A Study Evaluating ANV600 Single Agent or in Combination with Pembrolizumab in Participants with Advanced Solid Tumors (EXPAND-1)

NCT ID: NCT06470763

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2028-02-29

Brief Summary

The purpose of study ANV600-001 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, immunogenicity and antitumor activity of ANV600 administered as a single agent or in combination with pembrolizumab in adult participants with advanced solid tumors.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ANV600 single agent

Group Type: EXPERIMENTAL

ANV600

Intervention Type: DRUG

ANV600 administered by intravenous (IV) infusion

ANV600 in combination with pembrolizumab (KEYTRUDA®)

Group Type: EXPERIMENTAL

ANV600 + pembrolizumab (KEYTRUDA®)

Intervention Type: DRUG

ANV600 administered by intravenous (IV) infusion pembrolizumab (KEYTRUDA®) administered by intravenous (IV) infusion

Interventions

ANV600

ANV600 administered by intravenous (IV) infusion

Intervention Type: DRUG

ANV600 + pembrolizumab (KEYTRUDA®)

ANV600 administered by intravenous (IV) infusion pembrolizumab (KEYTRUDA®) administered by intravenous (IV) infusion

Intervention Type: DRUG

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.

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Anaveon AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status: RECRUITING

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

MD Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Site Status: RECRUITING

Institut Bergonie

Bordeaux, , France

Site Status: RECRUITING

CEPCM - AP-HM Hopital de la Timone

Marseille, , France

Site Status: RECRUITING

Oncopole Claudius Regaud, Toulouse

Toulouse, , France

Site Status: RECRUITING

Institut Gustave Roussy

Villejuif, , France

Site Status: RECRUITING

Charite Universitaetsmedizin Berlin

Berlin, , Germany

Site Status: RECRUITING

Krankenhaus Nordwest - Institut für Klinisch-Onkologische Forschung (IKF)

Frankfurt, , Germany

Site Status: RECRUITING

Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz

Mainz, , Germany

Site Status: RECRUITING

Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)

Amsterdam, , Netherlands

Site Status: RECRUITING

Vall d'Hebron Institute of Oncology (VHIO)

Barcelona, , Spain

Site Status: RECRUITING

START Madrid CIOCC

Madrid, , Spain

Site Status: RECRUITING

Clinica Universidad de Navarra - Pamplona

Pamplona, , Spain

Site Status: RECRUITING

INCLIVA Foundation

Valencia, , Spain

Site Status: RECRUITING

Ente Ospedaliero Cantonale - Istituto Oncologico della Svizzera Italiana

Bellinzona, , Switzerland

Site Status: RECRUITING

Cantonal Hospital St Gallen

Sankt Gallen, , Switzerland

Site Status: RECRUITING

Countries

United States; Belgium; France; Germany; Netherlands; Spain; Switzerland

Central Contacts

Medical Director, MD

Role: CONTACT

anaveonclinicaltrials@anaveon.com

+41615218383

Facility Contacts

Yusra Shao, MD

Role: primary

Anthony J Olszanski,, RPh, MD

Role: primary

Apostolia-Maria Tsimberidou, MD, PhD

Role: primary

Rachel Galot, MD

Role: primary

Sophie Cousin, MD

Role: primary

Pascale Tomasini, MD

Role: primary

Iphigénie Korakis, MD

Role: primary

Kaissa Ouali, MD

Role: primary

Sebastian Ochsenreither, MD

Role: primary

Thorsten Götze, MD

Role: primary

Alexander Desuki, MD

Role: primary

Neeltje Steeghs, MD

Role: primary

Elena Garralda, MD

Role: primary

Emiliano Calvo, MD PhD

Role: primary

Anna Vilalta Lacarra, MD

Role: primary

Valentina Gambardella, MD

Role: primary

Martina Imbimbo, MD

Role: primary

Markus Joerger, MD

Role: primary

Other Identifiers

EXPAND-1

Identifier Type: OTHER

Identifier Source: secondary_id

KEYNOTE-F78

Identifier Type: OTHER

Identifier Source: secondary_id

MK-3475-F78

Identifier Type: OTHER

Identifier Source: secondary_id

2023-509633-39-00

Identifier Type: CTIS

Identifier Source: secondary_id

ANV600-001

Identifier Type: -

Identifier Source: org_study_id