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Protocol # 20-079

Status

Recruiting

Description

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.

Condition

  • Breast Cancer
  • Colorectal Cancer
  • Ovarian Cancer
  • Non Small Cell Lung Cancer
  • Acral Lentiginous Melanoma

Interventions

  • ATRC-101

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

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

Secondary Outcome:

  • Maximum plasma concentration (Cmax) of ATRC-101
  • Elimination half-life (t1/2) of ATRC-101
  • Area under the plasma concentration-time curve from zero to the last measurable concentration [AUC(0-t)] of ATRC-101
  • Incidence of anti-drug antibodies (ADAs) and ATRC-101 neutralizing antibodies
  • Best Overall Response Rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Enumeration of tumor-infiltrating CD8+ lymphocytes (TILs) in tumor biopsy specimens at baseline and during treatment
  • Distribution of tumor-infiltrating CD8+ lymphocytes (TILs) in tumor biopsy specimens at baseline and during treatment

Enrollment

65

Study Start Date

February 11, 2020

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Atreca, Inc.

Source

Atreca, Inc.

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

Clinicaltrials.gov Identifier

NCT04244552

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.