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 - 9 of 9

  • Objective:

    Part A Dose Escalation

    Part A1: KIN-2787 Monotherapy

    • The primary objectives of Part A1 are to determine the safety and tolerability of oral
    administration of KIN-2787 including DLTs in participants with BRAF mutation-positive
    advanced or metastatic solid tumors or melanoma harboring an NRAS mutation, and to
    identify the MTD and/or the appropriate dose for further clinical investigation in Part B
    Dose Expansion.
    • Secondary objectives include characterization of PK properties and effect of food on PK
    of KIN-2787.
    • Exploratory objectives include additional characterization of KIN-2787 PK, effect of
    KIN-2787 on survival and other time-to-event endpoints, estimation of PD effects of
    KIN-2787 in blood samples and tumor biopsies, assessment of both genotype and
    genotypic changes under treatment to outcome.

    Part A2: KIN-2787 Plus Binimetinib Combination

    • The primary objectives of Part A2 are to determine the safety and tolerability of oral
    administration of KIN-2787 + binimetinib including DLTs in participants with oncogenic
    BRAF mutation-positive advanced or metastatic solid tumors and melanoma harboring
    an NRAS mutation, and to identify the MTD and/or the appropriate dose for further
    clinical investigation.
    • The secondary objective is characterization of PK properties of KIN-2787 and binimetinib
    in combination.
    • Exploratory objectives include additional characterization of KIN-2787 PK, effect of
    KIN-2787 on survival, and other time-to-event endpoints, estimation of PD effects of
    KIN-2787 in blood samples and tumor biopsies, assessment of both genotype and
    genotypic changes under treatment to outcome.

    Part B: Dose Expansion

    • The primary objective of the Part B Dose Expansion portion of the study is to assess
    preliminary evidence of the anti-cancer activity of KIN-2787 in participants with advanced
    or metastatic solid cancers that harbor any oncogenic BRAF genomic alteration.
    • The secondary objective is to further evaluate the safety, tolerability, and the PK
    characteristics of KIN-2787 at the RP2D.
    • Exploratory objectives include additional characterization of KIN-2787 PK, effect of
    KIN-2787 on survival and other time-to-event endpoints, estimation of PD effects of
    KIN-2787 in blood samples and tumor biopsies, assessment of both genotype and
    genotypic changes under treatment to outcome, evaluation of the PK of a new KIN-2787
    tablet formulation, impact on patient reported outcome (PRO) measures.

    Cancer Categories:
    • Lung,Skin
    Principal Investigator:
    • Uprety, Dipesh
    Karmanos Trial ID:
    • 2023-010
    Age Group:
    • Adult
    Phase:
    • Phase I
  • 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:

    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:

    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:
    1. Dose-escalation phase (Part A): To assess the safety and tolerability of multiple doses of TAB004 and define the maximum tolerated dose (MTD) or the maximum feasible dose(MFD) (highest protocol-defined dose of TAB004 in the absence of exceeding the MTD) in subjects with advanced solid malignancies including lymphoma.
    2. Cohort-expansion phase (Part B): To further characterize the safety profile of TAB004 in subjects with selected advanced solid malignancies, including lymphoma, and to evaluate the recommended Phase 2 dose (RP2D).
    Cancer Categories:
    • Hematologic (Blood Cancers),Lung,Skin
    Principal Investigator:
    • Shields, Anthony
    Karmanos Trial ID:
    • 2020-096
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:

    Primary Objectives:

    • To evaluate the safety and tolerability of SGN1 in patients with advanced solid tumor.

    Secondary Objectives:

    • To make a preliminary determination of the Maximum Tolerated Dose (MTD) and optimal biological dose (OBD).
    • To evaluate blood and urine levels of SGN1.
    • To evaluate bacterial shedding of SGN1.
    • To evaluate the anti-tumor effect of SGN1 in the treatment of patients with advanced solid tumor.
    • To evaluate additional safety measures.
    Cancer Categories:
    • Breast,Gastrointestinal (GI),Gynecologic,Head and Neck,Lung,Skin
    Principal Investigator:
    • Uprety, Dipesh
    Karmanos Trial ID:
    • 2021-073
    Age Group:
    • Adult
    Phase:
    • Phase I
  • 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