AB821 in Adult Participants With Locally Advanced or Metastatic Solid Tumors (NCT07027488) | Clinical Trial Compass
RecruitingPhase 1
AB821 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
United States50 participantsStarted 2025-08-05
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. ≥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:
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of Dose-Limiting Toxicities (DLTs) in patients with advanced melanoma
Timeframe: From the date of enrolment to the final follow up visit, approximately two years after the first dose
2
Frequency of Serious Adverse Events (SAEs) in patients with advanced melanoma
Timeframe: From the date of enrolment to the final follow up visit, approximately two years after the first dose
3
Frequency of Treatment-Emergent Adverse Events (TEAEs) in patients with advanced melanoma
Timeframe: From the date of enrolment to the final follow up visit, approximately two years after the first dose
4
Frequency of Adverse Events of Special Interest (AESIs) in patients with advanced melanoma
Timeframe: From the date of enrolment to the final follow up visit, approximately two years after the first dose
5
Frequency of Adverse Events (AEs) Leading to Dose Interruption in patients with advanced melanoma
Timeframe: From the date of enrolment to the final follow up visit, approximately two years after the first dose
6
Frequency of Adverse Events (AEs) Leading to Treatment Discontinuation in patients with advanced melanoma
. 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:
Exclusion criteria
. 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.
. 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.
Timeframe: From the date of enrolment to the final follow up visit, approximately two years after the first dose
7
Frequency of Deaths in patients with advanced melanoma
Timeframe: From the date of enrolment to the final follow up visit, approximately two years after the first dose