Advanced Melanoma and Normal or ImpairedPhase 1Asher-BioAB821NCT07027488
AB821 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing AB821 in people with Advanced Melanoma and Normal or Impaired and Advanced Melanoma, run by Yale University at 1 site in United States.
Trial summary
This study is a first-in-human, open-label, nonrandomized, single center Phase 1 dose-escalation study to assess the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity of AB821 monotherapy given every 2 weeks (Q2W) or every 3 weeks (Q3W) in participants with recurrent… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advanced Melanoma and Normal or Impaired, Advanced Melanoma
- What is being tested?
- AB821
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2025to Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years at the time consent is signed.
- Ability to provide written informed consent for the study.
- ECOG PS of 0 or 1.
- Participants of childbearing potential must not be pregnant at enrollment and agree to comply with contraception requirements. Participants with partners of childbearing potential must also comply with contraception requirements.
- Adequate organ function as defined below. Specimens must be collected within seven days prior to the start of the study treatment (i.e., Cycle 1 Day 1 [C1D1]) including:
- ANC> 1500/ul Platelet count>100,000 Hb>9 g/dl Calculated creatinine clearance> 50 mL/min Total bilirubin greater than or equal to 1.5 x ULN or direct bilirubin greater than or equal to ULN for participants with total bilirubin > 1.5 x ULN PT INR > 1.5 x ULN unless on anticoagulation Albumin > 3g/dl
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- Life expectancy of ≥12 weeks, per treating investigator's judgment.
- For Melanoma participants: Participants with unresectable or metastatic melanoma that have progressed on or after PD-1/PD-L1 checkpoint blockade (alone or with either CTLA-4 or LAG-3 checkpoint blockade).
- For other tumor types: Must have a recurrent histologically or cytologically proven metastatic or locally advanced solid tumor (non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), Merkel-cell carcinoma, bladder cancer, or squamous cell carcinoma of the head and neck (SCCHN)), meeting each of the following:
- Tumor that is not amenable to curative treatment with surgery or radiation.
- Tumor for which immune checkpoint inhibitors form part of standard-of-care therapy.
- Participant has received at least one prior line of systemic anticancer therapy in the recurrent or metastatic setting.
- Has measurable disease per RECIST v1.1 as assessed by the local site investigator/radiology.
Who cannot join
- Has a diagnosis of immunodeficiency.
- Prior stem cell, bone marrow, or organ transplant.
- Known history of HIV infection. No HIV testing is required unless mandated by local health authority.
- History of HBV (defined as HBV surface antigen reactive) or active HCV.
- Active autoimmune disease (non-immunotherapy induced conditions) that has required systemic treatment in the past two years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic immune-suppressive treatment and is allowed.
- Active Grade ≥2 diarrhea or enterocolitis.
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- Known active CNS metastases and/or carcinomatous meningitis. Individuals with previously treated brain metastases may participate provided they are radiologically stable (i.e., without evidence of progression for at least two weeks by repeat imaging, clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment).
- Any other current or previous malignancy within the previous three years except neoplasms that, in the opinion of the treating investigator and with the agreement of the sponsor-investigator, will not interfere with study-specific endpoints, e.g. basal cell carcinoma, localized tumors that have been fully excised with curative intent and no evidence of recurrence or metastasis, prostate cancer that is asymptomatic and does not require therapy other than anti-androgen therapy.
- Participant is a regular user, as determined by treating investigator judgment (including recreational use), of any illicit drugs or has a recent history (within the last year) of substance abuse (including alcohol), at the time of signing the Informed Consent Form (ICF).
- Has clinically significant heart disease that affects normal activities, including, unstable angina, or history of congestive heart failure (New York Heart Association Class II IV).
- History of acute myocardial infarction within the last six months.
- Has a history of new or worsening thrombosis (DVT/PE, other thrombo-embolic disease) within the last six months.
- Has a mean QTcF value of >470 ms.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the individuals' participation for the full duration of the study, such that it is not in the best interest of the individual to participate, in the opinion of the treating investigator.
- Has an active infection, requiring systemic therapy.
- Has had a severe hypersensitivity reaction to any components of the study treatment or any of their excipients.
- Is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within seven days prior the first dose of study treatment.
- Has received more than five prior lines of systemic treatment in the recurrent/metastatic setting.
- Has received prior radiotherapy within two weeks of start of study treatment or has had a history of radiation pneumonitis.
- Has a history of grade 3-4 autoimmune myocarditis or a history of Guillain Barre Syndrome.
- History of congestive heart failure with an ejection fraction < 40%.
- Participant with NSCLC only: Has received radiation therapy to the lung that is >30 Gy within six months of the first dose of study treatment.
- Has received previous IL-21 based therapy or prior therapy with AB248
- Prior systemic anticancer therapy including investigational agents within four weeks or, if shorter, within five half-lives prior to first dose of study treatment.
- Major surgery from which the participant has not fully recovered
- Has received a live or live attenuated vaccine within 30 days
- Current use of any prohibited concomitant medications.
- A participant of childbearing potential who has a positive serum pregnancy test within 14 days prior to treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale University
New Haven, Connecticut, 06510
Jialing Zhang, jialing.zhang@yale.edu
About this study
Official title: An Open-Label, Phase 1 Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AB821 in Adult Participants With Locally Advanced or Metastatic Melanoma and Other Solid Tumors
This study is a first-in-human, open-label, nonrandomized, single center Phase 1 dose-escalation study to assess the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity of AB821 monotherapy given every 2 weeks (Q2W) or every 3 weeks (Q3W) in participants with recurrent locally advanced or metastatic melanoma and other immune-responsive solid tumors. Immune-responsive solid tumors are defined as those for which immune checkpoint inhibitors form part of the standard-of-care therapy.
Read the detailed description
Phase 1 Dose-Escalation Participants with recurrent locally advanced or metastatic melanoma and immune-responsive solid tumors will be enrolled into dose-escalation cohorts. Patients with melanoma are required to have previously been treated with an inhibitor of PD1/L1, while patients with other solid tumors are required to have had previous systemic treatment regimen that may or may not include an inhibitor of PD1/L1. For DL3 and above, n ≥3; for DL1 and DL2, n=1, unless a Grade ≥2 AE or a DLT is observed, in which case the cohort will be expanded to at least 3 participants before further dose escalation. This will help determine the MTD or MAD and select the recommended Phase 1b or Phase 2 dose (RP1bD or RP2D).
Under protocol versions up to and including V 4.0, participants in dose-escalation cohorts were enrolled at least 48 hours apart, treated on a Q2W schedule, and followed for dose-limiting toxicities for 28 days (completion of two 14-day cycles of treatment).
Dose-Escalation Backfill Cohorts ased on emerging safety, PK, and pharmacodynamic data, additional participants may be enrolled in backfill cohorts, backfill slots may be used for other tumor types, not only melanoma, upon discussion with the sponsor-investigator at or below dose levels that cleared the dose-limiting toxicity (DLT) assessment and were determined to be safe and tolerable by the Data and Safety Monitoring Board (DSMB). Up to a maximum of 20 total participants may be enrolled in backfill cohorts, at the RP2D or at lower levels deemed efficacious to better assess safety and efficacy based on emerging data. Dose levels and justification are described in Section 4.3.
This study consists of a Screening phase, a Treatment phase, an end of treatment (EOT) Visit, a 30-, 60-, 90- day Safety Follow-up (SFU) phase, and a long-term follow-up (LTFU) phase. Upon completion of the SFU phase post EOT, ongoing safety, disease progression, survival status, and subsequent anticancer therapies will be assessed in the LTFU period.
During the treatment phase, participants who demonstrate disease progression per RECIST criteria may be allowed to continue AB821 if, in the opinion of the treating investigator, the participant is tolerating study treatment and deriving clinical benefit from continuing study treatment. If further progression is noted on subsequent imaging, participants may be allowed to continue on study based on discussion with the sponsor-investigator.
- Being tested
- AB821
- Keywords
- AB821, immune-responsive solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB821Drug
AB821 will be administered via IV infusion using weight-based dosing. AB821 will be administered over 30 minutes +/- 10 minutes. Participants will receive AB821 on Day 1 of each 14 or 21 day cycle for up to two years.
| Study group | Role | What they receive |
|---|---|---|
| AB821 | Experimental | AB821 is intended to be administered as a 30-minute IV infusion every 2 or 3 weeks. Dosage is calculated per body weight. Receives: Drug: AB821 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Dose-Limiting Toxicities (DLTs) in patients with advanced melanoma
The primary objective of this outcome measure is to assess the number of participants experiencing dose-limiting toxicities (DLTs) during the study period. DLTs are specific adverse events (AEs) that are considered significant enough to prevent an increase in dose or continuation of treatment.
Measured: From the date of enrolment to the final follow up visit, approximately two years after the first dose
Frequency of Serious Adverse Events (SAEs) in patients with advanced melanoma
This outcome measure aims to record the number of participants who experience serious adverse events (SAEs) while receiving AB821. An SAE is defined as any event that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Measured: From the date of enrolment to the final follow up visit, approximately two years after the first dose
Frequency of Treatment-Emergent Adverse Events (TEAEs) in patients with advanced melanoma
This measure will track the number of participants experiencing treatment-emergent adverse events (TEAEs) during the study. TEAEs are adverse events that emerge following the start of treatment with AB821 and are not present prior to treatment or represent an exacerbation of a pre-existing condition.
Measured: From the date of enrolment to the final follow up visit, approximately two years after the first dose
Frequency of Adverse Events of Special Interest (AESIs) in patients with advanced melanoma
This outcome measure focuses on the number of participants who experience adverse events of special interest (AESIs). AESIs are pre-specified medical occurrences that have been identified as important to monitor due to their potential impact on the risk-benefit profile of AB821.
Measured: From the date of enrolment to the final follow up visit, approximately two years after the first dose
Frequency of Adverse Events (AEs) Leading to Dose Interruption in patients with advanced melanoma
The objective of this measure is to document the number of participants who experience adverse events that result in a temporary interruption of AB821 administration. The interruptions could be due to the severity of the adverse event making it necessary to halt the dosing temporarily.
Measured: From the date of enrolment to the final follow up visit, approximately two years after the first dose
Frequency of Adverse Events (AEs) Leading to Treatment Discontinuation in patients with advanced melanoma
This outcome measure will track the number of participants who experience adverse events leading to the permanent discontinuation of treatment with AB821. These events warrant stopping the treatment altogether to ensure participant safety.
Measured: From the date of enrolment to the final follow up visit, approximately two years after the first dose
Frequency of Deaths in patients with advanced melanoma
The primary objective of this measure is to record the number of participants who die during the study period, irrespective of the cause. This encompasses any deaths occurring within the timeframe of the study and helps to monitor the overall impact of the study treatment on participant mortality.
Measured: From the date of enrolment to the final follow up visit, approximately two years after the first dose
Secondary outcomes (11)
Maximum Concentration (Cmax) of AB821 in Serum
The objective of this outcome measure is to determine the maximum concentration (Cmax) of AB821 in the serum of participants. Cmax represents the highest concentration that AB821 reaches in the bloodstream after administration. This parameter provides important insights into the peak level of drug exposure.
Measured: From the date of enrolment to the final follow up visit, approximately two years after the first dose
Assessing the immunogenicity of AB821 in patients with advanced melanoma
The secondary outcome measure will evaluate the immunogenicity of AB821 by monitoring the frequency and titer of anti-drug antibody (ADA) formation against AB821. Additionally, this measure will assess the potential effect of ADA formation on observed safety, pharmacokinetics (PK), and pharmacodynamics (PD) of AB821. The immunogenicity analysis aims to understand the immune response triggered by AB821 and its impact on the therapeutic's overall safety and efficacy profile.
Measured: From the date of enrolment to the final follow up visit, approximately two years after the first dose
Objective Response Rate (ORR) of AB821 in Patients with Advanced Melanoma
The objective response rate (ORR) will be determined according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. ORR is defined as the percentage of subjects achieving either a complete response (CR) or partial response (PR).
Measured: Screening, day 1 of cycle 4 (each cycle is 14 days), end of treatment and at long term follow up
Duration of Response (DOR) of AB821 in Patients with Advanced Melanoma
The duration of response (DOR) will be evaluated in subjects who have achieved a complete response (CR) or partial response (PR) as per RECIST v1.1 criteria. DOR is defined as the time from the initial response to documented disease progression or death.
Measured: Screening, day 1 of cycle 4 (each cycle is 14 days), end of treatment and at long term follow up
Disease Control Rate (DCR) of AB821 in Patients with Advanced Melanoma
Disease control rate (DCR) will be assessed according to the RECIST v1.1 criteria. DCR includes the percentage of subjects achieving complete response (CR), partial response (PR), or stable disease (SD).
Measured: Screening, day 1 of cycle 4 (each cycle is 14 days), end of treatment and at long term follow up
Progression-Free Survival (PFS) of AB821 in Patients with Advanced Melanoma
Progression-free survival (PFS) will be measured as the time from the start of treatment with AB821 to the first documentation of disease progression or death from any cause, based on RECIST v1.1 criteria.
Measured: Screening, day 1 of cycle 4 (each cycle is 14 days), end of treatment and at long term follow up
Overall Survival (OS) of AB821 in Patients with Advanced Melanoma
: Overall survival (OS) will be assessed as the time from the start of treatment with AB821 to the time of death from any cause.
Measured: Screening, day 1 of cycle 4 (each cycle is 14 days), end of treatment and at long term follow up
Time to Maximum Concentration (tmax) of AB821 in Serum
This outcome measure aims to identify the time to reach the maximum concentration (tmax) of AB821 in the serum. tmax is the duration it takes after administration for AB821 to reach its peak concentration in the bloodstream. This parameter helps in understanding the absorption rate of the drug.
Measured: From the date of enrolment to the final follow up visit, approximately two years after the first dose
Area Under the Curve from Time Zero to Last Measurable Concentration (AUC0-last) of AB821 in Serum
The objective of this measure is to calculate the area under the concentration-time curve from time zero to the last measurable concentration (AUC0-last) of AB821 in serum. AUC0-last provides an integrated measure of the overall exposure to AB821 over time.
Measured: From the date of enrolment to the final follow up visit, approximately two years after the first dose
Clearance (CL) of AB821 in Serum
This outcome measure focuses on determining the clearance (CL) of AB821 from the serum. CL represents the volume of serum from which AB821 is completely removed per unit time. This parameter is crucial for understanding how efficiently the drug is eliminated from the body.
Measured: From the date of enrolment to the final follow up visit, approximately two years after the first dose
Half-life (t½) of AB821 in Serum
The objective of this measure is to determine the half-life (t½) of AB821 in serum. t½ is the time taken for the concentration of AB821 in the serum to reduce to half its maximum level. This parameter gives an indication of the duration AB821 remains active in the body.
Measured: From the date of enrolment to the final follow up visit, approximately two years after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start5 Aug 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Melanoma and Normal or ImpairedStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Asher Biotherapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- Harriet Kluger, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027488
- Sponsor's protocol ID
- 2000038990
- Acronym
- Asher-BioAB821
- Status last verified
- Jun 2026
- First submitted
- 19 May 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase 1 Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AB821 in Adult Participants With Locally Advanced or Metastatic Melanoma and Other Solid Tumors
- ClinicalTrials.gov ID
- NCT07027488
- Acronym / sponsor ID
- Asher-BioAB821 / 2000038990
- Keywords
- AB821, immune-responsive solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Asher Biotherapeutics, Inc.
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 18 Jun 2025 (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.
This study is a first-in-human, open-label, nonrandomized, single center Phase 1 dose-escalation study to assess the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity of AB821 monotherapy given every 2 weeks (Q2W) or every 3 weeks (Q3W) in participants with recurrent locally advanced or metastatic melanoma and other immune-responsive solid tumors. Immune-responsive solid tumors are defined as those for which immune checkpoint inhibitors form part of the standard-of-care therapy.
Detailed description
Phase 1 Dose-Escalation Participants with recurrent locally advanced or metastatic melanoma and immune-responsive solid tumors will be enrolled into dose-escalation cohorts. Patients with melanoma are required to have previously been treated with an inhibitor of PD1/L1, while patients with other solid tumors are required to have had previous systemic treatment regimen that may or may not include an inhibitor of PD1/L1. For DL3 and above, n ≥3; for DL1 and DL2, n=1, unless a Grade ≥2 AE or a DLT is observed, in which case the cohort will be expanded to at least 3 participants before further dose escalation. This will help determine the MTD or MAD and select the recommended Phase 1b or Phase 2 dose (RP1bD or RP2D).
Under protocol versions up to and including V 4.0, participants in dose-escalation cohorts were enrolled at least 48 hours apart, treated on a Q2W schedule, and followed for dose-limiting toxicities for 28 days (completion of two 14-day cycles of treatment).
Dose-Escalation Backfill Cohorts ased on emerging safety, PK, and pharmacodynamic data, additional participants may be enrolled in backfill cohorts, backfill slots may be used for other tumor types, not only melanoma, upon discussion with the sponsor-investigator at or below dose levels that cleared the dose-limiting toxicity (DLT) assessment and were determined to be safe and tolerable by the Data and Safety Monitoring Board (DSMB). Up to a maximum of 20 total participants may be enrolled in backfill cohorts, at the RP2D or at lower levels deemed efficacious to better assess safety and efficacy based on emerging data. Dose levels and justification are described in Section 4.3.
This study consists of a Screening phase, a Treatment phase, an end of treatment (EOT) Visit, a 30-, 60-, 90- day Safety Follow-up (SFU) phase, and a long-term follow-up (LTFU) phase. Upon completion of the SFU phase post EOT, ongoing safety, disease progression, survival status, and subsequent anticancer therapies will be assessed in the LTFU period.
During the treatment phase, participants who demonstrate disease progression per RECIST criteria may be allowed to continue AB821 if, in the opinion of the treating investigator, the participant is tolerating study treatment and deriving clinical benefit from continuing study treatment. If further progression is noted on subsequent imaging, participants may be allowed to continue on study based on discussion with the sponsor-investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AB821 | Experimental | Drug: AB821AB821 is intended to be administered as a 30-minute IV infusion every 2 or 3 weeks. Dosage is calculated per body weight. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- ≥18 years at the time consent is signed.
- Ability to provide written informed consent for the study.
- ECOG PS of 0 or 1.
- Participants of childbearing potential must not be pregnant at enrollment and agree to comply with contraception requirements. Participants with partners of childbearing potential must also comply with contraception requirements.
- Adequate organ function as defined below. Specimens must be collected within seven days prior to the start of the study treatment (i.e., Cycle 1 Day 1 [C1D1]) including:
Key exclusion criteria (28 listed)
- Has a diagnosis of immunodeficiency.
- Prior stem cell, bone marrow, or organ transplant.
- Known history of HIV infection. No HIV testing is required unless mandated by local health authority.
- History of HBV (defined as HBV surface antigen reactive) or active HCV.
- Active autoimmune disease (non-immunotherapy induced conditions) that has required systemic treatment in the past two years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic immune-suppressive treatment and is allowed.
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 |
|---|---|---|
| AB821AB821 will be administered via IV infusion using weight-based dosing. AB821 will be administered over 30 minutes +/- 10 minutes. Participants will receive AB821 on Day 1 of each 14 or 21 day cycle for up to two years. | Drug | AB821 |
Primary outcome
Frequency of Dose-Limiting Toxicities (DLTs) in patients with advanced melanoma
Time frame: From the date of enrolment to the final follow up visit, approximately two years after the first dose
The primary objective of this outcome measure is to assess the number of participants experiencing dose-limiting toxicities (DLTs) during the study period. DLTs are specific adverse events (AEs) that are considered significant enough to prevent an increase in dose or continuation of treatment.
Frequency of Serious Adverse Events (SAEs) in patients with advanced melanoma
Time frame: From the date of enrolment to the final follow up visit, approximately two years after the first dose
This outcome measure aims to record the number of participants who experience serious adverse events (SAEs) while receiving AB821. An SAE is defined as any event that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Frequency of Treatment-Emergent Adverse Events (TEAEs) in patients with advanced melanoma
Time frame: From the date of enrolment to the final follow up visit, approximately two years after the first dose
This measure will track the number of participants experiencing treatment-emergent adverse events (TEAEs) during the study. TEAEs are adverse events that emerge following the start of treatment with AB821 and are not present prior to treatment or represent an exacerbation of a pre-existing condition.
Frequency of Adverse Events of Special Interest (AESIs) in patients with advanced melanoma
Time frame: From the date of enrolment to the final follow up visit, approximately two years after the first dose
This outcome measure focuses on the number of participants who experience adverse events of special interest (AESIs). AESIs are pre-specified medical occurrences that have been identified as important to monitor due to their potential impact on the risk-benefit profile of AB821.
Frequency of Adverse Events (AEs) Leading to Dose Interruption in patients with advanced melanoma
Time frame: From the date of enrolment to the final follow up visit, approximately two years after the first dose
The objective of this measure is to document the number of participants who experience adverse events that result in a temporary interruption of AB821 administration. The interruptions could be due to the severity of the adverse event making it necessary to halt the dosing temporarily.
Frequency of Adverse Events (AEs) Leading to Treatment Discontinuation in patients with advanced melanoma
Time frame: From the date of enrolment to the final follow up visit, approximately two years after the first dose
This outcome measure will track the number of participants who experience adverse events leading to the permanent discontinuation of treatment with AB821. These events warrant stopping the treatment altogether to ensure participant safety.
Frequency of Deaths in patients with advanced melanoma
Time frame: From the date of enrolment to the final follow up visit, approximately two years after the first dose
The primary objective of this measure is to record the number of participants who die during the study period, irrespective of the cause. This encompasses any deaths occurring within the timeframe of the study and helps to monitor the overall impact of the study treatment on participant mortality.
11 secondary outcomes
Maximum Concentration (Cmax) of AB821 in Serum
Time frame: From the date of enrolment to the final follow up visit, approximately two years after the first dose
Assessing the immunogenicity of AB821 in patients with advanced melanoma
Time frame: From the date of enrolment to the final follow up visit, approximately two years after the first dose
Objective Response Rate (ORR) of AB821 in Patients with Advanced Melanoma
Time frame: Screening, day 1 of cycle 4 (each cycle is 14 days), end of treatment and at long term follow up
Duration of Response (DOR) of AB821 in Patients with Advanced Melanoma
Time frame: Screening, day 1 of cycle 4 (each cycle is 14 days), end of treatment and at long term follow up
Disease Control Rate (DCR) of AB821 in Patients with Advanced Melanoma
Time frame: Screening, day 1 of cycle 4 (each cycle is 14 days), end of treatment and at long term follow up
Progression-Free Survival (PFS) of AB821 in Patients with Advanced Melanoma
Time frame: Screening, day 1 of cycle 4 (each cycle is 14 days), end of treatment and at long term follow up
Overall Survival (OS) of AB821 in Patients with Advanced Melanoma
Time frame: Screening, day 1 of cycle 4 (each cycle is 14 days), end of treatment and at long term follow up
Time to Maximum Concentration (tmax) of AB821 in Serum
Time frame: From the date of enrolment to the final follow up visit, approximately two years after the first dose
Area Under the Curve from Time Zero to Last Measurable Concentration (AUC0-last) of AB821 in Serum
Time frame: From the date of enrolment to the final follow up visit, approximately two years after the first dose
Clearance (CL) of AB821 in Serum
Time frame: From the date of enrolment to the final follow up visit, approximately two years after the first dose
Half-life (t½) of AB821 in Serum
Time frame: From the date of enrolment to the final follow up visit, approximately two years after the first dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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.
Harriet Kluger, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AB821 in people with Advanced Melanoma and Normal or Impaired and Advanced Melanoma, run by Yale University at 1 site in United States.
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 28 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: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Ladd (203-785-5702, stephanie.ladd@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Dose-Limiting Toxicities (DLTs) in patients with advanced melanoma (time frame: From the date of enrolment to the final follow up visit, approximately two years after the first dose). The study lists 7 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 16 Jun 2026.