Clinical Trials Actively Recruiting

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.

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

Primary Objective:

• The primary objective of this study is to assess the safety profile, including any DLT and identification of a MTD (if applicable), to support selection of the RP2D of anito-cel when administered to subjects with GMG.

Secondary Objectives:

• To quantify the clinical effect of anito-cel using standard clinical assessments, including Quantitative Myasthenia Gravis (QMG), Myasthenia Gravis Quality of Life (MG QoL 15R), Myasthenia Gravis Activities of Daily Living (MG ADL), MG Composite (MGC), Myasthenia Gravis Foundation of America (MGFA) Class, and MG Post Intervention Status (MG PIS)
• To determine the change from Baseline in the titer of myasthenia gravis-specific autoantibodies in all subjects following infusion of anito-cel
• To evaluate the PK in subjects treated with anito-cel in peripheral blood by VCN
• To characterize the treatment-free interval (period during which no non-steroidal therapy, including immunosuppressive therapy, is required) following cell infusion
• To characterize the corticosteroid dose reduction following cell infusion
• To determine the rate of disease related hospitalizations or treatment complications following treatment and descriptively compare to the rate of occurrence prior to treatment
• To assess for the presence of RCL in subjects

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).

Primary Objectives:

• To evaluate the antitumor activity of zanidatamab monotherapy in participants with locally advanced, unresectable, or metastatic HER2-overexpressing (IHC 3+) solid tumors

Secondary Objectives:

• To assess other antitumor efficacy parameters of zanidatamab monotherapy in participants with locally advanced, unresectable, or metastatic HER2-overexpressing (IHC 3+) solid tumors
• To evaluate the safety and tolerability of zanidatamab monotherapy in participants with locally advanced, unresectable, or metastatic HER2-overexpressing (IHC 3+) solid tumors
• To evaluate the PK of zanidatamab
• To evaluate the immunogenicity of zanidatamab
• To evaluate participant-reported tolerability of zanidatamab monotherapy in participants with locally advanced, unresectable, or metastatic HER2-overexpressing (IHC 3+) solid tumors

Primary Objectives:

Part 1

• To evaluate the safety and tolerability of PRT3789 in combination with pembrolizumab in patients with advanced or metastatic solid tumors

Part 2

• To evaluate the efficacy of PRT3789 in combination with pembrolizumab in patients with advanced or metastatic esophageal or NSCLC and deleterious SMARCA4 mutation

Secondary Objectives:

• To evaluate the efficacy of PRT3789 in combination with pembrolizumab
• To evaluate the safety and tolerability of PRT3789 in combination with pembrolizumab
• To evaluate the PK profile of PRT3789 in combination with pembrolizumab

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

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

Dose Escalation Part Objectives:

• To establish the preliminary recommended Phase II dose (RP2D) for PTM-101 when used as an adjunct to neoadjuvant therapy in subjects with treatment naïve, borderline resectable or locally advanced PDAC
• To characterize the safety and pharmacokinetic profile of a single administration of PTM-101, at two dose levels, when used as an adjunct to neoadjuvant therapy in subjects with treatment naïve, borderline resectable or locally advanced PDAC

Dose Expansion Part Objective:

• To assess early efficacy of PTM-101 when used at the preliminary RP2D as an adjunct to neoadjuvant therapy in subjects with treatment naïve, borderline resectable or locally advanced PDAC

Primary Objective:

• Estimate GVHD-free failure-free survival (GFFS) (a composite end point of survival without Grade III-IV aGVHD, cGVHD requiring immunosuppression, or primary or secondary graft failure requiring second definitive therapy) at 1 year after initiation of conditioning. GFFS will be evaluated separately for each transplant cohort.

Secondary Objectives:

• Estimate OS at 1 year after initiation of conditioning.
• Estimate FFS (a composite end point of survival without initiation of treatment with a second definitive therapy for curative intent) at 1 year after initiation of conditioning.
• Estimate the probability of being engrafted (i.e., without primary or secondary graft failure) and alive at 1 year after initiation of conditioning.
• Estimate the cumulative incidences of neutrophil recovery at Day +28 and Day +56 post-HSCT, platelet recovery at Day +100 post-HSCT, and red blood cell recovery at Day +100, Day +180, and Day +365 post-HSCT.
• Estimate the cumulative incidences of primary, secondary, and any graft failure at 1 year post-HSCT.
• Estimate the hematologic response classification according to the NIH criteria at Day +100, Day +180, and Day +365 post-HSCT.
• Estimate the cumulative incidences of Grade II-IV and Grade III-IV aGVHD at Day +100 post-HSCT.
• Estimate the cumulative incidences of all cGVHD and cGVHD requiring immunosuppression at 1 year post-HSCT.