Advanced Solid TumorsPhase 1NCT06039384
A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation
A Phase 1 study testing INCB099280 and adagrasib in people with Advanced Solid Tumors, run by Incyte Corporation at 14 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of INCB099280 in combination with adagrasib and to establish the MTD or identify RDE(s) for the combination of INCB099280 and adagrasib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- INCB099280 and adagrasib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 14 sitesin 4 countries
- Study dates
- 28 Dec 2023to 11 Jul 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- KRASG12C-mutated solid malignancy determined by a sponsor-approved assay using either tumor tissue or ctDNA.
- Histologically confirmed malignant solid tumor with locally advanced and/or metastatic disease.
- Only participants with NSCLC will be enrolled into Part 2 Cohort A.
- Only participants with CRC will be enrolled into Part 2 Cohort B.
- Part 1: Disease progression on or after at least 1 prior systemic treatment.
- Part 2 (Cohort A - NSCLC): Received an anti-PD-(L)1-containing regimen and platinum based chemotherapy regimen either concurrently or sequentially
Show all 11Show fewer
- Part 2 (Cohort B - CRC): Received at least 1 line of systemic therapy that includes the combination of fluoropyrimidine-based chemotherapy (in combination with oxaliplatin and/or irinotecan) and either a vascular endothelial growth factor-targeting monoclonal antibody or an anti-epidermal growth factor receptor monoclonal antibody (if RAS wild type). Participants with MSI-H/dMMR CRC must also have received a prior immune checkpoint inhibitor approved for this indication.
- Measurable disease according to RECIST v1.1.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Estimated life expectancy > 3 months.
- Willingness to avoid pregnancy.
Who cannot join
- Known additional malignancy that is progressing or requires active treatment.
- Central nervous system (CNS) metastases requiring treatment and/or leptomeningeal disease.
- Part 2 only: Prior treatment with an approved or investigational agent targeting KRASG12C.
- Toxicity from prior therapy that has not recovered to protocol-defined limits.
- Received thoracic radiation of > 30 Gy within 6 months of the first dose of study treatment.
- Participation in another interventional clinical study.
Show all 17Show fewer
- History or evidence of interstitial lung disease, including noninfectious pneumonitis.
- Presence of gastrointestinal condition that may affect drug absorption.
- Active autoimmune disease requiring systemic treatment, including corticosteroids exceeding a daily dose of 10 mg of prednisone or equivalent.
- Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy exceeding a daily dose of 10 mg of prednisone or equivalent.
- Active infection requiring systemic therapy.
- History of organ transplantation, including allogeneic stem cell transplantation.
- Receipt of systemic antibiotics within 28 days of the first dose of study treatment.
- Probiotic usage is prohibited during screening and throughout the study treatment period.
- Received a live vaccine within 28 days of the planned start of study drug.
- Laboratory values outside the Protocol-defined ranges.
- Other protocol-defined Inclusion/Exclusion Criteria may apply.
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
United States5 sites
Mary Crowley Cancer Research Centers McCrc Headquarters
Dallas, Texas, 75251
Henry Ford Health System
Detroit, Michigan, 48202
Inova Schar Cancer Institute
Falls Church, Virginia, 22042
Banner Md Anderson Cancer Center
Greeley, Colorado, 80631
Valkyrie Clinical Trials
Los Angeles, California, 90067
Spain4 sites
Hospital Hm Nou Delfos
Barcelona, 08023
Hospital General Universitario Vall D Hebron
Barcelona, 08035
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, 28223
Hospital Universitario Virgen Macarena
Seville, 41009
Italy3 sites
Fondazione Del Piemonte Per L Oncologia Ircc Candiolo
Candiolo, 10060
Irccs Istituto Clinico Humanitas
Rozzano, 20089
Centro Ricerche Cliniche Di Verona (Crc)
Verona, 37124
United Kingdom2 sites
Guys Hospital
London, SE1 9RT
Hammersmith Hospital
London, W12 0HS
About this study
Official title: A Phase 1 Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation
The purpose of this study is to evaluate the safety and tolerability of INCB099280 in combination with adagrasib and to establish the MTD or identify RDE(s) for the combination of INCB099280 and adagrasib.
- Conditions
- Advanced Solid Tumors
- Being tested
- INCB099280, adagrasib
- Keywords
- KRASG12C mutation, non-small cell lung cancer (NSCLC), colorectal cancer (CRC)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB099280Drug
Administered as specified in the treatment arm description
adagrasibDrug
Also called KRAZATI
Administered as specified in the treatment arm description
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Finding | Experimental | INCB099280 administered in combination with adagrasib in participants with previously treated KRAS glutamine to cysteine mutation at codon 12 (KRASG12C) mutant advanced solid tumors, will be evaluated to identify dose(s) for further evaluation in the dose expansion phase of the study. Receives: Drug: INCB099280; Drug: adagrasib |
| Part 2: Dose Expansion | Experimental | Up to 80 participants will be enrolled in 1 of 2 disease-specific cohorts: Cohort A: previously treated KRASG12C mutated non-small cell lung cancer (NSCLC) Cohort B: previously treated KRASG12C-mutated colorectal cancer (CRC). Up to 3 doses may be selected from Part 1: Dose Finding for the Part 2: Dose Expansion. Receives: Drug: INCB099280; Drug: adagrasib |
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)
DLTs were defined as protocol-defined toxicities occurring up to and including on Day 28, except those with a clear alternative explanation. Toxicities with a clear alternative explanation (e.g., due to disease progression) or transient (≤72 hours) abnormal laboratory values without associated clinically significant signs or symptoms based on investigator determination could have been deemed non-DLTs.
Measured: up to Day 28
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was defined any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or start of new anticancer therapy.
Measured: up to 574 days
Number of Participants With TEAEs Leading to Treatment Interruptions, Dose Reductions, and Permanent Discontinuation of INCB099280 and Adagarsib
An AE was defined any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or start of new anticancer therapy.
Measured: up to 574 days
Secondary outcomes (11)
Concentration of INCB099280
During the lead-in period, INCB099280 was administered as monotherapy. During the treatment period, INCB099280 and adagrasib were coadministered.
Measured: Lead-in Period Day -1 and Cycle 1 Day 8: predose and 0.5, 1, 2, 3, 4, 6, 8, and 12 hours postdose; predose on Day 1 of Cycles 1, 2, 4, and 6
Cmax of INCB099280 When Administered Alone and in Combination With Adagrasib
During the lead-in period, INCB099280 was administered as monotherapy. During the treatment period, INCB099280 and adagrasib were coadministered. Cmax was defined as the maximum plasma concentration of INCB099280. Lead-in Period: Day -1 and Cycle 1 Day 8: predose and 0.5, 1, 2, 3, 4, 6, 8, and 12 hours postdose; predose on Day 1 of Cycles 1, 2, 4, 6, 8, 12, and every fourth cycle thereafter. Without Lead-in Period: Cycle 1 Day 8: predose and 1, 2, and 4 hours postdose; predose on Day 1 of Cycles 1, 2, 4, 6, 8, 12, and every fourth cycle thereafter.
Measured: Day -1; Cycle 1 Day 8; Day 1 of Cycles 1, 2, 4, 6, 8, 12, and every fourth cycle thereafter
Cmax,ss of INCB099280 When Administered Alone and in Combination With Adagrasib
During the lead-in period, INCB099280 was administered as monotherapy. During the treatment period, INCB099280 and adagrasib were coadministered. Cmax,ss was defined as the maximum plasma concentration of INCB099280 at steady state. Lead-in Period: Day -1 and Cycle 1 Day 8: predose and 0.5, 1, 2, 3, 4, 6, 8, and 12 hours postdose; predose on Day 1 of Cycles 1, 2, 4, 6, 8, 12, and every fourth cycle thereafter. Without Lead-in Period: Cycle 1 Day 8: predose and 1, 2, and 4 hours postdose; predose on Day 1 of Cycles 1, 2, 4, 6, 8, 12, and every fourth cycle thereafter.
Measured: Day -1; Cycle 1 Day 8; Day 1 of Cycles 1, 2, 4, 6, 8, 12, and every fourth cycle thereafter
Cmin,ss of INCB099280 When Administered Alone and in Combination With Adagrasib
During the lead-in period, INCB099280 was administered as monotherapy. During the treatment period, INCB099280 and adagrasib were coadministered. Cmin,ss was defined as the minimum plasma concentration of INCB099280 at steady state. Lead-in Period: Day -1 and Cycle 1 Day 8: predose and 0.5, 1, 2, 3, 4, 6, 8, and 12 hours postdose; predose on Day 1 of Cycles 1, 2, 4, 6, 8, 12, and every fourth cycle thereafter. Without Lead-in Period: Cycle 1 Day 8: predose and 1, 2, and 4 hours postdose; predose on Day 1 of Cycles 1, 2, 4, 6, 8, 12, and every fourth cycle thereafter.
Measured: Day -1; Cycle 1 Day 8; Day 1 of Cycles 1, 2, 4, 6, 8, 12, and every fourth cycle thereafter
Tmax of INCB099280 When Administered Alone and in Combination With Adagrasib
During the lead-in period, INCB099280 was administered as monotherapy. During the treatment period, INCB099280 and adagrasib were coadministered. tmax was defined as the time to the maximum concentration of INCB099280. Lead-in Period: Day -1 and Cycle 1 Day 8: predose and 0.5, 1, 2, 3, 4, 6, 8, and 12 hours postdose; predose on Day 1 of Cycles 1, 2, 4, 6, 8, 12, and every fourth cycle thereafter. Without Lead-in Period: Cycle 1 Day 8: predose and 1, 2, and 4 hours postdose; predose on Day 1 of Cycles 1, 2, 4, 6, 8, 12, and every fourth cycle thereafter.
Measured: Day -1; Cycle 1 Day 8; Day 1 of Cycles 1, 2, 4, 6, 8, 12, and every fourth cycle thereafter
AUC0-tau of INCB099280 When Administered Alone and in Combination With Adagrasib
During the lead-in period, INCB099280 was administered as monotherapy. During the treatment period, INCB099280 and adagrasib were coadministered. AUC0-tau was defined as the area under the steady-state plasma or serum concentration-time curve over 1 dose interval of INCB099280. Lead-in Period: Day -1 and Cycle 1 Day 8: predose and 0.5, 1, 2, 3, 4, 6, 8, and 12 hours postdose; predose on Day 1 of Cycles 1, 2, 4, 6, 8, 12, and every fourth cycle thereafter. Without Lead-in Period: Cycle 1 Day 8: predose and 1, 2, and 4 hours postdose; predose on Day 1 of Cycles 1, 2, 4, 6, 8, 12, and every fourth cycle thereafter.
Measured: Day -1; Cycle 1 Day 8; Day 1 of Cycles 1, 2, 4, 6, 8, 12, and every fourth cycle thereafter
CLss/F of INCB099280 When Administered Alone and in Combination With Adagrasib
During the lead-in period, INCB099280 was administered as monotherapy. During the treatment period, INCB099280 and adagrasib were coadministered. CLss/F was defined as the apparent oral dose clearance of INCB099280 at steady state. Lead-in Period: Day -1 and Cycle 1 Day 8: predose and 0.5, 1, 2, 3, 4, 6, 8, and 12 hours postdose; predose on Day 1 of Cycles 1, 2, 4, 6, 8, 12, and every fourth cycle thereafter. Without Lead-in Period: Cycle 1 Day 8: predose and 1, 2, and 4 hours postdose; predose on Day 1 of Cycles 1, 2, 4, 6, 8, 12, and every fourth cycle thereafter.
Measured: Day -1; Cycle 1 Day 8; Day 1 of Cycles 1, 2, 4, 6, 8, 12, and every fourth cycle thereafter
Objective Response
Objective response was defined as having a best overall response of complete response (CR) or partial response (PR) assessed per Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1) by the investigator. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Measured: up to 470 days
Disease Control
Disease control was defined as defined as having a best overall response of CR, PR, or stable disease (SD) ≥15 weeks (from the start of treatment) assessed per RECIST v1.1 by the investigator. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Measured: up to 470 days
Duration of Response
Duration of response was defined as the time from the first CR or PR until disease progression (assessed per RECIST v1.1 by the investigator) or death from any cause, whichever occurred earlier. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Measured: up to 470 days
Kaplan-Meier Estimate of ≥6-month and ≥12-month Progression-free Survival (PFS)
≥6-month and ≥12-month PFS was defined as the absence of disease progression (assessed per RECIST v1.1 by the investigator) or death from any cause from the start of treatment to ≥6 or ≥12 months after treatment. A Kaplan-Meier estimate of PFS is an estimate of the probability that a participant will remain alive and free from disease progression (or relapse) at a given time point after starting treatment.
Measured: ≥6-months and ≥12-months (up to 470 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start28 Dec 2023
- Primary completion11 Apr 2025
- Study completion11 Jul 2025
Why it stopped: This was a strategic business decision. There were no safety concerns contributing to this decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced 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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mirati Therapeutics Inc.
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039384
- Sponsor's protocol ID
- INCB99280-204
- Other IDs
- 2023-503223-26-00, 2023
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2023
- Last updated
- 8 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation
- ClinicalTrials.gov ID
- NCT06039384
- Acronym / sponsor ID
- INCB99280-204
- Conditions
- Advanced Solid Tumors
- Keywords
- KRASG12C mutation, non-small cell lung cancer (NSCLC), colorectal cancer (CRC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This was a strategic business decision. There were no safety concerns contributing to this decision.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Mirati Therapeutics Inc.
- Study start
- 28 Dec 2023 (actual)
- Primary completion
- 11 Apr 2025 (actual)
- Study completion
- 11 Jul 2025 (actual)
- First posted
- 15 Sep 2023 (actual)
- Results
- Posted 8 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and tolerability of INCB099280 in combination with adagrasib and to establish the MTD or identify RDE(s) for the combination of INCB099280 and adagrasib.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Finding | Experimental | Drug: INCB099280, Drug: adagrasibINCB099280 administered in combination with adagrasib in participants with previously treated KRAS glutamine to cysteine mutation at codon 12 (KRASG12C) mutant advanced solid tumors, will be evaluated to identify dose(s) for further evaluation in the dose expansion phase of the study. |
| Part 2: Dose Expansion | Experimental | Drug: INCB099280, Drug: adagrasibUp to 80 participants will be enrolled in 1 of 2 disease-specific cohorts: Cohort A: previously treated KRASG12C mutated non-small cell lung cancer (NSCLC) Cohort B: previously treated KRASG12C-mutated colorectal cancer (CRC). Up to 3 doses may be selected from Part 1: Dose Finding for the Part 2: Dose Expansion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- KRASG12C-mutated solid malignancy determined by a sponsor-approved assay using either tumor tissue or ctDNA.
- Histologically confirmed malignant solid tumor with locally advanced and/or metastatic disease.
- Part 1: Disease progression on or after at least 1 prior systemic treatment.
- Part 2 (Cohort A - NSCLC): Received an anti-PD-(L)1-containing regimen and platinum based chemotherapy regimen either concurrently or sequentially
- Part 2 (Cohort B - CRC): Received at least 1 line of systemic therapy that includes the combination of fluoropyrimidine-based chemotherapy (in combination with oxaliplatin and/or irinotecan) and either a vascular endothelial growth factor-targeting monoclonal antibody or an anti-epidermal growth factor receptor monoclonal antibody (if RAS wild type). Participants with MSI-H/dMMR CRC must also have received a prior immune checkpoint inhibitor approved for this indication.
Key exclusion criteria (17 listed)
- Known additional malignancy that is progressing or requires active treatment.
- Central nervous system (CNS) metastases requiring treatment and/or leptomeningeal disease.
- Part 2 only: Prior treatment with an approved or investigational agent targeting KRASG12C.
- Toxicity from prior therapy that has not recovered to protocol-defined limits.
- Received thoracic radiation of > 30 Gy within 6 months of the first dose of study treatment.
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 |
|---|---|---|
| INCB099280Administered as specified in the treatment arm description | Drug | Part 1: Dose Finding, Part 2: Dose Expansion |
| adagrasibAlso: KRAZATIAdministered as specified in the treatment arm description | Drug | Part 1: Dose Finding, Part 2: Dose Expansion |
Primary outcome
Number of Participants With Dose-limiting Toxicities (DLTs)
Time frame: up to Day 28
DLTs were defined as protocol-defined toxicities occurring up to and including on Day 28, except those with a clear alternative explanation. Toxicities with a clear alternative explanation (e.g., due to disease progression) or transient (≤72 hours) abnormal laboratory values without associated clinically significant signs or symptoms based on investigator determination could have been deemed non-DLTs.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: up to 574 days
An adverse event (AE) was defined any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or start of new anticancer therapy.
Number of Participants With TEAEs Leading to Treatment Interruptions, Dose Reductions, and Permanent Discontinuation of INCB099280 and Adagarsib
Time frame: up to 574 days
An AE was defined any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or start of new anticancer therapy.
11 secondary outcomes
Concentration of INCB099280
Time frame: Lead-in Period Day -1 and Cycle 1 Day 8: predose and 0.5, 1, 2, 3, 4, 6, 8, and 12 hours postdose; predose on Day 1 of Cycles 1, 2, 4, and 6
Cmax of INCB099280 When Administered Alone and in Combination With Adagrasib
Time frame: Day -1; Cycle 1 Day 8; Day 1 of Cycles 1, 2, 4, 6, 8, 12, and every fourth cycle thereafter
Cmax,ss of INCB099280 When Administered Alone and in Combination With Adagrasib
Time frame: Day -1; Cycle 1 Day 8; Day 1 of Cycles 1, 2, 4, 6, 8, 12, and every fourth cycle thereafter
Cmin,ss of INCB099280 When Administered Alone and in Combination With Adagrasib
Time frame: Day -1; Cycle 1 Day 8; Day 1 of Cycles 1, 2, 4, 6, 8, 12, and every fourth cycle thereafter
Tmax of INCB099280 When Administered Alone and in Combination With Adagrasib
Time frame: Day -1; Cycle 1 Day 8; Day 1 of Cycles 1, 2, 4, 6, 8, 12, and every fourth cycle thereafter
AUC0-tau of INCB099280 When Administered Alone and in Combination With Adagrasib
Time frame: Day -1; Cycle 1 Day 8; Day 1 of Cycles 1, 2, 4, 6, 8, 12, and every fourth cycle thereafter
CLss/F of INCB099280 When Administered Alone and in Combination With Adagrasib
Time frame: Day -1; Cycle 1 Day 8; Day 1 of Cycles 1, 2, 4, 6, 8, 12, and every fourth cycle thereafter
Objective Response
Time frame: up to 470 days
Disease Control
Time frame: up to 470 days
Duration of Response
Time frame: up to 470 days
Kaplan-Meier Estimate of ≥6-month and ≥12-month Progression-free Survival (PFS)
Time frame: ≥6-months and ≥12-months (up to 470 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
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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. This study is not recruiting at the moment.
Incyte Medical Monitor study director
Incyte Corporation
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INCB099280 and adagrasib in people with Advanced Solid Tumors, run by Incyte Corporation at 14 sites in 4 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 11 inclusion and 17 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: stopped early, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Spain, Italy, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 8 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 Day 28). 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 8 Sep 2026.