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

Quadriga Biosciences, Inc.2 sites in 1 country15 target enrollmentJuly 20, 2020

Overview

Phase: Phase 1
Intervention: QBS10072S
Conditions: Astrocytoma
Sponsor: Quadriga Biosciences, Inc.
Enrollment: 15
Locations: 2
Primary Endpoint: Determination of maximum tolerated dose (MTD)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 20, 2020

End Date

December 22, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Quadriga Biosciences, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Dose escalation of QBS10072S

Intravenous administration of QBS10072S once every 4 weeks starting at 3mg/m2 and increasing dose levels in subsequent cohorts.

Intervention: QBS10072S

Outcomes

Primary Outcomes

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

Safety and tolerability assessed by adverse events and serious adverse events(28 days)
Peak Plasma Concentration (Cmax)(28 days)
Area under the plasma concentration versus time curve (AUC) of QBS10072S(28 days)
Half-life of QBS10072S in plasma (t1/2)(28 days)
Time to maximum concentration of QBS10072S in plasma (Tmax)(28 days)