A Study of DCC-2701 in Participants With Advanced Solid Tumors

Study Overview
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Brief Summary
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The main purpose of this study is to investigate the safety of the investigational drug DCC-2701 and whether it will work to help people who have advanced solid tumors or cancer that has spread to other parts of the body.

Detailed Description
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This is a first-in-human study of DCC-2701. The primary purpose of this study is to determine what dose of DCC-2701, can be given safely to patients with advanced solid tumors. The study will have two phases. The first phase will assess escalating doses of DCC-2701 in order to determine the maximally tolerated dose (MTD) and the optimal dosing regimen (ODR) of DCC-2701. Once the MTD and ODR is established, a dose expansion phase will further evaluate the safety of DCC-2701, as well as the activity of DCC-2701 in select solid tumor types.

Official Title
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A Multicenter Phase 1 Ascending Dose Study of DCC-2701 To Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Patients With Advanced Solid Tumors

Conditions
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Locally Advanced Tumors, Metastatic Solid Tumors, Cancers With MET Genomic Alterations, Cancers With TRK Genomic Alterations

Intervention / Treatment
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* Drug: DCC-2701 tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Advanced or metastatic solid tumor that has progressed or was not responsive to standard therapy The cancer has no proven effective therapy The cancer can be biopsied (depending on the tumor type and/or the dose of drug received, tumor biopsies may be required) Able to swallow tablets Exclusion Criteria: Have active central nervous system (CNS) metastasis Have an active infection of any kind (fungal, viral, or bacterial) Are pregnant or breastfeeding

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: DCC-2701 tablet<br>DCC-2701 tablets in escalating dose cohorts given orally BID (twice daily) every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met. | Drug: DCC-2701 tablet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose (MTD) of DCC-2701 |  | 28 days (1 cycle) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of DCC-2701 |  | Cycle 1: Predose and up to 24 hours postdose (Cycle = 28 Days) | 
| Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of DCC-2701 |  | Cycle 1: Predose and up to 24 hours postdose (Cycle = 28 Days) | 
| Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of DCC-2701 |  | Cycle 1: Predose and up to 24 hours postdose (Cycle = 28 Days) | 
| Number of Participants with Tumor Response according to Response Evaluations Criteria in Solid Tumors (RECIST) version 1.1 |  | Baseline through study completion (estimated as 18 months) |