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| Name | Class |
|---|---|
| Novotech (Australia) Pty Limited | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation of QBS10072S | Experimental | Intravenous administration of QBS10072S once every 4 weeks starting at 3mg/m2 and increasing dose levels in subsequent cohorts. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QBS10072S | Drug | QBS10072S targets cancers with high LAT1 expression. |
|
| Measure | Description | Time 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability assessed by adverse events and serious adverse events | 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. | 28 days |
| Peak Plasma Concentration (Cmax) |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St George Private Hospital | Kogarah | New South Wales | 2217 | Australia | ||
| Sydney Southwest Private Hospital |
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The dose escalation scheme for this trial employs an mTPI-2 design.
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Determine the maximum plasma concentration of QBS10072S. |
| 28 days |
| Area under the plasma concentration versus time curve (AUC) of QBS10072S | Determine 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 |
| Liverpool |
| New South Wales |
| 2170 |
| Australia |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D001932 | Brain Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D001943 | Breast Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D018281 | Cholangiocarcinoma |
| D015179 | Colorectal Neoplasms |
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D007680 | Kidney Neoplasms |
| D008113 | Liver Neoplasms |
| D008175 | Lung Neoplasms |
| D008545 | Melanoma |
| D010051 | Ovarian Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D000086002 | Mesothelioma, Malignant |
| D011471 | Prostatic Neoplasms |
| D012509 | Sarcoma |
| D014062 | Tongue Neoplasms |
| D013945 | Thymoma |
| D014571 | Urologic Neoplasms |
| D009362 | Neoplasm Metastasis |
| D009369 | Neoplasms |
| D005909 | Glioblastoma |
| D006261 | Headache |
| D014839 | Vomiting |
| D012640 | Seizures |
| D000077260 | Sleepiness |
| D000855 | Anorexia |
| D013064 | Speech Disorders |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D000091662 | Genital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004935 | Esophageal Diseases |
| D013272 | Stomach Diseases |
| D007674 | Kidney Diseases |
| D008107 | Liver Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018358 | Neuroendocrine Tumors |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D010182 | Pancreatic Diseases |
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D018301 | Neoplasms, Mesothelial |
| D010997 | Pleural Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009062 | Mouth Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014060 | Tongue Diseases |
| D018193 | Neoplasms, Complex and Mixed |
| D013953 | Thymus Neoplasms |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
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