NCT05271292: 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

Recruiting now Phase 1/Phase 2 Last updated 15 July 2024

What this trial tests

Phase 1/Phase 2 trial testing Chiauranib in Small Cell Lung Cancer in 36 participants. Currently enrolling.

Timeline

26 August 2022

Primary endpoint
1 March 2025

1 May 2025

Quick facts

Lead sponsor	Chipscreen Biosciences, Ltd.
Phase	Phase 1/Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	26 August 2022
Primary completion	1 March 2025
Estimated completion	1 May 2025
Sites	11 locations across United States

Drugs / interventions tested

• Chiauranib — full drug profile →

Conditions studied

• Small Cell Lung Cancer — all drugs for Small Cell Lung Cancer →
• Advanced Solid Malignant Tumor — all drugs for Advanced Solid Malignant Tumor →

Sponsor

Chipscreen Biosciences, Ltd. — full company profile →

Who can join

18 and older, any sex, with Small Cell Lung Cancer or Advanced Solid Malignant Tumor. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Incidence of adverse events (AEs) and other safety parameters
  Time frame: Until 30 days after a patient takes the last dose of the study drug
  Number of patients experienced AEs
• Incidence and characteristics of DLTs
  Time frame: 34 days
  Number of patients experienced any dose limited toxicity
• MTD and recommended Phase 2 dose (RP2D)
  Time frame: 34 days
  Determination of recommended phase II dose

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Aurora B Inhibitors as Cancer Therapeutics.
   Kovacs AH, Zhao D, Hou J. · · 2023 · cited 32× · PMID 37110619 · DOI 10.3390/molecules28083385
2. P53 and Rb Aberrations in Small Cell Lung Cancer (SCLC): From Molecular Mechanisms to Therapeutic Modulation.
   Papavassiliou KA, Sofianidi AA, Gogou VA, Anagnostopoulos N, et al · · 2024 · cited 19× · PMID 38473726 · DOI 10.3390/ijms25052479
3. Tumour-associated macrophages: versatile players in the tumour microenvironment.
   Ji ZZ, Chan MK, Chan AS, Leung KT, et al · · 2023 · cited 18× · PMID 37965573 · DOI 10.3389/fcell.2023.1261749
4. Strategies to overcome myeloid cell induced immune suppression in the tumor microenvironment.
   Cao J, Chow L, Dow S. · · 2023 · cited 16× · PMID 37114134 · DOI 10.3389/fonc.2023.1116016
5. Aurora kinase B inhibition in small-cell lung cancer: BCL-2 as a potential therapeutic biomarker and combination target.
   Hosoya K, Ozasa H. · · 2024 · cited 7× · PMID 38601438 · DOI 10.21037/tlcr-23-754
6. Inhibition of extranodal NK/T-cell lymphoma by Chiauranib through an AIF-dependent pathway and its synergy with L-asparaginase.
   Gao T, Huang J, Yin H, Huang J, et al · · 2023 · cited 5× · PMID 37160920 · DOI 10.1038/s41419-023-05833-w
7. Landscape and Treatment Options of Shapeshifting Small Cell Lung Cancer.
   Gu Y, Benavente CA. · · 2024 · cited 2× · PMID 38892831 · DOI 10.3390/jcm13113120
8. Mitotic Machinery Dysregulation in Lung Cancer: Biological Roles, Therapeutic Targeting, and Combination Strategies.
   Pinto B, Silva JPN, Silva PMA, Sarmento B, et al · · 2026 · PMID 42076055 · DOI 10.3390/pharmaceutics18040402