Trials / Unknown
UnknownNCT06047431
A Study of QL1706H in Patients With Advanced Solid Tumors
A Phase Ⅰ Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Efficacy of QL1706H in Advanced Solid Tumors
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Qilu Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label, Phase Ⅰ study of QL1706H in patients with advanced solid tumors. The study will evaluate the pharmacokenetics, safety, tolerability and preliminary efficacy of QL1706H.
Detailed description
The study is composed of 2 parts. Part 1 is a dose-escalation study to explore the pharmacokenetics (PK), safety, and tolerability of QL1706H. Part 2 of the study will explore the PK characteristics of differente intervals and sites of administration. All the PK parameters will determine the recommended Phase 2 dose (RP2D). The study was divided into screening/baseline, treatment and follow-up periods. Safety monitoring will be conducted throughout the study period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | QL1706H | QL1706H is the subcutaneousely administered formulation of QL1706, it contains two unique monoclonal antibodies. |
Timeline
- Start date
- 2023-10-01
- Primary completion
- 2024-12-01
- Completion
- 2025-12-01
- First posted
- 2023-09-21
- Last updated
- 2023-09-21
Source: ClinicalTrials.gov record NCT06047431. Inclusion in this directory is not an endorsement.