TerminatedPhase 1

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

Stopped: Sponsor Decision

United States87 participantsStarted 2020-02-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Individuals with BRAF mutant melanoma must have received BRAF inhibitors alone or in combination with a MEK inhibitor, if indicated.
✓. Individuals with NSCLC should have received platinum-based therapy unless contraindicated
✓. For monotherapy and pembrolizumab combination therapy cohorts: ≥ 1000/µL
✓. For PLD combination therapy cohort: ≥ 1500/µL
✓. For monotherapy and pembrolizumab combination therapy cohorts: ≤ 2 x ULN; or bilirubin ≤ 3 x ULN if due to Gilbert's or Crigler-Najjar disease
✓. For PLD combination therapy cohort: ≤ ULN
✓. For the pembrolizumab combination therapy cohort: A biopsy collected within 60 days of the planned first dose of investigational product while the participant is receiving anti-PD-1/anti-PD-L1 therapy is acceptable.
✓. For target-enriched expansion cohorts, enrollment will be limited to participants with pretreatment tumor biopsies demonstrating ATRC-101 target expression above a predefined threshold by IHC at a central laboratory.

Exclusion criteria

What they're measuring

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

Timeframe: 24 months

Trial details

NCT IDNCT04244552

SponsorAtreca, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-01

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