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 41

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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A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum
Objective:
Primary Objective:

To examine if letrozole monotherapy/maintenance is non-inferior to IV paclitaxel/carboplatin and maintenance letrozole with respect to PFS in women with stage II-IV primary low-grade serous carcinoma of the ovary or peritoneum after primary surgical cytoreduction.

Secondary Objectives:

To compare the nature, frequency and maximum degree of toxicity as assessed by CTCAE v5.0 for each treatment arm.

To compare the relative frequency of objective tumor response in those with measurable disease after cytoreductive surgery for each treatment arm.

To compare overall survival for each treatment arm.

To compare the CT\L and L\L arms with respect to patients adherence to letrozole therapy as measured by pill counts.
Cancer Categories:
Gynecologic
Principal Investigator:
Morris, Robert
Karmanos Trial ID:
NRG-GY019
Age Group:
Adult
Phase:
Phase III
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A first-in-human, Phase 1/2, open-label, multi-center, dose-escalation, dose-optimization, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of PARP1 selective inhibitor, IMP1734, in patients with advanced solid tumors
Objective:

Part 1 and Part 2

Primary Objectives:

To evaluate the safety and tolerability of IMP1734 as monotherapy and in combination with anti-cancer agents

To determine the MTD (or MAD) and RDE as monotherapy and in combination with anti-cancer
agents

Secondary Objectives:

To characterize the plasma PK profile of single and multiple doses of IMP1734

To assess preliminary anti-tumor activity of IMP1734 as monotherapy and in combination with anti-cancer agents

Part 3

Primary Objectives:

To estimate the anti-tumor activity of IMP1734

Secondary Objectives:

To further assess the anti-tumor activity of IMP1734

To further evaluate the safety and tolerability of IMP1734
Cancer Categories:
Breast,Gastrointestinal (GI),Gynecologic
Principal Investigator:
Shao, Yusra
Karmanos Trial ID:
2024-025
Age Group:
Adult
Phase:
Phase I/II
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A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-Oophosectomy to Reduce the Risk of Ovarian Cancer among BRCA1 Carriers [SOROCk]
Objective:

Primary Objective:

To compare the non-inferiority of bilateral salpingectomy (BLS) with delayed oophorectomy to bilateral salpingo-oophorectomy (BSO) to reduce the risk of ovarian cancer among women with deleterious BRCA1 germ-line mutations.

Secondary Objectives:

To prospectively assess estrogen deprivation symptoms in BLS patients as measured by the FACTES sub-scale compared to women in the BSO arm.

To determine if health-related QOL (FACT) is negatively impacted by menopausal symptoms (menopausal symptom checklist-MSCL), sexual dysfunction (FSFI), and cancer distress (IES) in women who have undergone BLS, in comparison to normative data (MSCL/FACT-ES) and data from BSO patients.

To assess medical decision making, as measured by the Shared Decision Making Questionnaire (SDM-Q-9) and Decision Regret Scale (DRS), and determine factors associated with the risk of reducing surgical treatment choice.

To assess adverse events, graded using CTCAE v5.0.
Cancer Categories:
Gynecologic
Principal Investigator:
Winer, Ira
Karmanos Trial ID:
NRG-CC008
Age Group:
Adult
Phase:
N/A
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A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of Second Mitochondrial-derived Activator of Caspases Mimetic BGB-24714 as Monotherapy and with Combination Therapies in Patients with Solid Tumors
Objective:

Phase 1a (Dose Escalation)

Primary Objectives:

To assess the safety and tolerability of BGB-24714 as monotherapy, in combination with chemotherapy, and in combination with concurrent chemoradiotherapy (cCRT) in patients with solid tumors

To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and recommended doses for expansion (RDFE) of BGB-24714 as monotherapy, in combination with chemotherapy, and in combination with cCRT

Secondary Objectives:

To assess the preliminary antitumor activity of BGB-24714 as monotherapy, in combination with chemotherapy, and in combination with cCRT

To characterize the pharmacokinetic (PK) profile of BGB-24714 and its major metabolite BGB-22437 following the administration of capsules as monotherapy, in combination with chemotherapy, and in combination with cCRT

Phase 1b (Dose Expansion)

Primary Objectives:

To assess the preliminary antitumor activity of BGB-24714 in combination with chemotherapy in patients with selected solid tumors

Secondary Objectives:

To further evaluate the secondary measures of antitumor activity of BGB-24714 in combination with chemotherapy in patients with selected solid tumors

To further characterize the safety and tolerability of BGB-24714 in combination with chemotherapy in patients with selected solid tumors

To further characterize the PK profile of BGB-24714 and its major metabolite in combination with chemotherapy in patients with selected solid tumors
Cancer Categories:
Gynecologic,Lung
Principal Investigator:
Winer, Ira
Karmanos Trial ID:
2024-057
Age Group:
Adult
Phase:
Phase I
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A Phase 1, First-in-Human, Open-Label, Dose-Escalation and Expansion Study of IMGN151 (anti-FRa antibody-drug conjugate) in Adult Patients with Recurrent Endometrial Cancer and Recurrent, High-Grade Recurrent Endometrial Cancer and Recurrent, High-Grade Serous Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers
Objective:

Dose-Escalation Phase

Co-Primary Objectives:

To assess safety and tolerability, including dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), or maximum administered dose (MAD; if no MTD is defined) of IMGN151 when administered intravenously

To determine recommended Phase 2 dose (RP2D) for IMGN151

Secondary Objectives:

To characterize the pharmacokinetics (PK) and immunogenicity of IMGN151

To assess objective response rate (ORR) for IMGN151 using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

To assess duration of response (DOR) for IMGN151 using RECIST v1.1

Expansion Phase

Primary Objective:

To assess ORR for IMGN151 using RECIST v1.1

Secondary Objectives:

To characterize safety and tolerability for IMGN151

To characterize the PK and immunogenicity of IMGN151

To assess DOR for IMGN151

To assess PFS for IMGN151
Cancer Categories:
Gynecologic
Principal Investigator:
Winer, Ira
Karmanos Trial ID:
2024-029
Age Group:
Adult
Phase:
Phase I
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A Phase 1, open-label, dose-escalation and dose-expansion study evaluating AO-252, a protein-protein interaction inhibitor of TACC3, in advanced solid tumors including triple negative breast cancer (TNBC), high-grade serous ovarian carcinoma (HGSOC), and endometrial cancer
Objective:

Primary Objective:

The primary objectives of this study are to determine the MTD/RP2D and safety profile of
AO-252 in patients with advanced TNBC, HGSOC, and endometrial cancer

Secondary Objectives:

Determine antitumor activity of AO-252 as assessed by objective response rate (ORR),
disease control rate (DCR), duration of response (DOR), time to progression (TTP), and
time to response (TTR).

Determine the pharmacokinetic (PK) profile of AO-252 including maximum plasma
concentration (Cmax), time to maximum plasma concentration (Tmax), and area under the
plasma concentration-time curve (AUC) over the dosing interval.
Cancer Categories:
Breast,Gynecologic
Principal Investigator:
Winer, Ira
Karmanos Trial ID:
2024-017
Age Group:
Adult
Phase:
Phase I
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A Phase 3, Randomized, Open-Label Study of Combination Therapy with Avutometinib plus Defactinib Versus Investigator's Choice of Treatment in Patients with Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
Objective:

Primary Objective:

To compare the progression-free survival (PFS) of the combination of avutometinib plus defactinib vs Investigator’s Choice of Treatment (ICT) in patients with recurrent LGSOC

Secondary Objectives:

To compare the combination of avutometinib plus defactinib vs ICT in patients with recurrent LGSOC with regard to additional efficacy parameters

To characterize the safety and tolerability of combination avutometinib plus defactinib vs ICT in patients with recurrent LGSOC

To determine the exposure of avutometinib and defactinib in patients with recurrent LGSOC treated with combination of avutometinib plus defactinib

To assess the health-related quality of life and disease related symptoms in patients with recurrent LGSOC treated with combination avutometinib plus defactinib vs ICT
Cancer Categories:
Gastrointestinal (GI),Gynecologic
Principal Investigator:
Morris, Robert
Karmanos Trial ID:
GOG-3097
Age Group:
Adult
Phase:
Phase III
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A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial of Selinexor in Maintenance Therapy After Systemic Therapy for Patients With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma
Objective:

Primary Objectives:

To evaluate the efficacy of selinexor compared to placebo as maintenance therapy

Key Secondary Objectives:

To compare overall OS in selinexor and placebo arms

Secondary Objectives:

To evaluate the safety and tolerability of selinexor

To compare selinexor and placebo for time to first subsequent therapy

To compare selinexor and placebo for time to second subsequent therapy

To compare selinexor and placebo for time until second progression

To assess the efficacy of selinexor compared to placebo, as assessed by a blinded independent central review (BICR)

To evaluate health-related quality of life (HRQoL) outcomes
Cancer Categories:
Gynecologic
Principal Investigator:
Gogoi, Radhika
Karmanos Trial ID:
GOG-3083
Age Group:
Adult
Phase:
Phase III
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A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Subjects with Advanced Solid Tumors
Objective:

Primary Objective:

To evaluate the safety and tolerability of GSK5733584 administered intravenously in subjects with advanced solid tumors to establish MTD or maximum applicable dose (MAD).

Secondary objectives:

To evaluate the PK profile of GSK5733584 administered intravenously in subjects with advanced solid tumors.

To evaluate the clinical activity of GSK5733584 administered intravenously in subjects with advanced solid tumors.

To evaluate the immunogenicity of GSK5733584 administered intravenously in subjects with advanced solid tumors.

To further evaluate the safety and tolerability of GSK5733584 administered intravenously in subjects with advanced solid tumors
Cancer Categories:
Breast,Gynecologic
Principal Investigator:
Winer, Ira
Karmanos Trial ID:
2024-053
Age Group:
Adult
Phase:
Phase I
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