Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - Confirmed diagnosis of: - For the monotherapy cohorts: Metastatic or unresectable BC, NSCLC, CRC, ovarian cancer, or acral melanoma that is refractory to standard therapy or for which no standard therapy exists.
- - For the pembrolizumab combination therapy cohort: Metastatic or unresectable NSCLC, CRC (only MSI-H or dMMR), melanoma (with the exception of uveal melanoma), HCC, HNSCC, ESCC or UC with prior or ongoing pembrolizumab treatment and have progressed or have achieved stable disease and who, in the judgment of their treating physicians, could benefit from the addition of ATRC-101 to improve or maintain their response.
- - 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: Metastatic or unresectable 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 BC that is refractory to other standard therapies.
- - Measurable disease based on RECIST v1.1, as assessed by the local site investigator/radiologist.
- - 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.
- - Absolute lymphocyte count (ALC) ≥ 500/ 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.
- - Albumin ≥ 3.0 g/dL.
- - Creatinine clearance or eGFR ≥ 30 mL/min as estimated by the Cockcroft-Gault equation.
- - AST/ALT ≤ 2 x ULN.
- - Bilirubin.
- - For monotherapy and pembrolizumab combination therapy cohorts: ≤ 2 x ULN; or bilirubin ≤ 3 x ULN if due to Gilbert's or Crigler-Najjar disease.
- - For PLD combination therapy cohort: ≤ ULN.
- - Available representative tumor specimens in paraffin blocks (preferred) or ≥ 20 unstained slides, with an associated pathology report, obtained after last systemic anticancer therapy and within 60 days prior to the planned first dose of investigational product.
- - Women of childbearing potential (WOCBP) and fertile males with partners who are WOCBP must use highly effective contraception (per CTFG 2014) from first dose and through 90 days after final dose of investigational product.
- - Willing and able to provide written informed consent and able to comply with all trial procedures.
- - Exclusion Criteria.
- - 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 basal or squamous cell carcinoma of the skin OR curatively treated in situ disease.
- - Autoimmune disease requiring systemic treatment (e.g., with disease modifying agents, corticosteroids, or immunosuppressive drugs) in the past 2 years.
- - Active or prior paraneoplastic neurologic disorder of the central nervous system (CNS) - Prior allograft.
- - 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.
- - 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 anti-Hepatitis B core (anti-HBc) 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.
- - Ongoing ≥ Grade 2 toxicity(ies) due to a previously administered anticancer agent with the following exceptions: - Grade 2 neuropathy or alopecia.
- - For the monotherapy cohorts: Grade 2 immune-related endocrinopathy attributed to a checkpoint inhibitor and controlled with hormone replacement alone.
- - Treatment with biological agents (including monoclonal antibodies) within 28 days of the planned first dose of investigational product with the following exception: o For the pembrolizumab combination therapy cohort: Pembrolizumab treatment within 28 days of the planned first dose of investigational product.
- - Treatment with radiation, chemotherapy or anticancer small molecule therapy within 14 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product.
- - For the PLD combination therapy cohort: - Prior treatment with PLD.
- - Prior treatment with doxorubicin or other anthracycline at cumulative doses greater than 300mg/m2.
- - Anthracycline equivalent doses: 1 mg Doxorubicin = 1.8 mg Epirubicin = 0.3 mg Mitoxantrone = 0.25 mg Idarubicin.
- - Anthracyclines or anti-HER2 agents, if last dose was administered < 1 year before enrollment.
- - Prior mediastinal irradiation > 3500 cGY.
- - Receipt of any investigational drug or device not otherwise specified above within 28 days or 5 half-lives (whichever is longer) prior to the planned first dose of investigational product.
- - Pregnant or breastfeeding; negative pregnancy status in WOCBP must be confirmed by serum pregnancy test at Screening.
- - History of ≥ Grade 3 infusion-related reaction associated with antibody administration, or: - For the monotherapy cohorts: Known allergy/intolerance to ATRC-101 or its excipients.
- - For the pembrolizumab combination therapy cohort: Known allergy/intolerance to ATRC-101, pembrolizumab, or their excipients.
- - For the PLD combination therapy cohort: Known allergy/intolerance to ATRC-101, doxorubicin, or to the excipients of ATRC-101 or PLD.
- - Major surgery or significant traumatic injury occurring within 28 days prior to the planned first dose of investigational product.
- - Prior treatment with ATRC-101.
- - Intercurrent illness that is either life-threatening or of clinical significance such that it might limit compliance with trial requirements, or in the Investigator's assessment would place the participant at an unacceptable risk for participation.
- - Receipt of a live, attenuated vaccine within 28 days of planned Cycle 1-Day 1.
- - For the pembrolizumab combination therapy cohort ONLY: - Experienced ≥ Grade 3 or higher immune related adverse events while on immunotherapy prior to enrollment.
- - Have not recovered from ≥ Grade 2 immune related adverse events attributed to immunotherapy prior to enrollment.
- - NSCLC with epidermal growth factor receptor (EGFR) or anaplastic lymphoma receptor tyrosine kinase (ALK) genomic tumor alterations.
- - Isolated intracranial relapse.
- - Interstitial lung disease or active, non-infectious pneumonitis.
- - Signs and symptoms consistent with clinically significant, decreased pulmonary function: (1) blood saturation oxygen level (SpO2) < 90% at rest on room air; (2) dyspnea at rest (CTCAE ≥ Grade 3) or supplemental oxygen used to maintain adequate oxygenation within 14 days prior to the planned first dose of investigational product.
- - Ongoing immune-related toxicity or immune-related toxicity at any time requiring systemic corticosteroids.
- - For the PLD combination therapy cohort ONLY: - Prior drug-induced cardiotoxicity, defined as a sustained decrease in the ejection fraction (EF) of > 15%.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Jonathan Benjamin, MD, PhD|
|Principal Investigator Affiliation||Atreca, Inc.|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Breast Cancer, Colorectal Cancer, Ovarian Cancer, Non-Small Cell Lung Cancer, Acral Lentiginous Melanoma, Head and Neck Squamous Cell Carcinoma, Hepatocellular Carcinoma, Esophageal Squamous Cell Carcinoma, Urothelial Carcinoma, DMMR Colorectal Cancer, MSI-H Colorectal Cancer, Melanoma, Platinum-Resistant Primary Peritoneal Carcinoma, Platinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Epithelial Ovarian Cancer|
For the ATRC-101 monotherapy cohorts, enrollment is restricted to adults with breast cancer (BC), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), ovarian cancer, and acral melanoma. For the pembrolizumab combination therapy cohort, enrollment is restricted to adults with NSCLC, CRC (only MSI-H or dMMR), melanoma (with the exception of uveal melanoma), hepatocellular carcinoma (HCC), head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC), or urothelial carcinoma (UC), that have been treated with pembrolizumab and have progressed or have achieved stable disease and who, in the judgment of their treating physicians, could benefit from the addition of ATRC-101 to improve or maintain their response. For the PLD combination therapy cohort, enrollment is restricted to adult females with metastatic or unresectable 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 BC that is refractory to other standard therapies.
Experimental: ATRC-101 Q3W
Experimental: ATRC-101 Q2W
Experimental: ATRC-101 Q3W + Pembrolizumab
Pembrolizumab 200mg IV Q3W or 400mg IV Q6W
Experimental: ATRC-101 Q2W + Pegylated liposomal doxorubicin (PLD)
PLD 40mg/m^2 IV Run-in period of 28 days, and then 40mg/m^2 IV Q4W
Biological: - ATRC-101
ATRC-101 is an engineered, fully-human IgG1 antibody derived from a naturally-occurring human antibody.
Biological: - Pembrolizumab
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).
Drug: - Pegylated liposomal doxorubicin (PLD)
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
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.