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New treatment option for Advanced Melanoma and Normal or Impaired
Official title AB821 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT07027488
What this study is testing
What is AB821?
AB821 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced melanoma and normal or impaired.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- ≥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...
- 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...
You likely can't join if
- 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...
- Active Grade ≥2 diarrhea or enterocolitis.
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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.
What rules you out
- 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)...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.