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 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
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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
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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
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A Phase I/IIa First-in-Human Study of [212Pb]VMT-a-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors
Objective:

Primary Objectives:

To evaluate the safety by rate of DLTs and AEs of [212Pb]VMT-α-NET in subjects with NETs.

To determine the recommended phase 2 dose (RP2D) of [212Pb]VMT-α-NET in PRRT-naïve subjects with NETs.

To determine the PK properties of [212Pb]VMT-α-NET.

To determine the ORR by RECIST v1.1 in subjects with NETs receiving [212Pb]VMT-α-NET in the dose-expansion phase.

Secondary Objectives:

To determine the ORR by RECIST v1.1 in subjects with NETs receiving [212Pb]VMT-α-NET in the dose-escalation phase.

To determine the DOR by RECIST v1.1 in subjects with NETs receiving [212Pb]VMT-α-NET.

To determine the PFS by RECIST v1.1 in subjects with NETs receiving [212Pb]VMTα-NET.

To determine the OS in subjects with NETs receiving [212Pb]VMT-α-NET.
Cancer Categories:
Gastrointestinal (GI),Lung
Principal Investigator:
Shields, Anthony
Karmanos Trial ID:
2025-004
Age Group:
Adult
Phase:
Phase I/II
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A Phase III Randomized Clinical Trial of Proton Craniospinal Irradiation Versus Involved-Field Radiotherapy for Patients with Breast Cancer or Non-Small Cell Lung Cancer Leptomeningeal Metastasis (RADIATE-LM)
Objective:

Primary Objective:

To compare overall survival (OS) between proton craniospinal irradiation (pCSI) and involved-field radiotherapy (IFRT) in patients with breast cancer or non-small cell lung cancer (NSCLC) leptomeningeal metastasis.

Secondary Objectives:

To compare central nervous system progression-free survival (CNS PFS) between pCSI and IFRT in patients with breast cancer or NSCLC leptomeningeal metastasis.

To compare time to CNS progression between pCSI and IFRT in patients with breast cancer or NSCLC leptomeningeal metastasis.

To compare CNS PFS between pCSI and IFRT in patients with breast cancer or NSCLC leptomeningeal metastasis, as evaluated by central review of imaging.

To compare the rate of radiation-induced central nervous system necrosis between pCSI vs. IFRT in patients with breast cancer or NSCLC leptomeningeal metastasis.

To characterize treatment-related adverse events using CTCAE v5.0.

To compare patient-reported outcomes (Symptoms Severity subscale per MDASI-BT and MDASI-SP) in patients with breast cancer or non-small cell lung cancer leptomeningeal metastasis
Cancer Categories:
Breast,Lung
Principal Investigator:
Yeh, Brian
Karmanos Trial ID:
NRG-BN014
Age Group:
Adult
Phase:
Phase III
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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
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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
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Phase 3 Multicenter, Open Label, Randomized Study of RMC-6236 versus Docetaxel in Patients with Previously Treated Unresectable or Metastatic NSCLC Harboring RAS Mutations
Objective:

Primary:

In the RAS (G12X-C) population, i.e., RAS G12X excluding G12C:

To compare the treatment effect of RMC-6236 versus docetaxel on:

PFS (per Investigator)

OS

Key Secondary

In the RAS (MUT) population:

To compare the treatment effect of RMC-6236 versus docetaxel on:

PFS (per Investigator)

OS

In the RAS (G12X-C) and RAS (MUT) populations:

To compare the treatment effect of RMC-6236 versus docetaxel on objective response (per Investigator)

Other Secondary

In the RAS (G12X-C) and RAS (MUT) populations:

To compare the treatment effect of RMC-6236 versus docetaxel on:

PFS (per BICR)

Objective response (per BICR)

In the RAS (G12X-C) and RAS (MUT) populations:

To compare the treatment effect of RMC-6236 versus docetaxel on:

DOR (per Investigator and per BICR)

TTR (per Investigator and per BICR)

In the RAS (G12X-C) and RAS (MUT) populations:

To compare the treatment effect of RMC-6236 versus docetaxel on QoLs using EORTC QLQ-LC13 and EORTC QLQ-C30

In the RAS (G12X-C) and RAS (MUT) population:

To compare safety and tolerability of RMC-6236 versus docetaxel

In the RAS (MUT) population:

To characterize the PK of RMC-6236
Cancer Categories:
Lung
Principal Investigator:
Hadid, Tarik
Karmanos Trial ID:
2025-028
Age Group:
Adult
Phase:
Phase III
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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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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
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