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

Phase 1

Completed

• Conditions: Advanced Solid Cancers; Cancer - Any cancer

• Registration Number: ACTRN12618000838213
• Lead Sponsor: Biosceptre (Aust) Pty Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-18
• Study Completion: 2020-05-11
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

1. Men and women who are >= 18 years old;
2. Provide written, informed consent to participate in the study and follow the study procedures;
3. 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;
4. Cytological or pathological evidence of cancer;
5. 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;
6. Life expectancy >= 12 weeks;
7. 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 Criteria

1. Inadequate haematologic or organ function;
2. 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;
3. Active corticosteriod therapy (e.g. prednisolone doses >10mg daily or dexamethasone doses >2mg daily or equivalents) within 14 days of initiation of study treatment;
4. ECOG performance status 2-4.
5. Allergies to any component of the BIL06v/Alhydrogel vaccine;
6. Uncontrolled active infection;
7. Known human immunodefciency virus (HIV) infection. HIV testing is not required at screening;
8. Pregnant or lactating women;
9. Active symptomatic or uncontrolled brain metastasis. Patients with treated or asymptomatic brain metastases before 14 days of study initiation are eligible;
10. Inability to comply with study and follow-up procedures.

Study & Design

• Study Type: Interventional
• Study Design: Not specified