Trial Title:
A Study Evaluating ANV600 Single Agent or in Combination with Pembrolizumab in Participants with Advanced Solid Tumors (EXPAND-1)
NCT ID:
NCT06470763
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Pembrolizumab
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ANV600
Description:
ANV600 administered by intravenous (IV) infusion
Arm group label:
ANV600 single agent
Intervention type:
Drug
Intervention name:
ANV600 + pembrolizumab (KEYTRUDA®)
Description:
ANV600 administered by intravenous (IV) infusion pembrolizumab (KEYTRUDA®) administered
by intravenous (IV) infusion
Arm group label:
ANV600 in combination with pembrolizumab (KEYTRUDA®)
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fox Chase Cancer Center
Address:
City:
Philadelphia
Zip:
19111
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anthony J Olszanski,, RPh, MD
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Apostolia-Maria Tsimberidou, MD, PhD
Facility:
Name:
Institut Bergonie
Address:
City:
Bordeaux
Country:
France
Status:
Recruiting
Contact:
Last name:
Sophie Cousin, MD
Facility:
Name:
CEPCM - AP-HM Hopital de la Timone
Address:
City:
Marseille
Country:
France
Status:
Recruiting
Contact:
Last name:
Pascale Tomasini, MD
Facility:
Name:
Oncopole Claudius Regaud, Toulouse
Address:
City:
Toulouse
Country:
France
Status:
Recruiting
Contact:
Last name:
Iphigénie Korakis, MD
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif
Country:
France
Status:
Recruiting
Contact:
Last name:
Kaissa Ouali, MD
Facility:
Name:
Charite Universitaetsmedizin Berlin
Address:
City:
Berlin
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Sebastian Ochsenreither, MD
Facility:
Name:
Krankenhaus Nordwest - Institut für Klinisch-Onkologische Forschung (IKF)
Address:
City:
Frankfurt
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Thorsten Götze, MD
Facility:
Name:
Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz
Address:
City:
Mainz
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Alexander Desuki, MD
Facility:
Name:
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)
Address:
City:
Amsterdam
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Neeltje Steeghs, MD
Facility:
Name:
START Madrid CIOCC
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Emiliano Calvo, MD PhD
Facility:
Name:
Clinica Universidad de Navarra - Pamplona
Address:
City:
Pamplona
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Anna Vilalta Lacarra, MD
Facility:
Name:
INCLIVA Foundation
Address:
City:
Valencia
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Valentina Gambardella, MD
Facility:
Name:
Ente Ospedaliero Cantonale - Istituto Oncologico della Svizzera Italiana
Address:
City:
Bellinzona
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Martina Imbimbo, MD
Facility:
Name:
Cantonal Hospital St Gallen
Address:
City:
St Gallen
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Markus Joerger, MD
Start date:
July 1, 2024
Completion date:
February 2028
Lead sponsor:
Agency:
Anaveon AG
Agency class:
Industry
Collaborator:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
Anaveon AG
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06470763
