NCT07333469

A Clinical Study of HX111 in Patients With Advanced Solid Tumor and Lymphoma

A Phase I/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of HX111 in Patients With Advanced Solid Tumor and Lymphoma

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Hanx Biopharmaceuticals (Wuhan) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The study will consist of a Phase I dose-escalation and Phase IIa dose-expansion component. Phase I dose-escalation phase will establish the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D),and evaluate the preliminary antitumor activity of HX111.

Detailed description

Phase I dose-escalation phase Eligible patients with advanced solid tumors and lymphoma will be enrolled. The total sample size is up to 54 patients enrolled for DLT evaluable population. Dose-limiting toxicities (DLTs) will be assessed from the first dose of study treatment (Day 1) until 21 days later (Day 22). The dose escalation will be guided by Bayesian optimal interval (BOIN) design. The target toxicity rate ϕ is 0.3, The alternative hypothesis toxicity rates are ϕ\_1=0.6ϕ and ϕ\_2=1.4ϕ, respectively. The posterior probability threshold for dose elimination is 0.95. The maximum number of evaluable subjects per dose group is 9. Dose escalation will continue until one of the following criteria is met

Conditions

• Solid Tumor and Lymphoma

Interventions

Type	Name	Description
DRUG	HX111 for injection	HX111, 0.5-2.5mg/kg, once every 3 weeks

Timeline

• Start date: 2026-01-19
• Primary completion: 2028-01-19
• Completion: 2030-01-19
• First posted: 2026-01-12
• Last updated: 2026-01-13