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 39

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, First-in-Human Study of MEN2501, a KIF18A Inhibitor, in Participants with Ovarian Cancer
Objective:

Primary Objectives:

Part A: To identify the maximum tolerated dose (MTD)/ maximum administrated dose (MAD) and recommended expansion doses for MEN2501 in platinum-resistant ovarian cancer

Part B: Establish the recommended phase 2 dose (RP2D) of MEN2501

Secondary Objectives:

Evaluate the safety and tolerability of MEN2501

To evaluate preliminary antitumor activity of MEN2501.

Characterize the PK profile of MEN2501 in plasma and urine and evaluate the effect of food on the PK when administered
Cancer Categories:
Gynecologic
Principal Investigator:
Winer, Ira
Karmanos Trial ID:
2025-088
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 1/2, open-label, multicenter, dose-escalation, and dose-optimization study to evaluate the safety, tolerability, and activity of EIK1004 (IMP1707) as monotherapy in participants with advanced solid tumors
Objective:

Primary Objectives:

To evaluate the safety and tolerability of EIK1004 as monotherapy to determine the MTD (or MAD) and RDE as monotherapy (Part 1)

To evaluate the safety and tolerability of EIK1004 as monotherapy (Part 2)

Secondary Objectives:

To characterize the plasma pharmacokinetic (PK) profile of single and multiple doses of EIK1004 (Part 1 and Part 2)

To assess preliminary antitumor activity* of EIK1004 as monotherapy (Part 1)

To assess preliminary antitumor activity of EIK1004 as monotherapy (Part 2)
Cancer Categories:
Breast,Gastrointestinal (GI),Gynecologic
Principal Investigator:
Shao, Yusra
Karmanos Trial ID:
2025-068
Age Group:
Adult
Phase:
Phase I/II
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A Phase 1a/b Multicenter, Open-Label Trial to Evaluate Safety, Tolerability, and Dosimetry of LY4257496, a GRPR-Targeted Radioligand Therapy, in Adults with GRPR-Positive Advanced Solid Tumors (OMNIRAY)
Objective:

Phase 1a Dose Escalation and Optimization

Primary Objectives

Dose Escalation: To assess the safety and tolerability of LY4257496 monotherapy

Dose Optimization: To determine the optimal dose and schedule of LY4257496 monotherapy in ER+/HER2- BCa

Secondary Objectives

Dose Escalation and Optimization: To assess antitumor activity of LY4257496 monotherapy

Dose Escalation: To assess the biodistribution and radiation dosimetry of LY4257496

Dose Escalation: To characterize the PK properties of LY4257496

Phase 1b Dose Expansion/Optimization

Primary Objectives

Dose Expansion: To assess the antitumor activity of LY4257496

Dose Optimization: To determine the optimal dose and schedule based on safety and efficacy of LY4257496 monotherapy or in combination with SOC therapy

Secondary Objectives

Dose Expansion: To assess the safety and tolerability of LY4257496

Dose Expansion: To assess, for each Dose Expansion cohort, the antitumor activity of LY4257496
Cancer Categories:
Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic
Principal Investigator:
Shields, Anthony
Karmanos Trial ID:
2025-079
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 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 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) versus Treatment of Investigator's Choice in Patients with Platinum Resistant Ovarian Cancer
Objective:

Primary Objective:

To compare progression-free-survival (PFS) in patients with platinum-resistant ovarian cancer (PROC) receiving rinatabart sesutecan (Rina-S) versus investigator’s choice of therapy (IC).

Secondary Objectives:

To assess additional measures of efficacy of Rina-S compared to IC in patients with PROC.

To assess the safety of Rina-S compared to IC in patients with PROC

To assess potential changes in QTc associated with Rina-S

To assess patient reported outcomes in patients receiving Rina-S and IC
Cancer Categories:
Gastrointestinal (GI),Gynecologic
Principal Investigator:
Morris, Robert
Karmanos Trial ID:
GOG-3107
Age Group:
Adult
Phase:
Phase III
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A Randomized Phase 3 Study Assessing the Efficacy and Safety of Olvi-Vec followed by Platinum-doublet Chemotherapy and Bevacizumab Compared with Platinum-doublet Chemotherapy and Bevacizumab in Women with Platinum-Resistant/Refractory Ovarian Cancer (OnPrime Study)
Objective:

Primary Objective:

The primary objective is to determine Progression-free Survival (PFS) by RECIST 1.1.

Key Secondary Objectives:

To determine Objective Response Rate (ORR) and Duration of Response (DOR) by RECIST 1.1, PFS by RECIST 1.1 (in modified population), PFS by iRECIST, Overall Survival (OS), and safety.

Key Other Objectives:

To determine ORR by the Gynecological Cancer Intergroup (GCIG) CA-125 criteria, and Clinical Benefit Rate [CBR = (CR + PR + SD ≥ 15 weeks)/total # of patients evaluated by RECIST 1.1 or iRECIST]. Additional analyses of efficacy endpoints in modified population are included.
Cancer Categories:
Gynecologic
Principal Investigator:
Morris, Robert
Karmanos Trial ID:
GOG-3076
Age Group:
Adult
Phase:
Phase III
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Multi-arm Phase 2 Study of Ubamatamab (REGN4018; MUC16×CD3 Bispecific Antibody) with or without Additional Agents in Platinum-Resistant Ovarian Cancer
Objective:

Primary Objectives:

Efficacy

To assess the Objective Response Rate (ORR) of ubamatamab alone or in combination with bevacizumab, cemiplimab + fianlimab, or PLD (separately by study arm)

Secondary Objectives:

Efficacy

To assess preliminary efficacy of ubamatamab combinations as measured by changes to CA-125 response, CR rate, disease control rate (DCR), duration of response (DOR), and progression-free survival (PFS).

Evaluate the ability of sarilumab to mitigate Grade ≥2 CRS

Safety

To assess the safety of ubamatamab monotherapy, and ubamatamab combinations including safety with sarilumab

To assess pharmacokinetics (PK) of ubamatamab, and fianlimab in combination therapy

To assess the immunogenicity of ubamatamab, fianlimab, and other experimental agents, as applicable
Cancer Categories:
Gastrointestinal (GI),Gynecologic
Principal Investigator:
Winer, Ira
Karmanos Trial ID:
2025-044
Age Group:
Adult
Phase:
Phase II
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