A Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors

Trial Title: A Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors

NCT ID: NCT05949632

Condition: Advanced Solid Tumors

Conditions: Official terms:
Neoplasms
Axitinib

Conditions: Keywords:
gynecologic tract cancer
ovarian cancer
primary peritoneum cancer
fallopian tube cancer
uterine cancer
cervical cancer
vulvar cancer
vaginal cancer
clear cell histology
mucinous adenocarcinoma
carcinosarcoma
serous adenocarcinoma
neuroendocrine histology
small cell histology
small-molecule pdl1 inhibitor
tyrosine kinase inhibitor
combination therapy

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Active, not recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Intervention model description: The study consists of 2 parts. In the Part 1 dose-escalation, participants will be enrolled in up to 6 dose levels of INCB099280 administered in combination with axitinib. In the Part 2 dose expansion, participants will be enrolled into 1 of 2 disease-specific cohorts at the dose(s) identified in Part 1.

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: INCB099280
Description: Administered as specified in the treatment arm description
Arm group label: Part 1: Dose Escalation
Arm group label: Part 2: Dose Expansion

Intervention type: Drug
Intervention name: axitinib
Description: Administered as specified in the treatment arm description
Arm group label: Part 1: Dose Escalation
Arm group label: Part 2: Dose Expansion

Summary: This study is being conducted to evaluate the safety and tolerability of INCB099280 in combination with axitinib and to assess the antitumor activity of INCB099280 in combination with axitinib. This study will only be open in the UK and EU.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 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 non-amenable to surgery or other curative treatments or procedures. - Must have disease progression on or after treatment with at least one prior systemic chemotherapy. - Eastern Cooperative Oncology Group performance status score of 0 or 1. - Life expectancy > 12 weeks. - Willingness to avoid pregnancy. Exclusion Criteria: - Known additional malignancy that is progressing or requires active treatment. - Central nervous system (CNS) metastases requiring treatment and/or leptomeningeal disease. - Toxicity from prior therapy that has not recovered to protocol-defined limits. - Prior receipt of an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent; treatment with an immune modulator (eg, CTLA-4, GITR, LAG3, TIM3, OX40, ICOS, IL-2, 4-1BB, CAR-T cell). - Prior therapy with antiangiogenic small-molecule TKIs targeting the VEGF pathway - Participation in another interventional clinical study while receiving INCB099280. - Impaired cardiac function or clinically significant cardiac disease. - History or evidence of interstitial lung disease including noninfectious pneumonitis. - Presence of gastrointestinal conditions that may affect drug absorption. - Any autoimmune disease requiring systemic treatment in the past 5 years. - Diagnosis of primary immunodeficiency or receiving chronic systemic steroid therapy at a daily dose exceeding 10 mg of prednisone or equivalent. - Active infection requiring systemic therapy. - History of organ transplantation, including stem cell transplantation. - Receipt of systemic antibiotics within 28 days of 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. - Inadequate organ function. Other protocol-defined Inclusion/Exclusion Criteria may apply.

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Addenbrookes Hospital

Address:
City: Cambridge
Zip: CB2 0QQ
Country: United Kingdom

Facility:
Name: Beatson West of Scotland Cancer Centrewester

Address:
City: Glasgow
Zip: G12 0YN
Country: United Kingdom

Facility:
Name: St Bartholomew'S Hospital

Address:
City: London
Zip: EC1A 7BE
Country: United Kingdom

Facility:
Name: Guys Hospital

Address:
City: London
Zip: SE1 9RT
Country: United Kingdom

Facility:
Name: The Royal Marsden

Address:
City: London
Zip: SW3 6JJ
Country: United Kingdom

Facility:
Name: The Royal Marsden Nhs Foundation Trust - Sutton

Address:
City: Sutton
Zip: SM2 5PT
Country: United Kingdom

Start date: April 16, 2024

Completion date: December 15, 2027

Lead sponsor:
Agency: Incyte Corporation
Agency class: Industry

Source: Incyte Corporation

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05949632