Advanced Solid Tumor Clinical Trials & Research at St. Joseph Health Medical Group

St. Joseph Health Medical Group is currently enrolling patients for the following advanced solid tumor clinical trials:

A Phase Ib Open‑Label, Dose‑Finding Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Avelumab in Combination with M9241 (NHS-IL12) in Subjects with Locally Advanced, Unresectable, or Metastatic Solid Tumors (EMD 0031)

Phase Ib

The purpose of this study is to evaluate the safety and preliminary efficacy of avelumab in combination with NHS-IL12 in subjects with metastatic or locally advanced unresectable solid tumors. This dose escalation study will establish a safe dose of NHS-IL12 and avelumab when given in combination. This clinical study is being proposed as part of a regular development program to design rational combination therapy with avelumab, in order to achieve clinical benefit with immunotherapy in a greater proportion of subjects. The indications for the 4 expansion cohorts to be selected are:

  • Urothelial carcinoma: patients with UC whose disease had progressed after treatment with platinum-based chemotherapy;
  • Non-small cell lung cancer: subjects with metastatic NSCLC who have not received systemic treatment for their metastatic disease and have low tumor PD-L1 expression. Subjects whose tumors have an activating EGFR mutation or ALK rearrangement are not be eligible, as standard of care treatment for these patients is with the appropriate targeted therapy;
  • Renal cell carcinoma: subjects with metastatic RCC who have failed prior therapy with any antibody / drug targeting T-cell co-regulatory proteins for advanced or metastatic disease, irrespective of the line of therapy in which it was received or whether it was received as monotherapy or part of a combination regimen;
  • Colorectal cancer: subjects with microsatellite instability (MSI)-low or microsatellite stable (MSS) metastatic CRC who have received at least 1 line of therapy for metastatic disease.

Treatment agent: Avelumab + NHS-IL12 (interleukin-12 Ab conjugate)
PI: Thomas Stanton, MD
Study Coordinator: Camille Shaffer // Camille.Shaffer@stjoe.org // (707) 521-3809
Resources and Links: clinicaltrials.gov NCT No: NCT02994953

eFT508 in Combination With PD-1/PD-L1 Inhibitor Therapy: A Study of Subjects Administered Anti-PD-1/Anti-PD-L1 Therapy That Are Experiencing Insufficient Response to Checkpoint Inhibitor Alone (eFFECTOR)

Phase II

This study will evaluate the safety, tolerability, antitumor activity, and PK of eFT508 in subjects who have initiated anti-PD-1/anti-PD-L1 monotherapy and either developed progressive disease on therapy or have undergone more than 12 weeks of anti-PD-1/anti-PD-L1 therapy with no evidence of progressive disease or complete response. Subjects will continue their anti-PD-1/anti-PD-L1 therapy, which they had already initiated per standard of care according to the package insert, and then initiate eFT508 prior to their next scheduled anti-PD-1/anti-PD-L1 therapy.

Treatment agent: eFT508 + PD-1/PD-L1 Inhibitor Therapy
PI: Thomas Stanton, MD
Study Coordinator: Camille Shaffer // Camille.Shaffer@stjoe.org // (707) 521-3809
Resources and Links: clinicaltrials.gov NCT No: NCT03616834

A Multi-Center, Open-Label, Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Fruquintinib in Advanced Solid Tumors (Hutchison)

Phase I

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of fruquintinib in patients with advanced solid tumors. Multiple doses fruquintinib will be used to investigate the metabolite profile of fruquintinib in the plasma of patients with advanced solid tumors.

Treatment agent: Fruquintinib
PI: Thomas Stanton, MD
Study Coordinator: Sabine Ucik // Sabine.Ucik@stjoe.org // (707) 521-3830
Resources and Links: clinicaltrials.gov NCT No: NCT03251378

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