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Protocol # 20-079

Status

Recruiting

Description

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.

Condition

  • Breast Cancer
  • Colorectal Cancer
  • Ovarian Cancer
  • Non-Small Cell Lung Cancer
  • Acral Lentiginous Melanoma
  • Head and Neck Squamous Cell Carcinoma
  • Hepatocellular Carcinoma
  • Esophageal Squamous Cell Carcinoma
  • Urothelial Carcinoma
  • DMMR Colorectal Cancer
  • MSI-H Colorectal Cancer
  • Melanoma
  • Platinum-Resistant Primary Peritoneal Carcinoma
  • Platinum-Resistant Fallopian Tube Carcinoma
  • Platinum-Resistant Epithelial Ovarian Cancer
  • Triple Negative Breast Cancer

Interventions

  • ATRC-101
  • Pembrolizumab
  • Pegylated liposomal doxorubicin (PLD)

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Incidence of DLTs (dose escalation cohorts only), 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
  • 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
  • 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
  • Levels of ATRC-101 immunoreactivity expressed as H-score, tumor proportion score, and maximum intensity
  • For the PLD Combination Therapy Cohort: ATRC-101 immunoreactivity in tumor biopsies at baseline and during treatment

Enrollment

240

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 Phase 1b Dose Escalation and Expansion Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Biological Activity of ATRC-101 as Monotherapy and in Combination With Other Anticancer Agents 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.