NCT04096638

Safety and Efficacy of SB 11285 Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors

A Phase 1a/1b Dose-escalation Study of Intravenously Administered SB 11285 Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: invoX Pharma Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 1a/1b, multicenter, open-label, non-randomized, dose-escalation, and cohort expansion study to examine the DLTs, MTD, and RP2D of SB 11285 administered as an IV infusion in patients with advanced solid tumors.

Detailed description

Part 1a of the study will assess the safety and tolerability of SB 11285 as monotherapy in eligible patients with advanced solid tumors. Part 1b will assess the safety and tolerability of SB 11285 in combination with atezolizumab in patients with advanced solid tumors. RP2D decisions will be based on the totality of data, including DLTs, tolerability, PK, pharmacodynamics, and efficacy, as available. Part 2 will further evaluate the combination RP2D of SB 11285 and atezolizumab in selected tumor types. Both Parts 1a and 1b of the study will use a standard 3+3 dose-escalation design with the dose escalated in successive cohorts of 3 to 6 patients each within each cohort in an open-label fashion. In Part 1a Monotherapy Dose Escalation, patients who meet eligibility criteria will receive IV SB 11285 as monotherapy weekly on Days 1, 8, 15, and 22 of repeated 28-day cycles in escalating doses. Once Dose Level 2 of Part 1a monotherapy have been evaluated by the Safety Review Committee (SRC) and have been declared to be safe to dose escalate to Dose Level 3, Dose Level 1 of Part 1b Combination Dose Escalation (SB 11285 combination with atezolizumab) will be opened for enrollment. After determination of MTD and RP2D in SB 11285 plus atezolizumab combination the Part 2 with Expansion Cohorts will commence to further evaluate the RP2D.

Conditions

• Melanoma
• Head and Neck Squamous Cell Carcinoma
• Solid Tumor

Interventions

Type	Name	Description
DRUG	SB 11285	SB 11285 2mg lyophilized powder for IV infusion
DRUG	Atezolizumab	1680 mg every 4 weeks

Timeline

• Start date: 2019-09-23
• Primary completion: 2024-07-16
• Completion: 2024-07-16
• First posted: 2019-09-20
• Last updated: 2024-10-31

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study