A Study of IOV-5001 in Adults With Advanced Solid Tumors

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorIovance Biotherapeutics, Inc.

About this trial

A Phase 1/2, multicenter, multi-cohort, open-label study of an autologous tumor-infiltrating lymphocytes (TIL) regimen with IOV-5001 in participants with previously treated advanced solid tumors

Eligibility criteria

Qualifiers

Participant must be ≥ 18 years of age at the time of signing the informed consent.

Radiographic disease progression: Participant has radiographic disease progression after the most recent line of therapy.

After having received platinum-based chemotherapy and an immune checkpoint inhibitor, either administered concurrently or sequentially for Stage IV disease.

Within 6 months of completion of the platinum component of platinum-based chemotherapy in the adjuvant or neoadjuvant setting and having progressed after receiving an immune checkpoint inhibitor in the neoadjuvant, adjuvant, or metastatic setting.

Disqualifiers

Participants with symptomatic untreated brain metastases. Participants with brain metastases may be enrolled with considerations and discussion with medical monitor.

Participant has an active medical illness(es) that, in the opinion of the investigator would pose increased risks for study participation. Participant has evidence of any active viral, bacterial, or fungal infection requiring ongoing systemic treatment or identified during screening.

Participant has any form of primary immunodeficiency (eg, severe combined immunodeficiency disease [SCID] or AIDS).

Participant has a history of hypersensitivity to any component of the study intervention.

Trial design

Treatments tested in this trial

  • IOV-5001

Treatment groups

106 Participants
are divided into 5 treatment groups

Locations

This trial has no locations

Sponsors and collaborators