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 16

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 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Patients with Metastatic HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Objective:

Phase 1a Dose Escalation

Primary Objectives:

To assess the safety and tolerability of BGB-43395 alone in patients with advanced solid tumors or as part of combination therapies in HR+/HER2- breast cancer and other selected tumor types.

To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and recommended dose(s) for expansion (RDFE[s]) of BGB-43395 alone in patients with advanced solid tumors or as part of combination therapies in HR+/HER2- breast cancer and other selected tumor types.

Secondary Objectives:

To assess the preliminary anticancer activity of BGB-43395 alone in patients with advanced solid tumors or as part of combination therapies in HR+/HER2- breast cancer and other selected tumor types.

To characterize the PK of BGB-43395 and its metabolite, BGB-48579, alone in patients with advanced solid tumors or as part of combination therapies in HR+/HER2- breast cancer and other selected tumor types.

Phase 1b: Dose Expansion Objectives and Endpoints

Primary Objectives:

To assess the antitumor activity in patients treated with BGB-43395 alone or as part of combination therapies in selected tumor cohorts.

Secondary Objectives:

To further assess the antitumor activity in patients treated with BGB-43395 alone or as part of combination therapies in selected tumor cohorts.

To further characterize the safety and tolerability of BGB-43395 alone or as part of combination therapies.

To further characterize the pharmacokinetics (PK) of BGB-43395 and its metabolite, BGB-48579, with combination therapies.
Cancer Categories:
Brain and Nervous System,Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Head and Neck,Lung,Skin
Principal Investigator:
Saif, Wasif
Karmanos Trial ID:
2024-063
Age Group:
Adult
Phase:
Phase I
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A Phase 2, Safety and Efficacy Study of PRT3789 in Combination with Pembrolizumab in Patients with Advanced or Metastatic Solid Tumors with a SMARCA4 Mutation
Objective:

Primary Objectives:

Part 1

To evaluate the safety and tolerability of PRT3789 in combination with pembrolizumab in patients with advanced or metastatic solid tumors

Part 2

To evaluate the efficacy of PRT3789 in combination with pembrolizumab in patients with advanced or metastatic esophageal or NSCLC and deleterious SMARCA4 mutation

Secondary Objectives:

To evaluate the efficacy of PRT3789 in combination with pembrolizumab

To evaluate the safety and tolerability of PRT3789 in combination with pembrolizumab

To evaluate the PK profile of PRT3789 in combination with pembrolizumab
Cancer Categories:
Gastrointestinal (GI),Gynecologic,Head and Neck,Lung,Skin
Principal Investigator:
Uprety, Dipesh
Karmanos Trial ID:
2025-005
Age Group:
Adult
Phase:
Phase II
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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 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:
Elayoubi, Jailan
Karmanos Trial ID:
2023-076
Age Group:
Adult
Phase:
Phase I
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A Phase 1, Open-Label, Dose Escalation and Expansion Study of ASP1012, an Oncolytic Virus, in Participants with Locally Advanced or Metastatic Solid Tumors
Objective:

Primary Objectives:

To determine the safety and tolerability of ASP1012 (±pembrolizumab) in participants with locally advanced or metastatic solid tumors

To determine the MTD and/or candidate RP2D of ASP1012

Secondary Objectives:

To evaluate the PK and virus shedding of ASP1012

To evaluate the ADAs of ASP1012

To evaluate anti-tumor effects of ASP1012

To evaluate tumor-specific virus delivery

To evaluate tumor biomarker changes related to ASP1012 treatment (CRC and ovarian)
Cancer Categories:
Gastrointestinal (GI),Gynecologic,Skin
Principal Investigator:
Shields, Anthony
Karmanos Trial ID:
2023-093
Age Group:
Adult
Phase:
Phase I
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