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 23

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 2/3, 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 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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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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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 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 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 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 II Multicenter Trial of ESK981 in Patients with Select Solid Tumors
Objective:

Primary Objectives:

Determine efficacy using proportion of patients alive and progression-free at 4 months within each cancer subtype

Secondary Objectives:

Determine overall response rate (ORR), duration of response (DoR), median progression-free survival (PFS) and overall survival (OS) within each cancer subtype

Determine safety and tolerability in each cancer subtype
Cancer Categories:
Gastrointestinal (GI),Genitourinary (GU),Head and Neck
Principal Investigator:
Cackowski, Frank
Karmanos Trial ID:
2024-009
Age Group:
Adult
Phase:
Phase II
Learn More

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