First in Human Study of QLS5316 in Solid Tumors

NCT07358884 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: QLS5316-101
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (1)

QLS5316

EXPERIMENTAL

patients with advanced solid tumors were administrated with varying doses of QLS5316 specified in protocol

Drug: QLS5316

Interventions

QLS5316 DRUG

Varying doses of QLS5316

QLS5316

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
• Life expectancy ≥ 3 months;
• Measurable disease per RECIST v1.1
• Adequate organ and marrow function as defined in the protocol
• 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
• 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.

You may not qualify if:

• Prior treatment with antibody-drug conjugates (ADCs) containing topoisomerase I inhibitors, or prior treatment with EGFR and/or c-MET targeted ADCs
• Untreated or active brain metastasis
• Presence of Grade ≥ 2 toxicity (according to the Common Terminology Criteria for Adverse Events (CTCAE Version 5.0) ) left over from prior therapy
• 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;
• Patients with a history of active tuberculosis, active autoimmune diseases or autoimmune diseases that may recur
• Patients with a history of severe cardiovascular and cardiovascular diseases
• Clinically uncontrollable third space effusion
• 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;
• Known hypersensitivity reactions or delayed-type sensitization to some components or analogues of the investigational drug

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Colorectal Neoplasms; Stomach Neoplasms; Squamous Cell Carcinoma of Head and Neck; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Stomach Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Shengxiang Ren, MD

CONTACT

021-65115006-3051; harry_ren@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 22, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 22, 2026

Record last verified: 2026-01