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 - 6 of 6

  • A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Patients with Metastatic HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

    Objective:

    Phase 1a Dose Escalation

    Primary Objectives:

    • To assess the safety and tolerability of BGB-43395 alone in patients with advanced solid tumors or as part of combination therapies in HR+/HER2- breast cancer and other selected tumor types.
    • To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and recommended dose(s) for expansion (RDFE[s]) of BGB-43395 alone in patients with advanced solid tumors or as part of combination therapies in HR+/HER2- breast cancer and other selected tumor types.

    Secondary Objectives:

    • To assess the preliminary anticancer activity of BGB-43395 alone in patients with advanced solid tumors or as part of combination therapies in HR+/HER2- breast cancer and other selected tumor types.
    • To characterize the PK of BGB-43395 and its metabolite, BGB-48579, alone in patients with advanced solid tumors or as part of combination therapies in HR+/HER2- breast cancer and other selected tumor types.

    Phase 1b: Dose Expansion Objectives and Endpoints

    Primary Objectives:

    • To assess the antitumor activity in patients treated with BGB-43395 alone or as part of combination therapies in selected tumor cohorts.

    Secondary Objectives:

    • To further assess the antitumor activity in patients treated with BGB-43395 alone or as part of combination therapies in selected tumor cohorts.
    • To further characterize the safety and tolerability of BGB-43395 alone or as part of combination therapies.
    • To further characterize the pharmacokinetics (PK) of BGB-43395 and its metabolite, BGB-48579, with combination therapies.
    Cancer Categories:
    • Brain and Nervous System,Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Head and Neck,Lung,Skin
    Principal Investigator:
    • Saif, Wasif
    Karmanos Trial ID:
    • 2024-063
    Age Group:
    • Adult
    Phase:
    • Phase I
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  • A Phase 1a/1b open-label, multicenter, dose-escalation, and dose expansion study to evaluate the safety and activity of TEV-56278, as a single agent and in combination with pembrolizumab, in participants with selected locally advanced or metastatic solid tumors

    Objective:

    Part 1

    Primary Objectives:

    • To characterize the safety and tolerability of TEV-56278 in the trial population
    • To determine a RP2D

    Secondary Objectives:

    • To characterize the serum pharmacokinetics of TEV-56278 in the trial population
    • To evaluate the antitumor activity of TEV-56278 in the trial population

    Part 2

    Primary Objectives:

    • To evaluate antitumor activity of TEV-56278 in the trial population

    Secondary Objectives:

    • To characterize the serum pharmacokinetics of TEV-56278 in the trial population
    • To determine the safety and tolerability of TEV-56278 in the trial population
    • To evaluate other measures of antitumor activity of TEV-56278 in the trial population
    Cancer Categories:
    • Brain and Nervous System,Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Head and Neck,Lung,Skin
    Principal Investigator:
    • Saif, Wasif
    Karmanos Trial ID:
    • 2024-045
    Age Group:
    • Adult
    Phase:
    • Phase I
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  • A Phase 1 Study of SGN-EGFRd2 in Advanced Solid Tumors

    Objective:

    Primary Objectives:

    • To evaluate the safety and tolerability of SGN-EGFRd2
    • To identify the maximum tolerated dose (MTD) of SGN-EGFRd2 (Part A)
    • To identify a recommended dose and schedule for SGN-EGFRd2 (Parts A and B)

    Secondary Objectives:

    • To assess the immunogenicity of SGN-EGFRd2
    • To assess the PK of SGN-EGFRd2
    • To assess the antitumor activity of SGN-EGFRd2
    Cancer Categories:
    • Brain and Nervous System,Gastrointestinal (GI),Lung
    Principal Investigator:
    • Mamdani, Hirva
    Karmanos Trial ID:
    • 2023-055
    Age Group:
    • Adult
    Phase:
    • Phase I
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  • A Pilot Study Of 1-(2-[18f]Fluoroethyl)-L-Tryptophan PET/CT Imaging In Human Cancers

    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:
    • 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
    Learn More