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 - 10 of 28

  • Objective:
    Primary Objective:
    • Phase I: To establish the preferred dose of niraparib in combination with radiation and ADT
    • Phase IIR: To compare the disease-free state, defined as PSA remaining less than 0.1 ng/ml at the end of ADT therapy in men with high risk prostate cancer treated with standard therapy with or without the addition of niraparib
    Secondary Objectives:
    • To further establish the safety and toxicity profile of standard treatment with radiation and androgen deprivation therapy specifically, two years from initiation of ADT, plus niraparib at the phase II dose
    • To compare the overall survival, prostate cancer-specific survival, local/regional or distant progression, and distant metastatic disease rates of standard therapy with or without the addition of niraparib. Although the clinical benefit of niraparib in combination with radiotherapy and ADT has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief in addition to dose, safety and tolerability.
    Cancer Categories:
    • Genitourinary (GU)
    Principal Investigator:
    • Yeh, Brian
    Karmanos Trial ID:
    • NRG-GU007
    Age Group:
    • Adult
    Phase:
    • Phase I/II
  • Objective:
    Primary Objective
    • Compare metastasis-free survival (MFS) of salvage RT and GnRH agonist/antagonist vs. RT/ GnRH agonist/antagonist with abiraterone acetate with prednisone and apalutamide for patients with pathologic node-positive prostate cancer after radical prostatectomy with detectable PSA.
    Secondary Objectives
    • Compare health-related quality of life (EPIC26, EQ5D5L, Brief Pain Inventory, PROMISFatigue) among the treatment arms.
    • Compare overall survival, biochemical progression-free survival, time to local-regional progression, time to castrate resistance, and cancer-specific survival among the treatment arms.
    • Compare the shor-tterm and long-term treatment-related adverse events among the treatment arms.
    Cancer Categories:
    • Genitourinary (GU)
    Principal Investigator:
    • Yeh, Brian
    Karmanos Trial ID:
    • NRG-GU008
    Age Group:
    • Adult
    Phase:
    • Phase III
  • Objective:

    Primary Objective:

    • To evaluate the efficacy of disitamab vedotin in previously treated subjects with LA/mUC as measured by confirmed ORR assessed by independent central review (ICR):
      • in all subjects,
      • in Cohort A (subjects with HER2 IHC 3+ or IHC 2+ with ISH+ tumors),
      • in Cohort B (subjects with HER2 IHC 2+ with ISH-negative or IHC 1+ tumors)

    Secondary Objectives:

    • To evaluate the efficacy of disitamab vedotin as measured by confirmed ORR assessed by Investigator: in all subjects and in Cohorts A and B
    • To evaluate the efficacy of disitamab vedotin as measured by DOR: in all subjects and in Cohorts A and B
    • To evaluate the efficacy of disitamab vedotin as measured by PFS: in all subjects and in Cohorts A and B
    • To evaluate the efficacy of disitamab vedotin as measured by DCR: in all subjects and in Cohorts A and B
    • To evaluate the efficacy of disitamab vedotin as measured by OS: in all subjects and in Cohorts A and B
    • To evaluate the safety and tolerability of disitamab vedotin
    • To investigate the PK characteristics of disitamab vedotin, free MMAE, and the total amount of
      conjugated or unconjugated antibody
    • To evaluate the immunogenicity of disitamab vedotin
    Cancer Categories:
    • Genitourinary (GU)
    Principal Investigator:
    • Heath, Elisabeth
    Karmanos Trial ID:
    • 2022-048
    Age Group:
    • Adult
    Phase:
    • Phase II
  • Objective:

    Primary Objectives:

    • To assess the safety and tolerability of ORIC-944
    • To assess the pharmacokinetics (PK) of ORIC-944

    Secondary Objectives:

    • To evaluate the preliminary antitumor activity of ORIC-944

    Exploratory Objectives:

    • To evaluate additional indicators of antitumor activity of ORIC-944
    • To characterize and/or quantify metabolites of ORIC-944 in plasma
    • To evaluate target engagement and the association of pharmacodynamic (PD) biomarkers with ORIC-944 antitumor activity and/or PK
    • To evaluate the association between potential predictive biomarkers and antitumor activity of ORIC-944
    Cancer Categories:
    • Genitourinary (GU)
    Principal Investigator:
    • Heath, Elisabeth
    Karmanos Trial ID:
    • 2022-031
    Age Group:
    • Adult
    Phase:
    • Phase I
  • 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 Objectives:

    Phase 1

    • Assess safety and tolerability of NUV-868 as monotherapy and determine the recommended phase 2 dose (RP2D) for monotherapy treatment

    Phase 1b

    • Assess safety and tolerability of NUV-868 as combination therapy and determine the recommended phase 2 combination dose (RP2cD) for each combination treatment
    • Evaluate the potential drug interaction between NUV-868 and olaparib
    • Evaluate the potential drug interaction between NUV-868 and enzalutamide

    Phase 2

    • Evaluate efficacy of NUV-868 as monotherapy

    Phase 2b

    • Evaluate efficacy of NUV-868 as combination therapy

    Secondary Objectives:

    Phase 1

    • Explore preliminary efficacy of NUV-868 as monotherapy
    • Characterize the PK profile of NUV-868
    • Characterize the effect of food on the PK profile of NUV-868

    Phase 1b

    • Explore preliminary efficacy of NUV-868 as combination treatment

    Phase 2

    • Further evaluate efficacy of NUV-868 as monotherapy

    Phase 2b

    • Further evaluate efficacy of NUV-868 as combination therapy

    Phase 2 and Phase 2b

    • Evaluate drug exposure response relationship

    Phase 1, 1b, 2 and Phase 2b

    • Further evaluate safety
    Cancer Categories:
    • Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic
    Principal Investigator:
    • Shields, Anthony
    Karmanos Trial ID:
    • 2022-026
    Age Group:
    • Adult
    Phase:
    • Phase I/II
  • Objective:

    Primary Objective:

    • to establish the maximum tolerated dose (MTD) and evaluate the safety and tolerability of HC-5404-FU when orally administered in a dose-escalating fashion in subjects with advanced solid tumors.

    Secondary Objectives:

    • to determine the plasma concentrations and pharmacokinetic (PK) parameters of HC-5404 following single and multiple doses of HC-5404 administered to subjects with advanced solid tumors
    • to preliminarily assess the potential antitumor activity of HC-5404-FU in terms of response rates and survival outcomes.
    Cancer Categories:
    • Breast,Gastrointestinal (GI),Genitourinary (GU),Lung
    Principal Investigator:
    • Uprety, Dipesh
    Karmanos Trial ID:
    • 2022-004
    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 OBJECTIVE:

    • To evaluate safety of IV and IT CF33-hNIS in monotherapy and in combination with pembrolizumab.  To determine Recommended Phase 2 Dose (RP2D) of CF33-hNIS in monotherapy and in combination with pembrolizumab.

    SECONDARY OBJECTIVES:

    • Anti-tumor activity of CF33-hNIS administered as a monotherapy and in combination with pembrolizumab based on objective response rate (ORR) using RECIST v1.1 (Seymour et al., 2017) and immune Response Evaluation Criteria in Solid Tumors (iRECIST) v1.0
    • Efficacy of IT and IV CF33-hNIS administered as a monotherapy and in combination with pembrolizumab:
      a. Progression-free survival (PFS)
      b. Overall survival (OS)
      c. Duration of Response (DOR)
      d. Disease Control Rate (DCR)
    • Viral titers of CF33-hNIS
    • Infection of tumors with CF33-hNIS
    Cancer Categories:
    • Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Head and Neck,Lung
    Principal Investigator:
    • Mamdani, Hirva
    Karmanos Trial ID:
    • 2021-071
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:

    Primary Objectives

    • To assess if the addition of darolutamide to ADT compared with ADT alone would result in superior clinical efficacy in participants with metastatic hormonesensitive prostate cancer (mHSPC) by superior progression-free survival (PFS)

    Secondary Objectives

    • To assess if the addition of darolutamide to ADT compared to ADT alone can prolong overall survival
    • To assess radiographic progression-free survival in participants who received darolutamide plus ADT
    • To assess if the addition of darolutamide to ADT compared to ADT alone can increase the time to castration-resistant prostate cancer (CRPC)
    • To assess the complete PSA response rate at 6 months in the ADT + darolutamide arm vs ADT alone
    • To assess the frequency of adverse events and the safety of darolutamide combined with ADT versus ADT alone
    Cancer Categories:
    • Genitourinary (GU)
    Principal Investigator:
    • Heath, Elisabeth
    Karmanos Trial ID:
    • 2021-063
    Age Group:
    • Adult
    Phase:
    • Phase II