History of Changes for Study: NCT04580485

INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors

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Study Record Versions

Version	Submitted Date	Changes
1	October 6, 2020	None (earliest Version on record)
2	October 8, 2020	Outcome Measures and Study Status
3	December 7, 2020	Study Status and Eligibility
4	January 4, 2021	Recruitment Status, Study Status, Contacts/Locations and Oversight
5	February 11, 2021	Study Status and Study Design
6	July 27, 2021	Study Status and Contacts/Locations
7	August 3, 2021	Study Status and Contacts/Locations
8	January 24, 2022	Study Status and Contacts/Locations
9	January 26, 2022	Study Status, Contacts/Locations, Eligibility, Conditions and Study Description
10	February 16, 2022	Study Status and Contacts/Locations
11	March 24, 2022	Study Status, Contacts/Locations and Study Design
12	March 30, 2022	Contacts/Locations and Study Status
13	April 6, 2022	Study Status and Contacts/Locations
14	June 1, 2022	Study Status and Contacts/Locations
15	June 27, 2022	Contacts/Locations and Study Status
16	November 4, 2022	Study Status and Contacts/Locations
17	June 7, 2023	Recruitment Status, Study Status, Contacts/Locations, Study Design and Eligibility
18	November 8, 2023	Study Status
19	March 6, 2024	Recruitment Status and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	INCB 106385-102
Brief Title:	INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors
Official Title:	A Phase 1, Open-Label, Multicenter Study of INCB106385 as Monotherapy or in Combination With Immunotherapy in Participants With Advanced Solid Tumors
Secondary IDs:

Study Status


Record Verification:	October 2020
Overall Status:	Not yet recruiting
Study Start:	November 16, 2020
Primary Completion:	May 9, 2023 [Anticipated]
Study Completion:	May 9, 2023 [Anticipated]

First Submitted:	September 22, 2020
First Submitted that Met QC Criteria:	October 6, 2020
First Posted:	October 8, 2020 [Actual]

Last Update Submitted that Met QC Criteria:	October 6, 2020
Last Update Posted:	October 8, 2020 [Actual]

Sponsor/Collaborators


Sponsor:	Incyte Corporation
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:

Study Description

Brief Summary:

This is a multicenter, open-label, dose-escalation/dose-expansion Phase 1 clinical study to investigate the safety, tolerability, PK profile, pharmacodynamics, and preliminary clinical efficacy of INCB106385 when given as monotherapy or in combination with INCMGA00012 in participants with selected CD8 T-cell-positive advanced solid tumors including SCCHN, NSCLC, ovarian cancer, CRPC, TNBC, or bladder cancer

Detailed Description:

Conditions


Conditions:	Ovarian Cancer Bladder Cancer Non Small Cell Lung Cancer Squamous Cell Carcinoma of Head and Neck Triple Negative Breast Cancer Castration Resistant Prostate Cancer
Keywords:	INCB106385 Advanced Solid Tumors PD-1

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 1
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Non-Randomized
Enrollment:	230 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Treatment Group A (TGA) - INCB106385 In part 1 dose escalation, the dose levels will be escalated following a BOIN design. In part 2 dose expansion, participants will be assigned to different groups based on their tumor types and treated at the RDE.	Drug: INCB106385 INCB106385 will be administered orally QD
Experimental: Treatment Group B (TGB) - INCB106385+INCMGA00012 In part 1 dose escalation, the dose levels will be escalated following a BOIN design. In part 2 dose expansion, participants will be assigned to different groups based on their tumor types and treated at the RDE.	Drug: INCB106385 INCB106385 will be administered orally QD Drug: INCMGA00012 INCMGA0012 will be administered IV once every 4 weeks (Q4W)

Outcome Measures


Primary Outcome Measures:
1.	Number of treatment-emergent adverse events (TEAE) [ Time Frame: Up to Approximately 28 months ] Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug up to 90 days after last dose of study drug.
Secondary Outcome Measures:
1.	Cmax of INCB106385 as a single agent or in combination with INCMGA00012 [ Time Frame: Up to 6 months ] Maximum observed plasma concentration.
2.	Tmax of INCB106385 as a single agent or in combination with INCMGA00012 [ Time Frame: Up to 6 months ] Time to maximum plasma concentration
3.	Cmin of INCB106385 as a single agent or in combination with INCMGA00012 [ Time Frame: Up to 6 months ] Minimum observed plasma concentration over the dose interval
4.	AUC of INCB106385 as a single agent or in combination with INCMGA00012 [ Time Frame: Up to 6 months ] Area under the plasma concentration-time curve
5.	CL/F of INCB106385 as a single agent or in combination with INCMGA00012 [ Time Frame: Up to 6 months ] Apparent oral dose clearance
6.	Objective Response Rate (ORR) [ Time Frame: Up to approximately 24 months ] Defined as the percentage of participants with a best overall response of CR or PR, as determined by investigator radiographic disease assessment according to RECIST v1.1.
7.	Disease Control Rate [ Time Frame: Up to approximately 24 months ] Defined as the percentage of participants with a best overall response of CR, PR, or SD, as determined by investigator radiographic disease assessment according to RECIST v1.1.
8.	Duration Of Response (DOR) [ Time Frame: Up to approximately 24 months ] Defined as the time from the earliest date of CR or PR until the earliest date of disease progression, as determined by investigator radiographic disease assessment according to RECIST v1.1, or death due to any cause if occurring sooner than progression.
9.	Decreased tumoral gene expression [ Time Frame: Predose and Week 5-6 ] Defined as the percent of patients with decreased tumoral targeted gene expression compared to baseline
10.	Increased immune cell activation in tumors [ Time Frame: Predose and Week 5-6 ] Defined as the percent of patients demonstrating increased immune cell activation in tumors compared to baseline

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Ability to comprehend and willingness to sign an ICF. Willing and able to conform to and comply with all Protocol requirements. Histologically or cytologically confirmed advanced/metastatic SCCHN, NSCLC, ovarian cancer, TNBC, CRPC or bladder cancer that progressed after treatment with available therapies (including anti PD-(L)1 therapy (if applicable). Willingness to undergo pre- and on-treatment tumor biopsy. Have CD8 T-cell-positive tumors. Presence of measurable disease according to RECIST v1.1. ECOG performance status 0 to 1. Life expectancy > 12 weeks. Willingness to avoid pregnancy or fathering children based. Acceptable laboratory parameters Exclusion Criteria: Clinically significant cardiac disease. Known or active CNS metastases and/or carcinomatous meningitis. Active or inactive autoimmune disease or syndrome that required systemic treatment in the past 2 years or receiving systemic therapy for an autoimmune or inflammatory disease.. Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (doses > 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment. Known additional malignancy that is progressing or requires active treatment,or history of other malignancy within 2 years of the first dose of study treatment. Has not recovered to ≤ Grade 1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting study treatment. Evidence of interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis. Immune-related toxicity during prior immune therapy for which permanent discontinuation of therapy is recommended, or any immune-related toxicity requiring intensive or prolonged immunosuppression to manage. Prior treatment with any adenosine pathway targeting drugs. Any prior chemotherapy, biological therapy, or targeted therapy to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment. Any prior radiation therapy within 28 days before the first dose of study treatment. Undergoing treatment with another investigational medication or having been treated with an investigational medication within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment. Concomitant treatment with strong CYP3A4 inhibitors or inducers. Receipt of a live vaccine within 30 days of the first dose of study treatment. Infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week of the first dose of study treatment. Evidence of HBV or HCV infection or risk of reactivation. Known history of HIV (HIV 1/2 antibodies). History of organ transplant, including allogeneic stem-cell transplantation. Known hypersensitivity or severe reaction to any component of study drug(s) or formulation components. Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study. Any condition that would, in the investigator's judgment, interfere with full participation in the study,pose a significant risk to the participant; or interfere with interpretation of study data

Contacts/Locations


Central Contact Person:	Incyte Corporation Call Center (US) Telephone: 1.855.463.3463 Email: medinfo@incyte.com
Central Contact Backup:	Incyte Corporation Call Center (ex-US) Telephone: +800 00027423 Email: eumedinfo@incyte.com
Study Officials:	Sven Gogov, M.D Study Director Incyte Corporation
Locations:

IPDSharing


Plan to Share IPD:	Yes Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
	Supporting Information: Study Protocol Statistical Analysis Plan (SAP)
	Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
	Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
	URL: https://www.incyte.com/our-company/compliance-and-transparency

References


Citations:
Links:
Available IPD/Information: