A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAvacta Life Sciences Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patient has been fully informed about the study and has signed the Informed Consent Form.
Male or female patients, ≥ 18 years of age.
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)
Disqualifiers
Has received trastuzumab within 7 months of the planned Cycle 1 Day 1 AVA6000 infusion.
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.
Trial design
Design model
Sequential
Treatments tested in this trial
AVA6000
DrugAVA6000 is a FAP-activated doxorubicin.
Treatment groups
158 Participants
are divided into 4 treatment groupsGroup A: AVA6000 Phase 1a Dose Escalation Q3WExperimental treatment 1 intervention
Group B: AVA6000 Phase 1a Dose Escalation Q2WExperimental treatment 1 intervention
Group C: AVA6000 Phase 1b Dose ExpansionExperimental treatment 1 intervention
Group D: AVA6000 Phase 1b Dose Expansion (dose identification)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose-limiting toxicities (DLTs)
Incidence and nature of DLTs
Time frame
Up to 28 days after the first dose of study therapy2
Adverse events (AEs)
Incidence and severity of treatment-emergent (TE) and treatment-related adverse events (TRAEs) and Seious Adverse Events (SAEs).
Time frame
From Day 1 until up to 30 days after last dose of study drug.3
Laboratory abnormalities
Incidence of clinically significant laboratory abnormalities and changes in laboratory values (haematology, coagulation, serum chemistry and urinalysis).
Time frame
From Day 1 until up to 30 days after last dose of study drug.4
Vital signs
Clinically significant changes in vital signs, physical examination findings, and ECG findings.
Time frame
From Day 1 until up to 30 days after last dose of study drug.Secondary outcomes
1
Maximum drug concentration (Cmax) of AVA6000 & Doxorubicin
Cmax (maximum plasma concentration) of AVA6000 and Doxorubicin after administration after Cycle 1 and 2 for 72 hours post-dose.
Time frame
Cycle 1 and Cycle 2, 0-72 hours post dose (Dose Escalation)2
Area under the curve (AUC) of AVA6000 & Doxorubicin
AUC (Area under the curve) of AVA6000 and Doxorubicin after administration after Cycle 1 and 2 for 72 hours post-dose.
Time frame
Cycle 1 and Cycle 2, 0-72 hours post dose (Dose Escalation)3
Elimination half-life (t1/2) of AVA6000 & Doxorubicin
t1/2 (Elimination half-life) of AVA6000 and Doxorubicin after administration after Cycle 1 and 2 for 72 hours post-dose.
Time frame
Cycle 1 and Cycle 2, 0-72 hours post dose (Dose Escalation)4
Renal clearance (CLr) of AVA6000 & Doxorubicin
CLr (Renal clearance) of AVA6000 and Doxorubicin after administration after Cycle 1 and 2 for 72 hours post-dose.
Time frame
Cycle 1 and Cycle 2, 0-72 hours post dose (Dose Escalation)Sponsors and contacts
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Source ClinicalTrials.gov