Clinical Trials Actively Recruiting

Primary Objective:

• To determine if the time to composite adverse endpoint (CAE) [defined as: 1)
  local tumor progression within the surgical bed; and/or 2) adverse radiation effect
  (ARE), the imaging correlate of post-SRS radiation necrosis; and/or 3) nodular
  meningeal disease (nMD)] is improved in patients treated with pre-resection SRS
  to the intact lesion versus those treated with post-resection SRS.

Secondary Objectives:

• To assess the trajectory of symptom burden in patients treated with preresection SRS to the intact lesion versus those treated to the post-resection
  surgical cavity as measured by MD Anderson Symptom Inventory for brain tumor
  (MDASI-BT)
• To determine whether there is improved overall survival (OS) in patients with
  resected brain metastases who undergo pre-resection SRS compared to patients
  who receive post-resection SRS.
• To compare rates of ARE, the imaging correlate of radiation necrosis, in patients
  who receive pre-resection SRS to patients who receive post-resection SRS.
• To determine whether there is increased time to whole brain radiotherapy (WBRT)
  in patients who receive pre-resection SRS compared to patients who receive postresection SRS.
• To assess the trajectory of neuro-cognitive function in patients treated with preresection SRS to the intact lesion versus those treated to the post-resection
  surgical cavity as measured by the Montreal Cognitive Assessment (MoCA).
• To compare rates of nodular meningeal disease in patients who receive preresection SRS to patients who receive post-resection SRS.
• To compare rates of local recurrence in the resection cavity for patients who
  receive pre-resection SRS to patients who receive post-resection SRS.
• To compare rates of local recurrence of intact, non-index metastases treated with SRS.
• To compare rates of distant brain failure in patients who receive pre-resection
  SRS to patients who receive post-resection SRS.
• To assess toxicity in the two treatment arms.

Primary Objectives:

• To evaluate the safety and tolerability of SGN-EGFRd2
• To identify the maximum tolerated dose (MTD) of SGN-EGFRd2 (Part A)
• To identify a recommended dose and schedule for SGN-EGFRd2 (Parts A and B)

Secondary Objectives:

• To assess the immunogenicity of SGN-EGFRd2
• To assess the PK of SGN-EGFRd2
• To assess the antitumor activity of SGN-EGFRd2

Primary Objectives:

Part 1: Dose Escalation

• Evaluate the safety and tolerability of
  KB-0742 in patients with
  relapsed/refractory (R/R) solid tumors or
  NHL

Part 2: Cohort Expansion

• Further evaluate the safety and tolerability
  of KB-0742 in defined patient cohorts

Secondary Objectives:

Part 1: Dose Escalation

• Characterize the PK of KB-0742
• Assess preliminary anti-tumor activity

Part 2: Cohort Expansion

• Further characterize the PK of KB-0742
• Further assess preliminary anti-tumor
  activity of KB-0742 in defined patient
  cohorts

Part 1 Dose Escalation of SLC-3010 Monotherapy and in Combination

Primary Objectives:

• To assess safety and tolerability of increasing dose levels ofSLC-3010
• To define the maximum tolerated dose (MTD) or maximum administered dose (MAD), and recommended Phase 2 dose (RP2D)

Secondary Objectives:

• To evaluate preliminary antitumor activity
• To characterize single and multiple dose PK of SLC-3010 and its metabolite TCB2 and IL-2
• To assess immunogenicity to SLC-3010

Part 2: Dose Expansion of SLC-3010 Monotherapy and in Combination

Primary Objectives:

• To evaluate efficacy of SLC-3010 and the combination.

Secondary Objectives:

• To evaluate anti-tumor activity
• To assess safety and tolerability of SLC-3010 at RP2D
• To characterize single and multiple dose PK of SLC-3010 and its metabolite TCB2 and IL-2
• To assess immunogenicity to SLC-3010

Primary Objective:

• The primary objective of this pilot study is to evaluate tracer uptake and metabolic trapping characteristics based on [18F]FETrp PET/CT in patients with intra- and extracranial cancers; specifically, to evaluate whether the tumors show increased tracer uptake as measured by both tumor maximal and mean standardized uptake value (SUVmax and SUVmean, respectively), as compared to non-tumor tissues. In the special case of breast tumor imaging, the primary objective will be the correlation between the tumors’ SUV values and the apparent volume of distribution (VD’) which will be calculated using kinetic modeling analysis.

Secondary Objectives:

• Using dynamic PET imaging to establish the optimal time frame when tracer uptake peaks.
• Using compartmental modeling (in tumors with the left ventricle of the heart in the field-of-view) to measure tracer transport and trapping variables.
• To obtain first in human safety, biodistribution, and radiation dosimetry data for [18F]FETrp PET/CT.

Primary Objectives:

• Determine the maximum tolerated dose (MTD) of CB-03-10 in subjects with advanced solid tumors
• Determine the dose-limiting toxicity (DLT) of CB-03-10 in subjects with advanced solid tumors

Secondary Objectives:

• Determine a recommended Phase 2 dose (RP2D) of CB-03-10
• Determine the safety profile of CB-03-10 in subjects with advanced solid tumors
• Evaluate the activity (response rate, PFS, and OS) of CB-03-10 in subjects with specific solid tumors (e.g., relapsed/refractory pancreatic adenocarcinoma, androgen independent prostate adenocarcinoma, relapsed/refractory triple-negative breast adenocarcinoma)
• Characterize the pharmacokinetics (PK) of CB-03-10 and its metabolite CB-03-05 as well as cortexolone in plasma and urine.