
Florida Cancer Specialists
Sarasota, Florida, 34232
Australia5 sites, 5 recruiting
- Recruiting
Chris Obrien Lifehouse
Camperdown, New South Wales, 02050
- Recruiting
St Vincent'S Hospital Sydney
Darlinghurst, New South Wales, 02010
- Recruiting
Peter Maccallum Cancer Centre
Melbourne, Victoria, 03000
- Recruiting
The Alfred Hospital
Melbourne, Victoria, 03004
- Recruiting
Linear Clinical Research
Nedlands, Western Australia, 06009
Belgium3 sites, 3 recruiting
- Recruiting
Cliniques Universitaires Ucl Saint-Luc
Brussels, 01200
- Recruiting
Universitair Ziekenhuis Antwerpen (Uza)
Edegem, 02650
- Recruiting
Universitair Ziekenhuis (Uz) Leuven
Leuven, 03000
France3 sites, 3 recruiting
- Recruiting
Centre Leon Berard
Lyon, 69373
- Recruiting
Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole
Toulouse, 31059
- Recruiting
Institut Gustave Roussy
Villejuif, 94805
Italy3 sites, 3 recruiting
- Recruiting
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan, 20133
- Recruiting
Irccs Istituto Clinico Humanitas
Rozzano, 20089
- Recruiting
Centro Ricerche Cliniche Di Verona
Verona, 37134
Spain3 sites, 3 recruiting
- Recruiting
Hospital General Universitario Vall D Hebron
Barcelona, 08035
- Recruiting
Fundacion Jimenez Diaz
Madrid, 28040
- Recruiting
Hospital Universitario Quironsalud Madrid
Madrid, 28223
Canada2 sites, 2 recruiting
- Recruiting
The Ottawa Hospital Cancer Center
Ottawa, Ontario, K1H 8L6
- Recruiting
Princess Margaret Cancer Center
Toronto, Ontario, M5G 2M9
Japan2 sites, 2 recruiting
- Recruiting
National Cancer Center Hospital East
Chiba, 277-0882
- Recruiting
The Cancer Institute Hospital of Jfcr
Tokyo, 135-0063
About this study
Official title: A Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.
- Conditions
- Solid Tumors
- Being tested
- INCB161734, Cetuximab, Retifanlimab, GEMNabP, mFOLFIRINOX
- Keywords
- INCB161734, KRASG12D Mutation, pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC)
- Medical subject headings
- Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB161734Drug
INCB161734 will be administered at protocol defined dose.
CetuximabDrug
Cetuximab will be administered at protocol defined dose.
RetifanlimabDrug
Retifanlimab will be administered at protocol defined dose.
GEMNabPDrug
GEMNabP will be administered at protocol defined dose.
mFOLFIRINOXDrug
mFOLFIRINOX will be administered at protocol defined dose.
FOLFOXDrug
FOLFOX will be administered at protocol defined dose.
FOLFIRIDrug
FOLFIRI will be administered at protocol defined dose.
INCA33890Drug
INCA33890 will be administered at protocol defined dose.
| Study group | Role | What they receive |
|---|---|---|
| Part 1a: Dose Escalation monotherapy | Experimental | INCB161734 at the protocol-defined dose strength based on cohort assignment. Receives: Drug: INCB161734 |
| Part 1b: Dose Expansion monotherapy | Experimental | INCB161734 at the protocol-defined dose strength based on cohort assignment. Receives: Drug: INCB161734 |
| Part 1c: Pharmacodynamic cohort | Experimental | INCB161734 at the protocol-defined dose strength based on cohort assignment. Receives: Drug: INCB161734 |
| Part 2a: Dose Escalation combination | Experimental | INCB161734 in combination at the protocol-defined dose strength based on cohort assignment. Receives: Drug: INCB161734; Drug: Cetuximab; Drug: Retifanlimab; Drug: GEMNabP; Drug: mFOLFIRINOX; Drug: FOLFOX; Drug: FOLFIRI; Drug: INCA33890 |
| Part 2b: Dose Expansion combination | Experimental | INCB161734 in combination at the protocol-defined dose strength based on cohort assignment. Receives: Drug: INCB161734; Drug: Cetuximab; Drug: Retifanlimab; Drug: GEMNabP; Drug: mFOLFIRINOX; Drug: FOLFOX; Drug: FOLFIRI; Drug: INCA33890 |
| Part 1d: Food-Effect | Experimental | Evaluate food effect on drug exposure as defined in the protocol. Receives: Drug: INCB161734 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 2 years and 90 days
Secondary outcomes (4)
INCB161734 pharmacokinetic (PK) in Plasma
INCB161734 concentration in plasma.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start4 Jan 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 710 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179160
- Sponsor's protocol ID
- INCB161734-101
- Other IDs
- 2023-507091-47-00, 2023
- Status last verified
- Jul 2026
- First submitted
- 12 Dec 2023
- Last updated
- 22 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
- ClinicalTrials.gov ID
- NCT06179160
- Acronym / sponsor ID
- INCB161734-101
- Conditions
- Solid Tumors
- Keywords
- INCB161734, KRASG12D Mutation, pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 710 participants (estimated)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 21 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1a: Dose Escalation monotherapy | Experimental | Drug: INCB161734INCB161734 at the protocol-defined dose strength based on cohort assignment. |
| Part 1b: Dose Expansion monotherapy | Experimental | Drug: INCB161734INCB161734 at the protocol-defined dose strength based on cohort assignment. |
| Part 1c: Pharmacodynamic cohort | Experimental | Drug: INCB161734INCB161734 at the protocol-defined dose strength based on cohort assignment. |
| Part 2a: Dose Escalation combination | Experimental | Drug: INCB161734, Drug: Cetuximab, Drug: Retifanlimab, Drug: GEMNabP, Drug: mFOLFIRINOX, Drug: FOLFOX, Drug: FOLFIRI, Drug: INCA33890INCB161734 in combination at the protocol-defined dose strength based on cohort assignment. |
| Part 2b: Dose Expansion combination | Experimental | Drug: INCB161734, Drug: Cetuximab, Drug: Retifanlimab, Drug: GEMNabP, Drug: mFOLFIRINOX, Drug: FOLFOX, Drug: FOLFIRI, Drug: INCA33890INCB161734 in combination at the protocol-defined dose strength based on cohort assignment. |
| Part 1d: Food-Effect | Experimental | Drug: INCB161734Evaluate food effect on drug exposure as defined in the protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCB161734INCB161734 will be administered at protocol defined dose. | Drug | Part 1a: Dose Escalation monotherapy, Part 1b: Dose Expansion monotherapy, Part 1c: Pharmacodynamic cohort, Part 1d: Food-Effect, Part 2a: Dose Escalation combination, Part 2b: Dose Expansion combination |
| CetuximabCetuximab will be administered at protocol defined dose. | Drug | Part 2a: Dose Escalation combination, Part 2b: Dose Expansion combination |
| RetifanlimabRetifanlimab will be administered at protocol defined dose. | Drug | Part 2a: Dose Escalation combination, Part 2b: Dose Expansion combination |
| GEMNabPGEMNabP will be administered at protocol defined dose. | Drug | Part 2a: Dose Escalation combination, Part 2b: Dose Expansion combination |
| mFOLFIRINOXmFOLFIRINOX will be administered at protocol defined dose. | Drug | Part 2a: Dose Escalation combination, Part 2b: Dose Expansion combination |
| FOLFOXFOLFOX will be administered at protocol defined dose. | Drug | Part 2a: Dose Escalation combination, Part 2b: Dose Expansion combination |
| FOLFIRIFOLFIRI will be administered at protocol defined dose. | Drug | Part 2a: Dose Escalation combination, Part 2b: Dose Expansion combination |
| INCA33890INCA33890 will be administered at protocol defined dose. | Drug | Part 2a: Dose Escalation combination, Part 2b: Dose Expansion combination |
Primary outcome
Number of participants with Dose Limiting Toxicities (DLTs)
Time frame: Up to 28 days
Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 2 years and 90 days
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.
Number of participants with TEAEs leading to dose modification or discontinuation
Time frame: Up to 2 years and 90 days
Number of participants with TEAEs leading to dose modification or discontinuation.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D MutationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Incyte Medical Monitor study director
Incyte Corporation
34 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INCB161734, Cetuximab and Retifanlimab in people with Solid Tumors, run by Incyte Corporation at 34 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Australia, Belgium, France, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Incyte Corporation Call Center (US) (1.855.463.3463, medinfo@incyte.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Dose Limiting Toxicities (DLTs) (time frame: Up to 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.