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 10

  • Objective:

    Primary Objectives:

    • To evaluate the feasibility of molecular characterization based on TMB for
      participant stratification, as assessed by the proportion of participants with less
      than or equal to a 21-day turnaround time for biopsy results in Stage I of the study.
    • To evaluate the feasibility of molecular characterization based on TMB and GEP
      (for TIS) for stratification in the overall study (Stage I and Stage II).
    • To evaluate the efficacy by overall response rate (ORR – defined as confirmed
      and unconfirmed partial responses plus complete responses) of cabozantinib plus
      nivolumab in each disease cohort, both across and within tumor biomarker
      subgroups.

    Secondary Objectives:

    • To assess the difference in ORR in each disease cohort between tumor marker
      subgroups separately for each disease cohort.
    • To assess safety and tolerability of this treatment in these populations.
    • To estimate disease control rate (DCR) in participants receiving cabozantinib plus
      nivolumab in each disease cohort, stratified by tumor biomarkers.
    • To estimate progression-free survival (PFS) in participants receiving cabozantinib
      plus nivolumab in each disease cohort, stratified by tumor biomarkers.
    • To estimate overall survival (OS) in participants receiving cabozantinib plus
      nivolumab in each disease cohort, stratified by tumor biomarkers.
    • To assess the proportion of patients with assay failure, and the time from the date
      of tissue collection to molecular group determination at the end of Stage I.
    • To assess turnaround time for TIS for at least 30 patients in Stage I to ensure that
      at least 75% have a turnaround time of <21 days. If TIS is not ready for real-time
      testing when 30 slots remain for Stage I, accrual will be paused until assay
      validation is complete
    Cancer Categories:
    • Head and Neck,Skin
    Principal Investigator:
    • Sukari, Ammar
    Karmanos Trial ID:
    • S2101
    Age Group:
    • Adult
    Phase:
    • Phase II
  • Objective:

    Dose Escalation (Monotherapy)

    Primary Objectives:

    • To evaluate safety and tolerability of MDNA11 administered in patients with advanced solid tumors
    • To identify RDE and/or MTD of MDNA11.

    Secondary Objectives:

    • To assess anti-tumor activity of MDNA11
    • To assess pharmacokinetic (PK) profile of MDNA11
    • To assess immunogenicity of MDNA11
    • To assess pharmacodynamic effects of MDNA11

    Dose Expansion (Monotherapy and Combination Therapy)

    Primary Objectives:

    • To further evaluate safety and tolerability of MDNA11 (alone or in combination with pembrolizumab)
    • To assess anti-tumor activity of MDNA11 (alone or in combination with pembrolizumab)

    Secondary Objectives:

    • To assess pharmacodynamic effects of MDNA11 (alone or in combination pembrolizumab) in peripheral blood
    • To assess pharmacodynamic effects and immune response of MDNA11 (alone or in combination pembrolizumab) in tumor tissue
    • To further assess PK profile of MDNA11
    • To assess immunogenicity of MDNA11 (alone or in combination pembrolizumab)
    Cancer Categories:
    • Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Head and Neck,Lung,Skin
    Principal Investigator:
    • Winer, Ira
    Karmanos Trial ID:
    • 2023-053
    Age Group:
    • Adult
    Phase:
    • Phase I/II
  • Objective:

    Primary Objective:

    • To evaluate the antitumor activity of disitamab vedotin in subjects with previously treated, locally-advanced unresectable or metastatic (LA/m) HER2 expressing solid tumors

    Secondary Objectives:

    • To evaluate the safety and tolerability profile of disitamab vedotin
    • To assess other measures of antitumor activity of disitamab vedotin per investigator assessment by other clinically relevant measures
    • To evaluate the pharmacokinetics (PK) of disitamab vedotin
    • To evaluate the immunogenicity of disitamab vedotin
    Cancer Categories:
    • Gastrointestinal (GI),Gynecologic,Head and Neck,Lung,Skin
    Principal Investigator:
    • Sukari, Ammar
    Karmanos Trial ID:
    • 2023-069
    Age Group:
    • Adult
    Phase:
    • Phase II
  • Objective:

    Primary Objectives:

    • Parts A, B, and C: Evaluate antitumor activity of tisotumab vedotin as a single agent as measured by investigator-determined confirmed objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
    • Part D: Evaluate antitumor activity of tisotumab vedotin in combination with pembrolizumab or with both pembrolizumab and carboplatin, as measured by investigator-determined confirmed objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Secondary Objectives:

    Parts A, B, and C:

    • Evaluate preliminary antitumor activity of tisotumab vedotin as a single agent, as measured by confirmed and unconfirmed ORR
    • Evaluate the safety and tolerability of tisotumab vedotin as a single agent, as measured by type, incidence, severity, seriousness, and relatedness of adverse events (AEs)

    Part D:

    • Evaluate preliminary antitumor activity of tisotumab vedotin in combination with pembrolizumab or with both pembrolizumab and a platinum agent (carboplatin or cisplatin), as measured by confirmed and unconfirmed ORR, per RECIST v1.1
    • Evaluate the safety and tolerability of tisotumab vedotin in combination with pembrolizumab or with both pembrolizumab and carboplatin, as measured by type, incidence, severity, seriousness, and relatedness of adverse events (AEs)
    • Evaluate preliminary safety and tolerability of tisotumab vedotin in combination with pembrolizumab and cisplatin

    All Parts of Study:

    • Assess pharmacokinetics (PK) and immunogenicity of tisotumab vedotin
    • Evaluate stability and control of disease as measured by disease control rate (DCR)
    • Evaluate durability of response as measured by duration of response (DOR)
    • Evaluate timing of response as measured by time to response (TTR)
    • Assess progression-free survival (PFS)
    • Assess survival as measured by overall survival (OS)

    Additional Objectives:

    • Assess Tissue Factor (TF) expression-response relationship
    • Assess biomarkers of biological activity and resistance and predictive biomarkers of response
    • Evaluate patient reported outcomes (PRO) and health-related quality of life (HRQOL) for Part D only
    Cancer Categories:
    • Gastrointestinal (GI),Head and Neck,Lung,Skin
    Principal Investigator:
    • Sukari, Ammar
    Karmanos Trial ID:
    • 2023-029
    Age Group:
    • Adult
    Phase:
    • Phase II
  • Objective:

    Part 1 Dose Escalation of SLC-3010 Monotherapy and in Combination

    Primary Objectives:

    • To assess safety and tolerability of increasing dose levels ofSLC-3010
    • To define the maximum tolerated dose (MTD) or maximum administered dose (MAD), and recommended Phase 2 dose (RP2D)

    Secondary Objectives:

    • To evaluate preliminary antitumor activity
    • To characterize single and multiple dose PK of SLC-3010 and its metabolite TCB2 and IL-2
    • To assess immunogenicity to SLC-3010

    Part 2: Dose Expansion of SLC-3010 Monotherapy and in Combination

    Primary Objectives:

    • To evaluate efficacy of SLC-3010 and the combination.

    Secondary Objectives:

    • To evaluate anti-tumor activity
    • To assess safety and tolerability of SLC-3010 at RP2D
    • To characterize single and multiple dose PK of SLC-3010 and its metabolite TCB2 and IL-2
    • To assess immunogenicity to SLC-3010
    Cancer Categories:
    • Brain and Nervous System,Breast,Genitourinary (GU),Head and Neck,Lung,Skin
    Principal Investigator:
    • Winer, Ira
    Karmanos Trial ID:
    • 2022-073
    Age Group:
    • Adult
    Phase:
    • Phase I/II
  • Objective:

    Primary Objectives:

    • To determine clinical benefit as described by the overall response rate (ORR) of nab-sirolimus via independent radiographic review (IRR) in patients with malignant solid tumors with pathogenic inactivating alterations in TSC1 or TSC2 genes

    Secondary Objectives:

    • To evaluate the duration of response (DOR), disease control rate (DCR), time to response (TTR), and progression-free survival (PFS) via IRR, and overall survival (OS) of nab-sirolimus
    • To evaluate changes in Quality-of-Life
    • To describe the safety and tolerability of nab-sirolimus
    Cancer Categories:
    • Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Lung,Skin
    Principal Investigator:
    • Uprety, Dipesh
    Karmanos Trial ID:
    • 2022-030
    Age Group:
    • Adult
    Phase:
    • Phase II
  • 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 1b part:

    • To assess the safety and tolerability of E7386 in combination with pembrolizumab in subjects with previously treated selected solid tumors
    • To determine the RP2D of E7386 in combination with pembrolizumab

    Phase 2 part:

    • To assess the ORR of E7386 in combination with pembrolizumab in subjects with previously treated selected solid tumors (melanoma, CRC, HCC) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

    Secondary Objectives:

    Phase 1b part only:

    • To assess tumor response according to RECIST 1.1

    Phase 1b and Phase 2 parts:

    • To assess duration of response (DOR) according to RECIST 1.1 per tumor cohort
    • To assess the disease control rate (DCR: the proportion of subjects with complete response [CR], partial response [PR], or stable disease [SD] after ≥5 weeks from the first dose) according to RECIST 1.1 per tumor cohort
    • To assess the clinical benefit rate (CBR: the proportion of subjects with CR, PR, or durable SD [duration of SD ≥23 weeks]) according to RECIST 1.1 per tumor cohort
    • To assess the safety and tolerability profile of E7386 in combination with pembrolizumab
    • To evaluate the PK profile of E7386 when co-administered with pembrolizumab in subjects
    Cancer Categories:
    • Gastrointestinal (GI),Other,Skin
    Principal Investigator:
    • Al Hallak, Mohammed
    Karmanos Trial ID:
    • 2022-016
    Age Group:
    • Adult
    Phase:
    • Phase I/II
  • Objective:
    Phase 1 Primary Objective: To investigate the safety and tolerability of single agent ZN-c3, including identification of the MTD/RP2D
    Secondary Objectives:
    1. To obtain preliminary estimates of antitumor efficacy of single agent ZN-c3
    2. To investigate the PK of single agent ZN-c3
    Exploratory: To investigate the pharmacodynamics of single agent ZN-c3

    Phase 2: Primary Objectives:
    1. To investigate the antitumor efficacy (objective response rate [ORR]) of ZN-c3 as a single agent and in combination with talazoparib and with pembrolizumab, respectively
    2. To investigate the safety of ZN-c3 as a single agent and in combination with talazoparib and with pembrolizumab,respectively, including the determination of a RP2D for the combinations

    Phase 2: Secondary Objectives:
    1. To further investigate the antitumor efficacy (duration of response [DOR], clinical benefit rate [CBR], progression-free survival [PFS]) of ZN-c3 as a single agent and in combination with talazoparib and with pembrolizumab, respectively
    2. To further determine the PK parameters of ZN-c3 and the combination drugs, as applicable

    Phase 2: Exploratory Objective: To investigate the pharmacodynamics of single agent ZN-c3 and in combination with talazoparib and with pembrolizumab, respectively.
    Cancer Categories:
    • Breast,Genitourinary (GU),Gynecologic,Lung,Skin
    Principal Investigator:
    • Mamdani, Hirva
    Karmanos Trial ID:
    • 2020-002
    Age Group:
    • Adult
    Phase:
    • Phase I/II
  • Objective:

    This pilot study will evaluate the use of [F-18] FLT and PET to measure tumor proliferation and the activity of thymidine kinase. This study may also assess the changes that occur after therapy. Finally we may compare the retention of [F-18] FLT in comparison to that of routine clinical measurements, such as CT, MRI or other imaging studies. One goal of this study is to better understand the abnormalities of thymidine metabolism in tumors in vivo. We may also compare imaging proliferation data using [F- 18] FLT to measurements of gene expression of proliferative and biochemical pathways made on tumor specimens obtained at biopsy.

    Cancer Categories:
    • Brain and Nervous System,Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Head and Neck,Hematologic (Blood Cancers),Lung,Other,Sarcoma,Skin
    Principal Investigator:
    • Shields, Anthony
    Karmanos Trial ID:
    • 2006-127
    Age Group:
    • Adult
    Phase:
    • N/A