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Not yet recruiting NCT07358884

First in Human Study of QLS5316 in Solid Tumors

Phase I Interventional Solid Tumors Colorectal Cancer Gastric Cancer or Gastroesophageal Junction Adenocarcinoma Head and Neck Squamous Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: QLS5316.
Who it may be relevant to
Registry conditions: Solid Tumors, Colorectal Cancer, Gastric Cancer or Gastroesophageal Junction Adenocarcinoma, Head and Neck Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug QLS5316
    Varying doses of QLS5316

Primary outcome measures

  • 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]
  • Number of Participants With Clinical Laboratory Test Abnormalities [Time frame: 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) [Time frame: From time of Informed Consent to 30 days post last dose of QLS5316]
  • Number of participants with physical examination abnormalities [Time frame: From time of Informed Consent to 30 days post last dose of QLS5316]
  • Number of participants with vital signs abnormalities [Time frame: From time of Informed Consent to 30 days post last dose of QLS5316]
  • DLT [Time frame: From time of first dose of QLS5316 to end of DLT period (21 days)]
  • MTD [Time frame: 1 year]
  • RP2D [Time frame: 2 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07358884 · QLS5316-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗