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 13

A first-in-human, open-label Phase 1/2 study to evaluate the safety and anti-tumor activity of ANV600 as single agent and in combination with pembrolizumab in participants with relapsed/refractory advanced solid tumors.
Objective:

Phase I (dose escalation)

Primary Objectives:

To identify the MTD and/or RP2D of ANV600 single agent and in combination with pembrolizumab

Secondary Objectives:

To characterize the PK of ANV600 single agent and in combination with pembrolizumab after single dose and repeated dosing

To evaluate the prevalence and incidence of immunogenicity of ANV600

To describe the anti-tumor activity of ANV600 as single agent and in combination with pembrolizumab

Phase II

Primary Objectives:

To assess the anti-tumor activity of ANV600 as single agent and in combination with pembrolizumab

Secondary Objectives:

To assess the anti-tumor activity of ANV600 as single agent and in combination with pembrolizumab

To assess the safety and tolerability ANV600 single agent and in combination with pembrolizumab for each cohort and in the overall study population

To characterize the PK of ANV600 single agent and in combination with pembrolizumab after single dose and repeated dosing

To evaluate the prevalence and incidence of immunogenicity of ANV600
Cancer Categories:
Lung,Skin
Principal Investigator:
Shao, Yusra
Karmanos Trial ID:
2024-070
Age Group:
Adult
Phase:
Phase I/II
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A Phase 1a/1b open-label, multicenter, dose-escalation, and dose expansion study to evaluate the safety and activity of TEV-56278, as a single agent and in combination with pembrolizumab, in participants with selected locally advanced or metastatic solid tumors
Objective:

Part 1

Primary Objectives:

To characterize the safety and tolerability of TEV-56278 in the trial population

To determine a RP2D

Secondary Objectives:

To characterize the serum pharmacokinetics of TEV-56278 in the trial population

To evaluate the antitumor activity of TEV-56278 in the trial population

Part 2

Primary Objectives:

To evaluate antitumor activity of TEV-56278 in the trial population

Secondary Objectives:

To characterize the serum pharmacokinetics of TEV-56278 in the trial population

To determine the safety and tolerability of TEV-56278 in the trial population

To evaluate other measures of antitumor activity of TEV-56278 in the trial population
Cancer Categories:
Brain and Nervous System,Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Head and Neck,Lung,Skin
Principal Investigator:
Saif, Wasif
Karmanos Trial ID:
2024-045
Age Group:
Adult
Phase:
Phase I
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A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants with Unresectable or Metastatic Melanoma
Objective:

Primary Objectives:

To demonstrate superiority of Arm A (fianlimab + cemiplimab) compared to Arm B (Opdualag) as measured by ORR

Secondary Objectives:

To describe PFS in Arm A and Arm B

To describe OS in Arm A and Arm B

To describe the duration of response (DOR) in Arm A and Arm B

To describe the disease control rate (DCR) in Arm A and Arm B

To describe ORR and PFS by investigator assessment in Arm A and Arm B

To assess the safety and tolerability of Arm A and Arm B

To characterize the pharmacokinetics (PK) of fianlimab and cemiplimab in Arm A

To assess the immunogenicity of fianlimab and cemiplimab
Cancer Categories:
Skin
Principal Investigator:
Shao, Yusra
Karmanos Trial ID:
2024-044
Age Group:
Adult
Phase:
Phase III
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A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BGC515 Capsules in Patients with Advanced Solid Tumors
Objective:

Part I: Dose Escalation Phase

Primary Objectives:

To evaluate the safety and tolerability of BGC515 Capsules in patients with malignant mesothelioma (MM), epithelioid hemangioendothelioma (EHE), or other advanced solid tumors.

To explore the dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD).

Secondary Objectives:

To evaluate the pharmacokinetics (PK) of BGC515 Capsules in patients with MM, EHE, or other advanced solid tumors.

To preliminarily evaluate the efficacy of BGC515 Capsules in patients with MM, EHE, or other advanced solid tumors.

Part II: Dose Expansion Phase

Primary Objectives:

To further evaluate the safety and tolerability of BGC515 Capsules in patients with MM, EHE, glioblastoma, or other advanced solid tumors including those with NF1/2 deficiency, YAP/TAZ fusion, LATS1/2 mutation, MST1/2 mutation, so as to determine the recommended phase 2 dose (RP2D).

To evaluate the preliminary efficacy of BGC515 Capsules in patients with MM, EHE, glioblastoma, or other advanced solid tumors including those with NF1/2 deficiency, YAP/TAZ fusion, LATS1/2 mutation, MST1/2 mutation.

Secondary Objectives:

To evaluate the PK of BGC515 Capsules in patients with MM, EHE, glioblastoma, or other advanced solid tumors including those with NF1/2 deficiency, YAP/TAZ fusion, LATS1/2 mutation, MST1/2 mutation.
Cancer Categories:
Breast,Gastrointestinal (GI),Genitourinary (GU),Head and Neck,Lung,Skin
Principal Investigator:
Winer, Ira
Karmanos Trial ID:
2024-064
Age Group:
Adult
Phase:
Phase I
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A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of GSK5764227 in Participants with Advanced Solid Tumors
Objective:

Phase 1a dose escalation

Primary Objectives:

To determine the MTD/MAD and evaluate the safety and tolerability of GSK5764227 in participants with advanced solid tumors.

Secondary Objectives:

To evaluate the PK profile of GSK5764227 in participants with advanced solid tumors.

To evaluate the clinical activity of GSK5764227 in participants with advanced solid tumors

To evaluate the immunogenicity of GSK5764227 in participants with advanced solid tumors.To evaluate the immunogenicity of GSK5764227 in participants with advanced solid tumors.

Phase 1b dose expansion

Primary Objectives:

To evaluate the clinical activity of GSK5764227 in participants with ES-SCLC or advanced solid tumors.

Secondary Objectives:

To evaluate the safety and tolerability of GSK5764227 in participants with ES-SCLC or advanced solid tumors

To evaluate additional measures of clinical benefit of GSK5764227 in participants with ES-SCLC or advanced solid tumors.

To evaluate the PK profile of GSK5764227 in participants with ES-SCLC or advanced solid tumors.

To evaluate the immunogenicity of GSK5764227 in participants with ES-SCLC or advanced solid tumors.
Cancer Categories:
Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Lung,Skin
Principal Investigator:
Saif, Wasif
Karmanos Trial ID:
2024-073
Age Group:
Adult
Phase:
Phase I
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A phase I dose-escalation and metabolomics study of metformin combined with chemotherapy and/or immunotherapy in solid malignancies
Objective:

Primary Objectives:

Evaluate the dose limiting toxicities (DLTs) of metformin alone and in combination with chemotherapy and/or immunotherapy (IO) in patients with solid malignancies

Determine the maximum tolerated dose (MTD) of metformin in combination with chemotherapy and/or IO in patients with solid malignancies

Secondary Objective:

Assess efficacy parameters
Cancer Categories:
Breast,Gastrointestinal (GI),Gynecologic,Lung,Skin
Principal Investigator:
Saif, Wasif
Karmanos Trial ID:
2024-050
Age Group:
Adult
Phase:
Phase I
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A Phase 1 Basket Study Evaluating the Safety and Feasibility of T-Plex, Autologous Customized T Cell Receptor-Engineered T Cells Targeting Multiple Peptide/HLA Antigens in Participants with Antigen-positive Locally Advanced (Unresectable) or Metastatic Solid Tumors: PLEXI-T
Objective:

Primary Objectives:

To investigate the safety of monotherapy and T- Plex combination TCR-Ts

To determine the recommended phase 2 dose of monotherapy and T- Plex combination TCR-Ts

Secondary Objectives:

To investigate preliminary anti-tumor activity of monotherapy and T- Plex combination TCR-Ts

To investigate the feasibility of repeat dosing of monotherapy and T- Plex combination TCR-Ts
Cancer Categories:
Gynecologic,Hematologic (Blood Cancers),Lung,Skin
Principal Investigator:
Winer, Ira
Karmanos Trial ID:
2023-086
Age Group:
Adult
Phase:
Phase I
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A Phase 1, Open-label Study of BS006, an Oncolytic Virus, Administered by Intratumoral Injection in Patients with Advanced/Metastatic Solid Tumors
Objective:

Primary Objectives:

To evaluate the safety and tolerability of BS006 in patients with advanced solid tumors

To estimate the maximum tolerated dose (MTD) of BS006

Secondary Objectives:

To preliminarily observe the anti-tumor efficacy of BS006 in patients with advanced solid tumors

To evaluate the biological activities of BS006 in tumor

To evaluate the biodistribution and viral shedding of BS006
Cancer Categories:
Breast,Skin
Principal Investigator:
Saif, Wasif
Karmanos Trial ID:
2023-076
Age Group:
Adult
Phase:
Phase I
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A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL - 2 Superkine, Administered Alone or in Combination with Immune Checkpoint Inhibitor in Patients with Advanced Solid Tumors
Objective:

Dose Escalation (Monotherapy)

Primary Objectives:

To evaluate safety and tolerability of MDNA11 administered in patients with advanced solid tumors

To identify RDE and/or MTD of MDNA11.

Secondary Objectives:

To assess anti-tumor activity of MDNA11

To assess pharmacokinetic (PK) profile of MDNA11

To assess immunogenicity of MDNA11

To assess pharmacodynamic effects of MDNA11

Dose Expansion (Monotherapy and Combination Therapy)

Primary Objectives:

To further evaluate safety and tolerability of MDNA11 (alone or in combination with pembrolizumab)

To assess anti-tumor activity of MDNA11 (alone or in combination with pembrolizumab)

Secondary Objectives:

To assess pharmacodynamic effects of MDNA11 (alone or in combination pembrolizumab) in peripheral blood

To assess pharmacodynamic effects and immune response of MDNA11 (alone or in combination pembrolizumab) in tumor tissue

To further assess PK profile of MDNA11

To assess immunogenicity of MDNA11 (alone or in combination pembrolizumab)
Cancer Categories:
Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Head and Neck,Lung,Skin
Principal Investigator:
Winer, Ira
Karmanos Trial ID:
2023-053
Age Group:
Adult
Phase:
Phase I/II
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AN OPEN-LABEL PHASE 1/2A STUDY OF GV20-0251 MONOTHERAPY AND GV20-0251 IN COMBINATION WITH PEMBROLIZUMAB IN PARTICIPANTS WITH ADVANCED AND/OR REFRACTORY SOLID TUMOR MALIGNANCIES
Objective:

Part A

Primary Objectives:

To characterize the safety and tolerability of GV20-0251 and establish the MTD and/or the RP2D of GV20-0251

Secondary Objectives:

To characterize the PK of GV20-0251

To characterize the immunogenicity of antiGV20-0251 ADA and nADA

To evaluate the preliminary anti-tumor activity of GV20-0251

Part B

Primary Objectives:

To evaluate the ORR per RECIST version 1.1 of GV20-0251 in different tumor types

Secondary Objectives:

To characterize the safety of GV20-0251

To characterize the PK of GV20-0251

To characterize the immunogenicity of GV20-0251

To evaluate the anti-tumor activity of GV20-0251
Cancer Categories:
Gastrointestinal (GI),Genitourinary (GU),Head and Neck,Lung,Skin
Principal Investigator:
Shao, Yusra
Karmanos Trial ID:
2023-106
Age Group:
Adult
Phase:
Phase I
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