A Phase 1b Trial of ATRC-101 in Adults With Advanced Solid Malignancies
- Conditions
- Breast CancerColorectal CancerOvarian CancerNon-Small Cell Lung CancerAcral Lentiginous MelanomaHead and Neck Squamous Cell CarcinomaHepatocellular CarcinomaEsophageal Squamous Cell CarcinomaUrothelial CarcinomaDMMR Colorectal Cancer
- Interventions
- Registration Number
- NCT04244552
- Lead Sponsor
- Atreca, Inc.
- 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.
- Detailed Description
For the monotherapy cohorts, including the efficacy expansion cohorts, enrollment is restricted to adults with inoperable, locally advanced or metastatic breast cancer, NSCLC, CRC, ovarian cancer, and acral melanoma, which are all tumor types that have demonstrated ATRC-101 immunoreactivity on at least 50% of tested commercially procured archival specimens.
For the pembrolizumab combination therapy cohort, enrollment is restricted to adults with 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, that have been treated with anti-PD-1 or anti-PD-L1 therapy 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.
For the PLD combination therapy cohort, enrollment is restricted to adult females with 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.
For target-enriched expansion cohorts, enrollment will be limited to participants with pretreatment tumor biopsies demonstrating ATRC-101 target expression above a predefined threshold by IHC at a central laboratory.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 87
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description ATRC-101 Q3W ATRC-101 - ATRC-101 Q2W ATRC-101 - ATRC-101 Q3W + Pembrolizumab ATRC-101 Pembrolizumab 200mg IV Q3W or 400mg IV Q6W ATRC-101 Q3W + Pembrolizumab Pembrolizumab Pembrolizumab 200mg IV Q3W or 400mg IV Q6W ATRC-101 Q2W + Pegylated liposomal doxorubicin (PLD) ATRC-101 PLD 40mg/m\^2 IV Run-in period of 28 days, and then 40mg/m\^2 IV Q4W ATRC-101 Q2W + Pegylated liposomal doxorubicin (PLD) Pegylated liposomal doxorubicin (PLD) PLD 40mg/m\^2 IV Run-in period of 28 days, and then 40mg/m\^2 IV Q4W
- Primary Outcome Measures
Name Time Method Incidence of DLTs (dose escalation cohorts only), treatment emergent adverse events (TEAEs), and changes in safety parameters 24 months
- Secondary Outcome Measures
Name Time Method 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 Levels of ATRC-101 immunoreactivity expressed as H-score, tumor proportion score, and maximum intensity 24 months For the PLD Combination Therapy Cohort: ATRC-101 immunoreactivity in tumor biopsies at baseline and during treatment 24 months Enumeration of tumor-infiltrating CD8+ lymphocytes (TILs) in tumor biopsy specimens at baseline and during treatment 24 months Distribution of tumor-infiltrating CD8+ lymphocytes (TILs) in tumor biopsy specimens at baseline and during treatment 24 months
Related Research Topics
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Trial Locations
- Locations (17)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
The University of Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
City of Hope
🇺🇸Duarte, California, United States
University of California, Los Angeles Hematology/Oncology
🇺🇸Los Angeles, California, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Florida Cancer Specialists
🇺🇸Lake Mary, Florida, United States
University of Miami Hospital - Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Nebraska Cancer Specialists
🇺🇸Omaha, Nebraska, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
🇺🇸New York, New York, United States
Scroll for more (7 remaining)Mayo Clinic🇺🇸Rochester, Minnesota, United States