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 17

A Randomized, Masked, Placebo Controlled, Phase II Trial of Concurrent Chemoradiation With BMX-001 In Patients with Head and Neck Squamous Cell Carcinoma Receiving Concurrent Chemoradiation
Objective:

Primary Objectives:

To compare the incidence of severe oral mucositis (SOM) between BMX-001 and placebo, defined as ≥ Grade 3 per WHO criteria from the start of radiation through 4 weeks after completion of study treatment, with additional assessments at 6, 8 and 12 weeks after completion of study treatment.

Secondary Objectives:

To compare the duration of SOM in the BMX-001 arm vs. placebo arm.

To assess the difference between arms in the OMWQ-HN change score from baseline to 4 weeks after the end of chemoradiation.

To describe the incidence and severity of xerostomia and radiation dermatitis, as measured by CTCAE v5.0, in both arms.

To compare the duration of radiation dermatitis in the BMX-001 arm vs. placebo arm.

To describe toxicity, as measured by CTCAE v5.0 and PRO-CTCAE, in both arms.
Cancer Categories:
Head and Neck
Principal Investigator:
Yeh, Brian
Karmanos Trial ID:
NRG-CC013
Age Group:
Adult
Phase:
Phase II
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Phase II Randomized Trial of Radiotherapy with or without Cisplatin for Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN) with TP53 Sequencing
Objective:

Primary Objective:

To evaluate the disease-free survival (DFS) of patients with stage III-IV SCCHN and disruptive p53 mutations after primary surgical resection followed by PORT alone or PORT with concurrent cisplatin.

Secondary Objectives:

To evaluate the DFS of patients with stage III-IV SCCHN and non-disruptive p53 mutations after primary surgical resection followed by PORT alone or PORT with concurrent cisplatin

To evaluate the DFS of patients with stage III-IV SCCHN and p53 wild type after primary surgical resection followed by PORT alone or PORT with concurrent cisplatin

To evaluate toxicities of PORT alone or PORT with concurrent cisplatin.

To evaluate p53 mutation as a predictive biomarker of survival benefit given post-operative concurrent radiation and cisplatin.

To identify potential genomic alterations in addition to TP53 mutations that may be developed to a novel treatment approach.
Cancer Categories:
Head and Neck,Lung
Principal Investigator:
Sukari, Ammar
Karmanos Trial ID:
EA3132
Age Group:
Adult
Phase:
Phase II
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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, 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 I, Open-Label, Multicenter, Dose Escalation and Expansion Study of HM16390, as a Single Agent and in Combination with pembrolizumab, in Patients with Advanced or Metastatic Solid Tumors
Objective:

Primary Objective:

To evaluate the safety and tolerability of HM16390 administered SC in subjects with advanced or metastatic solid tumors

Secondary Objectives:

To determine the MTD or recommended Phase II dose (RP2D) of HM16390 administered SC in subjects with advanced or metastatic solid tumors

To characterize the PK of HM16390 SC administration in subjects with advanced or metastatic solid tumors

To assess the anti-tumor effect of HM16390 SC administration in subjects with advanced or metastatic solid tumors
Cancer Categories:
Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Head and Neck,Lung,Skin
Principal Investigator:
Saif, Wasif
Karmanos Trial ID:
2025-024
Age Group:
Adult
Phase:
Phase I
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An Open-Label, Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics of the CTPS1 Inhibitor STP938 in Adult Subjects with Advanced Solid Tumors, With a Safety Expansion in Advanced CTPS2 Null Ovarian Cancer
Objective:

Primary Objectives:

Evaluate the safety and tolerability of single agent STP938

To determine the RP2D for STP938.

Secondary Objectives:

Evaluate the PK of STP938

Evaluate the preliminary clinical activity of single agent STP938.
Cancer Categories:
Brain and Nervous System,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Head and Neck,Lung,Skin
Principal Investigator:
Winer, Ira
Karmanos Trial ID:
2024-072
Age Group:
Adult
Phase:
Phase I
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A Phase 1 Study of CHS-114 in Participants with Advanced Solid Tumors
Objective:

Arm 1a and Arm 1b

Primary Objectives:

Select 2 doses of CHS-114 as a monotherapy to be considered as recommended dose for expansion (RDEs) in participants with advanced solid tumors and HNSCC following standard first-line therapy.

Secondary Objectives:

Evaluate the safety and tolerability of CHS114 monotherapy.

Evaluate the PK of CHS-114 as monotherapy.

Evaluate the preliminary antitumor activity of CHS-114 administered as monotherapy.

Evaluate the changes in FOXP3 levels within the tumor tissue (in participants undergoing pretreatment and on-treatment tumor biopsies).

Arm 2

Primary Objectives:

Evaluate the safety and tolerability of CHS-114 in combination with toripalimab in participants with HNSCC following standard first-line therapy

Secondary Objectives:

Evaluate the PK of CHS-114 and toripalimab when administered in combination.

Evaluate the preliminary antitumor activity of CHS-114 administered in combination with toripalimab.
Cancer Categories:
Head and Neck
Principal Investigator:
Sukari, Ammar
Karmanos Trial ID:
2023-099
Age Group:
Adult
Phase:
Phase I
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A Phase 1 Study of FT825/ONO-8250, an Off-the-Shelf CAR T-Cell Therapy, With or Without Monoclonal Antibodies, in HER2-Positive or Other Advanced Solid Tumors
Objective:

Primary Objectives:

To evaluate the safety and tolerability of FT825 with or without cetuximab following CY/FLU or bendamustine

To define the RP2D of FT825 with or without cetuximab following CY/FLU or bendamustine

Secondary Objectives:

To evaluate the antitumor activity of FT825 with or without cetuximab following CY/FLU or bendamustine

To characterize the PK of FT825 with or without cetuximab following CY/FLU or bendamustine
Cancer Categories:
Breast,Gastrointestinal (GI),Head and Neck,Lung
Principal Investigator:
Assad, Hadeel
Karmanos Trial ID:
2023-100
Age Group:
Adult
Phase:
Phase I
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A Phase 1 Study of SGN-PDL1V in Advanced Solid Tumors
Objective:

Primary Objectives:

To evaluate the safety and tolerability of SGN-PDL1V in subjects with advanced solid tumors.

To identify the maximum tolerated dose (MTD) of SGN-PDL1V in subjects with advanced solid tumors.

To identify a recommended dose and schedule for SGN-PDL1V.

Secondary Objectives:

To assess the antitumor activity of SGN-PDL1V.

To assess the pharmacokinetics (PK) of SGN-PDL1V.

To assess the immunogenicity of SGN-PDL1V.
Cancer Categories:
Breast,Gastrointestinal (GI),Head and Neck,Lung
Principal Investigator:
Sukari, Ammar
Karmanos Trial ID:
2023-045
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
Learn More

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