Clinical Trials Actively Recruiting

Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below.

Results 1 - 6 of 6

  • Objective:

    Primary Objectives:

    • Determine the maximum tolerated dose (MTD) of CB-03-10 in subjects with advanced solid tumors
    • Determine the dose-limiting toxicity (DLT) of CB-03-10 in subjects with advanced solid tumors

    Secondary Objectives:

    • Determine a recommended Phase 2 dose (RP2D) of CB-03-10
    • Determine the safety profile of CB-03-10 in subjects with advanced solid tumors
    • Evaluate the activity (response rate, PFS, and OS) of CB-03-10 in subjects with specific solid tumors (e.g., relapsed/refractory pancreatic adenocarcinoma, androgen independent prostate adenocarcinoma, relapsed/refractory triple-negative breast adenocarcinoma)
    • Characterize the pharmacokinetics (PK) of CB-03-10 and its metabolite CB-03-05 as well as cortexolone in plasma and urine.
    Cancer Categories:
    • Brain and Nervous System,Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Head and Neck,Lung,Other,Sarcoma,Skin
    Principal Investigator:
    • Winer, Ira
    Karmanos Trial ID:
    • 2022-036
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:

    Primary Objective:

    • The primary objective of this pilot study is to evaluate tracer uptake and metabolic trapping characteristics based on [18F]FETrp PET/CT in patients with intra- and extracranial cancers; specifically, to evaluate whether the tumors show increased tracer uptake as measured by both tumor maximal and mean standardized uptake value (SUVmax and SUVmean, respectively), as compared to non-tumor tissues. In the special case of breast tumor imaging, the primary objective will be the correlation between the tumors’ SUV values and the apparent volume of distribution (VD’) which will be calculated using kinetic modeling analysis.

    Secondary Objectives:

    • Using dynamic PET imaging to establish the optimal time frame when tracer uptake peaks.
    • Using compartmental modeling (in tumors with the left ventricle of the heart in the field-of-view) to measure tracer transport and trapping variables.
    • To obtain first in human safety, biodistribution, and radiation dosimetry data for [18F]FETrp PET/CT.
    Cancer Categories:
    • Brain and Nervous System,Breast,Genitourinary (GU)
    Principal Investigator:
    • Juhasz, Csaba
    Karmanos Trial ID:
    • 2022-010
    Age Group:
    • Adult
    Phase:
    • NA
  • Objective:

    Primary Objectives

    • Evaluate the safety and tolerability of JTX-8064 as monotherapy and in combination with JTX-4014, pembrolizumab or cemiplimab-rwlc (cemiplimab)
    • Determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) for JTX-8064 as monotherapy and in combination with JTX-4014, pembrolizumab or cemiplimab

    Secondary Objectives

    • Evaluate the pharmacokinetics (PK) and immunogenicity of JTX-8064 as monotherapy and in combination with JTX-4014, pembrolizumab or cemiplimab
    • For Stages 1 and 2, determine the receptor occupancy (RO) for LILRB2 on monocytes in whole blood following JTX-8064 administration
    • For Stages 3 and 4, evaluate the efficacy of JTX-8064 as monotherapy and in combination with JTX-4014, pembrolizumab or cemiplimab

    Exploratory Objectives

    • For Stages 1 and 2, evaluate the efficacy of JTX-8064 as monotherapy and in combination with JTX-4014, pembrolizumab or cemiplimab
    • For Stages 3 and 4, confirm the RO for LILRB2 on monocytes in whole blood following JTX-8064 administration
    • For Stages 1 to 4, assess the effects of JTX-8064 as monotherapy and in combination with JTX-4014, pembrolizumab or cemiplimab on serum cytokines, a comprehensive immunophenotyping panel, and additional exploratory pharmacodynamic (PD) biomarkers in whole blood, plasma, serum and peripheral blood mononuclear cells (PBMCs)
    • For Stages 1 to 4, retrospectively evaluate potential predictive biomarkers in whole blood, plasma, serum, PBMCs, archival and/or pre-treatment tumor biopsy tissue in subjects administered JTX-8064 as monotherapy and in combination with JTX-4014, pembrolizumab or cemiplimab
    • For Stages 3 and 4, compare ribonucleic acid (RNA) and immunohistochemistry (IHC) biomarkers in archival and pre-treatment biopsies
    Cancer Categories:
    • Brain and Nervous System,Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Lung,Skin
    Principal Investigator:
    • Al Hallak, Mohammed
    Karmanos Trial ID:
    • 2021-049
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:
    Primary Objectives
    • The primary objective is to determine the safety of partial brain radiation therapy plus temozolomide and chloroquine followed by Tumor Treating Fields (TTFs) plus temozolomide and chloroquine, specifically grade 3 or higher dermatitis within the first 3 months of the adjuvant therapy phase.

    Secondary Objectives
    • Secondary objective is to measure treatment effect via advanced MRI and AMT-PET. Measurement of the uptake and retention of AMT will be quantitated by maximum standardized uptake values (SUVmax) before and after treatment with TTFs plus temozolomide and chloroquine. AMT-PET results for patients enrolled in the study will be compared to historical control patients treated at our facility with TTFs but without chloroquine. AMT-PET scan results will also be correlated with MRI scan results. Response on MRI scans will be evaluated using RANO criteria.
    Cancer Categories:
    • Brain and Nervous System
    Principal Investigator:
    • Dominello, Michael
    Karmanos Trial ID:
    • 2018-148
    Age Group:
    • Adult
    Phase:
    • Pilot
  • Objective:
    Primary:
    1. Objective: To determine the safety and tolerability of MK-7684 monotherapy and to establish an RPTD
    2. Objective: To determine the safety and tolerability of MK-7684 in combination with pembrolizumab and to establish an RPTD for MK-7684 when used in combination with pembrolizumab
    Secondary:
    1. Objective: To characterize the pharmacokinetic (PK) profiles of MK-7684 when used as monotherapy and in combination with pembrolizumab
    2. Objective: To characterize the PK profile of pembrolizumab after administration of MK-7684 in the combination treatment arm
    3. Objective: To evaluate the anti-tumor activity of MK-7684 when used as monotherapy and in combination with pembrolizumab using Response Evaluat ion Criteria in Solid Tumors (RECIST, version 1.1) as assessed by investigator review and measured by overall response rate (ORR)
    Cancer Categories:
    • Brain and Nervous System,Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Head and Neck,Lung
    Principal Investigator:
    • Winer, Ira
    Karmanos Trial ID:
    • 2017-088
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:
    Cancer Categories:
    • Brain and Nervous System
    Principal Investigator:
    • Juhasz, Csaba
    Karmanos Trial ID:
    • 2011-053
    Age Group:
    • Both
    Phase:
    • NA