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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

NCT07358884•Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18 years
•2. Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
•3. Life expectancy ≥ 3 months;
•4. Measurable disease per RECIST v1.1
•5. Adequate organ and marrow function as defined in the protocol
•6. Dose escalation and PK expansion stages: Histologically or cytologically confirmed locally advanced or metastatic malignant solid tumors that cannot undergo radical surgery or radiotherapy, who have failed SOC or SOC is not available
•7. Cohort expansion stage: Patients with histologically or cytologically confirmed locally advanced or metastatic malignant solid tumors that cannot undergo radical surgery or radiotherapy, including CRC, GC/GEJ, HNSCC (mouth, oropharynx, hypopharynx or larynx), EGFR-sensitive mutant NSCLC and EGFR wild-type NSCLC or other advanced malignant solid tumors who have failed SOC or SOC is not available.

Exclusion Criteria

•1. Prior treatment with antibody-drug conjugates (ADCs) containing topoisomerase I inhibitors, or prior treatment with EGFR and/or c-MET targeted ADCs
•2. Untreated or active brain metastasis
•3. Presence of Grade ≥ 2 toxicity (according to the Common Terminology Criteria for Adverse Events (CTCAE Version 5.0) ) left over from prior therapy
•4. Patients with a history of interstitial lung disease (ILD)/non-infectious pneumonia, or patients whose suspected ILD/non-infectious pneumonia cannot be ruled out by imaging examination at screening; patients with radiation pneumonitis who do not require steroid treatment are allowed to be enrolled;
•5. Patients with a history of active tuberculosis, active autoimmune diseases or autoimmune diseases that may recur
•6. Patients with a history of severe cardiovascular and cardiovascular diseases
•7. Clinically uncontrollable third space effusion
•8. Presence of persistent uncontrolled systemic bacterial, fungal or viral infections or severe infections within 4 weeks before the first dose in the study, or active infections requiring systematic antibiotic treatment within 1 week before the first dose in the study;
•9. Known hypersensitivity reactions or delayed-type sensitization to some components or analogues of the investigational drug

Key Dates

Start Date

January 1, 2026

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2027

Last Updated

January 22, 2026

Enrollment

300

ESTIMATED participants

Conditions

Solid TumorsColorectal CancerGastric Cancer or Gastroesophageal Junction AdenocarcinomaHead and Neck Squamous Cell CarcinomaNon-small Cell Lung Cancer

Interventions

QLS5316

DRUG

Contacts

Shengxiang Ren, MD

CONTACT

021-65115006-3051 harry_ren@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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First in Human Study of QLS5316 in Solid Tumors

Inclusion Criteria

Exclusion Criteria

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