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

Who is this study for? Patients with relapsed/refractory small cell lung cancer
What treatments are being studied? Chiauranib
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient is at least 18 years of age, regardless of gender. Patient has a diagnosis of histologically or cytologically confirmed advanced solid malignant tumor (including SCLC, NSCLC, colorectal carcinoma, pancreatic carcinoma, hepatocellular carcinoma, ovarian cancer, neuroendocrine tumors, non-Hodgkin's lymphoma, and others) that has relapsed from or is refractory to standard therapy or for which no standard therapy exists.

• Patient has at least one measurable target lesion as defined by RECIST1.1, i.e., a lesion that has radiologic evidence of disease progression, after treatment with radiotherapy or local-regional therapy.

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at enrollment.

• Major organ functions meet the following criteria (no corrective treatment, such as G CSF, erythropoietin, and blood transfusion, within 2 weeks before enrollment):

‣ Hematology: absolute neutrophil count (ANC) ≥1.5×109/L, platelet ≥100×109/L, hemoglobin ≥100 g/L.

⁃ Biochemistry: total bilirubin ≤1.25×upper limit of normal (ULN), both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×ULN (≤5×ULN for patients with hepatic metastasis), creatinine clearance \>60 mL/min (according to Cockcroft-Gault equation), fasting triglyceride ≤3.0 mmol/L, fasting total cholesterol ≤7.75 mmol/L.

⁃ Coagulation panel: international normalized ratio (INR) \<1.5.

• Patient has a life expectancy ≥3 months.

• Patient is able to provide voluntary informed consent.

• Women of childbearing potential (WOCBP) must be willing and able to take highly effective contraceptive measures during the entire study treatment period and for 12 weeks after the last dose of study drug (see Appendix 11.7). Women of childbearing potential include premenopausal and not sterilized (by hysterectomy, bilateral ligation of fallopian tubes, or bilateral oophorectomy) females who have passed menarche.

• Male patients must be willing and able to use male condoms and their female partners who are WOCBP during the entire study treatment and for the 12 weeks after the last dose of the study drug.

Locations
United States
California
California Cancer Associates-Encintas
RECRUITING
Encinitas
Providence/St. Joe Cancer Institute/Crosson Cancer Institute
RECRUITING
Fullerton
Georgia
Winship Cancer Institute of Emory University
RECRUITING
Atlanta
Massachusetts
Dana Farber Cancer Institue
RECRUITING
Boston
Michigan
Karmanos Cancer Institute
RECRUITING
Detroit
Nevada
Comprehensive Cancer Centers of Nevada
RECRUITING
Las Vegas
Ohio
Gabrail Cancer Center Research
RECRUITING
Canton
Oklahoma
OU Health
RECRUITING
Oklahoma City
Tennessee
Sarah Cannon Research Center
RECRUITING
Nashville
Texas
North Houston Cancer Clinics
RECRUITING
Huntsville
Virginia
Virginia Cancer Specialists
RECRUITING
Fairfax
Contact Information
Primary
Zhijian Li, MD
zhijian_li@chipscreen.com
732-584-6269
Backup
Liz Wieland
Elizabeth_Wieland@chipscreen.com
Time Frame
Start Date: 2022-08-26
Estimated Completion Date: 2025-05
Participants
Target number of participants: 36
Treatments
Experimental: Study arm (35 mg)
Phase 1b: Patients will be enrolled sequentially in 3 dose-escalating cohorts (Chiauranib capsules 35, 50, and 65 mg, orally)
Experimental: Study arm (50 mg)
Phase 1b: Patients will be enrolled sequentially in 3 dose-escalating cohorts (Chiauranib capsules 35, 50, and 65 mg, orally)
Experimental: Study arm (65 mg)
Phase 1b: Patients will be enrolled sequentially in 3 dose-escalating cohorts (Chiauranib capsules 35, 50, and 65 mg, orally)
Sponsors
Leads: Chipscreen Biosciences, Ltd.

This content was sourced from clinicaltrials.gov

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