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 60

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 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 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
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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 Phase 3, Double-blind, Randomized Study of Zolbetuximab in Combination with Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in Participants Whose Tumors are HER2-negative, Claudin (CLDN) 18.2-positive and Programmed Death-ligand 1 (PD-L1)-positive
Objective:

Primary Objectives:

To evaluate the efficacy of zolbetuximab plus pembrolizumab and chemotherapy (CAPOX or mFOLFOX6) compared with placebo plus pembrolizumab and chemotherapy (CAPOX or mFOLFOX6) (as first-line treatment)

Secondary Objectives:

To evaluate the activity and efficacy of zolbetuximab plus pembrolizumab and chemotherapy compared with placebo plus pembrolizumab and chemotherapy

To evaluate the efficacy of zolbetuximab plus pembrolizumab and chemotherapy compared with placebo plus pembrolizumab and chemotherapy

To assess the safety and tolerability of zolbetuximab in combination with pembrolizumab and chemotherapy

To evaluate the PK of zolbetuximab in combination with pembrolizumab and chemotherapy

To evaluate the immunogenicity profile of zolbetuximab in combination with pembrolizumab and chemotherapy
Cancer Categories:
Gastrointestinal (GI)
Principal Investigator:
Saif, Wasif
Karmanos Trial ID:
2025-057
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
Learn More

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