Clinical Trials Actively Recruiting

Dual Primary Objectives:

• To compare progression-free survival (PFS) in frail or selected intermediate fit
  Newly Diagnosed Multiple Myeloma (NDMM) participants treated with VRd-Lite
  induction followed by Lenalidomide maintenance (Arm 1) versus DRd induction
  followed by Lenalidomide maintenance (Arm 2).
• To compare overall survival (OS) in frail or selected intermediate fit NDMM
  participants treated with VRd-Lite induction followed by lenalidomide maintenance
  (Arm 1) versus DRd induction followed by lenalidomide and daratumumab and
  hyaluronidase-fihj maintenance (Arm 3).

Secondary Objectives

• To compare PFS in Arm 1 versus Arm 3
• To compare OS in Arm 1 versus Arm 2.
• To compare OS in Arm 2 versus Arm 3, contingent upon significant results from both dual primary endpoints in favor of the respective experimental arms.
• To compare the overall response rate (ORR) of Arm 1 against the ORR of Arm 2 and Arm 3.
• To assess the safety of Arm 1 with the safety of Arm 2 and Arm 3.
• To explore veinous and arterial thrombo-embolism (VTE) incidence in participants receiving lenalidomide during induction across the three study arms.
• To describe median time to response (CR or better per IMWG criteria, VGPR or better per IMWG criteria, PR or better per IMWG criteria) on the three study arms.

Primary Objective:

• To compare major organ deterioration progression-free survival between participants randomized to the ASCT and non-ASCT arms of this study.

Secondary Objectives

• To compare overall survival (OS) between participants randomized to the ASCT and non-ASCT arms of this study.
• To compare rates of cardiac and renal organ responses between participants randomized to the ASCT and non-ASCT arms of this study.
• To compare rates of cardiac and renal organ progression between participants randomized to the ASCT and non-ASCT arms of the study.
• To compare the frequency and severity of toxicities between participants randomized to the ASCT and non-ASCT arms of this study.
• To compare minimal residual disease (MRD) negativity rates between participants randomized to the ASCT and non-ACST arms of this study.

Co-Primary Objectives:

• To compare the 3-year milestone progression free survival (PFS) probabilities in participants with previously untreated, low tumor burden follicular lymphoma randomized to the rituximab arm versus the mosunetuzumab arm.
• To compare progression free survival (PFS) in participants with previously untreated, low tumor burden follicular lymphoma randomized to the rituximab arm versus the mosunetuzumab arm.

Secondary Objectives:

• To compare overall survival (OS) between participants randomized to rituximab versus mosunetuzumab.
• To compare overall response rates at the Week 40 assessment between participants randomized to rituximab versus mosunetuzumab.
• To compare event free survival (EFS) between participants randomized to rituximab versus mosunetuzumab.
• To compare the frequency and severity of toxicities between participants randomized to rituximab versus mosunetuzumab.
• To compare the restricted chance of longer PFS (2-6 years) between participants randomized to rituximab versus mosunetuzumab.

Primary Objective:

• To assess whether participants with early stage TNBC randomized to receive
  anthracycline-free, taxane-platinum neoadjuvant chemotherapy with
  pembrolizumab have non-inferior breast cancer event-free survival (BC-EFS)
  compared to participants randomized to taxane-platinum-anthracycline
  neoadjuvant chemotherapy with pembrolizumab.

Secondary Objectives:

• To compare pathological complete response (pCR) and residual cancer burden
  (RCB) rates by randomized arm.
• To compare pCR and RCB rates between randomized arms by tumor infiltrating
  lymphocytes (TIL) status.
• To compare BC-EFS between randomized arms in the TIL-enriched and non-TIL
  enriched subgroups.
• To compare distant relapse-free survival and overall survival by randomized arm.
• To compare invasive breast cancer-free survival after surgery between
  randomized arms in pCR and residual disease groups.
• To compare the safety and tolerability by randomized arm among those that initiate
  therapy.

Primary Objectives:

• Evaluate SGR-3515 safety, tolerability, dose-limiting toxicities (DLTs) in participants with advanced solid tumors
• Identify the maximum tolerated dose (MTD) or maximum administered dose (MAD) and recommended phase 2 dose (RP2D) and recommended schedule (RP2S) of SGR-3515

Secondary Objectives:

• Evaluate SGR-3515 PK in participants with advanced solid tumors
• Evaluate SGR-3515 preliminary anti-tumor activity in participants with advanced solid tumors as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or the applicable disease specific criteria

Part A

Primary Objective:

• To compare the MMR rate at 24 weeks for olverembatinib versus bosutinib

Secondary Objectives:

• To compare the MMR rate at 96 weeks for olverembatinib versus bosutinib
• To compare additional parameters of the efficacy of olverembatinib versus bosutinib
• To compare the safety profile of olverembatinib versus bosutinib
• To characterize the Population PK of olverembatinib in the CML-CP population
• To evaluate Patient-Reported Outcome (PRO) measures of olverembatinib
• To evaluate Health Economics Outcomes Research (HEOR) measures of olverembatinib

Part B

Primary Objective:

• To evaluate the MMR rate by 24 weeks of olverembatinib in CML-CP patients with T315I mutation

Secondary Objectives:

• To evaluate the MMR rate by 96 weeks of olverembatinib in CML-CP patients with T315I mutation
• To compare additional parameters of the efficacy of olverembatinib in CML-CP patients with T315I mutation
• To evaluate the safety profile of olverembatinib in CML-CP patients with T315I mutation
• To characterize the population PK of olverembatinib in the CML-CP population with T315I mutation
• To evaluate PRO measures of olverembatinib
• To evaluate HEOR measures of olverembatinib

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 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.

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