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NCT Number: NCT07358884

First in Human Study of QLS5316 in 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.

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Key information

Conditions

Solid Tumors Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastric Cancer or Gastroesophageal Junction Adenocarcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Head and Neck Squamous Cell Carcinoma Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-small Cell Lung Cancer Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Squamous Cell Carcinoma of Head and Neck Stomach Diseases Stomach Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

QLS5316

Drug

Varying doses of QLS5316

Primary outcomes

  1. Number of participants with adverse events as assessed by NCI-CTCAE v5.0

    Time frame: From time of Informed Consent to 30 days post last dose of QLS5316

    To evaluate the safety and tolerability of QLS5316

  2. Number of Participants With Clinical Laboratory Test Abnormalities

    Time frame: From time of Informed Consent to 30 days post last dose of QLS5316

    Clinical laboratory test included Hematology, Blood and serum chemistry, Coagulation function, and Fecal occult blood.

  3. 12-lead ECG(Including heart rate, QT interval, QTc interval, and P-R interval)

    Time frame: From time of Informed Consent to 30 days post last dose of QLS5316

    Assessment of abnormal electrocardiogram parameters before and after treatment

  4. Number of participants with physical examination abnormalities

    Time frame: From time of Informed Consent to 30 days post last dose of QLS5316

    Including general conditions, skin and mucosa, systemic superficial lymph nodes, head and neck, chest, abdomen, spine and extremities, nervous system, and other examinations.

  5. Number of participants with vital signs abnormalities

    Time frame: From time of Informed Consent to 30 days post last dose of QLS5316

    Including body temperature, respiratory rate, pulse, blood pressure, and oxygen saturation

  6. DLT

    Time frame: From time of first dose of QLS5316 to end of DLT period (21 days)

    Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Protocol

  7. MTD

    Time frame: 1 year

    the maximum tolerated dose (MTD) or maximum administered dose (MAD, if MTD fails to be determined) of QLS5316 monotherapy

  8. RP2D

    Time frame: 2 year

    the recommended phase II dose of QLS5316 monotherapy

Study contacts

Contact information is provided by the study sponsor or research team.

Shengxiang Ren, MD

CONTACT

[email protected]

021-65115006-3051

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of QLS5316 Monotherapy in Patients With Advanced Solid Tumors

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 22, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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