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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04430842




Registration number
NCT04430842
Ethics application status
Date submitted
2/06/2020
Date registered
12/06/2020
Date last updated
7/07/2020

Titles & IDs
Public title
Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S
Scientific 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
Secondary ID [1] 0 0
QBS-72S-1001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Astrocytoma 0 0
Brain Cancer 0 0
Brain Metastases 0 0
Bladder Cancer 0 0
Breast Cancer 0 0
Cervical Cancer 0 0
Cholangiocarcinoma 0 0
Colorectal Cancer 0 0
Esophagus Cancer 0 0
Gastric Cancer 0 0
Head and Neck Cancer 0 0
Kidney Cancer 0 0
Liver Cancer 0 0
Lung Cancer 0 0
Melanoma 0 0
Ovarian Cancer 0 0
Pancreatic Cancer 0 0
Pleural Mesothelioma 0 0
Prostate Cancer 0 0
Sarcoma 0 0
Tongue Cancer 0 0
Thymic Carcinoma 0 0
Urinary Tract Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Children's - Brain
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Biliary tree (gall bladder and bile duct)
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Other cancer types
Cancer 0 0 0 0
Head and neck
Cancer 0 0 0 0
Oesophageal (gullet)
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Bladder

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - QBS10072S

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


Treatment: Drugs: QBS10072S
QBS10072S targets cancers with high LAT1 expression.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
28 days
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
28 days
Secondary outcome [2] 0 0
Peak Plasma Concentration (Cmax) - Determine the maximum plasma concentration of QBS10072S.
Timepoint [2] 0 0
28 days
Secondary outcome [3] 0 0
Area under the plasma concentration versus time curve (AUC) of QBS10072S - Determine the plasma concentration of QBS10072S over time.
Timepoint [3] 0 0
28 days
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
28 days
Secondary outcome [5] 0 0
Time to maximum concentration of QBS10072S in plasma (Tmax) - Determine the time it takes to achieve maximum concentration of QBS10072S in plasma.
Timepoint [5] 0 0
28 days

Eligibility
Key inclusion criteria
1. Male or female participants aged =18 years at the time of informed consent.

2. Adequate Bone Marrow Function

3. Adequate renal function

4. Adequate Liver Function

5. 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.

6. 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

7. At least one measurable lesion (as defined by RECIST version 1.1) that has not been
previously irradiated.

8. An ECOG PS 0 to 2.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. 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.

2. 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).

3. 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.

4. Major surgery within 4 weeks prior to study entry.

5. 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).

6. Systemic anticancer therapy within 4 weeks prior to study entry

7. Bleeding esophageal or gastric varices <2 months prior to the date of informed
consent.

8. Unmanageable ascites.

9. Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may
affect patient safety or interpretation of study results

10. On therapeutic anticoagulation, except low molecular weight heparin, vitamin K
antagonists or factor Xa inhibitors may be allowed following discussion with the
Sponsor.

11. 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).

12. Hypertension that cannot be controlled by medications (>150/90 mmHg despite optimal
medical therapy) or requiring more than two medications for adequate control.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St George Private Hospital - Kogarah
Recruitment hospital [2] 0 0
Sydney Southwest Private Hospital - Liverpool
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2170 - Liverpool

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Quadriga Biosciences, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04430842
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Quadriga Biosciences Clinical Trials Support
Address 0 0
Country 0 0
Phone 0 0
1 (650) 917 9098
Fax 0 0
Email 0 0
clinicaltrials@quadrigabiosciences.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04430842