NCT03409458

A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab

A Phase 1b/2a Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Promontory Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study of PT-112 in combination with the anti-PD-L1 antibody, avelumab, in selected advanced solid tumors. The study is to be conducted in two parts: the Dose Escalation Phase of PT-112 within the combination and the Dose Confirmation Phase in patients with non-small cell lung cancer who will be treated at the RP2D.

Detailed description

This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study of PT-112 in combination with the anti-PD-L1 antibody, avelumab, in selected advanced solid tumors. The study is to be conducted in two parts: the Dose Escalation Phase and the Dose Confirmation Phase. Enrollment for dose escalation and dose confirmation is complete.

Conditions

• Non-Small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	PT-112	The RP2D of PT-112 when used in combination with avelumab has been determined during dose escalation and is being confirmed in the NSCLC dose confirmation cohort. For the NSCLC confirmation cohort, PT-112 will be administered at a dose of 360 mg/m2 on Days 1, 8 and 15.
BIOLOGICAL	avelumab	Avelumab will be administered at a fixed dose of 800 mg on Days 1 and 15.

Timeline

• Start date: 2018-04-24
• Primary completion: 2022-06-01
• Completion: 2022-08-31
• First posted: 2018-01-24
• Last updated: 2023-11-18

Locations

6 sites across 2 countries: United States, Switzerland

Regulatory

• FDA-regulated drug study