Study Stopped
Sponsor Decision
A Phase 1b Trial of ATRC-101 in Adults With Advanced Solid Malignancies
A Phase 1b Dose Escalation and Expansion Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Biological Activity of ATRC-101 as Monotherapy and in Combination With Other Anticancer Agents in Adults With Advanced Solid Malignancies
1 other identifier
interventional
87
1 country
19
Brief Summary
ATRC-101-A01 is a Phase 1b, open-label dose escalation and expansion trial of ATRC-101, an engineered fully human immunoglobulin G, subclass 1 (IgG1) antibody derived from a naturally occurring human antibody. The safety, tolerability, PK, and biological activity of ATRC-101 will be characterized when administered every two weeks (Q2W) or every 3 weeks (Q3W) as a monotherapy or in combination with other anticancer agents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 breast-cancer
Started Feb 2020
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2020
CompletedFirst Posted
Study publicly available on registry
January 28, 2020
CompletedStudy Start
First participant enrolled
February 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2023
CompletedDecember 29, 2023
December 1, 2023
3.7 years
January 21, 2020
December 26, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of DLTs (dose escalation cohorts only), treatment emergent adverse events (TEAEs), and changes in safety parameters
24 months
Secondary Outcomes (9)
Maximum plasma concentration (Cmax) of ATRC-101
24 months
Elimination half-life (t1/2) of ATRC-101
24 months
Area under the plasma concentration-time curve from zero to the last measurable concentration [AUC(0-t)] of ATRC-101
24 months
Incidence of anti-drug antibodies (ADAs) and ATRC-101 neutralizing antibodies
24 months
Overall Response Rate (ORR), defined as the proportion of participants with a CR or a PR on two consecutive occasions > 4 weeks apart, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
24 months
- +4 more secondary outcomes
Study Arms (4)
ATRC-101 Q3W
EXPERIMENTALATRC-101 Q2W
EXPERIMENTALATRC-101 Q3W + Pembrolizumab
EXPERIMENTALPembrolizumab 200mg IV Q3W or 400mg IV Q6W
ATRC-101 Q2W + Pegylated liposomal doxorubicin (PLD)
EXPERIMENTALPLD 40mg/m\^2 IV Run-in period of 28 days, and then 40mg/m\^2 IV Q4W
Interventions
ATRC-101 is an engineered, fully-human IgG1 antibody derived from a naturally-occurring human antibody.
Pembrolizumab (Keytruda®) is a humanized immunoglobulin G4 monoclonal antibody with high specificity of binding to the programmed cell death 1 (PD-1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2).
Pegylated liposomal doxorubicin (PLD) is doxorubicin hydrochloride (HCl), an anthracycline topoisomerase inhibitor that can bind DNA and inhibit nucleic acid synthesis. PLD is doxorubicin HCL encapsulated in liposomes formulated with surface-bound methoxypolyethylene glycol
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of:
- For the monotherapy cohorts: Inoperable, locally advanced or metastatic breast cancer, NSCLC, CRC, ovarian cancer, or acral melanoma that is refractory to standard therapy or for which no standard therapy exists. Participants who are considered intolerant of or ineligible for standard therapy(ies), as well as participants who have been offered but refused standard therapy(ies), may also be eligible.
- For the pembrolizumab combination therapy cohort: Inoperable, locally advanced or metastatic NSCLC, CRC (only MSI-H or dMMR), melanoma (with the exception of uveal melanoma), HCC, HNSCC, ESCC,UC, or TNBC with prior or ongoing anti-PD-1 or anti-PD-L1 treatment and have progressed radiographically or have achieved stable disease for a minimum of two months and who, in the judgment of their treating physicians, could benefit from a combination of ATRC-101 and pembrolizumab . The anti-PD-1/anti-PD-L1 therapy must be FDA approved for their cancer indication at the time of screening. Patients with the tumor types eligible for monotherapy that are TMB-H, MSI-H or dMMR and have had an unsatisfactory response to anti-PD-1/anti-PD-L1 therapy may enroll for the pembrolizumab combination, and additional indications that have been identified as ATRC-101 target positive and are FDA approved for pembrolizumab may be added following discussion with the study Medical Monitor.
- Individuals with BRAF mutant melanoma must have received BRAF inhibitors alone or in combination with a MEK inhibitor, if indicated.
- Individuals with NSCLC should have received platinum-based therapy unless contraindicated
- For the PLD combination therapy cohort: Inoperable, locally advanced or metastatic high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer that is platinum resistant, defined as progression during or within 6 months of the last dose of platinum-based chemotherapy OR breast cancer that is refractory to other standard therapies.
- Measurable disease based on RECIST 1.1, as assessed by the local site investigator/radiologist. As per RECIST, lesions situated in an area treated with radiation or other loco-regional therapy are considered measurable only if progression has been demonstrated in such lesions following loco-regional therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Adequate organ and marrow function (i.e., without chronic, ongoing growth factor or transfusion support) at Screening as defined by the following laboratory parameters via central laboratory results:
- Absolute neutrophil count (ANC)
- For monotherapy and pembrolizumab combination therapy cohorts: ≥ 1000/µL
- For PLD combination therapy cohort: ≥ 1500/µL
- Platelet count ≥ 75,000/µL
- Hemoglobin ≥ 9.0 g/dL
- PT/INR, aPTT ≤ 1.5 x ULN unless participant is receiving a stable dose of therapeutic anticoagulation
- +11 more criteria
You may not qualify if:
- Individuals who meet any of the following criteria are not eligible to participate in this trial:
- Disease that is suitable for local therapy administered with curative intent.
- Malignant disease other than the malignancy to be investigated in this trial within the last 5 years with the exception of:
- a. malignancies previously treated with curative intent with a 5-year OS rate \>90% (consultation with the Medical Monitor is required prior to enrollment).
- Autoimmune disease requiring systemic treatment (e.g., with disease modifying agents, corticosteroids, or immunosuppressive drugs) in the past 2 years. Hormone replacement therapy (e.g., insulin, thyroxine, and replacement-dose hydrocortisone) is not considered systemic treatment for the autoimmune disease.
- Active or prior paraneoplastic neurologic disorder of the central nervous system (CNS) or history of leptomeningeal disease
- Clinically significant cardiovascular disease, e.g., cerebral vascular accident/stroke or myocardial infarction, within 6 months prior to first dose of investigational product, unstable angina, congestive heart failure (New York Heart Association ≥ Class III), or unstable cardiac arrhythmia requiring medication
- For the PLD Combination Therapy Cohort:
- Any history of documented congestive heart failure (CHF), arrhythmia, or uncontrolled hypertension (systolic BP \> 200 mmHg or diastolic BP \> 100 mmHg)
- Left ventricular ejection fraction measure by echocardiography or multigated radionuclide acquisition (MUGA) below normal limits for the institution
- Presence of active, symptomatic, or untreated CNS metastasis; or CNS metastasis that requires local directed therapy or increasing doses of corticosteroids within the 2 weeks prior to the planned first dose of investigational product. Individuals with treated and/or asymptomatic CNS disease may be enrolled if neurologically stable over the prior 2 weeks (and after consultation with the Medical Monitor) provided there is measurable disease (RECIST 1.1) outside of the CNS and there is no ongoing requirement for corticosteroids to manage the disease
- HIV infection with an AIDS-defining opportunistic infection within the past 12 months or with a CD4+ T cell count \<350/µL
- Hepatitis B surface antigen (HbsAg) positive OR Hepatitis B core antibody (anti-HBc or HBcAb) positive and HBV viral load above the lower limit of quantification
- Hepatitis C antibody positive with HCV viral load greater than or equal to the lower limit of quantification
- Infection requiring intravenous antibacterial, antiviral, or antifungal therapy within 2 weeks prior to the planned first dose of investigational product
- +32 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Atreca, Inc.lead
Study Sites (19)
Mayo Clinic
Phoenix, Arizona, 85054, United States
The University of Arizona Cancer Center
Tucson, Arizona, 85719, United States
City of Hope
Duarte, California, 91010, United States
University of California, Los Angeles Hematology/Oncology
Los Angeles, California, 90095, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Florida Cancer Specialists
Lake Mary, Florida, 32746, United States
University of Miami Hospital - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Mayo Clinic
Rochester, Minnesota, 55902, United States
Nebraska Cancer Specialists
Omaha, Nebraska, 68130, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Oncology Specialists of Charlotte
Charlotte, North Carolina, 28207, United States
Carolina BioOncology
Huntersville, North Carolina, 28078, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Stephenson Cancer Center, University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Oncology Consultants, PLLC
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sudha Khurana, PhD
Atreca, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2020
First Posted
January 28, 2020
Study Start
February 11, 2020
Primary Completion
November 1, 2023
Study Completion
November 1, 2023
Last Updated
December 29, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share