Phase 1 Trial of SYNC-T - Immunotherapy for Patients With Advanced/Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWilliams Cancer Foundation
About this trial
SV-101 is intended to overcome the complex and multifactorial nature of the mechanisms mediating tumor immune evasion, by the use of a combination of therapeutic agents that elicit multiple immuno-pharmacologic effects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female, aged >18 years old at the time of signed informed consent
Provide written informed consent and must be willing to adhere with treatment and follow-up.
Subjects with advanced and/or metastatic histologically or cytologically confirmed solid tumor who have not responded or progressed after standard therapies or for whom no further standard therapy exists or standard therapy is not available.
Meet all eligibility criteria
Disqualifiers
Has a known additional malignancy that is progressing or has required active treatment in the last 3 years, excluding basal and squamous cell carcinoma
Has undergone major surgery within 28 days prior to enrollment and has not recovered adequately from the toxicities and/or complications
Has an active infection (including tuberculosis) requiring systemic therapy
Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
Trial design
Design model
Single group
Treatments tested in this trial
SV-101
DrugSV-101 is intended to overcome the complex and multifactorial nature of the mechanisms mediating tumor immune evasion, by the use of a combination of therapeutic agents that elicit multiple immuno-pharmacologic effects.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Treatment ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Antitumor activity
To assess the preliminary antitumor activity of SV-101 as measured by RECIST 1.1 and iRECIST
Time frame
4-6 weeks after each treatmentSecondary outcomes
1
To evaluate rate of adverse events (AEs), including serious adverse events (SAEs) and AEs leading to treatment discontinuation
Safety assessment will include protocol-specified periodic physical examination findings, vital signs, ECOG performance status, protocol-specified laboratory variables (e.g. hematology, coagulation tests, serum chemistry, urine tests), AEs using CTCAE v5.1, and SAEs.
Time frame
Beginning at baseline and including pre-intervention/procedure and through study completion over 1 year periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
Williams Cancer Foundation
Lead sponsor
Syncromune, Inc.
Collaborator
Source ClinicalTrials.gov