NCT06368960

BM201 in Combination With Radiotherapy in Patients With Advanced Solid Tumors

The Study to Evaluate the Safety, PK, and Preliminary Efficacy of BM201 Injection Combined With Radiotherapy in Patients With Unresectable Locally Advanced or Metastatic Solid Tumors That Failed Standard Therapy

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: InnoBM Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a non-randomized，open-label，controlled multi-center Phase Ⅰ study to evaluate tolerability, pharmacokinetics, and preliminary efficacy of BM201 injection in combination with radiotherapy in patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors who have failed standard therapy or are unable to receive standard treatment.

Detailed description

This is a Phase I, open-label clinical study primarily designed to evaluate the safety and tolerability of BM201 injection in combination with radiotherapy in patients with advanced solid tumors.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
RADIATION	Radiotherapy	Radiation： Hypofractionated radiotherapy
DRUG	BM201 injection	BM201 injection：Dose escalation：24mg to 240mg

Timeline

• Start date: 2022-11-07
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-04-16
• Last updated: 2024-04-16

Locations

1 site across 1 country: China