Sulanda (surufatinib)

SUR combined with PDT can significantly enhance the inhibitory effect on CCA, and can be alleviated by two ferroptosis inhibitors (Ferrostatin-1, Deferoxamine). In conclusion, SUR combined with PDT exerted an anti-CCA effect by inducing ferroptosis. Combination therapy provides a new idea for the clinical treatment of CCA.

P2, N=30, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital

P2, N=160, Recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting --> Recruiting | Initiation date: Jul 2023 --> Jan 2024

P2/3, N=482, Not yet recruiting, Hutchmed

P2, N=40, Not yet recruiting, Wuhan Union Hospital, China

P=N/A, N=63, Not yet recruiting, Fudan University

P2, N=78, Active, not recruiting, Hutchmed | Trial primary completion date: Sep 2023 --> Sep 2024

P2, N=25, Recruiting, Qilu Hospital of Shandong University

P1/2, N=36, Active, not recruiting, Hutchison Medipharma Limited | Recruiting --> Active, not recruiting

P1/2, N=130, Completed, Hutchison Medipharma Limited | Active, not recruiting --> Completed

P1/2, N=13, Completed, Hutchmed | Active, not recruiting --> Completed

P2, N=34, Recruiting, Zhejiang Cancer Hospital

The insensitivity of sulfatinib to FGFR gatekeeper mutations highlights the indispensable interactions with the hydrophobic pocket for FGFR selectivity, whereas the rotatory flexibility may enable sulfatinib to overcome CSF-1R. This study not only sheds light on the structural basis governing sulfatinib's FGFR/CSF-1R inhibition, but also provides valuable insights into the rational design of dual- or multi-target FGFR inhibitors with selectivity for CSF-1R and sensitivity to gatekeeper mutations.

P2, N=20, Recruiting, Sun Yat-sen University

P2, N=41, Not yet recruiting, Wuhan Union Hospital, China

P2, N=18, Recruiting, Tongji Hospital | Not yet recruiting --> Recruiting | Trial primary completion date: Feb 2023 --> Jun 2024

P3, N=194, Recruiting, Hutchison Medipharma Limited | Trial completion date: Nov 2023 --> May 2025 | Trial primary completion date: Jul 2023 --> May 2025

P2, N=100, Not yet recruiting, Changhai Hospital

P=N/A, N=39, Not yet recruiting, Shanghai Changzheng Hospital

P2, N=41, Not yet recruiting, Wuhan Union Hospital, China

P2, N=20, Recruiting, Sun Yat-sen University | Not yet recruiting --> Recruiting

P1/2, N=41, Recruiting, Shanghai Zhongshan Hospital | Not yet recruiting --> Recruiting | Phase classification: P2 --> P1/2 | Initiation date: Jul 2023 --> Oct 2023

P2, N=29, Not yet recruiting, Fudan University

P2, N=20, Recruiting, Tianjin Medical University Cancer Institute and Hospital

P2, N=48, Recruiting, Zhejiang Cancer Hospital

Surufatinib in combination with toripalimab as neoadjuvant therapy for locally advanced DTC was feasible, and the majority of patients achieved R0/1 resection. It represents a new option for locally advanced DTC and needs further investigation.

Conclusions Pamiparib combined with Surufatinib as a new neoadjuvant "chemotherapy-free" regimen showed extremely high R0 and ORR rates with manageable toxicity profiles. Currently, the experiment is still ongoing and further analysis and reporting of more data will be conducted.

P2, N=61, Recruiting, Zhejiang University | Trial completion date: Jan 2025 --> Jun 2025 | Trial primary completion date: Jan 2023 --> Jun 2025

P2, N=160, Not yet recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University

Systemic treatment of sulfatinib can reduce immunosuppression cells M2-TAMs, Tregs, and myeloid-derived suppressor cells (MDSCs) and increase cytotoxic T-cell infiltration in tumors, the lungs, and the spleens. Our preclinical experiments have shown that sulfatinib can inhibit the proliferation, migration, and invasion of OS by playing a dual role on tumor cells and the tumor microenvironment simultaneously and systematically reverse immunosuppression to immune activation status, which could be translated into clinical trials.

Pharmacokinetics, safety, and antitumor efficacy of 300 mg QD oral surufatinib in US patients with pNETs and epNETs are consistent with previously reported studies in China and may support applicability of earlier surufatinib studies in US patients. Clinical trial registration: Clinicaltrials.gov NCT02549937.

P1/2, N=13, Active, not recruiting, Hutchmed | Trial completion date: Jun 2025 --> Jul 2023 | Trial primary completion date: Apr 2025 --> Jul 2023

P2, N=29, Recruiting, Tianjin Medical University Cancer Institute and Hospital

P1/2, N=39, Not yet recruiting, Fujian Cancer Hospital

Overall, surufatinib was characterized by a high DCR and a low disease progression rate, thus indicating that it could exert a good therapeutic effect on solid tumors. Additionally, surufatinib showed a lower RR for adverse effects compared with other treatment modalities.

P1/2, N=130, Active, not recruiting, Hutchison Medipharma Limited | Trial primary completion date: Jun 2022 --> Apr 2023

P1/2, N=130, Active, not recruiting, Hutchison Medipharma Limited | Completed --> Active, not recruiting | Trial completion date: Jun 2022 --> Jun 2023

Funding: Has not received any funding.Background: The three active agents (oxaliplatin, irinotecan and 5-FU/leucovorin) have demonstrated synergistic antitumor effects and could probably overcome resistance to standard doublet combination (FOLFOX/FOLFIRI) for mCRC... Surufatinib plus either mFOLFOX6/FOLFIRI or FOLFOXIRI as second-line treatment showed promising anti-tumor activity and acceptable safety profile in patients with mCRC. The trial is still recruiting, more data would be further analyzed and reported.

Surufatinib exhibited promising efficacy and manageable toxicity on pts with ICC in the real world.

P2, N=41, Not yet recruiting, Shanghai Zhongshan Hospital

Surufatinib and toripalimab combination showed a promising antitumor activity in 1L therapy for advanced PD-L1 positive NSCLC with manageable toxicity. This study might represent a potential treatment option for these pts. Clinical trial information: NCT04169672.