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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02228811

Enrollment

Registered

2014-08-29

Start date

2014-06-30

Completion date

2018-01-31

Last updated

2018-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

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.

Interventions

DRUGDCC-2701 tablet

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Maximum Tolerated Dose (MTD) of DCC-2701	28 days (1 cycle)

Secondary

Measure	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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026