First-in-Human Dose Escalation Trial of ATRC-101 in Adults With Advanced Solid Malignancies

Brief Title

First-in-Human Dose Escalation Trial of ATRC-101 in Adults With Advanced Solid Malignancies

Official Title

A First-in-Human Phase 1b Dose Escalation Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Biological Activity of ATRC-101 in Adults With Advanced Solid Malignancies

Brief Summary

      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.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Incidence of DLTs, treatment emergent adverse events (TEAEs), and changes in safety parameters

Secondary Outcome

 Maximum plasma concentration (Cmax) of ATRC-101

Condition

Breast Cancer

Intervention

ATRC-101

Study Arms / Comparison Groups

 ATRC-101 Dose Escalation
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

65

Start Date

February 11, 2020

Completion Date

March 2025

Primary Completion Date

December 2024

Eligibility Criteria

        Inclusion Criteria:

          -  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:

          -  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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 650-453-5279, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04244552

Organization ID

ATRC-101-A01


Responsible Party

Sponsor

Study Sponsor

Atreca, Inc.


Study Sponsor

, , 


Verification Date

September 2020