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

NCT06470763 | Active Not Recruiting Phase 1 FDA Drug

• 5 other identifiers: ANV600-001EXPAND-1KEYNOTE-F78MK-3475-F782023-509633-39-00
• Study Type: interventional
• Target: 240
• Locations: 7 countries
• Sites: 18

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

Outcome Measures

Primary Outcomes (4)

• Phase I dose escalation: Incidence of Dose Limiting Toxicities (DLT) with ANV600 single agent and in combination with pembrolizumab combination with pembrolizumab

  Day 1 up to 24 months

• Phase I dose escalation: Frequency and severity of treatment-emergent adverse events (TEAEs) with ANV600 and in combination with pembrolizumab

  Day 1 up to 24 months

• Phase II: Objective Response Rate (ORR) using RECIST v1.1

  Day 1 up to 24 months

• Phase II: Duration of Response (DOR) using RECIST v1.1

  Day 1 up to 24 months

Secondary Outcomes (9)

• Phase I Dose escalation: Serum concentration of ANV600 following a single dose and after repeated dosing

  Day 1 up to 24 months

• Phase I Dose escalation: Immunogenicity as indicated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (nAb)

  Day 1 up to 24 months

• Phase I Dose escalation: Objective response rate (ORR) using RECIST v1.1

  Day 1 up to 24 months

• Phase I Dose escalation: Duration of response (DOR) using RECIST v1.1

  Day 1 up to 24 months

• Phase II: Progression-free survival (PFS)

  Day 1 up to 24 months

Study Arms (2)

ANV600 single agent

EXPERIMENTAL

Drug: ANV600

ANV600 in combination with pembrolizumab (KEYTRUDA®)

EXPERIMENTAL

Drug: ANV600 + pembrolizumab (KEYTRUDA®)

Interventions

ANV600 DRUG

ANV600 administered by intravenous (IV) infusion

ANV600 single agent

ANV600 + pembrolizumab (KEYTRUDA®) DRUG

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

ANV600 in combination with pembrolizumab (KEYTRUDA®)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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:
• Autoimmune AEs controlled by replacement therapy (e.g., hypothyroidism, adrenal insufficiency)
• Vitiligo or alopecia
• 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;

Sponsors & Collaborators

• Anaveon AG: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (18)

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Location

Institut Bergonie

Bordeaux, France

Location

CEPCM - AP-HM Hopital de la Timone

Marseille, France

Location

Oncopole Claudius Regaud, Toulouse

Toulouse, France

Location

Institut Gustave Roussy

Villejuif, France

Location

Charite Universitaetsmedizin Berlin

Berlin, Germany

Location

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

Frankfurt, Germany

Location

Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz

Mainz, Germany

Location

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

Amsterdam, Netherlands

Location

Vall d'Hebron Institute of Oncology (VHIO)

Barcelona, Spain

Location

START Madrid CIOCC

Madrid, Spain

Location

Clinica Universidad de Navarra - Pamplona

Pamplona, Spain

Location

INCLIVA Foundation

Valencia, Spain

Location

Ente Ospedaliero Cantonale - Istituto Oncologico della Svizzera Italiana

Bellinzona, Switzerland

Location

Cantonal Hospital St Gallen

Sankt Gallen, Switzerland

Location

MeSH Terms

Interventions

pembrolizumab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 24, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

DE (3); NL (1); ES (4); US (3); CH (2); FR (4); BE (1)