NCT07042100

A Study to Test the Safety and Tolerability of SBO-154 in Patients With Advanced Solid Tumors.

A Phase 1, Multicentre, Open-label, Multiple-dose Study to Determine Safety, Tolerability, and Preliminary Efficacy of SBO-154 in Subjects With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 177 (estimated)
• Sponsor: Sun Pharma Advanced Research Company Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 study of SBO-154 in patients with advanced cancers who are unable to tolerate or have not previously responded to standard therapy available in the country. The study involves multiple doses and takes place at several centers.

Detailed description

This study has two parts. In Part 1, the goal to evaluate the safety and tolerability along with the highest dose that can be tolerated, or the dose(s) which can be chosen for further evaluation. In Part 2, the focus is on evaluating the safety of SBO-154 in specific types of advanced cancers.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	Dose level (DL)1	Administered IV every 3 weeks
BIOLOGICAL	DL2	Administered IV every 3 weeks
BIOLOGICAL	DL3	Administered IV every 3 weeks
BIOLOGICAL	DL4	Administered IV every 3 weeks
BIOLOGICAL	DL5	Administered IV every 3 weeks

Timeline

• Start date: 2025-08-12
• Primary completion: 2028-08-01
• Completion: 2030-08-01
• First posted: 2025-06-27
• Last updated: 2026-01-22

Locations

11 sites across 3 countries: United States, Australia, India

Regulatory

• FDA-regulated drug study