Trial Outcomes & Findings for A Study of ANV419 Alone or in Combination With Approved Treatment in Patients With Cutaneous Melanoma (OMNIA-1). (NCT NCT05578872)

Last Updated: 2025-08-26

Results Overview

Proportion of participants with a complete response (CR) or partial response (PR) to treatment as defined by RECIST v1.1 (ORR = CR + PR)

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

29 participants

Primary outcome timeframe

Day 1 up to 12 months

Results posted on

2025-08-26

Participant Flow

In line with the protocol, Parts 2 and 3 of the study were not initiated, as the prespecified efficacy criteria to graduate to Part 2 were not met during Part 1. No participants were enrolled in Parts 2 and 3 prior to the close of the study.

Participant milestones

Participant milestones
Measure	ANV419 Single Agent, Low Dose ANV419: ANV419 administered by intravenous (IV) infusion	ANV419 Single Agent, High Dose ANV419: ANV419 administered by intravenous (IV) infusion
Overall Study STARTED	14	15
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	14	15

Reasons for withdrawal

Reasons for withdrawal
Measure	ANV419 Single Agent, Low Dose ANV419: ANV419 administered by intravenous (IV) infusion	ANV419 Single Agent, High Dose ANV419: ANV419 administered by intravenous (IV) infusion
Overall Study Withdrawal by Subject	2	1
Overall Study Adverse Event	1	1
Overall Study Physician Decision	1	2
Overall Study Progressive disease	10	9
Overall Study Sponsor decision	0	1
Overall Study Toxicity and Patient's decision	0	1

Baseline Characteristics

A Study of ANV419 Alone or in Combination With Approved Treatment in Patients With Cutaneous Melanoma (OMNIA-1).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ANV419 Single Agent, Low Dose n=14 Participants ANV419: ANV419 administered by intravenous (IV) infusion	ANV419 Single Agent, High Dose n=15 Participants ANV419: ANV419 administered by intravenous (IV) infusion	Total n=29 Participants Total of all reporting groups
Age, Continuous	59.7 years STANDARD_DEVIATION 14.15 • n=5 Participants	59.8 years STANDARD_DEVIATION 13.92 • n=7 Participants	59.8 years STANDARD_DEVIATION 13.78 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 up to 12 months

Population: The efficacy population included patients who receive at least 1 dose of study drug and have at least 1 post-baseline tumor assessment. No patients achieved CR or PR.

Proportion of participants with a complete response (CR) or partial response (PR) to treatment as defined by RECIST v1.1 (ORR = CR + PR)

Outcome measures

Outcome measures
Measure	ANV419 Single Agent, Low Dose n=14 Participants ANV419: ANV419 administered by intravenous (IV) infusion	ANV419 Single Agent, High Dose n=14 Participants ANV419: ANV419 administered by intravenous (IV) infusion
Monotherapy Dose Expansion: Objective Response Rate (ORR) as Defined by RECIST v1.1	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 up to 12 months

Population: The efficacy population included patients who receive at least 1 dose of study drug and have at least 1 post-baseline tumor assessment. No patients achieved CR or PR so this outcome could not be assessed.

Time from first time measurement criteria are met for complete response (CR) or (PR) until the progressive disease or death.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 up to 12 months

Population: The efficacy population included patients who receive at least 1 dose of study drug and have at least 1 post-baseline tumor assessment.

Percentage of participants who have achieved Complete Response (CR), Partial Response (PR) and Stable Disease (SD).

Outcome measures

Outcome measures
Measure	ANV419 Single Agent, Low Dose n=14 Participants ANV419: ANV419 administered by intravenous (IV) infusion	ANV419 Single Agent, High Dose n=14 Participants ANV419: ANV419 administered by intravenous (IV) infusion
Monotherapy Dose Expansion: Disease Control Rate (DCR) According to RECIST v1.1	5 Participants	7 Participants

SECONDARY outcome

Timeframe: Day 1 up to 12 months

Population: The safety population is defined as all patients who receive at least 1 dose (or partial dose) of study drug(s).

Length of time participants lived with the disease without progressing (PD)

Outcome measures

Outcome measures
Measure	ANV419 Single Agent, Low Dose n=14 Participants ANV419: ANV419 administered by intravenous (IV) infusion	ANV419 Single Agent, High Dose n=15 Participants ANV419: ANV419 administered by intravenous (IV) infusion
Monotherapy Dose Expansion: Progression-free Survival (PFS) According to RECIST v1.1	2.2 months Interval 1.8 to 2.6	2.4 months Interval 1.4 to 4.4

SECONDARY outcome

Timeframe: Day 1 up to 6 months

Population: The Safety Population is defined as all patients who receive at least 1 dose (or partial dose) of study drug(s).

Proportion of participants who are alive at 6 months. This is an estimation based on Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	ANV419 Single Agent, Low Dose n=14 Participants ANV419: ANV419 administered by intravenous (IV) infusion	ANV419 Single Agent, High Dose n=15 Participants ANV419: ANV419 administered by intravenous (IV) infusion
Monotherapy Dose Expansion: Overall Survival (OS) Rate	0.8 Proportion of participants Interval 0.5 to 0.9	0.8 Proportion of participants Interval 0.5 to 0.9

SECONDARY outcome

Timeframe: Day 1 through study completion, an average of 3.7 months and a maximum of 14 months.

Population: The Safety Population is defined as all patients who receive at least 1 dose (or partial dose) of study drug(s)

Number of participants with TEAEs.

Outcome measures

Outcome measures
Measure	ANV419 Single Agent, Low Dose n=14 Participants ANV419: ANV419 administered by intravenous (IV) infusion	ANV419 Single Agent, High Dose n=15 Participants ANV419: ANV419 administered by intravenous (IV) infusion
Monotherapy Dose Expansion: Frequency of Treatment-Emergent Adverse Events (TEAEs)	14 Participants	15 Participants

SECONDARY outcome

Timeframe: Day 1 through study completion, an average of 3.7 months and a maximum of 14 months.

Population: The Safety Population is defined as all patients who receive at least 1 dose (or partial dose) of study drug(s)

Number of participants with TEAEs Grade 3 or more.

Outcome measures

Outcome measures
Measure	ANV419 Single Agent, Low Dose n=14 Participants ANV419: ANV419 administered by intravenous (IV) infusion	ANV419 Single Agent, High Dose n=15 Participants ANV419: ANV419 administered by intravenous (IV) infusion
Monotherapy Dose Expansion: Severity of TEAEs	12 Participants	13 Participants

SECONDARY outcome

Timeframe: Day 1 through study completion, an average of 3.7 months

Population: The Immunogenicity Population is defined as all patients who receive at least 1 dose of study drug and have at least 1 evaluable immunogenicity sample.

Number of patients with positive ADA at baseline and end of study.

Outcome measures

Outcome measures
Measure	ANV419 Single Agent, Low Dose n=14 Participants ANV419: ANV419 administered by intravenous (IV) infusion	ANV419 Single Agent, High Dose n=15 Participants ANV419: ANV419 administered by intravenous (IV) infusion
Monotherapy Dose Expansion: Prevalence of Specific Anti-ANV419 Antibodies (ADA) in Blood Prevalence of ADA positive at Baseline	5 Participants	5 Participants
Monotherapy Dose Expansion: Prevalence of Specific Anti-ANV419 Antibodies (ADA) in Blood Prevalence of ADA positive at End of Study	12 Participants	5 Participants

Adverse Events

ANV419 Single Agent, Low Dose

Serious events: 10 serious events

Other events: 14 other events

Deaths: 5 deaths

ANV419 Single Agent, High Dose

Serious events: 11 serious events

Other events: 15 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Director, MD

Anaveon AG

Phone: +41615218383

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI must obtain Sponsor's written approval before any disclosure. Sponsor may delete confidential info, require edits, and delay release: 60-day review plus one-time patent embargo ≤ 90 additional days (total ≤ 150). Publication otherwise allowed after multicenter paper or 12 months post-study.
Publication restrictions are in place

Restriction type: OTHER

Measure	ANV419 Single Agent, Low Dose n=14 participants at risk ANV419: ANV419 administered by intravenous (IV) infusion	ANV419 Single Agent, High Dose n=15 participants at risk ANV419: ANV419 administered by intravenous (IV) infusion
Blood and lymphatic system disorders Thrombocytopenic purpura	0.00% 0/14 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.	6.7% 1/15 • Number of events 1 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.
Cardiac disorders Atrial fibrillation	7.1% 1/14 • Number of events 1 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.	0.00% 0/15 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.
Cardiac disorders Sinus tachycardia	0.00% 0/14 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.	6.7% 1/15 • Number of events 1 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.
Gastrointestinal disorders Fistula of small intestine	0.00% 0/14 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.	6.7% 1/15 • Number of events 1 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.
General disorders Condition aggravated	0.00% 0/14 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.	6.7% 1/15 • Number of events 1 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.
General disorders Discomfort	0.00% 0/14 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.	6.7% 1/15 • Number of events 1 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.
General disorders Influenza like illness	7.1% 1/14 • Number of events 5 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.	6.7% 1/15 • Number of events 1 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.
Hepatobiliary disorders Jaundice cholestatic	0.00% 0/14 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.	6.7% 1/15 • Number of events 1 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.
Immune system disorders Cytokine release syndrome	42.9% 6/14 • Number of events 8 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.	20.0% 3/15 • Number of events 5 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.
Infections and infestations Spinal cord infection	7.1% 1/14 • Number of events 1 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.	0.00% 0/15 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.
Investigations Alanine aminotransferase increased	14.3% 2/14 • Number of events 2 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.	13.3% 2/15 • Number of events 2 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.
Investigations Aspartate aminotransferase increased	7.1% 1/14 • Number of events 1 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.	13.3% 2/15 • Number of events 2 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.
Investigations Blood bilirubin increased	0.00% 0/14 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.	6.7% 1/15 • Number of events 1 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.
Musculoskeletal and connective tissue disorders Osteonecrosis	7.1% 1/14 • Number of events 1 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.	0.00% 0/15 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/14 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.	6.7% 1/15 • Number of events 1 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.
Nervous system disorders Dementia Alzheimer's type	0.00% 0/14 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.	6.7% 1/15 • Number of events 1 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/14 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.	6.7% 1/15 • Number of events 1 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	7.1% 1/14 • Number of events 1 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.	0.00% 0/15 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/14 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.	6.7% 1/15 • Number of events 1 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/14 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.	6.7% 1/15 • Number of events 1 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.
Vascular disorders Hypotension	0.00% 0/14 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.	13.3% 2/15 • Number of events 5 • All AEs and SAEs were collected during the full study period from the signing of the ICF through study completion, an average of 3.7 months and a maximum of 14 months.