Clinical Trial Details

Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S

Print record Print record
Trial Information

Broad Health Condition Astrocytoma
Brain Cancer
Brain Metastases
Bladder Cancer
Breast Cancer
Cervical Cancer
Cholangiocarcinoma
Colorectal Cancer
Esophagus Cancer
Gastric Cancer
Head and Neck Cancer
Kidney Cancer
Liver Cancer
Lung Cancer
Melanoma
Ovarian Cancer
Pancreatic Cancer
Pleural Mesothelioma
Prostate Cancer
Sarcoma
Tongue Cancer
Thymic Carcinoma
Urinary Tract Cancer

Specific Health Condition























Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,

Hospital
St George Private Hospital
Sydney Southwest Private Hospital

Phase of TrialPhase 1

Trial summary

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.
Eligibility

Key inclusion criteria

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.

Minimum age18 Years

GenderAll

Can Healthy volunteers participate?No

Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Quadriga Biosciences, Inc.

Trial websitehttps://clinicaltrials.gov/show/NCT04430842

Trial IDNCT04430842