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

Sponsor
West China Hospital
Study ID
NCT07703163
Phase
PHASE1
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • SGLT 2 Inhibitors
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Canagliflozin — DRUG
    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.

Study Details

\*\*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.

Key Dates

First listed
Jul 14, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention group
    Canagliflozin: According to the drug's prescribing information, the recommended starting dose is 100 mg once daily (qd), taken orally before the first meal of the day. For patients who tolerate 100 mg qd and have an estimated glomerular filtration rate (eGFR) ≥60 ml/min/1.73 m² with a need for additional glycemic control, the dose may be increased to 300 mg qd. In this study's dose-escalation phase, two dose levels will be evaluated: 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.

Primary Outcome Measure

Number of Participants With Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0 [ Time Frame: Through study completion, an average of 1 year ]

Related Studies