Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S
Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S
This is a multi-center, open-label, dose escalation study to determine the safety,
 tolerability, pharmacokinetics, pharmacodynamics, and maximum tolerated dose (MTD) of
 QBS10072S in patients with advanced or metastatic cancers with high LAT1 expression. The MTD
 of QBS10072S will be confirmed in patients with relapsed or refractory grade 4 astrocytoma.
Inclusion Criteria:

 1. Male or female participants aged ≥18 years at the time of informed consent.

 2. Adequate Bone Marrow Function

 3. Adequate renal function

 4. Adequate Liver Function

 5. Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1
 except for AEs not constituting a safety risk by Investigator judgment.

 6. A histological or cytological diagnosis of a solid tumor that is advanced/metastatic,
 patients intolerant to standard treatment or, resistant to standard therapy* (per NCCN
 guidelines) or for which no curative therapy is available for the following tumor
 types:

 - Bladder, Brain, Breast, Cervical, Cholangiocarcinoma, Colorectal, Esophageal,
 Gastric, Head and Neck, Kidney, Liver, Lung, Melanoma, Ovarian, Pancreatic, Pleural
 mesothelioma, Prostate, Sarcoma, Tongue cancer, Thymic carcinomas, Urinary tract

 7. At least one measurable lesion (as defined by RECIST version 1.1) that has not been
 previously irradiated.

 8. An ECOG PS 0 to 2.

 Exclusion Criteria:

 1. Patients with tumor primarily localized to the brainstem or spinal cord. Presence of
 known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or
 leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or
 progressive growth.

 2. Patients with advanced/metastatic, symptomatic, visceral spread, that are at risk of
 life-threatening complications in the short term (including patients with massive
 uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and
 over 50% liver involvement).

 3. Patients with any other active malignancy within 3 years prior to enrollment, except
 for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.

 4. Major surgery within 4 weeks prior to study entry.

 5. Radiation therapy within 4 weeks prior to receiving the first QBS10072S dose (bone
 lesions requiring radiation may be treated with limited radiation therapy during this
 period).

 6. Systemic anticancer therapy within 4 weeks prior to study entry

 7. Bleeding esophageal or gastric varices <2 months prior to the date of informed
 consent.

 8. Unmanageable ascites.

 9. Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may
 affect patient safety or interpretation of study results

 10. On therapeutic anticoagulation, except low molecular weight heparin, vitamin K
 antagonists or factor Xa inhibitors may be allowed following discussion with the
 Sponsor.

 11. Any of the following in the previous 6 months: myocardial infarction, congenital long
 QT syndrome, Torsade de Pointes, clinically significant arrhythmias (including
 sustained ventricular tachyarrhythmia and ventricular fibrillation), left anterior
 hemiblock, bifascicular block, unstable angina, coronary/peripheral artery bypass
 graft, symptomatic congestive heart failure (New York Heart Association class III or
 IV), cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary
 embolism or other clinical significant episode of thromboembolic disease. Ongoing
 cardiac dysrhythmias of NCI CTCAE Grade ≥2, atrial fibrillation of any grade (Grade ≥2
 in the case of asymptomatic lone atrial fibrillation).

 12. Hypertension that cannot be controlled by medications (>150/90 mmHg despite optimal
 medical therapy) or requiring more than two medications for adequate control.