Clinical Trials Actively Recruiting

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 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 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

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

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:

Phase 1b:

• Confirm the safety and tolerability of pocenbrodib monotherapy in men with mCRPC
• Determine the RP2D of pocenbrodib as monotherapy in men with mCRPC

Phase 2a:

• Evaluate the clinical activity of pocenbrodib in men with mCRPC as monotherapy and in combination with abiraterone acetate, olaparib, or lutetium Lu 177 vipivotide tetraxetan (177Lu-PSMA-617)

Secondary objectives:

Phase 1b and Phase 2a:

• Characterize the PK of pocenbrodib in men with mCRPC
• Evaluate the relationship between exposure to pocenbrodib and effect (response, safety, and/or resistance)

Primary Objectives:

Part 1b:

• To determine the safety and tolerability of ZN-c3 in subjects with PROC

Part 2:

• To investigate the antitumor activity of ZN-c3 in subjects with PROC

Secondary Objectives:

Part 1b:

• To investigate the antitumor activity of ZN-c3 in subjects with PROC at different doses/schedules
• To investigate the plasma PK of ZN-c3

Part 2:

• To further investigate the antitumor activity of ZN-c3 in subjects with PROC
• To investigate the safety and tolerability of ZN-c3 in subjects with PROC
• To investigate the plasma PK of ZN-c3