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.

Request an Appointment Refer a Patient NCI Dictionary of Cancer Terms Clinical Trials App

Hide Search Criteria

Cancer Category

Enter Keyword

Clinical Trial Phase

Therapies Involved

Device Involved

Study Site

NCT ID

KCI Trial ID

Drug Involved

Principal Investigator

Clear Search

Results 1 - 10 of 54

A First-In-Human, Phase 1, Dose-Escalation Study of SGR-3515 In Participants with Advanced Solid Tumors
Objective:

Primary Objectives:

Evaluate SGR-3515 safety, tolerability, dose-limiting toxicities (DLTs) in participants with advanced solid tumors

Identify the maximum tolerated dose (MTD) or maximum administered dose (MAD) and recommended phase 2 dose (RP2D) and recommended schedule (RP2S) of SGR-3515

Secondary Objectives:

Evaluate SGR-3515 PK in participants with advanced solid tumors

Evaluate SGR-3515 preliminary anti-tumor activity in participants with advanced solid tumors as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or the applicable disease specific criteria
Cancer Categories:
Lung
Principal Investigator:
Winer, Ira
Karmanos Trial ID:
2024-098
Age Group:
Adult
Phase:
Phase I
Learn More
A Phase 1 Dose-Escalation Study to Investigate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamic Activity of CLN-619 (Anti-MICA/MICB Antibody) Alone and in Combination with Pembrolizumab in Patients with Advanced Solid Tumors
Objective:

Primary Objective:

Dose Escalation

To characterize the safety, tolerability, DLT and MTD (or maximum administered dose [MAD] or maximum biologically effective dose [MBED] if no MTD defined) of CLN-619 administered intravenously alone (Module A, Module D) or in combination with pembrolizumab (Module B) or in combination with chemotherapy (Module C) in patients with advanced solid tumors.

Dose Expansion

To evaluate the anti-tumor activity of CLN-619 alone and/or in combination with pembrolizumab (Module B) or with chemotherapy (Module C), as assessed by the Best Overall Response (BOR), ORR, Duration of Response (DoR), Progression Free Survival (PFS), Disease Control Rate (DCR), Overall Survival (OS), and the Clinical Benefit Rate (CBR), per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, in patients with advanced solid tumors.

Secondary Objectives:

To assess the PK profile of CLN-619 administered alone, - in combination with pembrolizumab or in combination with chemotherapy in patients with selected, advanced solid tumors.

To assess the immunogenicity of CLN-619 administered alone, in combination with pembrolizumab, or in combination with chemotherapy, in patients with selected, advanced solid tumors.
Cancer Categories:
Breast,Gastrointestinal (GI),Gynecologic,Lung
Principal Investigator:
Mamdani, Hirva
Karmanos Trial ID:
2024-089
Age Group:
Adult
Phase:
Phase I
Learn More
A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 in Subjects with HER2 Expressing Advanced Malignant Solid Tumors
Objective:

Primary Objectives:

To assess the safety and tolerability of BL-M07D1 in metastatic or unresectable HER2-expressing tumors

To determine the MTD if reached or MAD and two or more RDEs of BL-M07D1

Secondary Objectives:

To characterize the pharmacokinetics of BL-M07D1, total anti-HER2 antibody, and payload (Ed-04)

To investigate the antitumor activity of BL-M07D1
Cancer Categories:
Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Lung
Principal Investigator:
Saif, Wasif
Karmanos Trial ID:
2025-010
Age Group:
Adult
Phase:
Phase I
Learn More
A Phase 2, open-label, multicenter study to evaluate efficacy and safety of zanidatamab for the treatment of participants with previously treated HER2-expressing solid tumors (DiscovHER PAN-206)
Objective:

Primary Objectives:

To evaluate the antitumor activity of zanidatamab monotherapy in participants with locally advanced, unresectable, or metastatic HER2-overexpressing (IHC 3+) solid tumors

Secondary Objectives:

To assess other antitumor efficacy parameters of zanidatamab monotherapy in participants with locally advanced, unresectable, or metastatic HER2-overexpressing (IHC 3+) solid tumors

To evaluate the safety and tolerability of zanidatamab monotherapy in participants with locally advanced, unresectable, or metastatic HER2-overexpressing (IHC 3+) solid tumors

To evaluate the PK of zanidatamab

To evaluate the immunogenicity of zanidatamab

To evaluate participant-reported tolerability of zanidatamab monotherapy in participants with locally advanced, unresectable, or metastatic HER2-overexpressing (IHC 3+) solid tumors
Cancer Categories:
Breast,Gastrointestinal (GI),Gynecologic,Lung
Principal Investigator:
Winer, Ira
Karmanos Trial ID:
2024-099
Age Group:
Adult
Phase:
Phase II
Learn More
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
Learn More
A Randomized, Double-Blind, Multiregional Phase 3 Study of Ivonescimab Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy For The First-Line Treatment of Metastatic Non-Small Cell Lung Cancer
Objective:

Primary Objectives:

To compare OS between ivonescimab combined with platinum-doublet chemotherapy and pembrolizumab combined with platinum-doublet chemotherapy

To compare investigator assessed progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 between ivonescimab combined with platinum-doublet chemotherapy and pembrolizumab combined with platinum- doublet chemotherapy

Secondary Objectives:

To compare the objective response rate (ORR), disease control rate (DCR), and duration of response (DoR) between ivonescimab combined with platinum-doublet chemotherapy versus pembrolizumab combined with platinum-doublet chemotherapy, as assessed by investigator, based on RECIST v1.1

To evaluate the safety and tolerability of ivonescimab in combination with platinumdoublet chemotherapy and compare to pembrolizumab combined with platinum-doublet chemotherapy

To evaluate the pharmacokinetic profile of ivonescimab in combination with platinumdoublet chemotherapy

To evaluate the immunogenicity of ivonescimab
Cancer Categories:
Lung
Principal Investigator:
Uprety, Dipesh
Karmanos Trial ID:
2024-101
Age Group:
Adult
Phase:
Phase III
Learn More
A Randomized, Double-blinded, Multiregional Phase 3 Study of Ivonescimab Versus Pembrolizumab for the First-line Treatment of Metastatic Non-small Cell Lung Cancer in Patients Whose Tumors Demonstrate High PD-L1 Expression
Objective:

Primary Objectives:

To compare OS between ivonescimab versus pembrolizumab

To compare PFS assessed by the Independent Radiology Review Committee (IRRC) based on RECIST v1.1 between ivonescimab and pembrolizumab

Secondary Objectives:

To compare the ORR, DCR, and DoR between ivonescimab versus pembrolizumab, as assessed by the IRRC, based on RECIST v1.1

To evaluate the safety and tolerability of ivonescimab and compare to pembrolizumab

To evaluate the PK profile of ivonescimab

To evaluate the immunogenicity of ivonescimab
Cancer Categories:
Lung
Principal Investigator:
Uprety, Dipesh
Karmanos Trial ID:
2025-002
Age Group:
Adult
Phase:
Phase III
Learn More
Phase 1a/1b Study of LY3962673 in Patients with KRAS G12D-Mutant Solid Tumors
Objective:

Primary Objectives:

Phase 1a Primary

To assess the safety and tolerability of LY3962673 monotherapy

Phase 1a Secondary

To assess the antitumor activity of LY3962673 monotherapy

To characterize the PK properties of LY3962673 monotherapy

Phase 1b Primary

Dose Expansion: To assess the antitumor activity of LY3962673

Dose Optimization: To confirm the RP2D/optimal dose based on safety and efficacy of LY3962673

Phase 1b Secondary

Dose Expansion: To assess the safety and tolerability of LY3962673

Dose Expansion: To assess, for each Dose Expansion cohort, the antitumor activity per RECIST v1.1

All Cohorts: To characterize the PK properties of LY3962673
Cancer Categories:
Gastrointestinal (GI),Lung
Principal Investigator:
Al Hallak, Mohammed
Karmanos Trial ID:
2024-088
Age Group:
Adult
Phase:
Phase I
Learn More
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
Learn More
Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed By Concurrent Mediastinal Chemoradiation For Locally Advanced Non-Small Cell Lung Cancer
Objective:

Primary Objectives:

To compare the overall survival in patients with stage II-IIIC inoperable nodepositive
non-small cell lung cancer (NSCLC) after image guided, motion-managed
conventional radiotherapy to the primary tumor and nodal metastases (Arm 1) or after
image guided, motion-managed stereotactic body radiation therapy (SBRT) to the
primary tumor followed by conventionally fractionated radiotherapy to nodal
metastases (Arm 2) both given with concurrent platinum-based chemotherapy.

To compare progression-free survival between the experimental arm (Arm 2) and
control arm (Arm 1).

Secondary Objectives:

To compare objective response rate (as defined by RECIST v 1.1) between the
experimental arm and control arm

To compare the rate of local control between the experimental arm and control arm

To compare patterns of failure (primary, locoregional, or distant) between the
experimental arm and control arm

To compare changes in pulmonary function (FEV1 and DLCO assessed at
randomization and at 6 and 12 months following completion of radiation therapy)
between the experimental arm and control arm

To compare changes in quality of life and patient-reported outcomes assessed from
pre-treatment to 3 months following radiation therapy of each treatment arm

To determine acute and late toxicity profiles of each treatment arm as measured by
the CTCAEv5
Cancer Categories:
Lung
Principal Investigator:
Yeh, Brian
Karmanos Trial ID:
NRG-LU008
Age Group:
Adult
Phase:
Phase III
Learn More

1 2 3 4 5 6