A Study to Evaluate the Safety, Tolerability, and Antitumor Activity of INCB001158 Plus Epacadostat, With or Without Pembrolizumab, in Advanced Solid Tumors

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03361228
• Date of registration: 28/11/2017
• Prospective Registration: Yes
• Primary sponsor: Incyte Corporation
• Public title: A Study to Evaluate the Safety, Tolerability, and Antitumor Activity of INCB001158 Plus Epacadostat, With or Without Pembrolizumab, in Advanced Solid Tumors
• Scientific title: An Open-Label, Multicenter, Nonrandomized, Dose-Escalation, and Tumor-Expansion Phase 1/2 Study to Evaluate the Safety, Tolerability, and Antitumor Activity of INCB001158 Plus Epacadostat (INCB024360), With or Without Pembrolizumab, in Subjects With Advanced Solid Tumors
• Date of first enrolment: March 1, 2018
• Target sample size: 5
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03361228
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

France, Spain, United States

Contacts

• Name: Sven Gogov, MD
• Affiliation: Incyte Corporation

Key inclusion & exclusion criteria

Inclusion Criteria:

- For Phase 1, subjects with histologically or cytologically confirmed advanced or
metastatic solid tumors that have failed prior standard therapy (disease progression;
subject intolerance is also allowable).

- For Phase 2, subjects with the following tumor types who meet protocol-defined
criteria: advanced or metastatic NSCLC, melanoma, urothelial carcinoma, SCCHN, SCLC,
and CRC.

- Presence of at least 1 measurable lesion by computed tomography or magnetic resonance
imaging per RECIST v1.1.

- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.

- Resolution of all toxicities and any toxic effect(s) of the most recent prior therapy
to Grade 1 or less (except alopecia). Subjects with = Grade 2 neuropathy are an
exception and may enroll.

- Adequate renal, hepatic, and hematologic functions per protocol-defined laboratory
parameters within = 7 days before treatment initiation.

Exclusion Criteria:

- Participation in any other study in which receipt of an investigational study drug or
device occurred within 2 weeks or 5 half-lives (whichever is longer) before first
dose.

- Has received a prior monoclonal antibody within 4 weeks or 5 half-lives (whichever is
shorter) before administration of study drug.

- Prior chemotherapy or targeted small molecule therapy within 2 weeks before
administration of study treatment.

- Prior therapy with an IDO1 or arginase 1 inhibitor.

- Active autoimmune disease that has required systemic treatment in past 2 years.
Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement
therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of
systemic treatment.

- Receipt of a live vaccine within 30 days before the first dose of study treatment.

- Any history of serotonin syndrome after receiving serotonergic drugs.

- Use of protocol-defined prior/concomitant therapy.

- Known or suspected defect in the function of the urea cycle.

- History of gastrointestinal condition that may affect drug absorption.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Solid Tumors

Intervention(s)

Drug: INCB001158

Drug: Epacadostat

Drug: Pembrolizumab

Primary Outcome(s)

Phase 2 Only: Objective Response Rate (ORR) of INCB001158 in Combination With Epacadostat ± Pembrolizumab [Time Frame: Up to approximately 12 months per subject]

Phase 1 Only: Safety and Tolerability of INCB001158 in Combination With Epacadostat ± Pembrolizumab as Assessed by Number of Participants With a Treatment-emergent Adverse Event (TEAE) [Time Frame: Up to approximately 12 months per subject]

Secondary Outcome(s)

Disease Control Rate With INCB001158 in Combination With Epacadostat ± Pembrolizumab [Time Frame: Up to approximately 12 months per subject]

Phase 1 Only: ORR With INCB001158 in Combination With Epacadostat ± Pembrolizumab [Time Frame: Up to approximately 12 months per subject]

Progression-free Survival With INCB001158 in Combination With Epacadostat ± Pembrolizumab [Time Frame: Up to approximately 12 months per subject]

Plasma Pharmacokinetic Profile of INCB001158 and Epacadostat [Time Frame: Up to approximately 1 month]

Duration of Response With INCB001158 in Combination With Epacadostat ± Pembrolizumab [Time Frame: Up to approximately 12 months per subject]

Phase 2 Only: Safety and Tolerability of INCB001158 in Combination With Epacadostat ± Pembrolizumab as Assessed by Number of Participants With a TEAE [Time Frame: Up to approximately 12 months per subject]

Secondary ID(s)

INCB 01158-202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 21/05/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03361228