Trials / Not Yet Recruiting
Not Yet RecruitingNCT07358884
First in Human Study of QLS5316 in Solid Tumors
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of QLS5316 Monotherapy in Patients With Advanced Solid Tumors
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- Qilu Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a first-in-human (FIH) Phase I, multi-center, open-label, study of QLS5316, in patients with advanced solid tumors. The study aim to evaluating the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), and immunogenicity of QLS5316 as monotherapy.
Conditions
- Solid Tumors
- Colorectal Cancer
- Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
- Head and Neck Squamous Cell Carcinoma
- Non-small Cell Lung Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | QLS5316 | Varying doses of QLS5316 |
Timeline
- Start date
- 2026-01-01
- Primary completion
- 2027-12-01
- Completion
- 2027-12-01
- First posted
- 2026-01-22
- Last updated
- 2026-01-22
Source: ClinicalTrials.gov record NCT07358884. Inclusion in this directory is not an endorsement.