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