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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer; Non-small Cell Lung Cancer; Head and Neck Squamous Cell Carcinoma; Solid Tumors; Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
• Intervention / Treatment: Drug: QLS5316

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Shengxiang Ren, MD; Phone Number: 021-65115006-3051; Email: harry_ren@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QLS5316; patients with advanced solid tumors were administrated with varying doses of QLS5316 specified in protocol	Drug: QLS5316; Varying doses of QLS5316

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events as assessed by NCI-CTCAE v5.0	To evaluate the safety and tolerability of QLS5316	From time of Informed Consent to 30 days post last dose of QLS5316
Number of Participants With Clinical Laboratory Test Abnormalities	Clinical laboratory test included Hematology, Blood and serum chemistry, Coagulation function, and Fecal occult blood.	From time of Informed Consent to 30 days post last dose of QLS5316
12-lead ECG(Including heart rate, QT interval, QTc interval, and P-R interval)	Assessment of abnormal electrocardiogram parameters before and after treatment	From time of Informed Consent to 30 days post last dose of QLS5316
Number of participants with physical examination abnormalities	Including general conditions, skin and mucosa, systemic superficial lymph nodes, head and neck, chest, abdomen, spine and extremities, nervous system, and other examinations.	From time of Informed Consent to 30 days post last dose of QLS5316
Number of participants with vital signs abnormalities	Including body temperature, respiratory rate, pulse, blood pressure, and oxygen saturation	From time of Informed Consent to 30 days post last dose of QLS5316
DLT	Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Protocol	From time of first dose of QLS5316 to end of DLT period (21 days)
MTD	the maximum tolerated dose (MTD) or maximum administered dose (MAD, if MTD fails to be determined) of QLS5316 monotherapy	1 year
RP2D	the recommended phase II dose of QLS5316 monotherapy	2 year

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 5, 2026
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Rectal Diseases; Lung Diseases; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Colonic Diseases; Lung Neoplasms; Carcinoma; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Stomach Neoplasms; Colorectal Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: QLS5316-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No