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 16

  • Objective:

    Primary Objectives:

    Part 1

    • To evaluate the safety and tolerability of PRT3789 in combination with pembrolizumab in patients with advanced or metastatic solid tumors

    Part 2

    • To evaluate the efficacy of PRT3789 in combination with pembrolizumab in patients with advanced or metastatic esophageal or NSCLC and deleterious SMARCA4 mutation

    Secondary Objectives:

    • To evaluate the efficacy of PRT3789 in combination with pembrolizumab
    • To evaluate the safety and tolerability of PRT3789 in combination with pembrolizumab
    • To evaluate the PK profile of PRT3789 in combination with pembrolizumab
    Cancer Categories:
    • Gastrointestinal (GI),Gynecologic,Head and Neck,Lung,Skin
    Principal Investigator:
    • Uprety, Dipesh
    Karmanos Trial ID:
    • 2025-005
    Age Group:
    • Adult
    Phase:
    • Phase II
  • Objective:

    Phase I (dose escalation)

    Primary Objectives:

    • To identify the MTD and/or RP2D of ANV600 single agent and in combination with pembrolizumab

    Secondary Objectives:

    • To characterize the PK of ANV600 single agent and in combination with pembrolizumab after single dose and repeated dosing
    • To evaluate the prevalence and incidence of immunogenicity of ANV600
    • To describe the anti-tumor activity of ANV600 as single agent and in combination with pembrolizumab

    Phase II

    Primary Objectives:

    • To assess the anti-tumor activity of ANV600 as single agent and in combination with pembrolizumab

    Secondary Objectives:

    • To assess the anti-tumor activity of ANV600 as single agent and in combination with pembrolizumab
    • To assess the safety and tolerability ANV600 single agent and in combination with pembrolizumab for each cohort and in the overall study population
    • To characterize the PK of ANV600 single agent and in combination with pembrolizumab after single dose and repeated dosing
    • To evaluate the prevalence and incidence of immunogenicity of ANV600
    Cancer Categories:
    • Lung,Skin
    Principal Investigator:
    • Shao, Yusra
    Karmanos Trial ID:
    • 2024-070
    Age Group:
    • Adult
    Phase:
    • Phase I/II
  • 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
  • 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
  • Objective:

    Primary Objectives:

    • To demonstrate superiority of Arm A (fianlimab + cemiplimab) compared to Arm B (Opdualag) as measured by ORR

    Secondary Objectives:

    • To describe PFS in Arm A and Arm B
    • To describe OS in Arm A and Arm B
    • To describe the duration of response (DOR) in Arm A and Arm B
    • To describe the disease control rate (DCR) in Arm A and Arm B
    • To describe ORR and PFS by investigator assessment in Arm A and Arm B
    • To assess the safety and tolerability of Arm A and Arm B
    • To characterize the pharmacokinetics (PK) of fianlimab and cemiplimab in Arm A
    • To assess the immunogenicity of fianlimab and cemiplimab
    Cancer Categories:
    • Skin
    Principal Investigator:
    • Shao, Yusra
    Karmanos Trial ID:
    • 2024-044
    Age Group:
    • Adult
    Phase:
    • Phase III
  • Objective:

    Part I: Dose Escalation Phase

    Primary Objectives:

    • To evaluate the safety and tolerability of BGC515 Capsules in patients with malignant mesothelioma (MM), epithelioid hemangioendothelioma (EHE), or other advanced solid tumors.
    • To explore the dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD).

    Secondary Objectives:

    • To evaluate the pharmacokinetics (PK) of BGC515 Capsules in patients with MM, EHE, or other advanced solid tumors.
    • To preliminarily evaluate the efficacy of BGC515 Capsules in patients with MM, EHE, or other advanced solid tumors.

    Part II: Dose Expansion Phase

    Primary Objectives:

    • To further evaluate the safety and tolerability of BGC515 Capsules in patients with MM, EHE, glioblastoma, or other advanced solid tumors including those with NF1/2 deficiency, YAP/TAZ fusion, LATS1/2 mutation, MST1/2 mutation, so as to determine the recommended phase 2 dose (RP2D).
    • To evaluate the preliminary efficacy of BGC515 Capsules in patients with MM, EHE, glioblastoma, or other advanced solid tumors including those with NF1/2 deficiency, YAP/TAZ fusion, LATS1/2 mutation, MST1/2 mutation.

    Secondary Objectives:

    • To evaluate the PK of BGC515 Capsules in patients with MM, EHE, glioblastoma, or other advanced solid tumors including those with NF1/2 deficiency, YAP/TAZ fusion, LATS1/2 mutation, MST1/2 mutation.
    Cancer Categories:
    • Breast,Gastrointestinal (GI),Genitourinary (GU),Head and Neck,Lung,Skin
    Principal Investigator:
    • Winer, Ira
    Karmanos Trial ID:
    • 2024-064
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:

    Phase 1a dose escalation

    Primary Objectives:

    • To determine the MTD/MAD and evaluate the safety and tolerability of GSK5764227 in participants with advanced solid tumors.

    Secondary Objectives:

    • To evaluate the PK profile of GSK5764227 in participants with advanced solid tumors.
    • To evaluate the clinical activity of GSK5764227 in participants with advanced solid tumors
    • To evaluate the immunogenicity of GSK5764227 in participants with advanced solid tumors.To evaluate the immunogenicity of GSK5764227 in participants with advanced solid tumors.

    Phase 1b dose expansion

    Primary Objectives:

    • To evaluate the clinical activity of GSK5764227 in participants with ES-SCLC or advanced solid tumors.

    Secondary Objectives:

    • To evaluate the safety and tolerability of GSK5764227 in participants with ES-SCLC or advanced solid tumors
    • To evaluate additional measures of clinical benefit of GSK5764227 in participants with ES-SCLC or advanced solid tumors.
    • To evaluate the PK profile of GSK5764227 in participants with ES-SCLC or advanced solid tumors.
    • To evaluate the immunogenicity of GSK5764227 in participants with ES-SCLC or advanced solid tumors.
    Cancer Categories:
    • Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Lung,Skin
    Principal Investigator:
    • Saif, Wasif
    Karmanos Trial ID:
    • 2024-073
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:

    Primary Objectives:

    • To investigate the safety of monotherapy and T- Plex combination TCR-Ts
    • To determine the recommended phase 2 dose of monotherapy and T- Plex combination TCR-Ts

    Secondary Objectives:

    • To investigate preliminary anti-tumor activity of monotherapy and T- Plex combination TCR-Ts
    • To investigate the feasibility of repeat dosing of monotherapy and T- Plex combination TCR-Ts
    Cancer Categories:
    • Gynecologic,Hematologic (Blood Cancers),Lung,Skin
    Principal Investigator:
    • Winer, Ira
    Karmanos Trial ID:
    • 2023-086
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:

    Primary Objectives:

    • To evaluate the safety and tolerability of BS006 in patients with advanced solid tumors
    • To estimate the maximum tolerated dose (MTD) of BS006

    Secondary Objectives:

    • To preliminarily observe the anti-tumor efficacy of BS006 in patients with advanced solid tumors
    • To evaluate the biological activities of BS006 in tumor
    • To evaluate the biodistribution and viral shedding of BS006
    Cancer Categories:
    • Breast,Skin
    Principal Investigator:
    • Elayoubi, Jailan
    Karmanos Trial ID:
    • 2023-076
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:

    Primary Objectives:

    • To determine the safety and tolerability of ASP1012 (±pembrolizumab) in participants with locally advanced or metastatic solid tumors
    • To determine the MTD and/or candidate RP2D of ASP1012

    Secondary Objectives:

    • To evaluate the PK and virus shedding of ASP1012
    • To evaluate the ADAs of ASP1012
    • To evaluate anti-tumor effects of ASP1012
    • To evaluate tumor-specific virus delivery
    • To evaluate tumor biomarker changes related to ASP1012 treatment (CRC and ovarian)
    Cancer Categories:
    • Gastrointestinal (GI),Gynecologic,Skin
    Principal Investigator:
    • Shields, Anthony
    Karmanos Trial ID:
    • 2023-093
    Age Group:
    • Adult
    Phase:
    • Phase I