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A Phase 1b Trial of ATRC-101 in Adults With Advanced Solid Malignancies

NCT04244552 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2023-12-29

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Atreca, Inc.

    lead INDUSTRY

Principal Investigators

  • Sudha Khurana, PhD · Atreca, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-11
Primary Completion
2023-11-01
Completion
2023-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04244552 on ClinicalTrials.gov