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 - 10 of 174

A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AZD0516 as Monotherapy and in Combination with Anti-cancer Agents in Participants with Metastatic Prostate Cancer (SEACLIFF)
Objective:

Primary Objectives:

Dose Escalation (Part A)

To assess the safety and tolerability and to determine the MTD and/or RDE(s) of AZD0516 as monotherapy and in combination with anti-cancer agents.

Dose Optimisation (Part B)

To assess the preliminary antitumour activity of AZD0516 as monotherapy and in combination with anti-cancer agents.

To assess the safety and tolerability of AZD0516 as monotherapy and in combination with anti-cancer agents

Efficacy Expansion (Part C)

To assess the anti-tumour activity of AZD0516 as monotherapy and/or in combination with other anti-cancer agents.

Secondary Objectives:

Dose Escalation (Part A)

To assess the preliminary anti-tumour activity of AZD0516 as monotherapy and/or in combination with other anti-cancer agents.

Dose Escalation (Part A) and Dose Optimisation (Part B)

To characterise the PK of AZD0516 when given as monotherapy and in combination with anti-cancer agents.

To investigate STEAP2 expression and relationship to response to AZD0516.

To determine the immunogenicity of AZD0516 as monotherapy and in combination with anti-cancer agents.

Efficacy Expansion (Part C)

To further assess the safety and tolerability of AZD0516 as monotherapy and in combination with anti-cancer agents.
Cancer Categories:
Genitourinary (GU)
Principal Investigator:
Cackowski, Frank
Karmanos Trial ID:
2025-065
Age Group:
Adult
Phase:
Phase I/II
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A Multicenter, Randomized, Open-label, Phase 2 Study Evaluating the Safety and Efficacy of BMS-986504 Monotherapy in Participants with Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) with Homozygous MTAP Deletion After Progression on Prior Therapies
Objective:

Part 1: Dose Selection

Primary Objective:

To evaluate investigator-assessed objective response (OR) of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion by dose level

Secondary Objectives:

To evaluate investigator-assessed disease control (DC) of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion by dose level

To evaluate investigator-assessed clinical benefit (CB) of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion by dose level

To evaluate investigator-assessed duration of response (DOR) of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion by dose level

To evaluate investigator-assessed progression-free survival (PFS) of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion by dose level

To evaluate investigator-assessed time to objective response (TTOR) of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion by dose level

To assess the safety and tolerability of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion by dose level

Part 2 + Selected Dose from Part 1

Primary Objective:

To evaluate OR of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

Secondary Objectives:

To evaluate investigator-assessed OR of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To evaluate DC of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To evaluate investigator-assessed DC of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To evaluate CB of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To evaluate investigator-assessed CB of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To evaluate PFS of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To evaluate investigator-assessed PFS of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To evaluate TTOR of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To evaluate investigator-assessed TTOR of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To evaluate DOR of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To evaluate investigator-assessed DOR of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To assess OS of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To assess the safety and tolerability of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To assess the impact of disease symptoms and treatment on participant’s healthrelated quality-of-life in participants with advanced or metastatic NSCLC with homozygous MTAP deletion
Cancer Categories:
Lung
Principal Investigator:
Uprety, Dipesh
Karmanos Trial ID:
2025-053
Age Group:
Adult
Phase:
Phase II
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A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-Oophosectomy to Reduce the Risk of Ovarian Cancer among BRCA1 Carriers [SOROCk]
Objective:

Primary Objective:

To compare the non-inferiority of bilateral salpingectomy (BLS) with delayed oophorectomy to bilateral salpingo-oophorectomy (BSO) to reduce the risk of ovarian cancer among women with deleterious BRCA1 germ-line mutations.

Secondary Objectives:

To prospectively assess estrogen deprivation symptoms in BLS patients as measured by the FACTES sub-scale compared to women in the BSO arm.

To determine if health-related QOL (FACT) is negatively impacted by menopausal symptoms (menopausal symptom checklist-MSCL), sexual dysfunction (FSFI), and cancer distress (IES) in women who have undergone BLS, in comparison to normative data (MSCL/FACT-ES) and data from BSO patients.

To assess medical decision making, as measured by the Shared Decision Making Questionnaire (SDM-Q-9) and Decision Regret Scale (DRS), and determine factors associated with the risk of reducing surgical treatment choice.

To assess adverse events, graded using CTCAE v5.0.
Cancer Categories:
Gynecologic
Principal Investigator:
Winer, Ira
Karmanos Trial ID:
NRG-CC008
Age Group:
Adult
Phase:
N/A
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A Phase 1 Study of MOMA-341 as Monotherapy or in Combination Therapy in Participants with Advanced or Metastatic Solid Tumors
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
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A Phase 1, Multicenter, Open-Label, Dose Escalation, Dose Expansion and Dose Confirmation Study of BHV-1530 in Adult Participants with Advanced or Metastatic Solid Tumors
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
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A Phase 1, Open-Label, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Pralatrexate in Patients with Advanced Solid Tumor or Hematological Malignancy and either Normal Hepatic Function or Mild, Moderate, or Severe Hepatic Impairment
Objective:

Primary Objective

To evaluate the pharmacokinetic (PK) profile of pralatrexate when administered to patients with various degrees of hepatic impairment

Secondary Objectives

To evaluate the safety of pralatrexate when administered once weekly for 6 weeks of every 7-week treatment cycle

To establish the dosing recommendations for pralatrexate administered once weekly for 6 weeks of every 7-week treatment cycle in patients with hepatic impairment
Cancer Categories:
Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Lung
Principal Investigator:
Saif, Wasif
Karmanos Trial ID:
2025-029
Age Group:
Adult
Phase:
Phase I
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A phase 1a/b Study to Evaluate the Safety and Efficacy of OPB-101, an Autologous Mesothelin (MSLN) CAR-T Cell Therapy with Antigen-dependent Expression of OUTSMART designed IL-2 cytokine in Platinum-resistant Ovarian Cancer
Objective:

Phase 1a Escalation

Primary Objectives:

To evaluate the safety and tolerability of OPB-101 delivered intravenously, including dose-limiting toxicities(DLTs)

To determine the maximum tolerated dose (MTD) of OPB-101 and/or recommended Phase 1b dose(s)

Secondary Objectives:

To characterize the cellular kinetic profile of OPB-101

To assess preliminary anti-tumor activity of OPB-101

Phase 1b Expansion

Primary Objectives:

To determine the recommended phase 2 dose (RP2D)

To evaluate the anti-tumor activity of OPB-101

To further evaluate the safety and tolerability of OPB-101

Secondary Objectives:

To further characterize the cellular kinetic profile of OPB-101
Cancer Categories:
Genitourinary (GU),Gynecologic
Principal Investigator:
Winer, Ira
Karmanos Trial ID:
2025-061
Age Group:
Adult
Phase:
Phase I
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A Phase 1B Study of Combination ATR (M1774) and BET Inhibition (ZEN00-3694) to Exploit ARID1A Loss in Recurrent Ovarian and Endometrial Cancer
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
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A Phase 2 Open-Label, Multicenter Study to Evaluate Efficacy and Safety of ZN-c3 in Subjects with High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Objective:

Primary Objectives:

Part 1b:

To determine the safety and tolerability of ZN-c3 in subjects with PROC

Part 2:

To investigate the antitumor activity of ZN-c3 in subjects with PROC

Secondary Objectives:

Part 1b:

To investigate the antitumor activity of ZN-c3 in subjects with PROC at different doses/schedules

To investigate the plasma PK of ZN-c3

Part 2:

To further investigate the antitumor activity of ZN-c3 in subjects with PROC

To investigate the safety and tolerability of ZN-c3 in subjects with PROC

To investigate the plasma PK of ZN-c3
Cancer Categories:
Gastrointestinal (GI),Gynecologic
Principal Investigator:
Morris, Robert
Karmanos Trial ID:
GOG-3066
Age Group:
Adult
Phase:
Phase II
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A Phase 2 Study of Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF) in Combination with Fruquintinib in Refractory Metastatic Colorectal Cancer
Objective:

Primary Objective:

To evaluate overall survival after the combination of fruquintinib and AM RF EMF treatment in patients with refractory metastatic colorectal cancer

Secondary Objectives:

To evaluate the safety and tolerability of the combination of fruquintinib and AM RF EMF treatment in patients with refractory metastatic colorectal cancer

To evaluate the progression-free survival rate after the combination of fruquintinib and AM RF EMF treatment in patients with refractory metastatic colorectal cancer

To evaluate the rates of disease progression every 6 months up to 60 months after the combination of fruquintinib and AM RF EMF treatment in patients with refractory metastatic colorectal cancer
Cancer Categories:
Gastrointestinal (GI)
Principal Investigator:
Al Hallak, Mohammed
Karmanos Trial ID:
2025-035
Age Group:
Adult
Phase:
Phase II
Learn More

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