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 61

  • Objective:

    Primary Objectives:

    • To determine the maximum tolerated dose (MTD) and the dose-limiting toxicities
      (DLTs) for combination of ATR inhibitor (M1774) and BET inhibitor (ZEN003694) in
      women with recurrent clear cell, endometrioid, and platinum resistant high grade serous
      ovarian carcinoma (HGSOC) and clear cell and endometrioid endometrial carcinoma
      irrespective of ARID1A status (PART I).
    • To determine safety and tolerability in ARID1A pathogenic alteration (ARID1AMUT) and
      ARID1A wildtype (ARID1AWT) cohorts (ARID1A is an integral biomarker) in an
      expansion phase (PART II).
    • To determine change in pharmacodynamic biomarker expression of ƔH2AX (for ATR
      inhibition, integral biomarker) from pre-treatment and on-treatment tumor samples in
      ARID1AMUT and ARID1AWT expansion cohorts by immunohistochemistry (IHC) (PART
      II).

    Secondary Objectives:

    • To evaluate change in pharmacodynamic biomarker expression of cmyc (for BET inhibition,
      integrated biomarker) from pre-treatment and on-treatment tumor samples in ARID1AMUT
      and ARID1AWT expansion cohorts by Digital Spatial Profiling (DSP) (PART II).
    • To evaluate change in pharmacodynamic biomarker expression of ƔH2AX (for ATR
      inhibition, integrated biomarker) from pre-treatment and on-treatment tumor samples in
      ARID1AMUT and ARID1AWT expansion cohorts by DSP (PART II).
    • To investigate if ARID1A protein by IHC and DSP correlates with ARID1A pathogenic
      alteration in pre-treatment tumor biopsy samples (PART II).
    • To estimate objective response rate (ORR) and progression free survival (PFS) at 6 months in
      ARID1A pathogenic alteration and wildtype cohorts (PART II).
    Cancer Categories:
    • Gastrointestinal (GI),Gynecologic
    Principal Investigator:
    • Winer, Ira
    Karmanos Trial ID:
    • NRG-GY031
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:

    Primary Objectives:

    • To determine if overall survival (OS) is improved with proton beam therapy (PBT) treatment as compared to intensity modulated radiation therapy (IMRT) as part of planned protocol treatment for patients with esophageal cancer.
    • To determine if OS with PBT is non-inferior to IMRT as part of planned protocol treatment and that there will be less grade 3+ cardiopulmonary toxicity with PBT than with IMRT.

    Secondary Objectives:

    • To compare the symptom burden and impact on functioning of patients between treatment modalities based on Patient Reported Outcome (PRO) measures of symptoms using MD Anderson Symptom Inventory (MDASI) and PROMIS-Fatigue;
    • To compare the Quality-Adjusted Life Years (QALY) using EQ5D as a health outcome (Kilbridge 2010) between PBT and IMRT, if the protocol primary endpoint is met;
    • To assess the pathologic response rate between PBT and IMRT;
    • To assess the cost-benefit economic analysis of treatment between radiation modalities;
    • To compare the length of hospitalization after protocol surgery between PBT and IMRT;
    • To compare the incidence of grade 4 lymphopenia during chemoradiation between PBT and IMRT;
    • To compare lymphocyte nadir at first follow-up visit after completion of chemoradiation between PBT & IMRT;
    • To estimate the locoregional failure, distant metastatic free survival, and progression-free survival of patients treated with PBT versus IMRT;
    • To compare incidence of both early (< 90 days from treatment start) and late (≥ 90 days from treatment start) cardiovascular and pulmonary events between PBT versus IMRT;
    • To compare the Total Toxicity Burden (TTB) of IMRT versus PBT based on a composite index of 9 individual cardiopulmonary toxicities.

    Exploratory Objectives:

    • To collect biospecimens for future analyses, for example to assess cardiac and inflammatory biomarkers in association with treatment complications.
    Cancer Categories:
    • Gastrointestinal (GI)
    Principal Investigator:
    • Yeh, Brian
    Karmanos Trial ID:
    • NRG-GI006
    Age Group:
    • Adult
    Phase:
    • Phase III
  • Objective:

    Primary Objective:

    Dose Escalation

    • To characterize the safety, tolerability, DLT and MTD (or maximum administered dose [MAD] or maximum biologically effective dose [MBED] if no MTD defined) of CLN-619 administered intravenously alone (Module A, Module D) or in combination with pembrolizumab (Module B) or in combination with chemotherapy (Module C) in patients with advanced solid tumors.

    Dose Expansion

    • To evaluate the anti-tumor activity of CLN-619 alone and/or in combination with pembrolizumab (Module B) or with chemotherapy (Module C), as assessed by the Best Overall Response (BOR), ORR, Duration of Response (DoR), Progression Free Survival (PFS), Disease Control Rate (DCR), Overall Survival (OS), and the Clinical Benefit Rate (CBR), per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, in patients with advanced solid tumors.

    Secondary Objectives:

    • To assess the PK profile of CLN-619 administered alone, - in combination with pembrolizumab or in combination with chemotherapy in patients with selected, advanced solid tumors.
    • To assess the immunogenicity of CLN-619 administered alone, in combination with pembrolizumab, or in combination with chemotherapy, in patients with selected, advanced solid tumors.
    Cancer Categories:
    • Breast,Gastrointestinal (GI),Gynecologic,Lung
    Principal Investigator:
    • Uprety, Dipesh
    Karmanos Trial ID:
    • 2024-089
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:

    Primary Objectives:

    • To assess the safety and tolerability of BL-M07D1 in metastatic or unresectable HER2-expressing tumors
    • To determine the MTD if reached or MAD and two or more RDEs of BL-M07D1

    Secondary Objectives:

    • To characterize the pharmacokinetics of BL-M07D1, total anti-HER2 antibody, and payload (Ed-04)
    • To investigate the antitumor activity of BL-M07D1
    Cancer Categories:
    • Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Lung
    Principal Investigator:
    • Saif, Wasif
    Karmanos Trial ID:
    • 2025-010
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:

    Primary Objective:

    • To characterize the safety and tolerability of MOMA-341 as monotherapy or in combination with chemotherapy or immunotherapies

    Secondary Objectives:

    • To identify the RP2D(s) and/or recommended optimization doses of MOMA-341 as monotherapy and in combination with chemotherapies or immunotherapies
    • To characterize the PK profile of MOMA341 when administered as monotherapy and in combination with chemotherapies or immunotherapies
    • To assess the effects of food on the PK parameters of MOMA-341 (for select participants only)
    • To characterize the PK profile of irinotecan and its active metabolite SN-38 when administered in combination with MOMA341
    • To characterize preliminary evidence of antitumor activity associated with MOMA341 as monotherapy or in combination with chemotherapies or immunotherapies
    Cancer Categories:
    • Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic
    Principal Investigator:
    • Al Hallak, Mohammed
    Karmanos Trial ID:
    • 2025-047
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:

    Primary Objective:

    Dose-escalation and Dose-expansion Cohorts

    • To determine the safety profile, maximum tolerable dose (MTD), minimally reproducible active dose (MRAD), and recommended dose range (RDR) of BHV-1530 administered by IV infusion dosed Q3W.

    Dose-confirmation Cohorts

    • To determine the recommended dose (RD) of BHV-1530 for later phase trials.

    Secondary Objectives:

    Dose-escalation and Dose-expansion Cohorts

    • To assess the preliminary efficacy of BHV-1530
    • To determine the PK of BHV-1530, total antibody, and free payload TopoIx (BHC-0080269)
    • To assess the incidence of antidrug antibody (ADA) against BHV-1530

    Dose-confirmation Cohort

    • To assess the preliminary efficacy of BHV-1530
    • To determine the PK of BHV-1530, total antibody, and free payload TopoIx BHC-0080269
    • To assess the incidence of ADA against BHV-1530
    Cancer Categories:
    • Brain and Nervous System,Gastrointestinal (GI),Genitourinary (GU),Head and Neck
    Principal Investigator:
    • Shields, Anthony
    Karmanos Trial ID:
    • 2025-038
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:

    Dose-Escalation Part (Part 1)

    Primary Objectives:

    • To assess the safety and tolerability of YL217 in patients with advanced solid tumors
    • To determine the maximum tolerated dose (MTD) of YL217 in patients with advanced solid tumors

    Secondary Objectives:

    • To characterize the pharmacokinetics (PK) of YL217 antibody-drug conjugate (YL217-ADC), YL217 total antibody (YL217-TAb), and unconjugated payload YL0010014, metabolite YL0010034 and, if applicable, other potential metabolite(s)
    • To evaluate immunogenicity as measured by the presence of anti-drug antibodies (ADAs) in patients treated with YL217
    • To document any preliminary efficacy of YL217 in patients with advanced solid tumors

    Backfill Part (Part 2)

    Primary Objectives:

    • To further evaluate the safety and tolerability of YL217 in patients with advanced solid tumors
    • To determine the recommended dose(s) for expansion (RDE(s)) of YL217 in patients with advanced solid tumors

    Secondary Objectives:

    • To further evaluate the efficacy of YL217 in patients with advanced solid tumors
    • To characterize the PK of YL217-ADC, YL217-TAb, unconjugated payload YL0010014, metabolite YL0010034 and, if applicable, other potential metabolite(s)
    • To evaluate immunogenicity as measured by the presence of ADAs in patients treated with YL217

    Dose-Expansion Part (Part 3)

    Primary Objectives:

    • To further evaluate the efficacy of YL217 at the RDE(s) in patients with the selected advanced solid tumors such as colorectal adenocarcinoma, gastric, esophageal or gastroesophageal junction adenocarcinoma, and pancreatic adenocarcinoma
    • To determine the recommended phase 2 dose (RP2D) of YL217

    Secondary Objectives:

    • To further evaluate the safety and tolerability of YL217 at the RDE(s) in patients with the selected advanced solid tumors
    • To characterize the PK of YL217-ADC, YL217-TAb, unconjugated payload YL0010014, metabolite YL0010034 and, if applicable, other potential metabolite(s)
    • To evaluate immunogenicity as measured by the presence of ADAs in patients treated with YL217
    Cancer Categories:
    • Gastrointestinal (GI)
    Principal Investigator:
    • Saif, Wasif
    Karmanos Trial ID:
    • 2025-025
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:

    Part 1: Monotherapy Dose Escalation

    Primary Objectives:

    • Determine the Maximum Tolerated Dose and/or RDE for GSK4418959 as monotherapy (MTD and/or RDE).
    • Assess safety and tolerability of GSK4418959 as monotherapy within the DLT observation period.

    Secondary Objectives:

    • Characterize the PK properties of GSK4418959, as monotherapy
    • Further assess the safety and tolerability of GSK4418959 as monotherapy, within and outside of the DLT observation period.

    Part 2: Monotherapy Dose Expansion

    Primary Objectives:

    • Evaluate the preliminary anti-tumor activity of GSK4418959 in CRC and, separately, in EC.

    Secondary Objectives:

    • Further evaluate the safety of GSK4418959 administered at the RDE for CRC and/or for EC.
    • Further evaluate the anti-tumor activity of GSK4418959 in CRC and separately, in EC.
    • Characterize the PK properties of GSK4418959.

    Part 3: Combination Dose Escalation

    Primary Objectives:

    • Determine the Maximum Tolerated Dose and/or RDE for GSK4418959 in combination with dostarlimab (MTDc and/or RDEc).
    • Assess safety and tolerability of GSK4418959 in combination with dostarlimab within the DLT observation period.

    Secondary Objectives:

    • Characterize the PK properties of GSK4418959, in combination with dostarlimab.
    • Further assess the safety and tolerability of GSK4418959 in combination with dostarlimab, within and outside of the DLT observation period.
    Cancer Categories:
    • Gastrointestinal (GI),Gynecologic
    Principal Investigator:
    • Saif, Wasif
    Karmanos Trial ID:
    • 2024-092
    Age Group:
    • Adult
    Phase:
    • Phase I/II
  • Objective:

    Primary Objectives:

    Phase 1: Dose Escalation

    • To characterize the safety, tolerability, and dose-limiting toxicities (DLTs), and determine the recommended Phase 2 dose (RP2D) of STAR0602

    Phase 2: Dose Expansion

    • To further explore anti-tumor activity of STAR0602 in unresectable, locally advanced, or metastatic solid tumors

    Secondary Objectives:

    Phase 1: Dose Escalation

    • To evaluate preliminary antitumor activity of STAR0602 in unresectable, locally advanced, or metastatic solid tumors
    • To evaluate the PK profile of STAR0602 in serum after single and repeated IV infusions

    Phase 2: Dose Expansion

    • To further evaluate the antitumor activity of STAR0602
    • To evaluate the PK profile of STAR0602 in serum after single and repeated IV infusions
    • To further characterize the safety and tolerability of STAR0602

    Phase 1 and Phase 2: Dose Escalation and Dose Expansion

    • To assess antidrug antibody (ADA) formation after IV single and repeat dose administration of STAR0602
    Cancer Categories:
    • Gastrointestinal (GI),Genitourinary (GU),Gynecologic
    Principal Investigator:
    • Saif, Wasif
    Karmanos Trial ID:
    • 2024-091
    Age Group:
    • Adult
    Phase:
    • Phase I/II
  • Objective:

    Phase 1 (Dose Escalation)

    Primary Objectives:

    • To evaluate the safety and tolerability of DB-1311.
    • To determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) of DB-1311.

    Secondary Objectives:

    • To assess the preliminary antitumor activity of DB-1311.
    • To characterize the Pharmacokinetics (PK) of DB-1311 (DB-1311 antibodydrug conjugate [ADC], total anti- B7-H3 antibody, unconjugated payload P1021).
    • To assess the immunogenicity of DB1311 in targeted subjects.

    Phase 2a (Dose Expansion)

    Primary Objectives:

    • To assess the safety and tolerability of DB-1311 as monotherapy in targeted subject populations.
    • To assess the effectiveness of DB-1311 as monotherapy by assessment of objective response rate (ORR) by investigator.

    Secondary Objectives:

    • To further assess the PK of DB-1311 (DB-1311 ADC, total anti-B7-H3 antibody, unconjugated payload P1021).
    • To evaluate the prevalence and incidence of anti-drug antibody (ADA) against DB1311 in serum via a validated assay.
    • To evaluate the preliminary efficacy of DB-1311 with additional efficacy parameters.
    Cancer Categories:
    • Gastrointestinal (GI),Genitourinary (GU),Lung
    Principal Investigator:
    • Winer, Ira
    Karmanos Trial ID:
    • 2024-080
    Age Group:
    • Adult
    Phase:
    • Phase I/II