Auraza (chiauranib) / Chipscreen - LARVOL DELTA

Chiauranib for Advanced or Unresectable Soft Tissue Sarcoma(STS) (clinicaltrials.gov) - P2 | N=40 | Completed | Sponsor: Chipscreen Biosciences, Ltd. | Active, not recruiting ➔ Completed

Trial completion • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Chiauranib in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov) - P2 | N=42 | Recruiting | Sponsor: Chipscreen Biosciences, Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

AK104-212: A Study of AK104 in Combination With Chiauranib in Patients With Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=36 | Completed | Sponsor: Akeso | Active, not recruiting ➔ Completed | Trial completion date: Jan 2025 ➔ Jul 2024 | Trial primary completion date: Dec 2024 ➔ Jul 2024

IO biomarker • Trial completion • Trial completion date • Trial primary completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • ATRX

Phase 3 Clinical Study of Chiauranib Capsule in Patients With Small-cell Lung Cancer (clinicaltrials.gov) - P3 | N=184 | Completed | Sponsor: Chipscreen Biosciences, Ltd. | Recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Apr 2024 | Trial primary completion date: Dec 2024 ➔ Apr 2024

Trial completion • Trial completion date • Trial primary completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Phase 3 Clinical Study of Chiauranib Capsule in Patients With Small-cell Lung Cancer (clinicaltrials.gov) - P3 | N=180 | Recruiting | Sponsor: Chipscreen Biosciences, Ltd. | Trial completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Phase II Study of Chiauranib in Combine With Capecitabine in TNBC (clinicaltrials.gov) - P2 | N=9 | Terminated | Sponsor: Chipscreen Biosciences, Ltd. | N=38 ➔ 9 | Recruiting ➔ Terminated; During the enrollment period of this project, due to the increasing proportion of patients receiving capecitabine adjuvant therapy and the large number of trials competing for the same number of lines in various centers

Enrollment change • Metastases • Trial termination • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

The Phase III clinical trial application for first-line treatment of extensive disease small cell lung cancer with Chiauranib has been approved (PRNewswire) - "On November 1, Shenzhen Chipscreen Biosciences Co., Ltd...received the 'Drug Clinical Trial Approval Notice' approved by the National Medical Products Administration. The company's self-developed original new drug, Chiauranib, combined with PD - (L) 1 monoclonal antibody and standard chemotherapy for the first-line treatment of extensive stage small cell lung cancer, has been approved for phase III clinical trials."

New P3 trial • Small Cell Lung Cancer

Efficacy and safety of chiauranib in a combination therapy in platinum-resistant or refractory ovarian cancer: a multicenter, open-label, phase Ib and II study. (PubMed, Mol Cancer) - P1/2, P2 | "This was the first study to evaluate chiauranib, a novel multi-targeted kinase inhibitor in patients with ovarian cancer. The administration of chiauranib along with etoposide or weekly-paclitaxel significantly enhanced the efficacy with manageable adverse events. This warrants further clinical studies on this novel treatment. A phase III study is promising and ongoing."

Combination therapy • Journal • P1 data • Gynecology • Oncology • Ovarian Cancer • Refractory Ovarian Cancer • Solid Tumor • Women's Health

Phase 3 Clinical Study of Chiauranib Capsule in Patients With Small-cell Lung Cancer (clinicaltrials.gov) - P3 | N=180 | Recruiting | Sponsor: Chipscreen Biosciences, Ltd. | Trial primary completion date: Mar 2024 ➔ Dec 2024

Trial primary completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Phase II Study of Chiauranib in Combine With Capecitabine in TNBC (clinicaltrials.gov) - P2 | N=38 | Recruiting | Sponsor: Chipscreen Biosciences, Ltd. | Trial completion date: Aug 2024 ➔ Dec 2024 | Trial primary completion date: Mar 2024 ➔ Dec 2024

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

Chiauranib for Advanced Solid Malignant Tumors and Relapsed/Refractory SCLC. (clinicaltrials.gov) - P1/2 | N=36 | Recruiting | Sponsor: Chipscreen Biosciences, Ltd. | Trial completion date: Apr 2024 ➔ May 2025 | Trial primary completion date: Mar 2024 ➔ Mar 2025

Metastases • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Small Cell Lung Cancer • Solid Tumor

Chiauranib for Advanced or Unresectable Soft Tissue Sarcoma(STS) (clinicaltrials.gov) - P2 | N=40 | Active, not recruiting | Sponsor: Chipscreen Biosciences, Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2024 ➔ Dec 2024 | Trial primary completion date: Feb 2024 ➔ Dec 2024

Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Mass Balance Study of [14C]Chiauranib (clinicaltrials.gov) - P=N/A | N=6 | Completed | Sponsor: Chipscreen Biosciences, Ltd. | Recruiting ➔ Completed | Trial primary completion date: Nov 2023 ➔ Mar 2024

Trial completion • Trial primary completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Chiauranib in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov) - P2 | N=42 | Not yet recruiting | Sponsor: Chipscreen Biosciences, Ltd.

Metastases • New P2 trial • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

A Study of AK104 in Combination With Chiauranib in Patients With Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=36 | Active, not recruiting | Sponsor: Akeso | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2025 ➔ Jan 2025

Enrollment closed • Trial completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • ATRX

Chiauranib for Advanced Solid Malignant Tumors and Relapsed/Refractory SCLC. (clinicaltrials.gov) - P1/2 | N=36 | Recruiting | Sponsor: Chipscreen Biosciences, Ltd. | Phase classification: P1b/2 ➔ P1/2

Metastases • Phase classification • Colorectal Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Small Cell Lung Cancer • Solid Tumor

[VIRTUAL] Combination of CS2164 and Venetoclax Shows Synergistic Antitumor Effect in High-Grade B-Cell Lymphomas with ConcomitantMYCandBCL2Rearrangements (ASH 2020) - "The underlying mechanisms for the synergy of the two drugs included the blockade of Rad51 recombinase-dependent DNA repair, the perturbation of the delicate balance of BCL2 family proteins that induced mitochondrial membrane depolarization and subsequently led to the proapoptotic effect, as well as the inhibition of PI3K/AKT/mTOR pathway and MYC expression. In summary, these findings suggest that the regimen of CS2164 and venetoclax combination is highly effective to eliminate HGBCL-DHL cellsin vitroandin vivoand thus provide a rational treatment paradigm to strip HGBCL-DHL of its protection fromMYCandBCL2rearrangements."

IO biomarker • Hematological Malignancies • Immunology • Inflammation • Lymphoma • Oncology • MYC • RAD51

Chiauranib for Advanced or Unresectable Soft Tissue Sarcoma(STS) (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Chipscreen Biosciences, Ltd. | N=30 ➔ 40

Enrollment change • Metastases • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

A Study of AK104 in Combination With Chiauranib in Patients With Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=42 | Recruiting | Sponsor: Akeso | Trial primary completion date: Dec 2023 ➔ Dec 2024

Combination therapy • Trial primary completion date • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

In silico targeting of colony-stimulating factor-1 receptor: delineating immunotherapy in cancer. (PubMed, Explor Target Antitumor Ther) - "The 3D conformers of edicotinib, DCC-3014, ARRY-382, BLZ-945, chiauranib, dovitinib, and sorafenib were obtained from PubChem Database. Pyrimidines are potent inhibitors that interact with CSF1R residues. DCC-3014 and ARRY-382 exhibit exceptional pharmaceutical potential exhibiting great structural stability and affinity."

IO biomarker • Journal • Oncology • CSF1R

CHIPRO: Chiauranib Plus Weekly Paclitaxel in Patients With Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer (clinicaltrials.gov) - P3 | N=376 | Recruiting | Sponsor: Chipscreen Biosciences, Ltd. | Trial primary completion date: Jul 2023 ➔ Dec 2024

Trial primary completion date • Oncology • Ovarian Cancer • Refractory Ovarian Cancer • Solid Tumor

Mass Balance Study of [14C]Chiauranib (clinicaltrials.gov) - P=N/A | N=6 | Recruiting | Sponsor: Chipscreen Biosciences, Ltd. | Trial completion date: Jun 2023 ➔ Dec 2023 | Trial primary completion date: Jan 2023 ➔ Nov 2023

Trial completion date • Trial primary completion date • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

Phase Ib/II Study of Chiauranib in Patients With Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Chipscreen Biosciences, Ltd. | Recruiting ➔ Completed | N=27 ➔ 48 | Trial completion date: Dec 2022 ➔ May 2023

Enrollment change • Trial completion • Trial completion date • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

Inhibition of extranodal NK/T-cell lymphoma by Chiauranib through an AIF-dependent pathway and its synergy with L-asparaginase. (PubMed, Cell Death Dis) - "This study demonstrates Chiauranib's positive efficacy toward NKTL through the activation of the AIF-dependent apoptosis pathway for the first time. The novel and multi-targets of Chiauranib and the synergistic effect with L-asparaginase may provide a promising therapy for NKTL patients."

Journal • Hematological Malignancies • Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • BAX • CASP3 • CASP8 • FAS • KIT

Inhibition of extranodal NK/T-cell lymphoma by Chiauranib through an AIF-dependent pathway and its synergy with L-asparaginase (Cell Death Dis, Nature) - "The knockdown of AIF in vitro and in vivo dramatically blocked the efficacy of Chiauranib on NKTL....We found that L-asparaginase triggered CD95 (Fas/Apo-1)-caspase 8-caspase 3 apoptotic pathway in NKTL cells, and combination of Chiauranib and L-asparaginase exhibited a synergistic effect, suggesting a feasibility to combine these two drugs for effective treatment of NKTL."

Preclinical • Hematological Malignancies • Lymphoma • Oncology