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

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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Randomized Phase II/III Trial of Consolidation Radiation + Immunotherapy for ES-SCLC: RAPTOR Trial
Objective:

Primary Objective

Phase II:

To compare investigator-assessed progression free survival (PFS) between atezolizumab plus radiotherapy and atezolizumab alone

Phase III:

To compare overall survival (OS) between atezolizumab plus radiotherapy and atezolizumab alone

Secondary Objectives

To assess the toxicity between the atezolizumab plus radiotherapy arm and the atezolizumab arm

To assess the impact of adding radiotherapy on PFS and OS in patients with 1-3 visible tumors and >3 visible tumors

To assess the impact of adding radiotherapy on PFS and OS in patients receiving consolidation radiotherapy to all visible disease (“complete consolidation”) and patients who do not receive consolidation radiation to all visible disease (“incomplete consolidation”)
Cancer Categories:
Lung
Principal Investigator:
Yeh, Brian
Karmanos Trial ID:
NRG-LU007
Age Group:
Adult
Phase:
Phase II/III
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A first-in-human, open-label Phase 1/2 study to evaluate the safety and anti-tumor activity of ANV600 as single agent and in combination with pembrolizumab in participants with relapsed/refractory advanced solid tumors.
Objective:

Phase I (dose escalation)

Primary Objectives:

To identify the MTD and/or RP2D of ANV600 single agent and in combination with pembrolizumab

Secondary Objectives:

To characterize the PK of ANV600 single agent and in combination with pembrolizumab after single dose and repeated dosing

To evaluate the prevalence and incidence of immunogenicity of ANV600

To describe the anti-tumor activity of ANV600 as single agent and in combination with pembrolizumab

Phase II

Primary Objectives:

To assess the anti-tumor activity of ANV600 as single agent and in combination with pembrolizumab

Secondary Objectives:

To assess the anti-tumor activity of ANV600 as single agent and in combination with pembrolizumab

To assess the safety and tolerability ANV600 single agent and in combination with pembrolizumab for each cohort and in the overall study population

To characterize the PK of ANV600 single agent and in combination with pembrolizumab after single dose and repeated dosing

To evaluate the prevalence and incidence of immunogenicity of ANV600
Cancer Categories:
Lung,Skin
Principal Investigator:
Shao, Yusra
Karmanos Trial ID:
2024-070
Age Group:
Adult
Phase:
Phase I/II
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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 MULTICENTER, OPEN-LABEL PHASE 1/1B / PHASE 2 DOSE-FINDING, SAFETY, AND PHARMACOKINETIC STUDY OF MBRC-101, AN ANTI-EPHA5 MONOMETHYL AURISTATIN E (MMAE) ANTIBODY DRUG CONJUGATE, IN ADVANCED REFRACTORY SOLID TUMORS
Objective:

Primary Objectives:

Phase 1

To identify potential OBRD and dosing regimens of MBRC-101

To establish the MTD of MBRC-101 using 1 or more dosing regimens

To identify potential RP2Ds and regimens of MBRC-101

Phase 1b

To evaluate the safety of MBRC-101 at potential OBRDs, RP2Ds and dosing regimens

To evaluate preliminary clinical activity of MBRC-101 at potential OBRDs and dosing regimens

Phase 2

To evaluate the efficacy of MBRC-101 at the RP2D

Secondary Objectives:

Phase 1

To evaluate other measures of preliminary clinical activity of MBRC-101

Phase 2

To evaluate other measures of clinical activity

To evaluate the safety of MBRC-101 at RP2Ds and dosing regimens

Phase 1/1b and Phase 2

To characterize single and multiple-dose PK profiles of MBRC-101

To evaluate incidence and persistence of anti-MBRC-101 Ab formation

To evaluate biomarkers of clinical response and resistance, safety, pharmacodynamic activity, and/or mechanism of action of MBRC-101
Cancer Categories:
Breast,Gastrointestinal (GI),Lung
Principal Investigator:
Uprety, Dipesh
Karmanos Trial ID:
2024-078
Age Group:
Adult
Phase:
Phase I
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A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1311 in Subjects with Advanced/Metastatic Solid Tumors
Objective:

Phase 1 (Dose Escalation)

Primary Objectives:

To evaluate the safety and tolerability of DB-1311.

To determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) of DB-1311.

Secondary Objectives:

To assess the preliminary antitumor activity of DB-1311.

To characterize the Pharmacokinetics (PK) of DB-1311 (DB-1311 antibodydrug conjugate [ADC], total anti- B7-H3 antibody, unconjugated payload P1021).

To assess the immunogenicity of DB1311 in targeted subjects.

Phase 2a (Dose Expansion)

Primary Objectives:

To assess the safety and tolerability of DB-1311 as monotherapy in targeted subject populations.

To assess the effectiveness of DB-1311 as monotherapy by assessment of objective response rate (ORR) by investigator.

Secondary Objectives:

To further assess the PK of DB-1311 (DB-1311 ADC, total anti-B7-H3 antibody, unconjugated payload P1021).

To evaluate the prevalence and incidence of anti-drug antibody (ADA) against DB1311 in serum via a validated assay.

To evaluate the preliminary efficacy of DB-1311 with additional efficacy parameters.
Cancer Categories:
Gastrointestinal (GI),Genitourinary (GU),Lung
Principal Investigator:
Winer, Ira
Karmanos Trial ID:
2024-080
Age Group:
Adult
Phase:
Phase I/II
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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 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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A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of GSK5764227 in Participants with Advanced Solid Tumors
Objective:

Phase 1a dose escalation

Primary Objectives:

To determine the MTD/MAD and evaluate the safety and tolerability of GSK5764227 in participants with advanced solid tumors.

Secondary Objectives:

To evaluate the PK profile of GSK5764227 in participants with advanced solid tumors.

To evaluate the clinical activity of GSK5764227 in participants with advanced solid tumors

To evaluate the immunogenicity of GSK5764227 in participants with advanced solid tumors.To evaluate the immunogenicity of GSK5764227 in participants with advanced solid tumors.

Phase 1b dose expansion

Primary Objectives:

To evaluate the clinical activity of GSK5764227 in participants with ES-SCLC or advanced solid tumors.

Secondary Objectives:

To evaluate the safety and tolerability of GSK5764227 in participants with ES-SCLC or advanced solid tumors

To evaluate additional measures of clinical benefit of GSK5764227 in participants with ES-SCLC or advanced solid tumors.

To evaluate the PK profile of GSK5764227 in participants with ES-SCLC or advanced solid tumors.

To evaluate the immunogenicity of GSK5764227 in participants with ES-SCLC or advanced solid tumors.
Cancer Categories:
Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Lung,Skin
Principal Investigator:
Saif, Wasif
Karmanos Trial ID:
2024-073
Age Group:
Adult
Phase:
Phase I
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A Randomized Phase 2 Platform Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments, for Perioperative Treatment of Patients With Resectable Non-Small Cell Lung Cancer
Objective:

Primary

To evaluate the anti-tumor activity of cemiplimab plus chemotherapy plus novel cancer treatments as compared to cemiplimab plus chemotherapy for the perioperative treatment of resectable NSCLC.

Secondary

To evaluate the safety profile of cemiplimab plus chemotherapy plus novel cancer treatments ascompared to cemiplimab plus chemotherapy.

To evaluate the feasibility of surgery in participants receiving cemiplimab plus chemotherapy plus novel cancer treatments as compared to cemiplimab plus chemotherapy.

To evaluate the immunogenicity of cemiplimab and novel anti-cancer agents in the investigational arms, and to evaluate the immunogenicity of cemiplimab in the control arm.

To evaluate the efficacy of cemiplimab plus chemotherapy plus novel cancer treatments as compared to cemiplimab plus chemotherapy.

.
Cancer Categories:
Lung
Principal Investigator:
Hadid, Tarik
Karmanos Trial ID:
2024-068
Age Group:
Adult
Phase:
Phase II
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