Clinical Trials Actively Recruiting

Primary Objective:

• To determine if ado-trastuzumab emtansine (T-DM1) shows better progression-free survival (PFS) when compared to docetaxel plus trastuzumab (TH) in recurrent and/or metastatic (R/M) HER2-positive salivary gland cancer (SGC) patients who have not previously received HER2 therapy for unresectable or recurrent and/or metastatic disease, as determined by local assessment.

Secondary Objectives:

• To compare the overall response rate (ORR) by RECIST v1.1 criteria between arms;
• To compare overall survival (OS) between arms;
• To compare toxicity using CTCAE v5.0 criteria between arms;
• To assess patient-reported toxicity, as measured by the PRO-CTCAE, between arms, and explore patient-reported symptomatic adverse events (AEs) for tolerability of each treatment arm as measured by the PRO-CTCAE.

Primary Objectives:

• To compare antitumor activity in ORR per
  Response Evaluation Criteria in Solid Tumor
  (RECIST) Guidelines version (v) 1.1 as assessed
  by blinded independent central review (BICR)
  in patients with incurable metastatic /
  recurrent HNSCC patients progressed on after
  anti-PD-1 and platinum containing therapy,
  treated with petosemtamab monotherapy vs
  investigator’s choice monotherapy
• To compare OS in patients with incurable
  metastatic / recurrent HNSCC progressed on
  after anti-PD-1 and platinum-containing
  therapy, treated with petosemtamab
  monotherapy vs investigator’s choice
  monotherapy

Secondary Objectives:

• To evaluate antitumor activity in ORR per
  RECIST v1.1 as assessed by investigator review
• To evaluate antitumor activity in DOR per
  RECIST v1.1 as assessed by BICR and
  investigator review
• To evaluate antitumor activity in TTR per
  RECIST v1.1 as assessed by BICR and
  investigator review
• To evaluate antitumor activity in PFS per
  RECIST v1.1 as assessed by BICR and by
  investigator review
• To evaluate antitumor activity in CBR per
  RECIST v1.1 as assessed by BICR and by
  investigator review
• To evaluate safety and tolerability of
  petosemtamab monotherapy
• To evaluate patient health-related quality of
  life (HRQL) using the European Organisation
  for Research and Treatment of Cancer (EORTC)
  validated Quality of Life of Cancer Patients
  Questionnaire (QLQ-C30)
• To evaluate patient HRQL using the updated
  EORTC validated Quality of Life of Head and
  Neck Cancer Patients Questionnaire (QLQH&N43)
• To characterize the PK of petosemtamab
• To characterize the population PK of
  petosemtamab
• To characterize the immunogenicity of
  petosemtamab

Primary Objectives:

• To evaluate the feasibility of molecular characterization based on TMB for
  participant stratification, as assessed by the proportion of participants with less
  than or equal to a 21-day turnaround time for biopsy results in Stage I of the study.
• To evaluate the feasibility of molecular characterization based on TMB and GEP
  (for TIS) for stratification in the overall study (Stage I and Stage II).
• To evaluate the efficacy by overall response rate (ORR – defined as confirmed
  and unconfirmed partial responses plus complete responses) of cabozantinib plus
  nivolumab in each disease cohort, both across and within tumor biomarker
  subgroups.

Secondary Objectives:

• To assess the difference in ORR in each disease cohort between tumor marker
  subgroups separately for each disease cohort.
• To assess safety and tolerability of this treatment in these populations.
• To estimate disease control rate (DCR) in participants receiving cabozantinib plus
  nivolumab in each disease cohort, stratified by tumor biomarkers.
• To estimate progression-free survival (PFS) in participants receiving cabozantinib
  plus nivolumab in each disease cohort, stratified by tumor biomarkers.
• To estimate overall survival (OS) in participants receiving cabozantinib plus
  nivolumab in each disease cohort, stratified by tumor biomarkers.
• To assess the proportion of patients with assay failure, and the time from the date
  of tissue collection to molecular group determination at the end of Stage I.
• To assess turnaround time for TIS for at least 30 patients in Stage I to ensure that
  at least 75% have a turnaround time of <21 days. If TIS is not ready for real-time
  testing when 30 slots remain for Stage I, accrual will be paused until assay
  validation is complete

Primary Objectives Phase II:

To determine if patient-reported neck and shoulder function and related quality of life (QOL) at 6 months after surgery using the Neck Dissection Impairment Index (NDII) is superior with Sentinel Lymph Node (SLN) biopsy compared to Elective Neck Dissection (END) for treatment of early-stage oral cavity squamous cell carcinoma (OCSCC) (cT1-2N0).

Primary Objectives Phase III:

• To determine if disease-free survival (DFS) is non-inferior with SLN biopsy compared to END for treatment of early-stage OCSCC (cT1-2N0).
• To determine if patient-reported neck and shoulder function and related QOL at 6 months after surgery using NDII is superior with SLN biopsy compared to END for treatment of early-stage OCSCC (cT1-2N0).

Secondary Objectives:

• To compare patterns of failure (local-regional relapse and distant metastasis) between surgical arms.
• To measure and compare overall survival (OS) between surgical arms.
• To measure and compare the toxicity of the two surgical arms.
• To measure longitudinal patient-reported neck and shoulder function and related QOL between surgical arms, using the following instruments:
• Neck Dissection Impairment Index (NDII)
• Abbreviated Disabilities of the Arm, Shoulder and Hand (QuickDASH)
• Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N)
• To assess the length of hospitalization, post-operative drain placement, and operative morbidity between arms.
• To estimate the negative predictive rate of FDG PET/CT for N0 neck in patients with T1 and T1-2 oral cavity squamous cell cancer (OCSCC) patients in the END arm.
• To assess nodal metastases rates between arms.
• To assess the pathologic false omission rate (FOR) in the SLN biopsy arm.
• To determine if patient-reported neck and shoulder function and related QOL at 6 months after surgery using the NDII is superior with the SLN biopsy compared to the END in low-risk patients.

Module A Monotherapy—dose escalation

Primary Objective:

• To investigate the safety and tolerability of EP0031 given as monotherapy

Secondary Objective:

• To characterize the PK of EP0031 given as monotherapy, after a single dose and at steady state after multiple dosing

Modules B and C Monotherapy—dose expansion

Primary Objective:

• To assess the efficacy of EP0031 given as monotherapy in patients with RET-altered tumours who have progressed following firstgeneration SRI therapy and in patients with RET-altered tumors with no prior SRI therapy (by RECIST v1.1)

Secondary Objectives:

• To investigate the safety and tolerability of EP0031 given as monotherapy
• To characterize the PK of EP0031 given as monotherapy

Arm 1a and Arm 1b

Primary Objectives:

• Select 2 doses of CHS-114 as a monotherapy to be considered as recommended dose for expansion (RDEs) in participants with advanced solid tumors and HNSCC following standard first-line therapy.

Secondary Objectives:

• Evaluate the safety and tolerability of CHS114 monotherapy.
• Evaluate the PK of CHS-114 as monotherapy.
• Evaluate the preliminary antitumor activity of CHS-114 administered as monotherapy.
• Evaluate the changes in FOXP3 levels within the tumor tissue (in participants undergoing pretreatment and on-treatment tumor biopsies).

Arm 2

Primary Objectives:

• Evaluate the safety and tolerability of CHS-114 in combination with toripalimab in participants with HNSCC following standard first-line therapy

Secondary Objectives:

• Evaluate the PK of CHS-114 and toripalimab when administered in combination.
• Evaluate the preliminary antitumor activity of CHS-114 administered in combination with toripalimab.

Primary Objectives:

• To evaluate the safety and tolerability of FT825 with or without cetuximab following CY/FLU or bendamustine
• To define the RP2D of FT825 with or without cetuximab following CY/FLU or bendamustine

Secondary Objectives:

• To evaluate the antitumor activity of FT825 with or without cetuximab following CY/FLU or bendamustine
• To characterize the PK of FT825 with or without cetuximab following CY/FLU or bendamustine

Primary Objectives:

• To assess the safety and tolerability of AB598 in participants with advanced malignancies

Secondary Objectives:

• To describe the pharmacokinetic (PK) profile of AB598 in participants with advanced malignancies
• To assess the immunogenicity to AB598 in participants with advanced malignancies
• To assess the preliminary clinical activity of AB598 in patients with advanced malignancies

Primary Objective:

• To evaluate the antitumor activity of disitamab vedotin in subjects with previously treated, locally-advanced unresectable or metastatic (LA/m) HER2 expressing solid tumors

Secondary Objectives:

• To evaluate the safety and tolerability profile of disitamab vedotin
• To assess other measures of antitumor activity of disitamab vedotin per investigator assessment by other clinically relevant measures
• To evaluate the pharmacokinetics (PK) of disitamab vedotin
• To evaluate the immunogenicity of disitamab vedotin

Primary Objectives:

• To characterize the safety and tolerability of different dose levels of ZL-1218 when administered as a single agent and in combination with pembrolizumab (200 mg IV Q3 week), including dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended dose (RD) of ZL-1218.

Secondary Objectives:

• To assess the preliminary efficacy of ZL-1218 when administered as a single agent and in combination with pembrolizumab.
• To characterize the pharmacokinetics (PK) of ZL-1218 as a single agent or in combination with pembrolizumab, after a single dose and multiple doses.
• To evaluate the immunogenicity of ZL-1218 as a single agent or in combination with pembrolizumab, after a single dose and multiple doses.