TerminatedPhase 1/2

Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors

Stopped: Strategic considerations

United States200 participantsStarted 2016-09-23

Plain-language summary

The primary objective of this study is to assess the safety and tolerability of rovalpituzumab tesirine in subjects with specific delta-like protein 3-expressing advanced solid tumors.

Who can participate

Age range18 Years – 99 Years

SexALL

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Inclusion criteria

✓. Chemotherapy, small molecule inhibitors, radiation, and/or other investigational anticancer agents (excluding investigational monoclonal antibodies): 2 weeks.
✓. Immune-checkpoint inhibitors (e.g., anti-programmed death protein 1 \[PD-1\], anti-programmed death-ligand 1 \[PD-L1\], or anti-cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\]), monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based therapies: 4 weeks (2 weeks with documented disease progression).

Exclusion criteria

✕. Any active grade 3 or higher (per National Cancer Institute Common Terminology Criteria for Adverse Events version \[NCI CTCAE\] 4.03) viral, bacterial, or fungal infection within 2 weeks of the first dose of the study drug. Routine antimicrobial prophylaxis is permitted.
✕. Known seropositivity for or active infection by human immunodeficiency virus (HIV).
✕. Active Hepatitis B (by surface antigen expression or polymerase chain reaction) or C (by polymerase chain reaction) infection or on hepatitis-related antiviral therapy within 6 months of first dose of study drug.

What they're measuring

Summary of Treatment-Emergent Adverse Events (TEAEs), by Dose and Neuroendocrine (NEC) or Non-NEC Disease Groups

Timeframe: From first dose of study drug through 30 days after last dose. The overall mean number of 6-week treatment cycles was 1 (range 1.0, 5.0).

Trial details

NCT IDNCT02709889

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-08-27

Results submitted2020-08-11

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