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.
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Results 1 - 4 of 4

  • A phase Ia/Ib, open label, multicenter, dose-escalation study of BI 907828 in patients with advanced or metastatic solid tumors

    Objective:

    Phase Ia – Dose escalation

    Primary Objectives:

    • The main objective of the dose-escalation part of the trial is to determine the maximum tolerated dose (MTD), based on the frequency of patients experiencing dose limiting toxicities (DLT) during the first treatment cycle, and the recommended dose for expansion (RDE) of BI 907828 monotherapy, and to evaluate its safety and tolerability, by monitoring the occurrence and severity of adverse events (AEs), in two different schedules (Arm A with one single dose every 21 days, Arm B with one single dose on Days 1 and 8, every 28 days).

    Secondary Objectives:

    • The determination of the pharmacokinetic (PK) profile of BI 907828 monotherapy, and the preliminary assessment of anti-tumor activity in patients with advanced or metastatic solid tumors.

    Phase Ib – Dose expansion

    Primary Objectives:

    • In dose expansion, the main objectives of Cohort 1 and Cohort 2 are to assess efficacy, and to further assess the safety and PK profiles of BI 907828 at the RDE, and to determine the RP2D of BI 907828 for TP53 wt and MDM2 amplified sarcomas, NSCLC, urothelial, gastric, biliary tract, PDAC and other tumor types.
    Cancer Categories:
    • Gastrointestinal (GI),Genitourinary (GU),Lung,Sarcoma
    Principal Investigator:
    • Shields, Anthony
    Karmanos Trial ID:
    • 2022-086
    Age Group:
    • Adult
    Phase:
    • Phase I
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  • A Controlled Multi-Arm Phase 1 Study Evaluating the Safety and Feasibility of TCell Receptor Engineered Donor T Cells Targeting HA1 (TSC-100) or HA2 (TSC-101) in HLA-A*02:01 Positive Patients Undergoing Haploidentical Allogeneic Peripheral Blood Stem Cell Transplantation

    Objective:

    Primary Objective:

    • To investigate the safety of repeated dosing of TSC-100 and TSC-101 in HLA-A*02:01 positive participants undergoing haploidentical allogeneic peripheral blood stem cell transplantation and determine the optimally tolerated dose range

    Secondary Objectives:

    • To investigate the efficacy of TSC-100 and TSC-101 combined with the SOC compared with that of the SOC alone in participants undergoing haploidentical allogeneic peripheral blood stem cell transplantation
    • To assess the immunogenicity of TSC-100 and TSC-101
    Cancer Categories:
    • Hematologic (Blood Cancers),Sarcoma
    Principal Investigator:
    • Uberti, Joseph
    Karmanos Trial ID:
    • 2022-023
    Age Group:
    • Adult
    Phase:
    • Phase I
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  • Open Label, Multicenter, Phase 1 Study to Evaluate the Maximum Tolerated Dose of Orally Administered CB-03-10 with Dose Expansion Phase, in Subjects with Advanced Solid Tumors

    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
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  • Use of [F-18] FLT for Imaging with Positron Emission Tomography (PET)

    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
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