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 19

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 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 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 2/3, Randomized Study of INBRX-106 Combined With Pembrolizumab Versus Pembrolizumab as First-Line Treatment for Patients With Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) Expressing PD-L1 (CPS >=20) (HexAgon-HN)
Objective:

Primary Objective:

To compare the efficacy of INBRX-106 + pembrolizumab vs pembrolizumab

Secondary Objective:

To further compare the efficacy of INBRX-106 + pembrolizumab vs pembrolizumab

To evaluate the safety and tolerability of INBRX-106 + pembrolizumab vs pembrolizumab

To compare the impact of INBRX-106 + pembrolizumab vs pembrolizumab on pain, function, and HRQoL
Cancer Categories:
Head and Neck
Principal Investigator:
Sukari, Ammar
Karmanos Trial ID:
2024-066
Age Group:
Adult
Phase:
Phase II/III
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A phase 3 open-label, randomized, controlled study to evaluate the efficacy and safety of petosemtamab compared with investigator's choice monotherapy treatment in previously treated patients with incurable, metastatic/recurrent head and neck squamous cell carcinoma
Objective:

Primary Objectives:

To compare antitumor activity in ORR per
Response Evaluation Criteria in Solid Tumor
(RECIST) Guidelines version (v) 1.1 as assessed
by blinded independent central review (BICR)
in patients with incurable metastatic /
recurrent HNSCC patients progressed on after
anti-PD-1 and platinum containing therapy,
treated with petosemtamab monotherapy vs
investigator’s choice monotherapy

To compare OS in patients with incurable
metastatic / recurrent HNSCC progressed on
after anti-PD-1 and platinum-containing
therapy, treated with petosemtamab
monotherapy vs investigator’s choice
monotherapy

Secondary Objectives:

To evaluate antitumor activity in ORR per
RECIST v1.1 as assessed by investigator review

To evaluate antitumor activity in DOR per
RECIST v1.1 as assessed by BICR and
investigator review

To evaluate antitumor activity in TTR per
RECIST v1.1 as assessed by BICR and
investigator review

To evaluate antitumor activity in PFS per
RECIST v1.1 as assessed by BICR and by
investigator review

To evaluate antitumor activity in CBR per
RECIST v1.1 as assessed by BICR and by
investigator review

To evaluate safety and tolerability of
petosemtamab monotherapy

To evaluate patient health-related quality of
life (HRQL) using the European Organisation
for Research and Treatment of Cancer (EORTC)
validated Quality of Life of Cancer Patients
Questionnaire (QLQ-C30)

To evaluate patient HRQL using the updated
EORTC validated Quality of Life of Head and
Neck Cancer Patients Questionnaire (QLQH&N43)

To characterize the PK of petosemtamab

To characterize the population PK of
petosemtamab

To characterize the immunogenicity of
petosemtamab
Cancer Categories:
Head and Neck
Principal Investigator:
Hadid, Tarik
Karmanos Trial ID:
2024-023
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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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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Phase 1/2 Dose Escalation and Cohort Expansion Study Evaluating MCLA-158 (Petosemtamab) as Single-Agent or in Combination in Advanced Solid Tumors
Objective:

Dose escalation (completed)

Primary Objective:

To determine the preliminary RP2D of single-agent petosemtamab in mCRC patients who have progressed on chemotherapy, with or without an anti-VEGF therapy, and with an anti-EGFR therapy (if RAS WT)

Secondary Objectives:

To characterize the safety and tolerability of petosemtamab

To evaluate preliminary antitumor activity

To characterize the PK of petosemtamab

To characterize the immunogenicity of petosemtamab

Dose expansion (single-agent nonrandomized early expansion, 2L/3L HNSCC, 3L+ mCRC, and esophageal cohorts)

Primary Objective:

To determine the ORR per RECIST v1.1 as assessed by investigator review

Secondary Objectives:

To further evaluate antitumor activity per RECIST v1.1 as assessed by investigator review

For 3L+ mCRC only: To evaluate antitumor activity per RECIST v1.1 as assessed by blinded independent central review (BICR)

To evaluate overall survival (OS) (Note: this is an exploratory objective for the esophageal cohort)

To characterize safety and tolerability of single-agent petosemtamab

To characterize the PK of petosemtamab

To characterize the immunogenicity of petosemtamab

Dose expansion (single-agent, randomized expansion in 2L/3L HNSCC cohort)

Primary Objectives:

To descriptively characterize all relevant clinical safety and efficacy data

To characterize the exposure-safety relationship of petosemtamab administered at 1100 mg and 1500 mg Q2W in terms of TEAEs

Secondary Objectives:

To characterize the exposure-efficacy relationship of petosemtamab administered at 1100 mg and 1500 mg Q2W in terms of the sum of the diameters of target lesions

To characterize the exposure-safety relationship of petosemtamab administered at 1100 mg and 1500 mg Q2W in terms of Grades 3-4 TEAEs, IRRs, and nonIRR TEAEs

To evaluate antitumor activity per RECIST v1.1 as assessed by investigator review

To characterize other safety endpoints of 1100 mg and 1500 mg Q2W dose of single-agent petosemtamab

To characterize the PK of petosemtamab

To characterize the immunogenicity of petosemtamab

Dose expansion (combination with pembrolizumab [1L HNSCC], FOLFIRI [mCRC], or FOLFOX [mCRC] cohorts)

Primary Objectives:

To determine the ORR per RECIST v1.1 as assessed by investigator review

To characterize safety of petosemtamab combination therapies

Secondary Objectives:

To further evaluate antitumor activity per RECIST v1.1 as assessed by investigator review

For mCRC combination cohorts only: To evaluate antitumor activity per RECIST v1.1 as assessed by BICR

To characterize other safety endpoints and tolerability of petosemtamab combination therapies

To characterize the PK of petosemtamab when administered as combination therapy

To characterize the immunogenicity of petosemtamab when administered as combination therapy
Cancer Categories:
Gastrointestinal (GI),Head and Neck
Principal Investigator:
Al Hallak, Mohammed
Karmanos Trial ID:
2024-100
Age Group:
Adult
Phase:
Phase I/II
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