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 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 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 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 1/2, Open-Label, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of INX-315 in Patients with Advanced Cancer
Objective:

Part A (Dose Escalation

Primary Objectives

To determine the safety and tolerability of INX-315 monotherapy and in combination with fulvestrant.

To recommend at least two dosages of INX-315 to be evaluated in the expansion portion (Part B).

Secondary Objectives

To characterize the systemic PK profile of INX-315 monotherapy and in combination with fulvestrant

To evaluate the antitumor activity of INX-315 per RECIST v1.1 as a monotherapy and in combination with fulvestrant.

Part B (Ovarian Cancer Dose Expansion)

Primary Objectives

To confirm the safety and tolerability of INX-315 when administered at the dosages selected from Part A.

To evaluate the antitumor activity of INX-315 per RECIST v1.1.

To determine the Recommended Phase 2 Dose (RP2D) based on data from Parts A and B.

Secondary Objectives

To characterize the systemic PK profile of INX-315.

To evaluate the antitumor activity of INX-315 per RECIST v1.1 in terms of other efficacy endpoints.

Part C (Breast Cancer Combination Treatment)

Primary Objectives

To determine the safety and tolerability of INX-315 in combination with abemaciclib and fulvestrant

To evaluate the antitumor activity of INX-315 in combination with abemaciclib and fulvestrant per RECIST v1.1.

Secondary Objectives

To characterize the systemic PK profile of INX-315 and abemaciclib and active metabolites (M2 and M20) alone and in combination with INX-315.

To evaluate the antitumor activity of INX-315 in combination with abemaciclib and fulvestrant per RECIST v1.1 in terms of other efficacy endpoints.

To determine the recommended dose or doses for further study
Cancer Categories:
Breast,Gynecologic
Principal Investigator:
Winer, Ira
Karmanos Trial ID:
2024-097
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 2, multicenter, open-label study of lifileucel (tumor-infiltrating lymphocytes [TIL]) in participants with previously treated advanced endometrial cancer
Objective:

Primary Objectives:

To evaluate the efficacy of lifileucel as measured by ORR per RECIST v1.1 in participants with dMMR or pMMR tumors based on the central laboratory assessment of MMR status

Secondary Objectives:

To evaluate the efficacy of lifileucel as measured by CR rate, DOR, DCR, PFS, and OS in participants with dMMR or pMMR tumors based on the central laboratory assessment of MMR status

To demonstrate safety and tolerability of lifileucel in participants with advanced endometrial cancer
Cancer Categories:
Gynecologic
Principal Investigator:
Morris, Robert
Karmanos Trial ID:
2024-087
Age Group:
Adult
Phase:
Phase II
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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 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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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
Learn More

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