Clinical Trials Logo

Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT05338658
Other study ID # 2021LS105
Secondary ID
Status Suspended
Phase Phase 1
First received
Last updated
Start date May 19, 2023
Est. completion date January 2027

Study information

Verified date July 2023
Source Masonic Cancer Center, University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a single center Phase I study with extension of peptide alarm therapy (PAT) administered by intratumoral (IT) injection during the 1st course of a standard of care intravenous PD-1/PD-L1 inhibitor for the treatment of locally advanced or metastatic solid tumor cancers that has failed to be controlled after one or more prior therapies including a previous PD-1/PD-L1 inhibitor


Recruitment information / eligibility

Status Suspended
Enrollment 21
Est. completion date January 2027
Est. primary completion date January 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Must be seropositive for CMV and EBV. - Must have at least one HLA-A*0201 allele. This screening can be performed after determining CMV and EBV seropositivity is established or, if available, from the results of previous tumor profiling by any CLIA-certified lab (i.e. Caris, FoundationOne). - 18 years or older at the time of signing the pre-screening consent. - ECOG Performance Status 0 or 1. - Adequate organ function within 14 days of study enrollment - Cardiac: New York Heart Association (NYHA) Functional Classification Class I. - Pulmonary: oxygen saturation = 90% on room air. - Time between last dose of prior anti-cancer therapy and Day 1 of this study: - Chemotherapy: a minimum of 28 days since last treatment. - Targeted therapy, immunotherapy, investigational agents: a minimum of 45 days since last dose (at least 2 months for anti-VEGF) - Prior palliative radiotherapy within 7 days of start of study treatment. Participants must have recovered from all radiation-related toxicities (prior irradiation to targeted lesions is not permitted) - Must have recovered to CTCAE =Grade 1 from previous treatment related acute toxicities. - Persons of childbearing potential or with partners of childbearing potential must be willing to abstain from heterosexual activity or to use a highly effect form of contraception from the time of study enrollment until at least 4 months after the last dose of PD-1/PD-L1 inhibitor. - Able to understand and provide voluntary written consent prior to the performance of any research related activity. Exclusion Criteria: - Pregnant or breast feeding. - Requires therapeutic anticoagulation for which it is deemed unsafe to discontinue anticoagulation for 5 days prior to Cycle 1 through Day 7 of Cycle 1 - Class II or greater New York Heart Association Functional Classification criteria or serious cardiac arrhythmias likely to increase the risk of cardiac complications of therapy (e.g. ventricular tachycardia, frequent ventricular ectopy, or supraventricular tachyarrhythmia requiring chronic therapy) - Known active CNS metastases - Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). - Has received a live vaccine within 30 days prior to the first dose of study drug. - Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to study enrollment. - Prior bone marrow and/or solid organ transplant. - Has severe hypersensitivity (=Grade 3) to prior PD-1/PD-L1 and/or any of its excipients. - Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. - Has an active infection requiring systemic therapy. - Known seropositive for HIV or known active Hepatitis B or C infection with detectable viral load by PCR - Known history of active TB (Bacillus Tuberculosis) - Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. - Has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, interstitial lung disease, non-infectious pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements in the opinion of the treating investigator.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Peptide Alarm Therapy (PAT)
PAT is given on Day 1 by IT injection after the 1st anti PD-1/PD-L1 infusion and again 36-48 hours later on Day 3.

Locations

Country Name City State
United States Masonic Cancer Center at University of Minnesota Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum tolerated dose (MTD) of peptide alarm therapy (PAT) Use CTCAE v5 criteria to count toxicities per patient including proportions and their 95% confidence intervals will be calculated End of Treatment (typically at day 43)
Secondary Progression free survival (PFS) Kaplan-Meier curves will be used to estimate with a 95% confidence interval. 6 Months
See also
  Status Clinical Trial Phase
Recruiting NCT05580991 - Intratumoral CAN1012(Selective TLR7 Agonist) in Subjects With Solid Tumors Phase 1
Recruiting NCT05691608 - MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2 N/A
Active, not recruiting NCT02846038 - Understanding Communication in Healthcare to Achieve Trust (U-CHAT)
Recruiting NCT05159388 - A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors Phase 1/Phase 2
Completed NCT03181854 - Randomized Controlled Trial of Integrated Early Palliative Care N/A
Recruiting NCT05981703 - A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors Phase 1
Recruiting NCT06014502 - Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Solid Tumors Phase 1
Recruiting NCT04107311 - Prospective Analysis of Intestinal Microbiome and Autoimmune Panels as Predictors of Toxicity in ImmunOncology Patients
Active, not recruiting NCT04078152 - Durvalumab Long-Term Safety and Efficacy Study Phase 4
Completed NCT02250157 - A Dose-regimen Finding Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oratecan in Subjects With Advanced Malignancies Phase 1
Recruiting NCT05566574 - A Study of RP-3500 in Combination With Standard Radiation Therapy in People With Solid Tumor Cancer Phase 1/Phase 2
Recruiting NCT03943004 - Trial of DFP-14927 in Advanced Solid Tumors Phase 1
Recruiting NCT06036836 - Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010) Phase 2
Recruiting NCT05525858 - KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II
Recruiting NCT05798546 - Treatment of Advanced Solid Tumors With Neo-T(GI-NeoT-02) Phase 1
Terminated NCT04586335 - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Phase 1
Active, not recruiting NCT00479128 - Bortezomib With Gemcitabine/Doxorubicin in Patients With Urothelial Cancer and Other Solid Tumors Phase 1
Recruiting NCT04143789 - Evaluation of AP-002 in Patients With Solid Tumors Phase 1/Phase 2
Not yet recruiting NCT04550663 - NKG2D CAR-T(KD-025) in the Treatment of Relapsed or Refractory NKG2DL+ Tumors Phase 1
Completed NCT03980041 - Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275) Phase 2