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Clinical Trial Record

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

2020-07-20

2022-09-21

2022-12-22

15

Study Overview

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.

N/A

  • 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
  • DRUG: QBS10072S
  • QBS-72S-1001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2020-06-02  

N/A  

2023-01-16  

2020-06-10  

N/A  

2023-01-18  

2020-06-12  

N/A  

2023-01  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Dose escalation of QBS10072S

Intravenous administration of QBS10072S once every 4 weeks starting at 3mg/m2 and increasing dose levels in subsequent cohorts.

DRUG: QBS10072S

  • QBS10072S targets cancers with high LAT1 expression.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Determination of maximum tolerated dose (MTD)MTD will be determined by presence of AEs as characterized by type, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy.28 days
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Safety and tolerability assessed by adverse events and serious adverse eventsSafety and tolerability will be determined by adverse events as characterized by type, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy.28 days
Peak Plasma Concentration (Cmax)Determine the maximum plasma concentration of QBS10072S.28 days
Area under the plasma concentration versus time curve (AUC) of QBS10072SDetermine the plasma concentration of QBS10072S over time.28 days
Half-life of QBS10072S in plasma (t1/2)Determine the half life of QBS10072S in plasma; the half-life of a drug is the time taken for the plasma concentration of a drug to reduce to half its original value.28 days
Time to maximum concentration of QBS10072S in plasma (Tmax)Determine the time it takes to achieve maximum concentration of QBS10072S in plasma.28 days

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Novotech (Australia) Pty Limited
  • : ,

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available