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 49

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 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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An Open-label, Dose Escalation and Expansion, Phase 1/2 Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-188, an Anti-CCR8 Antibody-Drug-Conjugate, as a Single Agent in Adult Participants With Select Locally Advanced or Metastatic Solid Tumors
Objective:

Primary Objective:

Phase 1 dose escalation:

To determine the safety and tolerability of TAK-188 administered in adult participants with locally advanced or metastatic solid tumors.

Phase 2 dose expansion:

To assess the preliminary efficacy of TAK-188 in recurrent locally advanced or metastatic NSCLC, PD-L1 positive SCCHN, and gastroesophageal (esophageal, gastroesophageal junction, and gastric) adenocarcinoma post anti-PD-(L)1 therapy.

Secondary Objective:

Phase 1 dose escalation:

To determine the RDE(s) of TAK-188.

To characterize the PK of TAK-188.

To evaluate the preliminary efficacy of TAK-188 in locally advanced or metastatic solid tumors.

To evaluate the changes from baseline of Treg abundance, Teff abundance and/or the ratio of Teffs:Tregs within the TME in response to treatment with TAK-188.

To assess the immunogenicity of TAK-188.

Phase 2 dose expansion:

To further assess the preliminary efficacy of TAK-188 in recurrent locally advanced or metastatic NSCLC, PD-L1 positive SCCHN, and GEA post anti-PD-(L)1 therapy.

To characterize the PK of TAK-188.

To evaluate the changes from baseline of Treg abundance, Teff abundance, and/or the ratio of Teffs:Tregs within the TME in response to treatment with TAK-188.

To assess the immunogenicity of TAK-188.

Safety Objective:

Phase 2 dose expansion:

To determine the safety and tolerability of TAK-188 in participants with locally advanced or metastatic NSCLC, SCCHN, and GEA.
Cancer Categories:
Gastrointestinal (GI),Lung
Principal Investigator:
Saif, Wasif
Karmanos Trial ID:
2025-081
Age Group:
Adult
Phase:
Phase I/II
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Phase III Randomized Trial of Proton Beam Therapy (PBT) Versus Intensity Modulated Photon Radiotherapy (IMRT) For the Treatment of Esophageal Cancer
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
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Randomized Phase III Trial of mFOLFIRINOX vs. FOLFOX With Nivolumab for First-Line Treatment of Metastatic HER2- Gastroesophageal Adenocarcinoma
Objective:

Primary Objective:

To determine if overall survival (OS) is improved in patients who received mFOLFIRINOX +/- nivolumab in comparison to FOLFOX +/- nivolumab as first-line chemotherapy for metastatic gastroesophageal adenocarcinoma.

Secondary Objectives:

To compare other indices of efficacy, including progression-free survival, objective response rates and duration of response between both treatment arms

To evaluate safety and tolerability associated with treatment in each of the treatment arms

To evaluate the proportion of patients receiving second line of therapy in both arms

To evaluate tolerability of the treatment in both arms using PRO-CTCAE
Cancer Categories:
Gastrointestinal (GI)
Principal Investigator:
Al Hallak, Mohammed
Karmanos Trial ID:
A022102
Age Group:
Adult
Phase:
Phase III
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A MULTICENTER, OPEN-LABEL PHASE 1/1B / PHASE 2 DOSE-FINDING, SAFETY, AND PHARMACOKINETIC STUDY OF MBRC-101, AN ANTI-EPHA5 MONOMETHYL AURISTATIN E (MMAE) ANTIBODY DRUG CONJUGATE, IN ADVANCED REFRACTORY SOLID TUMORS
Objective:

Primary Objectives:

Phase 1

To identify potential OBRD and dosing regimens of MBRC-101

To establish the MTD of MBRC-101 using 1 or more dosing regimens

To identify potential RP2Ds and regimens of MBRC-101

Phase 1b

To evaluate the safety of MBRC-101 at potential OBRDs, RP2Ds and dosing regimens

To evaluate preliminary clinical activity of MBRC-101 at potential OBRDs and dosing regimens

Phase 2

To evaluate the efficacy of MBRC-101 at the RP2D

Secondary Objectives:

Phase 1

To evaluate other measures of preliminary clinical activity of MBRC-101

Phase 2

To evaluate other measures of clinical activity

To evaluate the safety of MBRC-101 at RP2Ds and dosing regimens

Phase 1/1b and Phase 2

To characterize single and multiple-dose PK profiles of MBRC-101

To evaluate incidence and persistence of anti-MBRC-101 Ab formation

To evaluate biomarkers of clinical response and resistance, safety, pharmacodynamic activity, and/or mechanism of action of MBRC-101
Cancer Categories:
Breast,Gastrointestinal (GI),Lung
Principal Investigator:
Uprety, Dipesh
Karmanos Trial ID:
2024-078
Age Group:
Adult
Phase:
Phase I
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A Multicenter, Open-label, First-in-Human Study of TYRA-430 in Advanced Hepatocellular Carcinoma and Other Solid Tumors with Activating FGF/FGFR pathway aberrations (SURF431)
Objective:

Primary Objectives:

To characterize the safety and tolerability of TYRA-430 in participants with advanced hepatocellular carcinoma and other solid tumors with FGF/FGFR pathway alterations

Secondary Objectives:

To characterize the PK profile of TYRA-430 and its metabolite and to correlate drug exposure with safety assessments and measures of antitumor activity

To evaluate the preliminary antitumor activity of the optimal dose of TYRA-430 in participants with advanced, previously treated hepatocellular carcinoma
Cancer Categories:
Brain and Nervous System,Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Head and Neck,Lung
Principal Investigator:
Saif, Wasif
Karmanos Trial ID:
2025-007
Age Group:
Adult
Phase:
Phase I
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A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 in Subjects with HER2 Expressing Advanced Malignant Solid Tumors
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
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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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