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 57

A Phase 1B Study of Combination ATR (M1774) and BET Inhibition (ZEN00-3694) to Exploit ARID1A Loss in Recurrent Ovarian and Endometrial Cancer
Objective:

Primary Objectives:

To determine the maximum tolerated dose (MTD) and the dose-limiting toxicities
(DLTs) for combination of ATR inhibitor (M1774) and BET inhibitor (ZEN003694) in
women with recurrent clear cell, endometrioid, and platinum resistant high grade serous
ovarian carcinoma (HGSOC) and clear cell and endometrioid endometrial carcinoma
irrespective of ARID1A status (PART I).

To determine safety and tolerability in ARID1A pathogenic alteration (ARID1AMUT) and
ARID1A wildtype (ARID1AWT) cohorts (ARID1A is an integral biomarker) in an
expansion phase (PART II).

To determine change in pharmacodynamic biomarker expression of ƔH2AX (for ATR
inhibition, integral biomarker) from pre-treatment and on-treatment tumor samples in
ARID1AMUT and ARID1AWT expansion cohorts by immunohistochemistry (IHC) (PART
II).

Secondary Objectives:

To evaluate change in pharmacodynamic biomarker expression of cmyc (for BET inhibition,
integrated biomarker) from pre-treatment and on-treatment tumor samples in ARID1AMUT
and ARID1AWT expansion cohorts by Digital Spatial Profiling (DSP) (PART II).

To evaluate change in pharmacodynamic biomarker expression of ƔH2AX (for ATR
inhibition, integrated biomarker) from pre-treatment and on-treatment tumor samples in
ARID1AMUT and ARID1AWT expansion cohorts by DSP (PART II).

To investigate if ARID1A protein by IHC and DSP correlates with ARID1A pathogenic
alteration in pre-treatment tumor biopsy samples (PART II).

To estimate objective response rate (ORR) and progression free survival (PFS) at 6 months in
ARID1A pathogenic alteration and wildtype cohorts (PART II).
Cancer Categories:
Gastrointestinal (GI),Gynecologic
Principal Investigator:
Winer, Ira
Karmanos Trial ID:
NRG-GY031
Age Group:
Adult
Phase:
Phase I
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Phase III Randomized Trial of Proton Beam Therapy (PBT) Versus Intensity Modulated Photon Radiotherapy (IMRT) For the Treatment of Esophageal Cancer
Objective:

Primary Objectives:

To determine if overall survival (OS) is improved with proton beam therapy (PBT) treatment as compared to intensity modulated radiation therapy (IMRT) as part of planned protocol treatment for patients with esophageal cancer.

To determine if OS with PBT is non-inferior to IMRT as part of planned protocol treatment and that there will be less grade 3+ cardiopulmonary toxicity with PBT than with IMRT.

Secondary Objectives:

To compare the symptom burden and impact on functioning of patients between treatment modalities based on Patient Reported Outcome (PRO) measures of symptoms using MD Anderson Symptom Inventory (MDASI) and PROMIS-Fatigue;

To compare the Quality-Adjusted Life Years (QALY) using EQ5D as a health outcome (Kilbridge 2010) between PBT and IMRT, if the protocol primary endpoint is met;

To assess the pathologic response rate between PBT and IMRT;

To assess the cost-benefit economic analysis of treatment between radiation modalities;

To compare the length of hospitalization after protocol surgery between PBT and IMRT;

To compare the incidence of grade 4 lymphopenia during chemoradiation between PBT and IMRT;

To compare lymphocyte nadir at first follow-up visit after completion of chemoradiation between PBT & IMRT;

To estimate the locoregional failure, distant metastatic free survival, and progression-free survival of patients treated with PBT versus IMRT;

To compare incidence of both early (< 90 days from treatment start) and late (≥ 90 days from treatment start) cardiovascular and pulmonary events between PBT versus IMRT;

To compare the Total Toxicity Burden (TTB) of IMRT versus PBT based on a composite index of 9 individual cardiopulmonary toxicities.

Exploratory Objectives:

To collect biospecimens for future analyses, for example to assess cardiac and inflammatory biomarkers in association with treatment complications.
Cancer Categories:
Gastrointestinal (GI)
Principal Investigator:
Hyde, Christian
Karmanos Trial ID:
NRG-GI006
Age Group:
Adult
Phase:
Phase III
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Randomized Phase II/III Trial of First Line Platinum/Etoposide with or without Atezolizumab (NSC #783608) in Patients with Advanced or Metastatic Poorly Differentiated Extrapulmonary Neuroendocrine Carcinomas (NEC)
Objective:

Primary Objectives

Among patients with metastatic extrapulmonary poorly differentiated small cell NEC, to compare overall survival (OS, measured from randomization) in a fixed sequence as follows:

Compare the combination of induction platinum/etoposide and atezolizumab followed by maintenance atezolizumab (Arm 1) versus induction platinum/etoposide alone (Arm 3)

Compare the combination of induction platinum/etoposide and atezolizumab followed by observation (Arm 2) versus induction platinum/etoposide alone (Arm 3)

Compare the combination of induction platinum/etoposide and atezolizumab followed by maintenance atezolizumab (Arm 1) versus the combination of induction platinum/etoposide and atezolizumab followed by observation (Arm 2)

Secondary Objective(s)

To compare OS, measured from start of observation/maintenance, across arms

To compare progression-free survival (PFS) (measured from randomization and measured from start of observation/maintenance) across arms

To compare objective response rate (ORR = confirmed and unconfirmed partial response (PR) + confirmed and unconfirmed complete response (CR)) across arms among patients with measurable disease at randomization

To compare clinical benefit rate (CBR = confirmed and unconfirmed PR + confirmed and unconfirmed CR + stable disease (SD)) across arms among patients with measurable disease at randomization

To compare the duration of response (DOR) across arms

To evaluate the safety and tolerability of each arm

Additional Objective

To bank tumor and blood samples for future biomarker correlative studies
Cancer Categories:
Gastrointestinal (GI)
Principal Investigator:
Al Hallak, Mohammed
Karmanos Trial ID:
S2012
Age Group:
Adult
Phase:
Phase II/III
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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 1/2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Subjects with Unresectable, Locally Advanced, or Metastatic Solid Tumors that are Antigen-rich (START-001)
Objective:

Primary Objectives:

Phase 1: Dose Escalation

To characterize the safety, tolerability, and dose-limiting toxicities (DLTs), and determine the recommended Phase 2 dose (RP2D) of STAR0602

Phase 2: Dose Expansion

To further explore anti-tumor activity of STAR0602 in unresectable, locally advanced, or metastatic solid tumors

Secondary Objectives:

Phase 1: Dose Escalation

To evaluate preliminary antitumor activity of STAR0602 in unresectable, locally advanced, or metastatic solid tumors

To evaluate the PK profile of STAR0602 in serum after single and repeated IV infusions

Phase 2: Dose Expansion

To further evaluate the antitumor activity of STAR0602

To evaluate the PK profile of STAR0602 in serum after single and repeated IV infusions

To further characterize the safety and tolerability of STAR0602

Phase 1 and Phase 2: Dose Escalation and Dose Expansion

To assess antidrug antibody (ADA) formation after IV single and repeat dose administration of STAR0602
Cancer Categories:
Gastrointestinal (GI),Genitourinary (GU),Gynecologic
Principal Investigator:
Saif, Wasif
Karmanos Trial ID:
2024-091
Age Group:
Adult
Phase:
Phase I/II
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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 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) versus Treatment of Investigator's Choice in Patients with Platinum Resistant Ovarian Cancer
Objective:

Primary Objective:

To compare progression-free-survival (PFS) in patients with platinum-resistant ovarian cancer (PROC) receiving rinatabart sesutecan (Rina-S) versus investigator’s choice of therapy (IC).

Secondary Objectives:

To assess additional measures of efficacy of Rina-S compared to IC in patients with PROC.

To assess the safety of Rina-S compared to IC in patients with PROC

To assess potential changes in QTc associated with Rina-S

To assess patient reported outcomes in patients receiving Rina-S and IC
Cancer Categories:
Gastrointestinal (GI),Gynecologic
Principal Investigator:
Morris, Robert
Karmanos Trial ID:
GOG-3107
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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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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