Personalized vaccine for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial evaluates the safety, tolerability, and response to a personalized autologous tumor vaccine (ATV) formulated with Advax adjuvant in patients with advanced solid cancers. The vaccine is created from tumor proteins extracted from patients' own tumors, combined with a non-inflammatory adjuvant. Participants will receive doses of the vaccine over several cycles, with the primary focus on monitoring adverse effects and secondary outcomes including response rates and survival metrics. The study aims to improve treatment options for patients who have not responded to existing therapies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subjects must have histologically or cytologically confirmed advanced solid cancers or hematological cancers (lymphomas only)
* Subjects must have received at least one prior therapy for this disease, with the exception that subjects for whom no standard therapy options exist or who decline standard therapies can be considered for inclusion after discussions with the investigator team.
* Performance status ≤ 2 (ECOG performance status)
* Subjects or their parents if a child must have the ability to understand and the willingness to sign a written informed consent document.
* If no suitable cancer tissue is already available to make the vaccine, to be enrolled in the trial participants must be willing to undergo surgery and/or fresh tumour biopsy to obtain tissue to allow the preparation of the vaccine and their primary care team needs to have agreed to perform these procedures for them to obtain tumour tissue. The trial team will provide advice on appropriate tissue collection and arrange transport and processing but are not responsible for arranging such surgery or paying for its cost.

Exclusion Criteria:

* Subjects receiving any other investigational agents within the preceding 4 weeks.
* Pregnant women because of the unknown risk of adverse events in the foetus secondary to treatment of the mother with ATV.
* Any potential participant where suitable cancer tissue is not available for preparation of the vaccine
* Any condition that the Investigator deems may make a potential participant unsuitable for entry into the trial.

Where it's running

• Arasmi
  Adelaide, South Australia, Australia Recruiting

Study contacts

• Principal investigator: Dimitar Sajkov, MBBS/PhD — Arasmi
• Study coordinator: Sharen Pringle, GradCert
• Email: office@arasmi.org
• Phone: 0437033400

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• SumMET: Targeted radioligand therapy for c-MET–positive solid tumors

  This first‑in‑human study tests the safety and potential effectiveness of a radioligand therapy called [225Ac]Ac-FL-261 in adults with advanced or metastatic solid tumors that overexpress c-MET.

  Recruiting at 2 sites Phase 1/2 Full-Life Technologies UK Limited · Minneapolis, Minnesota and 1 other locations · NCT07873450

• SHR-4595 Injection in Advanced Solid Tumors: Safety, Tolerability, and Dosing in Phase 1

  This early-phase trial tests SHR-4595 injections to see if they are safe and tolerable for adults with advanced solid tumors who have exhausted standard treatments.

  Recruiting at 2 sites Phase 1 Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Shenyang, Liaoning and 1 other locations · NCT07830199

• FAPI PET imaging with FAPI-RuiJ and FAPI-04 in solid tumors

  This study tests two FAP-targeted PET tracers (FAPI-RuiJ and FAPI-04) to see which better detects, stages, and monitors solid tumors.

  Recruiting Ruijin Hospital · Shanghai · NCT07776899

• Trop-2 Targeted PET/CT for Recurrent and Metastatic Thyroid Cancer

  This study tests whether a Trop-2 targeted PET/CT scan can better detect recurrent or metastatic thyroid cancer in adults than another PET/CT scan (FAPI).

  Recruiting The First Affiliated Hospital of Xiamen University · Xiamen, Fujian · NCT07753499

• SI-B036 in locally advanced or metastatic breast cancer and other solid tumors

  Scientists are testing SI-B036 to see if it is safe and tolerable in adults with advanced breast cancer or other solid tumors and to get early signals of whether it might help.

  Recruiting Phase 1 Sichuan Baili Pharmaceutical Co., Ltd. · Beijing, Beijing Municipality · NCT07753226

• Methylscape test in body fluids for multi-cancer detection in Colombia

  A simple blood, urine, or saliva test called Methylscape is being tested to see if it can detect multiple cancers and identify where the signal is coming from, using people with cancer and healthy volunteers in Colombia.

  Recruiting Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo · Bogotá, Bogota D.C. · NCT07741435

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.