Colorectal Cancer, Gastric Cancer or Gastroesophageal Junction Adenocarcinoma, Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer, Solid Tumors
Conditions
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.
Interventions
DRUGQLS5316
Varying doses of QLS5316
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events as assessed by NCI-CTCAE v5.0 | From time of Informed Consent to 30 days post last dose of QLS5316 | To evaluate the safety and tolerability of QLS5316 |
| Number of Participants With Clinical Laboratory Test Abnormalities | 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. |
| 12-lead ECG(Including heart rate, QT interval, QTc interval, and P-R interval) | From time of Informed Consent to 30 days post last dose of QLS5316 | Assessment of abnormal electrocardiogram parameters before and after treatment |
| Number of participants with physical examination abnormalities | 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. |
| Number of participants with vital signs abnormalities | From time of Informed Consent to 30 days post last dose of QLS5316 | Including body temperature, respiratory rate, pulse, blood pressure, and oxygen saturation |
| DLT | 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 |
| MTD | 1 year | the maximum tolerated dose (MTD) or maximum administered dose (MAD, if MTD fails to be determined) of QLS5316 monotherapy |
| RP2D | 2 year | the recommended phase II dose of QLS5316 monotherapy |
Contacts
CONTACTShengxiang Ren, MD
Outcome results
None listed