A Phase 2 Study Evaluating INCB099280 in Participants with Select Solid Tumors WHO Are Immune Checkpoint Inhibitor–Naïve

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Incyte Corp.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

27 Nov 2023 → 4 Feb 2026

Decision date (initial)

2023-09-05

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Incyte Corporation

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Safety

To determine the safety, tolerability, and preliminary efficacy of INCB099280 400 mg BID, 600 mg BID, and 800 mg BID in participants with advanced solid tumors.

Secondary objectives 2

1. To determine the efficacy of INCB099280 400 mg BID, 600 mg BID, and 800 mg BID with respect to disease control and response duration in participants with advanced solid tumors.
2. To characterize the INCB099280 PK in plasma in participants with advanced solid tumors.

Conditions and MedDRA coding

Recurrent or advanced/metastatic solid tumors who are immunotherapy naive and may or may not have been treated with prior therapy for their disease.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Ability to comprehend and willingness to sign a written ICF for the study.
2. Age 18 years or older inclusive at the time of signing the ICF.
3. Prior systemic therapy, diagnoses, and disease settings as follows: a. Immunotherapy naive b. Measurable disease per RECIST v1.1 c. One of the following disease settings: see protocol
4. ECOG performance score of 0 or 1 (except for UC, where a score of up to 2 is permitted).
5. Life expectancy > 3 months
6. Willingness to avoid pregnancy or fathering children

Exclusion criteria 28

1. Known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of disease recurrence for 3 years since initiation of that therapy.
2. CNS metastases requiring treatment and/or leptomeningeal disease.
3. Toxicity from prior therapy that has not recovered to ≤ Grade 1 or baseline
4. Prior receipt of an anti–PD-1, anti–PD-L1, or anti–PD-L2 agent or treatment with an immune modulator
5. Received thoracic radiation of > 30 Gy within 6 months of the first dose of study treatment.
6. Participation in another interventional clinical study while receiving INCB099280.
7. Treatment with anticancer medications or investigational drugs within the detailed intervals before the first administration of study drug
8. Impaired cardiac function or clinically significant cardiac disease
9. History or evidence of interstitial lung disease including noninfectious pneumonitis.
10. Presence of gastrointestinal conditions that may affect drug absorption, as well as those that interfere with gastrointestinal transit
11. Any autoimmune disease requiring systemic treatment in the past 5 years, including corticosteroids of a daily dose exceeding 10 mg of prednisone or equivalent
12. Diagnosis of primary immunodeficiency or receiving chronic systemic steroid therapy at a daily dose exceeding 10 mg of prednisone or equivalent
13. HIV infection and any one or more of the following: CD4+ T-cell count < 200 cells/µL, detectable viral load per parameters of assay, or antiretroviral therapy regimen containing moderate or potent CYP3A4/CYP3A5 inhibitors or inducers
14. Active infection requiring systemic therapy, with the exception of HIV and hepatitis
15. History of organ transplantation, including allogeneic stem cell transplantation.
16. Known hypersensitivity or severe reaction to any component of study drug or formulation components.
17. Postoperative complications preventing the participant from adhering protocol assessments and procedures.
18. Receipt of systemic antibiotics within 28 days of first dose of study treatment.
19. Probiotic usage is prohibited during screening and throughout the study treatment period.
20. Received a live vaccine within 28 days of the planned start of study drug. Note: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, some shingles, yellow fever, rabies, BCG, and typhoid vaccines. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live-attenuated vaccines and are not allowed. Note: If enrolled, participants should not receive live vaccine during the study and up to 28 days after the last dose of study drug.
21. Treatment with moderate and potent CYP3A4/CYP3A5 inhibitors or inducers
22. Unable to be weaned off of a prohibited medication before the initiation of study treatment.
23. Participants with laboratory values at screening as defined in the protocol
24. Clinically significant ECG abnormality, including average QTcF interval > 480 milliseconds
25. Active HBV or HCV as follows (testing must be performed): a.Detectable HBV DNA (viral load) and HBsAg. b. Participants with chronic HBV infection with active disease who meet the criteria for anti-HBV therapy are required to be on a suppressive antiviral therapy prior to initiation of study treatment. c. Active HCV is defined as a positive HCV antibody result and quantitative HCV RNA (viral load) result greater than the lower limit of detection
26. Pregnant, expecting to conceive, or breastfeeding or expecting to father children
27. Any condition that would, in the investigator's judgment, interfere with full participation in the study
28. The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection, or who are unable to express their consent per article L.1121-8 of the French Public Health Code, not affiliated to a social security per article L.1121-8-1 of the French Public Health Code.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Objective response, defined as having a best overall response of confirmed CR or PR by investigator assessment per RECIST v1.1.
2. Incidence of TEAEs, assessed by physical examinations, changes in vital signs and ECGs, and analysis of clinical laboratory samples.
3. Incidence of TEAEs leading to dose interruption, dose reduction, or study drug discontinuation.

Secondary endpoints 6

1. Disease control, defined as having a best overall response of confirmed CR or PR, or SD, after a minimum of 15 weeks following the initiation of study treatment by investigator assessment per RECIST v1.1.
2. DOR, defined as the time from the earliest date of confirmed CR or PR to the earliest date of disease progression by investigator assessment per RECIST v1.1 or death due to any cause if occurring sooner than progression.
3. TTR, defined as the time from the date of first dose to the earliest date of confirmed CR or PR by BICR per RECIST v1.1 or composite criteria for metastatic cSCC and WHO criteria for locally advanced cSCC.
4. PFS, defined as the time from the date of first dose to the earliest date of disease progression by BICR per RECIST v1.1 or composite criteria for metastatic cSCC and WHO criteria for locally advanced cSCC or death due to any cause if occurring sooner than progression.
5. OS, defined as the time from the date of first dose to death due to any cause.
6. INCB099280 concentration in plasma.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Incyte Corp.

Sponsor organisation

Incyte Corp.

Address

1801 Augustine Cut Off

City

Wilmington

Postcode

19803-4404

Country

United States

Scientific contact point

Organisation

Incyte Corp.

Contact name

Clinical Trial Information

Public contact point

Organisation

Incyte Corp.

Contact name

Clinical Trial Information

Third parties 4

Locations

3 EU/EEA countries · 19 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 28 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications