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 171

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 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 1/2, 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 Phase 3 Study of the selective anaplastic lymphoma kinase (ALK) inhibitor NVL-655 compared to alectinib in first-line treatment of patients with ALK-positive advanced non-small cell lung cancer (ALKAZAR)
Objective:

Primary Objective:

To evaluate the efficacy of NVL-655 compared to alectinib in patients with treatment-naïve ALK-positive advanced NSCLC

Secondary Objectives:

To assess additional measures of efficacy of NVL-655 compared to alectinib in patients with treatment-naïve ALK-positive advanced NSCLC

To evaluate the safety and tolerability of NVL-655 compared to alectinib

To evaluate and compare patient-reported measures of health-related quality of life (QoL), lung cancer symptoms, patient functioning, and side effects of treatment
Cancer Categories:
Lung
Principal Investigator:
Uprety, Dipesh
Karmanos Trial ID:
2025-054
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
Learn More

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