NCT03398720

Safety and Tolerability of HTI-1066 in Subjects With Advanced Solid Tumors

A Two-Part, Phase 1, Open-Label, Multicenter, Non-Randomized, Dose Escalation/Expansion Study to Evaluate the Safety and Tolerability of HTI-1066 in Subjects With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

HTI-1066 is a novel ADC being developed for the treatment of cancers in patients with overexpression of c-Met. This 2-part, Phase 1 study evaluates the safety the tolerability of HTI-1066 in subjects with advanced solid tumors.

Detailed description

This is a 2-part dose escalation and dose expansion study. Dose escalation uses a modified "3+3" design and continues until a maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is identified. In part 2, subjects with selected tumor types will be enrolled at the MTD or RP2D.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	HTI-1066 dose level 1	Starting dose level
DRUG	HTI-1066 dose level 2	2nd dose level
DRUG	HTI-1066 dose level 3	3rd dose level
DRUG	HTI-1066 dose level 4	4th dose level

Timeline

• Start date: 2017-12-31
• Primary completion: 2018-12-31
• Completion: 2019-12-31
• First posted: 2018-01-12
• Last updated: 2018-01-12

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study