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Safety and Efficacy of Canagliflozin in Patients With Locally Advanced or Advanced Solid Cancer

NCT07703163 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-07-14

No results posted yet for this study

Summary

\*\*Revised version:\*\*

Locally advanced or advanced solid tumors remain a major clinical challenge despite multimodal treatments, including surgery, radiotherapy, chemotherapy, targeted therapy, and immunotherapy. For patients with unresectable, recurrent, metastatic, or treatment-refractory disease, prognosis remains poor, and effective therapeutic strategies are still urgently needed. Immune checkpoint inhibitors (ICIs), particularly PD-1/PD-L1 blockade, have transformed the treatment landscape of multiple solid tumors by reinvigorating anti-tumor immune responses through inhibition of the PD-1/PD-L1 pathway. However, only a subset of patients derive durable benefit from immunotherapy, and primary or acquired resistance remains common, highlighting the need for rational combination strategies to enhance anti-tumor efficacy.

Intriguingly, sodium-glucose cotransporter 2 inhibitors, originally developed as anti-diabetic agents, have shown emerging anti-tumor potential through metabolic regulation and modulation of the tumor microenvironment. In particular, combining SGLT-2 inhibition with immune checkpoint blockade may enhance tumor control through metabolic-immunologic crosstalk. Preclinical evidence suggests that the SGLT-2 inhibitor canagliflozin may suppress tumor growth and potentially improve the efficacy of PD-1 blockade. Based on this rationale, this phase II trial investigates the safety and efficacy of canagliflozin combined with tislelizumab in patients with locally advanced or advanced solid tumors, evaluating its impact on progression-free survival, overall survival, objective response rate, and tumor microenvironment modulation. This study aims to explore a novel metabolic-immunotherapy strategy based on dual metabolic and immune regulation, potentially providing a new therapeutic option for patients with locally advanced or advanced solid tumors.

Conditions

Interventions

DRUG

Canagliflozin

Low-dose cohort: 100 mg qd, taken before the first meal of the day. High-dose cohort: Starting dose of 100 mg qd for 1 week. If tolerated, the dose will escalate to 300 mg qd, taken before the first meal of the day.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2028-07-31
Completion
2028-07-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07703163 on ClinicalTrials.gov