CompletedPhase 1ACTRN12618000838213

A phase 1 clinical trial of BIL06v/Alhydrogel to evaluate the safety, tolerability, immunogenicity and anti-tumour activity and to determine the most effective dose of BIL06v/Alhydrogel to treat patients with advanced forms of solid cancers

A Phase 1 Study to Evaluate the Safety, Tolerability, Immunogenicity and Anti-Tumour Activity of BIL06v/Alhydrogel in Patients with Advanced Solid Tumours

Sponsor

Biosceptre (Aust) Pty Limited

Enrollment

30 participants

Start Date

Aug 15, 2018

Study Type

Interventional

Conditions

Advanced Solid Cancers

Summary

Purpose The purpose of this study is to evaluate the safety, tolerability, immunogenicity and anti-tumour activity of BIL06v/Alhydrogel in patients with advanced solid tumours. Who is it for? Adults who have locally advanced or metastatic solid tumours. Study details This is a two-cohort study which means approximately 10-15 participants assigned to 1 dose of BIL06v/Alhydrogel®, and a different cohort of 10-15 participants assigned to a different dose of BIL06v/Alhydrogel®. In total, approximately 20-30 participants will be enrolled in this study at 2-4 sites in Australia. Participants will be assigned to a cohort and dose level by the study doctor. The study treatment will take place in two parts depending on the number of treatments each participant receives (see below). Participants who are continuing to benefit from the study treatment, according to the study doctor, may continue to receive study treatment, as appropriate, for up to approximately 2 years. Part 1 In Part 1, BIL06v/Alhydrogel® is administered every 14 days up to the 12th treatment (22 weeks) as subcutaneous injections (a short needle is used to inject the drug under the skin). Dose Level 1: 1.0mg each dose Dose Level 2: 1.5mg each dose A maximum of 15 participants will be enrolled in each dose level group. Dosing at the next level will occur sequentially, after completion of enrolment of participants in the first dose cohort. Treatment will be monitored by the study doctor/s, and the medically qualified Safety Review Committee (SRC) to ensure safety is maintained. The SRC may choose to change the planned dose schedule based on results from the previous groups. Part 2 Once a participant has received 12 injections of BIL06v/Alhydrogel®, which will occur at the end of Cycle 6, the participant will enter Part 2 of the study. In Part 2, which will start in Cycle 7, study treatments will be given at 28 day intervals. Participants will continue to receive the same dose once every 28 days until the study doctor determines participants are not benefiting from treatment or if participants are not compliant with the study protocol. Participants will be required to attend a Screening Visit to assess their eligibility for the study up to two weeks before being given BIL06v/Alhydrogel®. Participants will need to return to the study site for a Treatment Visit (Day 1) for administration of BIL06v/Alhydrogel® and to have a number of assessments performed to check their general health. During the treatment period, participants will be required to attend the study site for BIL06v/Alhydrogel® administration every 14 days (treatment cycles 1-6) and every 28 days thereafter (cycles 7 and beyond), for ongoing safety, tolerability, immunogenicity and clinical assessments to be conducted. Biosceptre hopes this treatment may extend overall survival for some participants.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria7

Men and women who are >= 18 years old;
Provide written, informed consent to participate in the study and follow the study procedures;
Patients with locally advanced or metastatic solid tumour cancers refractory to at least one course of prior standard systemic therapy, or who refuse or want to delay standard therapy, or for whom no effective standard therapy is available;
Cytological or pathological evidence of cancer;
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Patients who refuse or want to delay standard therapy must have an ECOG performance status of 0;
Life expectancy >= 12 weeks;
Women of child bearing potential must agree and commit to the use of a highly effective method of contraception, as determined to be acceptable by the investigator, from the time of informed consent until 90 days after the last dose of the investigational product. Men must agree and commit to use a barrier method of contraception while on treatment and for 90 days after the last dose of the investigational product.

Exclusion Criteria10

Inadequate haematologic or organ function;
Any anti-cancer therapy, including chemotherapy, hormonal therapy, biologic therapy, targeted therapy, anti-angiogenic therapy, surgery or radiotherapy within 14 days prior to initiation of study treatment, with certain exceptions;
Active corticosteriod therapy (e.g. prednisolone doses >10mg daily or dexamethasone doses >2mg daily or equivalents) within 14 days of initiation of study treatment;
ECOG performance status 2-4.
Allergies to any component of the BIL06v/Alhydrogel vaccine;
Uncontrolled active infection;
Known human immunodefciency virus (HIV) infection. HIV testing is not required at screening;
Pregnant or lactating women;
Active symptomatic or uncontrolled brain metastasis. Patients with treated or asymptomatic brain metastases before 14 days of study initiation are eligible;
Inability to comply with study and follow-up procedures.

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Interventions

This is an open label Phase 1 study of BIL06v/Alhydrogel® administered as a subcutaneous (SC) injection as a single agent every 2 weeks for 12 doses. Two doses, 1000ug and 1500ug, will be explored. An initial set of 10 patients will be enrolled in the 1000ug dose cohort; if there are no safety concerns, another 10 patients are planned for the 1500ug dose cohort. Throughout each dose cohort, the members of the Safety Review Committee (SRC) will review the safety data at such times and such frequency as determined clinically appropriate by the SRC. As an added safety measure, the first dose in all patients will be 500µg. If there is no Dose Limiting Toxicity (DLT) in 14 days following the first dose in each patient, dosing will continue at the assigned dose level with no subsequent intrapatient dose-escalation. After a patient is enrolled, no specific window of time is needed to pass before the next patient is allowed to enrol in that cohort. If less than 8 patients, in each cohort, are treated for 5 cycles (10 doses) or more, then those patients without suitable BIL06v/Alhydrogel® exposure will be replaced. A suitable number of patients will be enrolled to ensure reasonable confidence that at least 8 patients per cohort will be treated for 5 cycles (10 doses) or more. A maximum of 30 patients will be recruited for this study irrespective of the number of patients who drop out. A cycle is a period of 28 days. BIL06v/Alhydrogel® will be administered by the Principal Investigator or their designated study staff. The trial will be conducted in accordance with the trial protocol and any deviations from the trial protocol must be adequately documented and reported.