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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04430842|
Recruitment Status : Active, not recruiting
First Posted : June 12, 2020
Last Update Posted : September 16, 2022
|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|
|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)|
|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|
|Actual Study Start Date :||July 20, 2020|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: Dose escalation of QBS10072S
Intravenous administration of QBS10072S once every 4 weeks starting at 3mg/m2 and increasing dose levels in subsequent cohorts.
QBS10072S targets cancers with high LAT1 expression.
- 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.
- 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.
- Peak Plasma Concentration (Cmax) [ Time Frame: 28 days ]Determine the maximum plasma concentration of QBS10072S.
- Area under the plasma concentration versus time curve (AUC) of QBS10072S [ Time Frame: 28 days ]Determine the plasma concentration of QBS10072S over time.
- 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.
- 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.
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
|Australia, New South Wales|
|St George Private Hospital|
|Kogarah, New South Wales, Australia, 2217|
|Sydney Southwest Private Hospital|
|Liverpool, New South Wales, Australia, 2170|