A single centre, open label, first in human, phase 1 dose escalating study to evaluate the safety, tolerability and preliminary efficacy of an autologous cancer vaccine, RGSH4K, administered intradermally in patients with advanced cancers.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000516583
• Date of registration: 22/05/2015
• Prospective Registration: Yes
• Primary sponsor: Regeneus Ltd
• Public title: A single centre, open label, first in human, phase 1 dose escalating study to evaluate the safety, tolerability and preliminary efficacy of an autologous cancer vaccine, RGSH4K, administered intradermally in patients with advanced cancers.
• Scientific title: In patients with advanced solid tumours, is an autologous cancer vaccine (RGSH4K), safe and tolerable, and can a biologically active dose be identified?
• Date of first enrolment: 03/09/2015
• Target sample size: 21
• Recruitment status: Stopped early
• URL: https://anzctr.org.au/ACTRN12615000516583.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Type of endpoint: Safety;
• Phase: Phase 1

Countries of recruitment

Australia

Contacts

• Name: Ms Janet Wilson

• Name: Ms Iona Nicolson-Bowles

Key inclusion & exclusion criteria

Inclusion criteria: Summary:
- aged 18 years or over
- has banked approximately 1 gram of fresh frozen tumour in the Regeneus tumour bank
- have advanced solid tumours which are inoperable or refractory to treatment, or chemoradiotherapy is contraindicated, or where standard treatments have failed or do not exist, or in a palliative setting where the patient has refused chemotherapy or it is contraindicated.
Exclusion criteria: - Rapidly progressing malignancy
- History of organ transplant and/or current immunosuppressive therapy, current systemic corticosteroids
- concurrent anticancer therapy, or within 4 weeks of vaccine
- Autoimmune disease
- known positive HIV or tests positive to HIV

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cancer - Any cancer

Advanced solid tumours;
Advanced solid tumours

Intervention(s)

RGSH4K is a vaccine formulated from a patient's own tumour material. Briefly, the tumour cells are lysed or burst to release the proteins and tumour associated antigens. The proteins are further processed in a proprietary procedure and combined with streptavidin, a novel immunostimulant. No live, viable cells remain in the vaccine. Vaccines are prepared on study entry, are stored frozen, and provided individually for injection at Weeks 1, 4 and 7.

Three (3) doses of streptavidin are being assessed in this study: 100 ug, 250 ug, and 500 ug. Each set of vaccines manufactured is unique to each patient and will therefore be a unique batch.

The vaccine is admixed with 200 uL of Freund's Incomplete Adjuvant immediately before administration. Three (3) vaccines in total are administered: Week 1, Week 4, and Week 7. Each vaccine is given as a single, small volume injection intradermally.

Primary Outcome(s)

Safety of RGSH4K as measured by vital signs, physical examinations, ECG and laboratory assessments.[Vital signs, ECG, physical examinations and laboratory assessments are measured at the following visits: Weeks 1, 4, 7, 10, 12, 24. At week 12, laboratory assessments are not done. ]

Safety of RGSH4K as measured by the incidence and nature of adverse events using the CTCAE grading scale for adverse events. [Adverse events are collected from the time of informed consent and at each study visit: Weeks 1, 4, 7, 10, 12, and 24. ]

Secondary Outcome(s)

Determination of a biologically active dose of RGSH4K as measured by blood cancer markers relevant to the type of cancer a patient has. [Relevant blood cancer markers will be assessed at weeks 1, 7, 12, and 24. ]

Determination of a biologically active dose of RGSH4K as measured by CT/MRI (whichever method is most appropriate for the cancer type)[CT/MRI is done at screening, week 12, and at week 24. ]

Determination of a biologically active dose of RGSH4K as measured by immunology biomarkers: white cell differential, mast cells, B cells (CD20+, CD40+, CD80+) and cytokines (VEGF, IL-6, IFN, TNF)[Immunology biomarkers are assessed at weeks 1, 4, 7, 12, and 24. ]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Regeneus Ltd

Ethics review

Status: Approved
Approval date:
Contact:

Bellberry Ltd

Results

• Results available: Yes
• Date Posted: 29/07/2019
• Date Completed: 02/05/2018