A Phase 1/2, Open-Label, Dose-Escalation, Safety Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety and tolerability and assess preliminary efficacy of INCAGN01949 in subjects with advanced or metastatic solid tumors.

Official Title
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A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors

Conditions
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Advanced Malignancies, Metastatic Cancer

Intervention / Treatment
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* Drug: INCAGN01949


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent. Subjects who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or who refuse standard treatment. There is no limit to the number of prior treatment regimens. Part 1: Subjects with advanced or metastatic solid tumors. Part 2: Subjects with advanced or metastatic adenocarcinoma of the endometrium, ovarian cancer, renal cell carcinoma, melanoma, and non-small cell lung cancer. Presence of measureable disease based on RECIST v1.1. Eastern Cooperative Oncology Group performance status 0 or 1. Exclusion Criteria: Laboratory and medical history parameters not within the protocol-defined range. Receipt of anticancer medications or investigational drugs within the protocol-defined intervals before the first administration of study drug. Has not recovered to ≤ Grade 1 from toxic effects of prior therapy (including prior immunotherapy) and/or complications from prior surgical intervention before starting therapy. Receipt of a live vaccine within 30 days of planned start of study drug. Active autoimmune disease that required systemic treatment in the past.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INCAGN01949<br> | Drug: INCAGN01949<br>* Initial cohort dose of INCAGN01949 monotherapy at the protocol-defined starting dose, with subsequent cohort escalations based on protocol-specific criteria. The recommended dose will be taken forward into expansion cohorts.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-related Adverse Events | Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment | From screening through 60 days after end of treatment, up to 11 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma | To evaluate the Cmax of INCAGN01949 in subjects with advanced or metastatic solid tumors. | Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6 | 
| Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949 | To evaluate the AUC0-t of INCAGN01949 in subjects with advanced or metastatic solid tumors | Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6 | 
| Objective Response Rate Per RECIST and Modified RECIST | ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination. | Baseline and every 8 weeks,up to 11 months | 
| Duration of Response Per RECIST and Modified RECIST | ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination. | Baseline and every 8 weeks, up to 11 months | 
| Progression-free Survival Per RECIST and Modified RECIST | ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination. | Baseline and every 8 weeks, up to 11 months | 
| Duration of Disease Control Per RECIST and Modified RECIST | ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination. | Baseline and every 8 weeks, up to 11 months | 
| Time to Maximum Concentration of INCAGN01949 in Plasma | To evaluate the Tmax of INCAGN01949 in subjects with advanced or metastatic solid tumors. | Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6 | 
| Summary of Trough Concentrations(Cmin) of INCAGN01949 | To evaluate the Cmin of INCAGN01949 in subjects with advanced or metastatic solid tumors. Cmin is the minimum observed concentration of INCAGN1949 | Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solid tumor, adenocarcinoma of the endometrium, ovarian cancer, renal cell carcinoma, melanoma, non-small cell lung cancer, OX40, immunoglobulin G monoclonal antibody