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

NCT05271292 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-07-16

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Chiauranib

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

Sponsors & Collaborators

  • Chipscreen Biosciences, Ltd.

    lead INDUSTRY

Principal Investigators

  • Cabilia Pichardo, MD · Executive Director of Clinical Development

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-26
Primary Completion
2025-03-31
Completion
2025-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05271292 on ClinicalTrials.gov