AB821 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
≥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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
AB821
DrugAB821 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: AB821Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From the date of enrolment to the final follow up visit, approximately two years after the first dose2
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.
Time frame
From the date of enrolment to the final follow up visit, approximately two years after the first dose3
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.
Time frame
From the date of enrolment to the final follow up visit, approximately two years after the first dose4
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.
Time frame
From the date of enrolment to the final follow up visit, approximately two years after the first doseSecondary outcomes
1
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.
Time frame
From the date of enrolment to the final follow up visit, approximately two years after the first dose2
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.
Time frame
From the date of enrolment to the final follow up visit, approximately two years after the first dose3
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).
Time frame
Screening, day 1 of cycle 4 (each cycle is 14 days), end of treatment and at long term follow up4
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.
Time frame
Screening, day 1 of cycle 4 (each cycle is 14 days), end of treatment and at long term follow upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
Asher Biotherapeutics, Inc.
Collaborator
Source ClinicalTrials.gov