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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04430842
Recruitment Status : Recruiting
First Posted : June 12, 2020
Last Update Posted : July 7, 2020
Sponsor:
Collaborator:
Novotech (Australia) Pty Limited
Information provided by (Responsible Party):
Quadriga Biosciences, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
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 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Sequential Assignment
Intervention Model Description: The dose escalation scheme for this trial employs an mTPI-2 design.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open Label, Multi-Center, Single and Multiple Dose, Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S in Previously Treated Patients With Advanced or Metastatic Cancers With High LAT1 Signatures, and in Patients With Relapsed or Refractory Grade 4 Astrocytoma
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021


Arm Intervention/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 Measures :
  1. Determination of maximum tolerated dose (MTD) [ Time Frame: 28 days ]
    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.


Secondary Outcome Measures :
  1. Safety and tolerability assessed by adverse events and serious adverse events [ Time Frame: 28 days ]
    Safety 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.

  2. Peak Plasma Concentration (Cmax) [ Time Frame: 28 days ]
    Determine the maximum plasma concentration of QBS10072S.

  3. Area under the plasma concentration versus time curve (AUC) of QBS10072S [ Time Frame: 28 days ]
    Determine the plasma concentration of QBS10072S over time.

  4. Half-life of QBS10072S in plasma (t1/2) [ Time Frame: 28 days ]
    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.

  5. Time to maximum concentration of QBS10072S in plasma (Tmax) [ Time Frame: 28 days ]
    Determine the time it takes to achieve maximum concentration of QBS10072S in plasma.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04430842


Contacts
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Contact: Quadriga Biosciences Clinical Trials Support 1 (650) 917 9098 clinicaltrials@quadrigabiosciences.com

Locations
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Australia, New South Wales
St George Private Hospital Recruiting
Kogarah, New South Wales, Australia, 2217
Contact: Paul De Souza, MBBS FRACP    (61) 40 400 3220    paulds@uow.edu.au   
Contact: Shu Pan    (61) 285945785    pans@ramsayhealth.com.au   
Sydney Southwest Private Hospital Recruiting
Liverpool, New South Wales, Australia, 2170
Contact: Adam Cooper, MBBS FRACP    (61) 42 370 2208    Adam.Cooper@health.nsw.gov.au   
Contact: Admir Huseincehajic    (61) 287389156    admir.huseincehajic@sswahs.nsw.gov.au   
Sponsors and Collaborators
Quadriga Biosciences, Inc.
Novotech (Australia) Pty Limited
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Responsible Party: Quadriga Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT04430842    
Other Study ID Numbers: QBS-72S-1001
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Quadriga Biosciences, Inc.:
Brain tumor
Cancer
Oncology
Neuro-oncology
Tumor removal
Phase 1
Dose escalation
Metastatic
Brain metastasis
Brain metastases
GBM
Astrocytoma
Glioblastoma
Glioblastoma multiforme
Brain
Neurology
Neuroscience
Headaches
Vomiting
Seizures
Drowsiness
Chemotherapy
Surgery
Radiation
Blurred vision
Loss of appetite
Speech difficulty
Changes in ability to think and learn
Changes in mood and personality
Persistent headaches
Additional relevant MeSH terms:
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Neoplasm Metastasis
Brain Neoplasms
Cholangiocarcinoma
Esophageal Neoplasms
Tongue Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Head and Neck Neoplasms
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms, Mesothelial
Mouth Neoplasms
Neoplasms, Complex and Mixed
Thymus Neoplasms
Thoracic Neoplasms
Astrocytoma
Mesothelioma
Thymoma
Digestive System Diseases
Gastrointestinal Diseases