RecruitingPhase 1Phase 2NCT05271292

Chiauranib for Advanced Solid Malignant Tumors and Relapsed/Refractory SCLC.

A Phase 1b/2, Single-Arm, Open-Label, Dose-Escalation, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Chiauranib for the Treatment of Advanced Solid Tumors and Relapsed/Refractory SCLC


Sponsor

Chipscreen Biosciences, Ltd.

Enrollment

36 participants

Start Date

Aug 26, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 1b/2, single-arm, open-label, dose-escalation study including 2 stages: Phase 1b: Dose-Escalation Stage (Single-Dose and Consecutive-Dose Periods) Phase 2: recommended Phase 2 dose (RP2D) of chiauranib will be given to all patients enrolled in this phase once daily for 28-day cycles continuously with no interruption between cycles.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests chiauranib, a new oral targeted therapy, alone and in combination with other cancer drugs, for people with advanced solid tumors or relapsed/refractory small cell lung cancer (SCLC). **You may be eligible if...** - You are 18 or older with a confirmed advanced solid tumor (including lung, colon, liver, ovarian, pancreatic, or blood cancers) - Your cancer has progressed after standard treatment, or no standard treatment exists - You have at least one measurable tumor site - Your performance status is good (ECOG 0–1) - Your organ function (blood counts, liver, kidneys) meets required thresholds **You may NOT be eligible if...** - You have uncontrolled brain metastases - You have had major surgery or significant bleeding in the recent past - You have uncontrolled high blood pressure or significant heart disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGChiauranib

Phase 1b: Each patient will undergo both a single-dose period (6 days) and a consecutive-dose (1 cycle of 28 days) period Phase 2: Patients will take the RP2D once daily for 28-day cycles continuously with no interruption between cycles


Locations(11)

California Cancer Associates-Encintas

Encinitas, California, United States

Providence/St. Joe Cancer Institute/Crosson Cancer Institute

Fullerton, California, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Dana Farber Cancer Institue

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Gabrail Cancer Center Research

Canton, Ohio, United States

OU Health

Oklahoma City, Oklahoma, United States

Sarah Cannon Research Center

Nashville, Tennessee, United States

North Houston Cancer Clinics

Huntsville, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT05271292


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