Clinical Trials Actively Recruiting

Primary Objective:

• To evaluate the disease-free survival (DFS) of patients with stage III-IV SCCHN and disruptive p53 mutations after primary surgical resection followed by PORT alone or PORT with concurrent cisplatin.

Secondary Objectives:

• To evaluate the DFS of patients with stage III-IV SCCHN and non-disruptive p53 mutations after primary surgical resection followed by PORT alone or PORT with concurrent cisplatin
• To evaluate the DFS of patients with stage III-IV SCCHN and p53 wild type after primary surgical resection followed by PORT alone or PORT with concurrent cisplatin
• To evaluate toxicities of PORT alone or PORT with concurrent cisplatin.
• To evaluate p53 mutation as a predictive biomarker of survival benefit given post-operative concurrent radiation and cisplatin.
• To identify potential genomic alterations in addition to TP53 mutations that may be developed to a novel treatment approach.

Primary Objective:

• To select optimal efficacious dose/schedule, evaluate anti-tumor activity, and assess the safety of sapanisertib monotherapy in patients with metastatic, relapsed/refractory NFE2L2-mutant and wild-type sqNSCLC

Secondary Objectives:

• To evaluate the durability of response to sapanisertib in NFE2L2-mutated and wildtype sqNSCLC
• To evaluate overall survival of patients with NFE2L2-mutated and wild-type relapsed/ refractory sqNSCLC

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.

Primary Objective:

• to establish the maximum tolerated dose (MTD) and evaluate the safety and tolerability of HC-5404-FU when orally administered in a dose-escalating fashion in subjects with advanced solid tumors.

Secondary Objectives:

• to determine the plasma concentrations and pharmacokinetic (PK) parameters of HC-5404 following single and multiple doses of HC-5404 administered to subjects with advanced solid tumors
• to preliminarily assess the potential antitumor activity of HC-5404-FU in terms of response rates and survival outcomes.

Primary Objectives:

• Dose Escalation: To determine the MTD and identify the recommended Phase 2 dose (RP2D) of paclitaxel administered as Oraxol in combination with pembrolizumab in subjects with advanced solid tumors
• Dose Expansion: To assess the ORR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.121 associated with Oraxol administered in combination with pembrolizumab in subjects with NSCLC or advanced/metastatic gastric/gastroesophageal cancer

Secondary Objectives:

Dose Escalation:

• To evaluate the safety, tolerability, and DLTs of Oraxol when administered in combination with pembrolizumab in subjects with advanced solid tumors
• To describe the pharmacokinetics of oral paclitaxel and its metabolites, when administered as Oraxol in combination with pembrolizumab in subjects with advanced solid tumors
• To evaluate the activity of Oraxol in combination with pembrolizumab in subjects with advanced solid tumors

Dose Expansion:

In subjects with NSCLC or advanced gastric/gastro-esophageal cancer, the secondary
objectives are:

• To evaluate the safety and tolerability of Oraxol administered in combination with pembrolizumab
• To evaluate the disease control rate (DCR) and DOR associated with Oraxol administered in combination with pembrolizumab
• To determine the time to response associated with Oraxol administered in combination with pembrolizumab
• To determine the OS and PFS after the initiation of treatment with Oraxol and pembrolizumab
• To describe the pharmacokinetics of oral paclitaxel and its metabolites, when administered as Oraxol in combination with pembrolizumab

Primary Objectives:

• To evaluate the safety and tolerability of SGN1 in patients with advanced solid tumor.

Secondary Objectives:

• To make a preliminary determination of the Maximum Tolerated Dose (MTD) and optimal biological dose (OBD).
• To evaluate blood and urine levels of SGN1.
• To evaluate bacterial shedding of SGN1.
• To evaluate the anti-tumor effect of SGN1 in the treatment of patients with advanced solid tumor.
• To evaluate additional safety measures.

Part A (Dose escalation)

Primary Objectives:

• To determine the safety profile, maximum tolerated dose (MTD), and recommended dose of NBF-006 for Part B in patients with advanced NSCLC, pancreatic, or colorectal cancer for dose levels 1-4 (0.15, 0.3, 0.6, and 1.2 mg/kg) and in patients with KRAS-mutated NSCLC for dose level 5 (1.6 mg/kg)

Secondary Objectives:

• To evaluate preliminary efficacy of NBF-006 in patients with advanced NSCLC, pancreatic, or colorectal cancer for dose levels 1-4 (0.15, 0.3, 0.6, and 1.2 mg/kg) and in patients with KRAS-mutated NSCLC for dose level 5 (1.6 mg/kg)
• To investigate the PK of NBF-006

Exploratory Objectives:

• To evaluate correlation between biomarkers and clinical outcome
• To evaluate correlation between KRAS-mutations and clinical outcome

Part B (Dose expansion)

Primary Objectives:

• To evaluate preliminary efficacy and safety profile of NBF-006 in patients with KRAS-mutated NSCLC

Secondary Objectives:

• To investigate the PK of NBF-006

Exploratory Objectives:

• To evaluate GSTP mRNA KD in surrogate tissue (PBMCs) and correlation between biomarkers and clinical outcome

Primary Objectives:

The primary objective of Phase 1 is to:

• Assess the safety and tolerability of DF6002 as monotherapy, and to determine the maximum tolerated dose (MTD) of Subcutaneous (SC) DF6002 in patients with advanced (unresectable, recurrent, or metastatic) solid tumors in selected indications.

The primary objective of Phase 1b is to:

• Assess the safety and tolerability of SC DF6002 in combination with intravenous (IV) Nivolumab, and to determine the MTD of DF6002 in combination with Nivolumab in patients with advanced (unresectable, recurrent, or metastatic) solid tumors in selected indications.

The primary objective of Phase 2 is:

• To assess the Objective Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per an Independent Endpoint Review Committee (IERC), for all Efficacy Expansion Cohorts testing the clinical activity of DF6002 as a monotherapy or in combination with nivolumab.

Secondary Objectives

Phase 1

• Characterize the safety of DF6002 as a monotherapy and in combination with nivolumab
• Characterize the pharmacokinetics (PK) of DF6002 and the PK profiles of DF6002 and nivolumab when given in combination
• Evaluate immunogenicity of DF6002
• Evaluate the immunogenicity of nivolumab, when given in combination with DF6002
• Assess ORR, as determined by the Investigator using RECIST 1.1.
• Assess duration of response (DOR), as determined by the Investigator using RECIST 1.1.
• Assess clinical benefit rate (CBR), as determined by the Investigator

Phase 2

• Characterize the safety of DF6002 as a monotherapy and in combination with nivolumab
• Characterize the PK of DF6002 as a monotherapy and the PK profiles of DF6002 and nivolumab when given in combination
• Assess DOR per an IERC using RECIST 1.1.
• Assess CBR per IERC using RECIST 1.1. CBR is defined as the percentage of patients with complete response (CR), partial response (PR), or stable disease (SD) as best response.
• Evaluate the immunogenicity of DF6002 as a monotherapy and each of DF6002 and nivolumab when give in combination, and investigate potential correlation between exposure and clinical activity.
• Assess progression free survival (PFS) per an IERC using RECIST 1.1.
• Assess median overall survival (OS) time.

PRIMARY OBJECTIVE:

• To evaluate safety of IV and IT CF33-hNIS in monotherapy and in combination with pembrolizumab.  To determine Recommended Phase 2 Dose (RP2D) of CF33-hNIS in monotherapy and in combination with pembrolizumab.

SECONDARY OBJECTIVES:

• Anti-tumor activity of CF33-hNIS administered as a monotherapy and in combination with pembrolizumab based on objective response rate (ORR) using RECIST v1.1 (Seymour et al., 2017) and immune Response Evaluation Criteria in Solid Tumors (iRECIST) v1.0
• Efficacy of IT and IV CF33-hNIS administered as a monotherapy and in combination with pembrolizumab:
  a. Progression-free survival (PFS)
  b. Overall survival (OS)
  c. Duration of Response (DOR)
  d. Disease Control Rate (DCR)
• Viral titers of CF33-hNIS
• Infection of tumors with CF33-hNIS

Primary Efficacy Objective:

• The primary efficacy objective for this study is to evaluate the efficacy of atezolizumab in combination with tiragolumab compared with durvalumab in the ITT and the PD-L1-positive populations on the basis of the following endpoint:
  • IRF-assessed PFS after randomization, defined as the time from randomization to the first occurrence of disease progression, as determined by the IRF according to RECIST v1.1, or death from any cause, whichever occurs first

Secondary Efficacy Objective:

• The secondary efficacy objective for this study is to evaluate the efficacy of atezolizumab plus tiragolumab compared with durvalumab in the ITT and the PD-L1positive populations on the basis of the following endpoints:
  • OS after randomization, defined as the time from randomization to death from any cause
  • Investigator-assessed PFS after randomization, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first
  • Confirmed ORR, defined as the proportion of patients with a confirmed objective response (i.e., CR or a PR on two consecutive occasions 4 weeks apart), as determined by the IRF and investigator according to RECIST v1.1
  • DOR in patients with confirmed ORR, defined as the time from the first occurrence of a documented objective response to disease progression as determined by the IRF and investigator according to RECIST v1.1 or death from any cause, whichever occurs first
  • PFS rate at 12 months, 18 months, and 24 months, defined as the proportion of patients who have not experienced disease progression as determined by the IRF and investigator according to RECIST v1.1 or death from any cause at 12 months, 18 months and 24 months, respectively
  • OS rate at 12 months, 24 months, 36 months, and 48 months, defined as the proportion of patients who have not died from any cause at 12 months, 24 months, 36 months, and 48 months, respectively
  • Time to death or distant metastasis (TTDM), defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis
  • Time to confirmed deterioration (TTCD) in patient-reported physical functioning and global health status (GHS), as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30), and in patient-reported lung cancer symptoms for cough, dyspnea (a multi-item subscale), and chest pain, as measured through the use of the EORTC Quality-of-Life Questionnaire Lung Cancer Module (QLQ-LC13)