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

STATUS

Recruiting
End date

Mar 28, 2025
participants needed

65
sponsor

Atreca, Inc.

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Updated on 19 February 2024

See if I qualify

cancer

blood transfusion

breast cancer

measurable disease

growth factor

ovarian cancer

cancer of the ovary

cancer treatment

cancer therapy

colorectal cancer

melanoma

non-small cell lung cancer

ovarian ca

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.

Details

Condition	Non-Small Cell Lung Cancer, Non-Small Cell Lung Cancer, Ovarian disorder, Colorectal Cancer, Colorectal Cancer, Rectal disorder, Breast Cancer, Breast Cancer, Ovarian Cancer, Ovarian Cancer, Acral Lentiginous Melanoma
Age	18-100 years
Treatment	ATRC-101
Clinical Study Identifier	NCT04244552
Sponsor	Atreca, Inc.
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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/L
	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

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