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Completed

NCT Number: NCT04430842

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.

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Key information

Conditions

Astrocytoma Adenocarcinoma Adenoma Adnexal Diseases Anorexia Bladder Cancer Brain Cancer Brain Diseases Brain Metastases Brain Neoplasms Breast Cancer Breast Diseases Breast Neoplasms Carcinoma Central Nervous System Diseases Central Nervous System Neoplasms Cervical Cancer Cholangiocarcinoma Colonic Diseases Colorectal Cancer Colorectal Neoplasms Communication Disorders Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Diseases Esophageal Neoplasms Esophagus Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Glioblastoma Glioma Gonadal Disorders Head and Neck Cancer Head and Neck Neoplasms Headache Hemic and Lymphatic Diseases Intestinal Diseases Intestinal Neoplasms Kidney Cancer Kidney Diseases Kidney Neoplasms Language Disorders Liver Cancer Liver Diseases Liver Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Lymphatic Diseases Male Urogenital Diseases Melanoma Mesothelioma Mesothelioma, Malignant Mouth Diseases Mouth Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplastic Processes Nervous System Diseases Nervous System Neoplasms Neurobehavioral Manifestations Neuroectodermal Tumors Neuroendocrine Tumors Neurologic Manifestations Nevi and Melanomas Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pain Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Pleural Mesothelioma Pleural Neoplasms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Seizures Signs and Symptoms Signs and Symptoms, Digestive Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Sleepiness Speech Disorders Stomach Diseases Stomach Neoplasms Stomatognathic Diseases Thoracic Neoplasms Thymic Carcinoma Thymoma Thymus Neoplasms Tongue Cancer Tongue Diseases Tongue Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urinary Tract Cancer Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

St George Private Hospital, Kogarah, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female participants aged ≥18 years at the time of informed consent.
  • Adequate Bone Marrow Function
  • Adequate renal function
  • Adequate Liver Function
  • 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.
  • 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
  • At least one measurable lesion (as defined by RECIST version 1.1) that has not been previously irradiated.
  • An ECOG PS 0 to 2.

Exclusion criteria

  • 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.
  • 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).
  • 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.
  • Major surgery within 4 weeks prior to study entry.
  • 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).
  • Systemic anticancer therapy within 4 weeks prior to study entry
  • Bleeding esophageal or gastric varices <2 months prior to the date of informed consent.
  • Unmanageable ascites.
  • Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect patient safety or interpretation of study results
  • On therapeutic anticoagulation, except low molecular weight heparin, vitamin K antagonists or factor Xa inhibitors may be allowed following discussion with the Sponsor.
  • 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).
  • Hypertension that cannot be controlled by medications (>150/90 mmHg despite optimal medical therapy) or requiring more than two medications for adequate control.

Treatment and study plan

QBS10072S

Drug

QBS10072S targets cancers with high LAT1 expression.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Quadriga Biosciences, Inc.

Industry

Collaborators

  • Novotech (Australia) Pty Limited

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 12, 2020
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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