A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours (NCT04969835) | Clinical Trial Compass
RecruitingPhase 1
A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours
United States, United Kingdom158 participantsStarted 2021-07-16
Plain-language summary
This is a first-in-human (FIH), Phase 1 open-label, multicentre dose escalation study investigating AVA6000 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumours that are likely to be FAP positive. The study consists of an initial Phase 1a dose escalation portion and a subsequent Phase 1b dose expansion portion upon completion of the dose escalation portion.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. The patient has been fully informed about the study and has signed the Informed Consent Form.
✓. Male or female patients, ≥ 18 years of age.
✓. a) Phase 1a: patients with tumours reported to be FAP positive with histological or cytological confirmation of a locally advanced (unresectable) and/or metastatic:
✓. High grade soft tissue sarcoma: histologically proven locally advanced or metastatic, unresectable progressive or recurrent DDLS or UPS who have received 0 or 1 prior lines of therapy in the locally advanced or metastatic setting
✓. SGC: Locally advanced or metastatic salivary gland confirmed by histopathology that cannot be completely resected by surgery who have received 0 or 2 prior lines of therapy in the locally advanced or metastatic setting. In addition, patients with adenoid cystic carcinoma subtypes must not have received prior cytotoxic therapy for locally advanced or metastatic disease. Adenoid cystic carcinoma subtype may be capped at 15 patients (assuming cohort of approximately 30 patients)
✓. TNBC: Locally advanced or metastatic triple negative breast cancer confirmed by histopathology who have received any prior therapy in the locally advanced or metastatic setting. Patients must be BRCA wild-type.
✓. In Phase 1b, patients must meet the following additional criteria:
✓. Has a life expectancy of ≥12 weeks, in the opinion of the investigator.
Exclusion criteria
✕. Has received trastuzumab within 7 months of the planned Cycle 1 Day 1 AVA6000 infusion.
What they're measuring
1
Dose-limiting toxicities (DLTs)
Timeframe: Up to 28 days after the first dose of study therapy
2
Adverse events (AEs)
Timeframe: From Day 1 until up to 30 days after last dose of study drug.
3
Laboratory abnormalities
Timeframe: From Day 1 until up to 30 days after last dose of study drug.
4
Vital signs
Timeframe: From Day 1 until up to 30 days after last dose of study drug.
5
Cardiac safety
Timeframe: From Day 1 until up to 30 days after last dose of study drug.
✕. Has received a prior total cumulative anthracycline dose of ≥ 350 mg/m2 doxorubicin (or equivalent anthracycline dose).
✕. Has clinically significant or untreated central nervous system (CNS) metastases or leptomeningeal disease requiring treatment, as determined by the Investigator.
✕. Patients who have any history of an active (requiring treatment) other malignancy (except any in-situ carcinoma, non-melanoma skin carcinoma and early prostate cancer with a normal PSA) within 2 years of study entry.
✕. Has a significant, uncontrolled, concomitant disease that could affect compliance with the protocol.
✕. In the opinion of the investigator, has uncontrolled hypertension (systolic blood pressure \>150 mm Hg and/or diastolic blood pressure \>100 mm Hg), unstable angina, CHF (New York Heart Association (NYHA) Class \>II), left ventricular ejection fraction (LVEF) \<55% or the low limit of institutional normal limit (whichever is lower) by echocardiogram (ECHO), serious cardiac arrhythmia requiring treatment (exceptions include atrial fibrillation, paroxysmal supraventricular tachycardia), history of myocardial infarction within 6 months prior to Cycle 1 Day 1, or history of uncontrolled cardiovascular disease or high-sensitivity troponin above normal at baseline (T or I).
✕. Has a screening baseline mean corrected QTcF interval by Fridericia (QTcF) of \>480 msec. Electrocardiograms (ECGs) will be evaluated locally at the investigator site. Has any clinically significant abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \>250 msec). Has any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, known family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval, a baseline resting bradycardia \<45 beats/min or a baseline resting tachycardia of \>100 beats/min.