Clinical trial NCT05949632: A Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors
Official title: A Phase 1/2 Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumors
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
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2023-07-18
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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

Brief 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.


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.

Primary outcomes:
measure: Part 1: Number of participants with Dose Limiting Toxicities (DLTs)
timeFrame: Up to 21 days
measure: Part 1: Number of participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to 2 years and 90 days
measure: Part 1: Number of participants with TEAEs leading to dose modification
timeFrame: Up to 2 years
measure: Part 2: Objective response rate (ORR)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Part 2: Number of participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to 2 years and 90 days
measure: Part 2: Number of participants with TEAEs leading to dose modification
timeFrame: Up to 2 years
measure: Part 1: Objective response rate (ORR)
timeFrame: Up to 2 years
measure: Disease Control Rate (DCR)
timeFrame: Up to 2 years
measure: Duration of Response (DOR)
timeFrame: Up to 2 years
measure: INCB099280 and axitinib plasma concentrations.
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centrewester
city: London
country: United Kingdom
facility: St Bartholomew'S Hospital
city: London
country: United Kingdom
facility: Guys Hospital
city: London
country: United Kingdom
facility: The Royal Marsden
city: Sutton
country: United Kingdom
facility: The Royal Marsden Nhs Foundation Trust - Sutton
Study officials:
affiliation: Incyte Corporation
name: Philomena Colucci
role: STUDY_DIRECTOR
References: