Advanced Solid TumorPhase 1ANV419-001NCT04855929
A Study Evaluating Safety and Therapeutic Activity of ANV419 in Patients with Advanced Cancer.
A Phase 1 study testing ANV419 and Ipilimumab in people with Advanced Solid Tumor and Adult Disease, run by Anaveon AG at 5 sites in 3 countries.
Trial summary
The purpose of this study is to test the safety and efficacy of ANV419 (single agent) and in combination with ipilimumab in patients with relapsed/refractory 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, Adult Disease, Lung Cancer
- What is being tested?
- ANV419 and Ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 25 May 2021to 18 Jul 2024
- Phase
- Phase 1
- 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
- Ability of the patient or legal guardian to understand the purpose of the study, provide signed and dated informed consent from the patient prior to performing any protocol-related procedures (including Screening evaluations), and be able and willing to comply with the study procedures.
- Male or female aged ≥ 18 years.
- Advanced solid tumors with evidence of progressive disease as per RECIST no longer than 3 months before Informed Consent form (ICF) signature, without any subsequent curative intent treatment.
- Parts A and B only: Histologically confirmed relapsed/refractory advanced solid tumor, progressing after at least one line of treatment for advanced or metastatic disease
- Part C only: Previously treated advanced NSCLC without a driver mutation who have progressed after first line standard chemo-immunotherapy: Patients must have measurable disease using RECIST v1.1, A maximum of 1 line of therapy is permitted, Patients with high expression of PD-L1 which were treated with first line checkpoint inhibitor monotherapy may have received a maximum of 2 lines of therapy
- Part D only: Histologically confirmed relapsed/refractory advanced solid tumors progressing after at least one line of treatment for advanced disease. Patients with NSCLC who do not meet inclusion criteria for Part C, are eligible for Part D
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- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
- Adequate pulmonary, cardiovascular, hematological, liver and renal function, per Investigator judgment.
- All acute toxic effects, of any prior anticancer therapy (e.g., radiotherapy, chemotherapy, or surgical procedures) must have resolved to CTCAE v5.0 grade ≤1 (except alopecia [any grade] or fatigue [up to grade 2 allowed]).
- Negative serum pregnancy test at screening and a negative (urine or serum) pregnancy test within 7 days prior to study day 1 in women of childbearing potential and women <12 months after menopause.
- Women who are not postmenopausal and who have not undergone surgical sterilization: must agree to use highly effective methods of contraception during the treatment period and until 6 months after the last dose of study treatment. They must also agree to not donate eggs (ova, oocytes) during the same timeframe.
- All men with childbearing potential partners must agree to use highly effective methods of contraception and barrier contraception (condom) during the treatment period and for 6 months after the last dose of study treatment. They must also agree to not donate sperm during the same timeframe.
- Availability and willingness of patients to obtain a baseline and on treatment biopsy of the tumor. Available archived biopsies (frozen or formalin fixed) may serve as baseline specimens, in patients who have residual tumor masses which can only be accessed with significant risk
Who cannot join
- Carcinomatous meningitis and/or symptomatic central nervous system (CNS) metastases. Definitively treated CNS metastases (e.g., radiotherapy) stable for at least 6 weeks prior to Day 1 of study drug administration are acceptable.
- Participants with an active second malignancy. Patients with precancerous lesions, concomitant early stages of prostate or breast cancer not requiring active treatment (past conditions currently resolved > 3 years prior to Screening are also acceptable), and squamous cell carcinoma of the skin not requiring systemic treatment are acceptable.
- Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including uncontrolled diabetes mellitus, history of relevant pulmonary disorders, (e.g., severe bronchospasm, obstructive pulmonary disease), hyperthyroidism due to thyroiditis and known autoimmune diseases or other disease with ongoing fibrosis. Stable vitiligo, autoimmune thyroiditis, and preexisting treated type 1 diabetes are acceptable and are not exclusion criteria.
- Significant cardiovascular/cerebrovascular disease, including myocardial infarction or transient ischemic attack (TIA) within 6 months prior to Day 1 of study drug administration.
- Active infections, or uncontrolled infection requiring systemic antibiotics within one week (7 days) preceding Day 1 of treatment
- Hemoglobin (Hb) <9 g/dL, transfusion of red blood cells allowed to reach threshold target.
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- Neutrophils <1500 /mm3.
- Platelets <100'000/mm3.
- Liver: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5xULN, if due to liver metastasis or primary liver cancer, AST or ALT >5x ULN.
- Total bilirubin > upper limit of normal (ULN) (in documented Gilbert's syndrome, direct bilirubin > ULN).
- International normalized ratio (INR) >1.5xULN.
- Serum creatinine > ULN and estimated creatinine clearance < 50 mL/min using the Cockcroft-Gault formula.
- Confirmed replicating human immunodeficiency virus (HIV) or confirmed active (replicative) hepatitis B virus or hepatitis C virus infection. Patients with treated non-replicative disease are acceptable.
- Evidence of hepatic cirrhosis with Child-Pugh score C.
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding > Grade 2 that give reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug.
- Major surgery or significant traumatic injury <28 days prior to the first ANV419 infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment.
- Severe altered mental status.
- Pregnant or breastfeeding women.
- Known hypersensitivity to any of the components of ANV419 or its formulation.
- Concurrent therapy with any other investigational drug within one month prior to Day 1 of study drug administration.
- Active untreated immune-related endocrinopathies untreatable with replacement. Prior immune related toxicities > Grade 3 after treatment with immunostimulatory drugs (e.g., colitis, neuropathy) that have not completely resolved.
- Chronic treatment with systemic immunosuppressive medications above 10 mg/day prednisolone equivalent for any reason.
- Additional exclusion criteria for Part D:
- Experienced unacceptable drug-related toxicity with prior ipilimumab treatment (defined as toxicities that required second line immunosuppression, ie, not controlled by steroids alone)
- Received ipilimumab within 6 months prior to cycle 1 day 1.
- Known hypersensitivity to ipilimumab or any of its excipients
- Patients with active autoimmune disease or a history of autoimmune disease (other than vitiligo and adequately controlled endocrine deficiencies such as hypothyroidism),
- Symptomatic interstitial lung disease
- Concomitant use of therapeutic anti-coagulation (e.g.to treat pulmonary embolus or deep vein thrombosis). Prophylactic anti-coagulation is permitted.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Spain2 sites
Hospital Vall d'Hebrón
Barcelona
START Madrid, Hospital Universitario HM Sanchinarro
Madrid
Switzerland2 sites
University Hospital Basel
Basel
Cantonal Hospital St.Gallen
Sankt Gallen
About this study
Official title: ANV419 First in Human Study Phase 1: Open-label, Dose Escalation Study of ANV419 As Single Agent and in Combination with Ipilimumab in Patients with Relapsed/Refractory Advanced Solid Tumors
The purpose of this study is to test the safety and efficacy of ANV419 (single agent) and in combination with ipilimumab in patients with relapsed/refractory advanced solid tumors.
Read the detailed description
The purpose of this First-in-Human, open-label, dose escalation study is to assess the initial safety and efficacy profile of ANV419 intravenous infusion alone and in combination with ipilimumab in patients with advanced solid tumours. It will evaluate the safety and tolerability of ANV419 alone and in combination with ipilimumab and, the safest and best dose of ANV419 when used alone or in combination.
- Conditions
- Advanced Solid Tumor, Adult Disease, Lung Cancer
- Being tested
- ANV419, Ipilimumab
- Keywords
- IL-2, ANV419, Cancer, Relapsed, Refractory, Ipilimumab
- Medical subject headings
- Disease, Lung Neoplasms, Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANV419Drug
ANV419 administered by intravenous (IV) infusion
IpilimumabDrug
Ipilimumab administered by intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| ANV419 single agent | Experimental | Not described Receives: Drug: ANV419 |
| Ipilimumab + ANV419 | Experimental | Not described Receives: Drug: ANV419; Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monotherapy: Number of Dose-Limiting Toxicities (DLTs)
Measured: Day 1 to Day 14
Combination: Number of Dose-Limiting Toxicities (DLTs)
Measured: Day 1 to Day 21
Monotherapy: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Day 1 up to 12 months
Combination: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Day 1 up to 12 months
Monotherapy: Recommended Phase 2 Dose
Measured: Day 1 to Day 28
Combination: Recommended Phase 2 Dose
Measured: Day 1 to Day 28
Secondary outcomes (10)
Objective response rate (ORR) assessed by RECIST v1.1 for solid tumors
Measured: Day 1 up to 12 months
Plasma concentration of ANV419 in blood
Measured: Day 1 up to 12 months
Impact of ANV419 on the expression of markers of PBMC lineage in blood
Measured: Day 1 up to 12 months
Levels of specific anti-ANV419 antibodies in blood
Measured: Day 1 up to 12 months
Disease control according to RECIST v1.1
Measured: Day 1 up to 12 months
Progression-free survival (PFS) according to RECIST v1.1
Measured: Day 1 up to 12 months
Duration of response (DOR) according to RECIST v1.1
Measured: Day 1 up to 12 months
Overall survival (OS)
Measured: Day 1 up to 12 months
Quality of life assessed with European Quality of Life Five Dimensions (EQ-5D-5L)
Measured: Day 1 up to 12 months
Quality of life assessed with European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Measured: Day 1 up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start25 May 2021
- Primary completion18 Jul 2024
- Study completion18 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anaveon AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eduard Gasal, MD, Study director, Anaveon AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855929
- Sponsor's protocol ID
- ANV419-001
- Acronym
- ANV419-001
- Status last verified
- Nov 2024
- First submitted
- 15 Apr 2021
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Joerger M, Calvo E, Laubli H, Lopez J, Alonso G, Corral de la Fuente E, Hess D, Konig D, Sanchez Perez V, Bucher C, Jethwa S, Garralda E. Phase 1 first-in-human dose-escalation study of ANV419 in patients with relapsed/refractory advanced solid tumors. J Immunother Cancer. 2023 Nov 21;11(11):e007784. doi: 10.1136/jitc-2023-007784.
PubMed 38243906
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANV419 First in Human Study Phase 1: Open-label, Dose Escalation Study of ANV419 As Single Agent and in Combination with Ipilimumab in Patients with Relapsed/Refractory Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04855929
- Acronym / sponsor ID
- ANV419-001 / ANV419-001
- Conditions
- Advanced Solid Tumor, Adult Disease, Lung Cancer
- Keywords
- IL-2, ANV419, Cancer, Relapsed, Refractory, Ipilimumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Anaveon AGIndustry (pharma, biotech, devices)
- Study start
- 25 May 2021 (actual)
- Primary completion
- 18 Jul 2024 (actual)
- Study completion
- 18 Jul 2024 (actual)
- First posted
- 22 Apr 2021 (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 this study is to test the safety and efficacy of ANV419 (single agent) and in combination with ipilimumab in patients with relapsed/refractory advanced solid tumors.
Detailed description
The purpose of this First-in-Human, open-label, dose escalation study is to assess the initial safety and efficacy profile of ANV419 intravenous infusion alone and in combination with ipilimumab in patients with advanced solid tumours. It will evaluate the safety and tolerability of ANV419 alone and in combination with ipilimumab and, the safest and best dose of ANV419 when used alone or in combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ANV419 single agent | Experimental | Drug: ANV419 |
| Ipilimumab + ANV419 | Experimental | Drug: ANV419, Drug: Ipilimumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Ability of the patient or legal guardian to understand the purpose of the study, provide signed and dated informed consent from the patient prior to performing any protocol-related procedures (including Screening evaluations), and be able and willing to comply with the study procedures.
- Male or female aged ≥ 18 years.
- Advanced solid tumors with evidence of progressive disease as per RECIST no longer than 3 months before Informed Consent form (ICF) signature, without any subsequent curative intent treatment.
- Parts A and B only: Histologically confirmed relapsed/refractory advanced solid tumor, progressing after at least one line of treatment for advanced or metastatic disease
- Part C only: Previously treated advanced NSCLC without a driver mutation who have progressed after first line standard chemo-immunotherapy: Patients must have measurable disease using RECIST v1.1, A maximum of 1 line of therapy is permitted, Patients with high expression of PD-L1 which were treated with first line checkpoint inhibitor monotherapy may have received a maximum of 2 lines of therapy
Key exclusion criteria (29 listed)
- Carcinomatous meningitis and/or symptomatic central nervous system (CNS) metastases. Definitively treated CNS metastases (e.g., radiotherapy) stable for at least 6 weeks prior to Day 1 of study drug administration are acceptable.
- Participants with an active second malignancy. Patients with precancerous lesions, concomitant early stages of prostate or breast cancer not requiring active treatment (past conditions currently resolved > 3 years prior to Screening are also acceptable), and squamous cell carcinoma of the skin not requiring systemic treatment are acceptable.
- Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including uncontrolled diabetes mellitus, history of relevant pulmonary disorders, (e.g., severe bronchospasm, obstructive pulmonary disease), hyperthyroidism due to thyroiditis and known autoimmune diseases or other disease with ongoing fibrosis. Stable vitiligo, autoimmune thyroiditis, and preexisting treated type 1 diabetes are acceptable and are not exclusion criteria.
- Significant cardiovascular/cerebrovascular disease, including myocardial infarction or transient ischemic attack (TIA) within 6 months prior to Day 1 of study drug administration.
- Active infections, or uncontrolled infection requiring systemic antibiotics within one week (7 days) preceding Day 1 of treatment
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 |
|---|---|---|
| ANV419ANV419 administered by intravenous (IV) infusion | Drug | ANV419 single agent, Ipilimumab + ANV419 |
| IpilimumabIpilimumab administered by intravenous (IV) infusion | Drug | Ipilimumab + ANV419 |
Primary outcome
Monotherapy: Number of Dose-Limiting Toxicities (DLTs)
Time frame: Day 1 to Day 14
Combination: Number of Dose-Limiting Toxicities (DLTs)
Time frame: Day 1 to Day 21
Monotherapy: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 up to 12 months
Combination: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 up to 12 months
Monotherapy: Recommended Phase 2 Dose
Time frame: Day 1 to Day 28
Combination: Recommended Phase 2 Dose
Time frame: Day 1 to Day 28
10 secondary outcomes
Objective response rate (ORR) assessed by RECIST v1.1 for solid tumors
Time frame: Day 1 up to 12 months
Plasma concentration of ANV419 in blood
Time frame: Day 1 up to 12 months
Impact of ANV419 on the expression of markers of PBMC lineage in blood
Time frame: Day 1 up to 12 months
Levels of specific anti-ANV419 antibodies in blood
Time frame: Day 1 up to 12 months
Disease control according to RECIST v1.1
Time frame: Day 1 up to 12 months
Progression-free survival (PFS) according to RECIST v1.1
Time frame: Day 1 up to 12 months
Duration of response (DOR) according to RECIST v1.1
Time frame: Day 1 up to 12 months
Overall survival (OS)
Time frame: Day 1 up to 12 months
Quality of life assessed with European Quality of Life Five Dimensions (EQ-5D-5L)
Time frame: Day 1 up to 12 months
Quality of life assessed with European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Time frame: Day 1 up to 12 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 8 Nov 2024.
- Derived from this study: PubMed 38243906Joerger M, Calvo E, Laubli H, Lopez J, Alonso G, Corral de la Fuente E, Hess D, Konig D, Sanchez Perez V, Bucher C, Jethwa S, Garralda E. Phase 1 first-in-human dose-escalation study of ANV419 in patients with relapsed/refractory advanced solid tumors. J Immunother Cancer. 2023 Nov 21;11(11):e007784. doi: 10.1136/jitc-2023-007784.
- Individual participant dataSharing planned: No
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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.
Eduard Gasal, MD study director
Anaveon AG
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ANV419 and Ipilimumab in people with Advanced Solid Tumor and Adult Disease, run by Anaveon AG at 5 sites in 3 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 13 inclusion and 29 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 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain, Switzerland, United Kingdom. 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 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.
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?
Monotherapy: Number of Dose-Limiting Toxicities (DLTs) (time frame: Day 1 to Day 14). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04855929, which also lists 1 linked publication.
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 8 Nov 2024.