NCT04886765

A Study to Evaluate the Safety and Efficacy of ALMB-0168 in Patients With Osteosarcoma

A Phase I/II, Multi-center, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of ALMB-0168 in Patients With Osteosarcoma

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 238 (estimated)
• Sponsor: AlaMab Therapeutics (Shanghai) Inc. · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I / II, multi-center, single-arm, open-label study to evaluate the safety and efficacy of ALMB-0168 in patients with osteosarcoma whose prior standard treatment have failed.

Detailed description

This is a phase I / II, multi-centre, single-arm, open-label study with two parts, a dose-escalation phase (Part I) and a dose-expansion phase (part II). In part I, patients with osteosarcoma whose prior standard treatment have failed will be assigned to receive sequentially higher doses of ALMB-0168 intravenously. The dose-escalation initially will follow an accelerated titration design for the first two dosing groups, then follow a classic 3+3 design. The maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of ALMB-0168 will be determined in part I. In Part II, 1-3 expansion cohorts will begin to further assess the safety profile and explore efficacy, and each cohort will enroll up to 60 patients with high-grade osteosarcoma in each cohort. All patients will receive multiple administration of ALMB-0168 until either the disease progresses or intolerable toxicity occurs.

Conditions

• Osteosarcoma

Interventions

Type	Name	Description
DRUG	ALMB-0168	ALMB-0168 will be administered intravenously until either the disease progresses or intolerable toxicity occurs.

Timeline

• Start date: 2021-05-01
• Primary completion: 2023-11-01
• Completion: 2024-05-01
• First posted: 2021-05-14
• Last updated: 2021-05-14