A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Select Advanced Solid Tumors

JRCT ID: jRCT2031220663

Registered date:27/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Advanced Solid Tumor
• Date of first enrollment: 05/04/2023
• Target sample size: 203
• Countries of recruitment: United States,Japan,Australia,Japan,Belgium,Japan,France,Japan
• Study type: Interventional

Intervention(s)

Cohort 1:
Participants with select solid tumors who are immunotherapy treatment-naive.
INCB099280 administered orally in 25 mg or 100 mg tablets once daily or twice daily on each day of each 28-day cycle.
Cohort 2:
Participants with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR) tumors who are immunotherapy treatment-naive.
INCB099280 administered orally in 25 mg or 100 mg tablets once daily or twice daily on each day of each 28-day cycle.
Cohort 3:
Participants with progression of any solid tumor treated with an approved anti-PD-1 monoclonal antibody therapy.
INCB099280 administered orally in 25 mg or 100 mg tablets once daily or twice daily on each day of each 28-day cycle.

Outcome(s)

• Primary Outcome: Number of treatment-emergent adverse events

Secondary Outcome

1. Cmax of INCB099280
2. tmax of INCB099280
3. Cmin of INCB099280
4. AUC0-t of INCB099280
5. t1/2 of INCB099280
6. Lambda-z of INCB099280
7. CL/F of INCB099280
8. Vz/F of INCB099280

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Must have disease progression after treatment with available therapies that are known to confer clinical benefit or must be intolerant to or ineligible for standard treatment.
2. Histologically confirmed advanced solid tumors (protocol-defined select solid tumors) with measurable lesions per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) that are considered nonamenable to surgery or other curative treatments or procedures.
3. Eastern Cooperative Oncology Group performance status score of 0 or 1.
4. Life expectancy > 12 weeks.
5. Willingness to avoid pregnancy or fathering children.

Exclude criteria

1. Laboratory values outside the Protocol-defined ranges.
2. Clinically significant cardiac disease.
3. History or presence of an electrocardiogram that, in the investigator's opinion, is clinically meaningful.
4. Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases).
5. Known additional malignancy that is progressing or requires active treatment.
6. Has not recovered to <= Grade 1 or baseline from toxic effects of prior therapy (including prior IO) and/or complications from prior surgical intervention before starting study treatment.
7. Prior receipt of an anti-PD-L1 therapy.
8. Treatment with anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
9. A 28-day washout for systemic antibiotics is required.
10. Probiotic usage while on study and during screening is prohibited.
11. Active infection requiring systemic therapy.
12. Known history of Human Immunodeficiency Virus (HIV)
13. Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.

Related Information

• Primary Sponsor: Eiji Ueda
• Secondary ID(s): NCT04242199