Advanced Solid TumorPhase 1/2NCT06470763
A Study Evaluating ANV600 Single Agent or in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (EXPAND-1)
A Phase 1/2 study testing ANV600 and ANV600 + pembrolizumab (KEYTRUDA®) in people with Advanced Solid Tumor, run by Anaveon AG at 18 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- ANV600 and ANV600 + pembrolizumab (KEYTRUDA®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 18 sitesin 7 countries
- Study dates
- 1 Jul 2024to 22 Jun 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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:
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- 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;
- 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
Trial locations and contacts
18 sites in 7 countries.
18 sites in 7 countries
France4 sites
Institut Bergonie
Bordeaux
CEPCM - AP-HM Hopital de la Timone
Marseille
Oncopole Claudius Regaud, Toulouse
Toulouse
Institut Gustave Roussy
Villejuif
Spain4 sites
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona
START Madrid CIOCC
Madrid
Clinica Universidad de Navarra - Pamplona
Pamplona
INCLIVA Foundation
Valencia
United States3 sites
Karmanos Cancer Institute
Detroit, Michigan, 48201
MD Anderson Cancer Center
Houston, Texas, 77030
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Germany3 sites
Charite Universitaetsmedizin Berlin
Berlin
Krankenhaus Nordwest - Institut für Klinisch-Onkologische Forschung (IKF)
Frankfurt
Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz
Mainz
Switzerland2 sites
Ente Ospedaliero Cantonale - Istituto Oncologico della Svizzera Italiana
Bellinzona
Cantonal Hospital St Gallen
Sankt Gallen
Netherlands1 site
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)
Amsterdam
About this study
Official title: 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)
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
- Being tested
- ANV600, ANV600 + pembrolizumab (KEYTRUDA®)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANV600Drug
ANV600 administered by intravenous (IV) infusion
ANV600 + pembrolizumab (KEYTRUDA®)Drug
ANV600 administered by intravenous (IV) infusion pembrolizumab (KEYTRUDA®) administered by intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| ANV600 single agent | Experimental | Not described Receives: Drug: ANV600 |
| ANV600 in combination with pembrolizumab (KEYTRUDA®) | Experimental | Not described Receives: Drug: ANV600 + pembrolizumab (KEYTRUDA®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I dose escalation: Incidence of Dose Limiting Toxicities (DLT) with ANV600 single agent and in combination with pembrolizumab combination with pembrolizumab
Measured: 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
Measured: Day 1 up to 24 months
Phase II: Objective Response Rate (ORR) using RECIST v1.1
Measured: Day 1 up to 24 months
Phase II: Duration of Response (DOR) using RECIST v1.1
Measured: 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
Measured: 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)
Measured: Day 1 up to 24 months
Phase I Dose escalation: Objective response rate (ORR) using RECIST v1.1
Measured: Day 1 up to 24 months
Phase I Dose escalation: Duration of response (DOR) using RECIST v1.1
Measured: Day 1 up to 24 months
Phase II: Progression-free survival (PFS)
Measured: Day 1 up to 24 months
Phase II: Overall Survival (OS)
Measured: Day 1 up to 24 months
Phase II: Frequency and severity of treatment-emergent adverse events (TEAEs) with ANV600 and in combination with pembrolizumab
Measured: Day 1 up to 24 months
Phase II: PK parameters based on ANV600 serum levels following a single dose and after repeated dosing
Measured: Day 1 up to 24 months
Phase II: Immunogenicity as indicated by the incidence of antidrug antibodies (ADA) and neutralizing antibodies (nAb)
Measured: Day 1 up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start1 Jul 2024
- Primary completion22 Jun 2026
- Study completion22 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anaveon AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470763
- Sponsor's protocol ID
- ANV600-001
- Other IDs
- EXPAND-1, KEYNOTE-F78, MK-3475-F78, 2023-509633-39-00, 2023
- Status last verified
- Jul 2026
- First submitted
- 14 Jun 2024
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06470763
- Acronym / sponsor ID
- ANV600-001
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Anaveon AGIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 22 Jun 2026 (actual)
- Study completion
- 22 Jun 2026 (actual)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ANV600 single agent | Experimental | Drug: ANV600 |
| ANV600 in combination with pembrolizumab (KEYTRUDA®) | Experimental | Drug: ANV600 + pembrolizumab (KEYTRUDA®) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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;
Key exclusion criteria (19 listed)
- 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]);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANV600ANV600 administered by intravenous (IV) infusion | Drug | ANV600 single agent |
| ANV600 + pembrolizumab (KEYTRUDA®)ANV600 administered by intravenous (IV) infusion pembrolizumab (KEYTRUDA®) administered by intravenous (IV) infusion | Drug | ANV600 in combination with pembrolizumab (KEYTRUDA®) |
Primary outcome
Phase I dose escalation: Incidence of Dose Limiting Toxicities (DLT) with ANV600 single agent and in combination with pembrolizumab combination with pembrolizumab
Time frame: 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
Time frame: Day 1 up to 24 months
Phase II: Objective Response Rate (ORR) using RECIST v1.1
Time frame: Day 1 up to 24 months
Phase II: Duration of Response (DOR) using RECIST v1.1
Time frame: Day 1 up to 24 months
9 secondary outcomes
Phase I Dose escalation: Serum concentration of ANV600 following a single dose and after repeated dosing
Time frame: 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)
Time frame: Day 1 up to 24 months
Phase I Dose escalation: Objective response rate (ORR) using RECIST v1.1
Time frame: Day 1 up to 24 months
Phase I Dose escalation: Duration of response (DOR) using RECIST v1.1
Time frame: Day 1 up to 24 months
Phase II: Progression-free survival (PFS)
Time frame: Day 1 up to 24 months
Phase II: Overall Survival (OS)
Time frame: Day 1 up to 24 months
Phase II: Frequency and severity of treatment-emergent adverse events (TEAEs) with ANV600 and in combination with pembrolizumab
Time frame: Day 1 up to 24 months
Phase II: PK parameters based on ANV600 serum levels following a single dose and after repeated dosing
Time frame: Day 1 up to 24 months
Phase II: Immunogenicity as indicated by the incidence of antidrug antibodies (ADA) and neutralizing antibodies (nAb)
Time frame: Day 1 up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ANV600 and ANV600 + pembrolizumab (KEYTRUDA®) in people with Advanced Solid Tumor, run by Anaveon AG at 18 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France, Spain, United States, Germany, Switzerland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I dose escalation: Incidence of Dose Limiting Toxicities (DLT) with ANV600 single agent and in combination with pembrolizumab combination with pembrolizumab (time frame: Day 1 up to 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.