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Terminated Phase 1 Interventional

A Phase 1 Study Evaluating CB-5083 in Subjects With Advanced Solid Tumors

ClinicalTrials.gov ID: NCT02243917

Public ClinicalTrials.gov record NCT02243917. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 10, 2026, 6:58 AM EST

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Official title

A Phase 1, Open-Label, Dose Escalation and Dose Expansion Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of Orally Administered CB-5083 in Subjects With Advanced Solid Tumors

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a multicenter, open-label, Phase 1 study of orally administered CB-5083 in adult subjects with advanced metastatic solid tumors. The study will be conducted in 2 parts: an initial Dose Escalation Phase (Phase 1a) of CB-5083 in subjects with advanced metastatic solid tumors who have progressed or are non-responsive to available therapies and for which no standard therapy exists, followed by a Dose Expansion Phase (Phase 1b) which will include 1 to 4 arms: one arm in subjects with RAS mutated mCRC; optionally, at sponsors discretion, 3 additional arms may be added for subjects with advanced RCC, advanced pNET, or solid tumors with mutations in the RAS-MAPK pathway.

Study identification

NCT ID
NCT02243917
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 1
Lead sponsor
Cleave Biosciences, Inc.
Industry
Enrollment
62 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 11, 2014 (Actual)
Primary completion
Aug 25, 2017 (Actual)
Completion
Aug 25, 2017 (Actual)
Last update posted
Feb 27, 2018

2014 – 2017

United States locations

U.S. sites
6
U.S. states
5
U.S. cities
6

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02243917, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 27, 2018 · Synced Nov 10, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02243917 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →