The research company Atreca, Inc is conducting the clinical trial First-in-Human Dose Escalation Trial of ATRC-101 in Adults With Advanced Solid Malignancies.
ATRC-101-A01 is a first-in-human, Phase 1b, open-label trial to characterize the safety, tolerability, pharmacokinetics (PK), and biological activity of escalating doses of ATRC-101, an engineered, fully human immunoglobulin G, subclass 1 (IgG1) antibody derived from a naturally-occurring human antibody.
It is planned to include 65 participants.
Actual study start date is February 11, 2020. The researchers expect to complete the study by March 2025.
One primary outcome measure is Incidence of DLTs, treatment emergent adverse events (TEAEs), and changes in safety parameters.
The following population may be included into the study:
- Confirmed diagnosis of metastatic or unresectable breast cancer, NSCLC, colorectal cancer, 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.
- Measurable disease based on RECIST v1.1 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 - Available representative tumor specimens in paraffin blocks (preferred) or ≥ 20 unstained slides, with an associated pathology report, obtained after last systemic anti-cancer 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 include:
- 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.
- Primary immunodeficiency affecting cellular immunity (2017 IUIS Classification.
- Active autoimmune disease with the exception of Type I Diabetes Mellitus, hypothyroidism requiring hormone replacement only, an autoimmune dermatologic condition that is managed without systemic therapy, or autoimmune arthritis that is managed without systemic therapy.
- 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 the first dose of investigational product, unstable angina, congestive heart failure (New York Heart Association ≥ Class III), or unstable cardiac arrhythmia requiring medication .
- 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 (after consultation with the Medical Monitor) - 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 - 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.
- Treatment with radiation, chemotherapy or anticancer small molecule therapy within 14 days or 5 half-lives (whichever is longer) prior to the planned first dose of investigational product. Treatment with nitrosoureas or mitomycin C require a 42-day washout prior to the planned first dose of investigational product.
- Receipt of any investigational drug or device not otherwise specified above within 14 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.
- Known allergy/intolerance to ATRC-101 or its excipients; or history of ≥ Grade 3 infusion reaction associated with antibody administration.
- Major surgery or significant traumatic injury occurring within 28 days prior to the planned first dose of investigational product. If major surgery occurred > 28 days prior to Cycle 1-Day 1, individual must have recovered adequately from the toxicity and/or complications from the intervention prior to Cycle 1-Day 1.
- 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 is one of the inclusion criteria.
The more detailed description of the study can be found here: https://ichgcp.net/clinical-trials-registry/NCT04244552
Clinical Research News
Upcoming Clinical Trials
NCT04024696RecruitingA Clinical Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Abexinostat in Chinese PatientsConditions: Non Hodgkin Lymphoma
NCT04016090RecruitingConditions: Healthy Aging, Aging, Menopause
NCT04014348RecruitingGeospatial Analysis of Neighborhood Environmental Stress in Relation to Biological Markers of Cardiovascular Health and Health Behaviors in WomenConditions: Cardiovascular (CV) Risk
NCT04013217RecruitingConditions: Solid Tumor
NCT04034251RecruitingIntraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal CarcinomatosisConditions: Gastric Adenocarcinoma, Gastric Cancer, Esophagogastric Junction, Peritoneal Carcinomatosis
NCT04033445RecruitingConditions: Ulcerative Colitis
NCT04050007RecruitingConditions: Respiratory Insufficiency
NCT04049604RecruitingConditions: Maternal Neoplasia
NCT04045600RecruitingConditions: Aggression, Self-injurious Behavior
Recent CRA jobs
Senior Director, Real World Evidence
Data Management Lead (Bloemfontein, Centurion or Decentralized, SA)
Senior Associate Clinical Outcomes Assessment (UK/EU locations)
Senior Director, Business Transformation Relationship Management
Associate Scientific Director, Genomic Medicine
SD/D, Business Unit Head, Medical Communication, APAC
Data Coordinator - MRL
Systems Engineer Co-Op - Fall 2021
Software Development Co-Op - Fall 2021