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 61

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:
Yeh, Brian
Karmanos Trial ID:
NRG-GI006
Age Group:
Adult
Phase:
Phase III
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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:
Uprety, Dipesh
Karmanos Trial ID:
2024-089
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 1 Study of MOMA-341 as Monotherapy or in Combination Therapy in Participants with Advanced or Metastatic Solid Tumors
Objective:

Primary Objective:

To characterize the safety and tolerability of MOMA-341 as monotherapy or in combination with chemotherapy or immunotherapies

Secondary Objectives:

To identify the RP2D(s) and/or recommended optimization doses of MOMA-341 as monotherapy and in combination with chemotherapies or immunotherapies

To characterize the PK profile of MOMA341 when administered as monotherapy and in combination with chemotherapies or immunotherapies

To assess the effects of food on the PK parameters of MOMA-341 (for select participants only)

To characterize the PK profile of irinotecan and its active metabolite SN-38 when administered in combination with MOMA341

To characterize preliminary evidence of antitumor activity associated with MOMA341 as monotherapy or in combination with chemotherapies or immunotherapies
Cancer Categories:
Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic
Principal Investigator:
Al Hallak, Mohammed
Karmanos Trial ID:
2025-047
Age Group:
Adult
Phase:
Phase I
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A Phase 1, Multicenter, Open-Label, Dose Escalation, Dose Expansion and Dose Confirmation Study of BHV-1530 in Adult Participants with Advanced or Metastatic Solid Tumors
Objective:

Primary Objective:

Dose-escalation and Dose-expansion Cohorts

To determine the safety profile, maximum tolerable dose (MTD), minimally reproducible active dose (MRAD), and recommended dose range (RDR) of BHV-1530 administered by IV infusion dosed Q3W.

Dose-confirmation Cohorts

To determine the recommended dose (RD) of BHV-1530 for later phase trials.

Secondary Objectives:

Dose-escalation and Dose-expansion Cohorts

To assess the preliminary efficacy of BHV-1530

To determine the PK of BHV-1530, total antibody, and free payload TopoIx (BHC-0080269)

To assess the incidence of antidrug antibody (ADA) against BHV-1530

Dose-confirmation Cohort

To assess the preliminary efficacy of BHV-1530

To determine the PK of BHV-1530, total antibody, and free payload TopoIx BHC-0080269

To assess the incidence of ADA against BHV-1530
Cancer Categories:
Brain and Nervous System,Gastrointestinal (GI),Genitourinary (GU),Head and Neck
Principal Investigator:
Shields, Anthony
Karmanos Trial ID:
2025-038
Age Group:
Adult
Phase:
Phase I
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A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL217 in Patients with Advanced Solid Tumors
Objective:

Dose-Escalation Part (Part 1)

Primary Objectives:

To assess the safety and tolerability of YL217 in patients with advanced solid tumors

To determine the maximum tolerated dose (MTD) of YL217 in patients with advanced solid tumors

Secondary Objectives:

To characterize the pharmacokinetics (PK) of YL217 antibody-drug conjugate (YL217-ADC), YL217 total antibody (YL217-TAb), and unconjugated payload YL0010014, metabolite YL0010034 and, if applicable, other potential metabolite(s)

To evaluate immunogenicity as measured by the presence of anti-drug antibodies (ADAs) in patients treated with YL217

To document any preliminary efficacy of YL217 in patients with advanced solid tumors

Backfill Part (Part 2)

Primary Objectives:

To further evaluate the safety and tolerability of YL217 in patients with advanced solid tumors

To determine the recommended dose(s) for expansion (RDE(s)) of YL217 in patients with advanced solid tumors

Secondary Objectives:

To further evaluate the efficacy of YL217 in patients with advanced solid tumors

To characterize the PK of YL217-ADC, YL217-TAb, unconjugated payload YL0010014, metabolite YL0010034 and, if applicable, other potential metabolite(s)

To evaluate immunogenicity as measured by the presence of ADAs in patients treated with YL217

Dose-Expansion Part (Part 3)

Primary Objectives:

To further evaluate the efficacy of YL217 at the RDE(s) in patients with the selected advanced solid tumors such as colorectal adenocarcinoma, gastric, esophageal or gastroesophageal junction adenocarcinoma, and pancreatic adenocarcinoma

To determine the recommended phase 2 dose (RP2D) of YL217

Secondary Objectives:

To further evaluate the safety and tolerability of YL217 at the RDE(s) in patients with the selected advanced solid tumors

To characterize the PK of YL217-ADC, YL217-TAb, unconjugated payload YL0010014, metabolite YL0010034 and, if applicable, other potential metabolite(s)

To evaluate immunogenicity as measured by the presence of ADAs in patients treated with YL217
Cancer Categories:
Gastrointestinal (GI)
Principal Investigator:
Saif, Wasif
Karmanos Trial ID:
2025-025
Age Group:
Adult
Phase:
Phase I
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A Phase 1/2 First-Time-in-Human, open-label, multicenter, dose escalation and expansion study of the oral DNA Helicase Werner Inhibitor (WRNi) GSK4418959 alone or in combination with other anti-cancer agents in adult participants with Mismatch Repair-deficient (dMMR) or Microsatellite Instability-High (MSI-H) solid tumors (SYLVER)
Objective:

Part 1: Monotherapy Dose Escalation

Primary Objectives:

Determine the Maximum Tolerated Dose and/or RDE for GSK4418959 as monotherapy (MTD and/or RDE).

Assess safety and tolerability of GSK4418959 as monotherapy within the DLT observation period.

Secondary Objectives:

Characterize the PK properties of GSK4418959, as monotherapy

Further assess the safety and tolerability of GSK4418959 as monotherapy, within and outside of the DLT observation period.

Part 2: Monotherapy Dose Expansion

Primary Objectives:

Evaluate the preliminary anti-tumor activity of GSK4418959 in CRC and, separately, in EC.

Secondary Objectives:

Further evaluate the safety of GSK4418959 administered at the RDE for CRC and/or for EC.

Further evaluate the anti-tumor activity of GSK4418959 in CRC and separately, in EC.

Characterize the PK properties of GSK4418959.

Part 3: Combination Dose Escalation

Primary Objectives:

Determine the Maximum Tolerated Dose and/or RDE for GSK4418959 in combination with dostarlimab (MTDc and/or RDEc).

Assess safety and tolerability of GSK4418959 in combination with dostarlimab within the DLT observation period.

Secondary Objectives:

Characterize the PK properties of GSK4418959, in combination with dostarlimab.

Further assess the safety and tolerability of GSK4418959 in combination with dostarlimab, within and outside of the DLT observation period.
Cancer Categories:
Gastrointestinal (GI),Gynecologic
Principal Investigator:
Saif, Wasif
Karmanos Trial ID:
2024-092
Age Group:
Adult
Phase:
Phase I/II
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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
Learn More

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