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Chiauranib

Protein Kinase Inhibitors

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Phase 1b: Patients will be enrolled sequentially in 3 dose-escalating cohorts (Chiauranib capsules 35, 50, and 65 mg, orally)

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

Zhijian Li, MD

Liz Wieland

Christina Spencer

Alberto Besseduo, MD

Mirza "Hadi" Al Baig

Yung Lyou, MD

Mashunte Holmes

Jennifer Carlisle

Diandra Ocot

Jacob Sands, MD

Hirva Mamdani, MD

Ann Lovelace

Liawaty Ho

Nashat Gabrail, MD

Christina Caldwell

Abdul Rafeh Naqash

David R Spigel, MD

Elham Abbasi, MD

Roham Garvashi, MD

Carrie Friedman

Alexander Spira, MD

Cabilia Pichardo, MD

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.

Phase 1b:

Patients with 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 will be enrolled to the 35 mg, 50 mg and 65 mg dose cohorts in this stage. The starting dose is 35 mg, and each higher dose cohort will not enroll until the lower dose is deemed safe.

After screening, eligible patients will be enrolled sequentially in 3 dose-escalating cohorts. Based on an estimated average body weight of 60 kg, the initial dose of chiauranib will be 35 mg once daily, and the dose will be escalated to 50 mg and 65 mg once daily, depending on the occurrence and frequency of DLTs. The 3+3 design will be employed in dose escalation decisions.

Each dose cohort will enroll at least 3 patients. Overenrolling dosing cohorts is allowed to allow for potential screen failures and/or subjects who end up being not evaluable by not completing the DLT evaluation period. Each subject will undergo both a single-dose period (6 days) and a consecutive-dose (1 cycle of 28 days) period, as described below. DLTs will be evaluated during this period (a total of 34 days).

Phase 2:

SCLC patients with progressive disease or recurrence after at least 2 previous regimens, including one platinum-based chemotherapy, will be enrolled in this stage. The RP2D will be given to all subjects enrolled in this stage. Subjects will take the RP2D chiauranib once daily for 28-day cycles continuously with no interruption between cycles.

Patients will be enrolled sequentially in 3 dose-escalating cohorts (Chiauranib capsules 35mg, 50 mg and 65 mg once daily)

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

Number of patients experienced any dose limited toxicity

Determination of recommended phase II dose

Efficacy outcomes in patients with ATRX gene mutation and wild-type respectively.

Chipscreen Biosciences, Ltd.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Chiauranib for Advanced Solid Malignant Tumors and Relapsed/Refractory SCLC.	NCT05271292	Small Cell Lung... Advanced Solid ...	Chiauranib	18 Years -	Chipscreen Biosciences, Ltd.
Chiauranib for Advanced Solid Malignant Tumors and Relapsed/Refractory SCLC.	NCT05271292	Small Cell Lung... Advanced Solid ...	Chiauranib	18 Years -	Chipscreen Biosciences, Ltd.

Spots Global Cancer Trial Database for advanced solid malignant tumor