Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics … (NCT04430842) | Clinical Trial Compass
CompletedPhase 1
Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S
Australia15 participantsStarted 2020-07-20
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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:
✓. 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.