Evaluating ANV600 alone or with pembrolizumab for advanced solid tumors

A First-in-human, Open-label, Multicenter Phase I/II Study to Evaluate the Safety and Anti-tumor Activity of ANV600 As Single Agent and in Combination with Pembrolizumab in Participants with Advanced Solid Tumors (EXPAND-1)

This study is testing a new treatment called ANV600, alone and with pembrolizumab, to see if it helps adults with advanced solid tumors that don't have other treatment options.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Anaveon AG (Industry-sponsored)
• Drugs / interventions: pembrolizumab, prednisone
• Locations: 18 sites (Detroit, Michigan and 17 other locations)
• Trial ID: NCT06470763 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity of ANV600, both as a standalone treatment and in combination with pembrolizumab, in adults with advanced solid tumors. Participants will be monitored for their response to the treatment and any side effects experienced. The study is divided into two phases, with Phase I focusing on patients with unresectable or metastatic solid tumors lacking standard treatment options, and Phase II targeting specific tumor types.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced unresectable or metastatic solid tumors and an ECOG performance status of 0 to 1.

Not a fit: Patients with solid tumors for which standard care treatments are available or those with a life expectancy of less than three months may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that currently have limited treatment alternatives.

How similar studies have performed: Other studies have shown promise in using immunotherapy combinations for advanced solid tumors, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* The participant provides written informed consent for the trial;
* Life-expectancy ≥ 3 months;
* Able to comply with the Protocol as judged by the Investigator;
* ≥ 18 years of age on day of signing informed consent;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
* Measurable disease per RECIST v1.1;
* Adequate organ function, defined as:

  * Absolute neutrophil count (ANC) ≥1200/µL;
  * Platelet count ≥100 000/µL;
  * Hemoglobin ≥9.0 g/dL;
  * Measured or calculated creatinine clearance ≥50 mL/min;
  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases);
  * Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \>1.5 × ULN;
* Phase I: Advanced unresectable or metastatic solid tumors for which no standard of care treatments are available, or participants who cannot tolerate such treatment;
* Phase II: Tumor-specific cohorts in adult participants with advanced solid tumors:

  * Cohort A: Unresectable Stage III or Stage IV cutaneous melanoma (excl. mucosal and uveal), which has progressed on/after treatment with a PD-1/L1 checkpoint inhibitor;
  * Cohort B: Unresectable or metastatic squamous or non-squamous non-small cell lung cancer (NSCLC) not eligible for an approved targeted therapy, which has progressed on/after treatment with a PD-1/L1 checkpoint inhibitor;
  * Cohort C: Recurrent and/or unresectable/metastatic head and neck squamous cell carcinoma (HNSCC) (except nasopharyngeal carcinoma), after platinum failure and a PD-1/L1 checkpoint inhibitor.

Additional inclusion criteria apply as per study protocol

Exclusion criteria

* Pancreatic cancer (e.g. PDAC) (Phase I only);
* Primary or secondary adrenal insufficiency (Phase I only);
* History of allergic reactions attributed to any of the excipients of ANV600, such as sucrose, histidine or polysorbate 80. For combination only: severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients;
* Investigational agent (including investigational device) within 4 weeks or an interval of five half-lives of the respective investigational agent prior to study Day 1, whichever is shorter;
* Received IL-2 or IL-2 analogues as anti-cancer therapy within 18 months prior to study Day 1 (except IL-2 given in combination with cell therapy \[e.g. TILs\]);
* Not recovered (i.e. ≤ Grade 1 at baseline) from AEs resulting from prior immunotherapies with the following exceptions:

  1. Autoimmune AEs controlled by replacement therapy (e.g., hypothyroidism, adrenal insufficiency)
  2. Vitiligo or alopecia
  3. Psoriasis;
* Received prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to treatment; Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible. Participants with endocrine related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible.
* For combination only: Have received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g.CTLA-4, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher irAE;
* Active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment;
* Additional malignancy that is progressing or has required active treatment within the past 3 years;
* Active autoimmune disease that has required systemic treatment in the past 2 years;
* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug;
* Allogeneic tissue/solid organ or stem cell transplant;
* History of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease;
* Active infection requiring systemic therapy;

Additional exclusion criteria apply per study protocol

Where this trial is running

Detroit, Michigan and 17 other locations

• Karmanos Cancer Institute — Detroit, Michigan, United States (Recruiting)
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (Recruiting)
• MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
• Cliniques Universitaires Saint-Luc — Bruxelles, Belgium (Recruiting)
• Institut Bergonie — Bordeaux, France (Recruiting)
• CEPCM - AP-HM Hopital de la Timone — Marseille, France (Recruiting)
• Oncopole Claudius Regaud, Toulouse — Toulouse, France (Recruiting)
• Institut Gustave Roussy — Villejuif, France (Recruiting)
• Charite Universitaetsmedizin Berlin — Berlin, Germany (Recruiting)
• Krankenhaus Nordwest - Institut für Klinisch-Onkologische Forschung (IKF) — Frankfurt, Germany (Recruiting)
• Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz — Mainz, Germany (Recruiting)
• Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) — Amsterdam, Netherlands (Recruiting)
• Vall d'Hebron Institute of Oncology (VHIO) — Barcelona, Spain (Recruiting)
• START Madrid CIOCC — Madrid, Spain (Recruiting)
• Clinica Universidad de Navarra - Pamplona — Pamplona, Spain (Recruiting)
• INCLIVA Foundation — Valencia, Spain (Recruiting)
• Ente Ospedaliero Cantonale - Istituto Oncologico della Svizzera Italiana — Bellinzona, Switzerland (Recruiting)
• Cantonal Hospital St Gallen — St Gallen, Switzerland (Recruiting)

Study contacts

• Study coordinator: Medical Director, MD

Conditions Advanced Solid Tumor