Thanh P. Ho, M.D.

Closed for Enrollment

• A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB308 in Combination With AB122 in Participants With Advanced Malignancies Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

  The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of AB308 in combination with zimberelimab (AB122) in participants with advanced malignancies.

• A Phase 1/2 Open-Label, Multicenter Study to Characterize the Safety and Tolerability of CFT8634 in Subjects With Locally Advanced or Metastatic SMARCB1-Perturbed Cancers, Including Synovial Sarcoma and SMARCB1-Null Tumors Rochester, Minn., Jacksonville, Fla.

  The objectives of Phase 1 and Phase 2 of this study are to characterize the safety and tolerability of CFT8634 in subjects with locally advanced or metastatic SMARCB1-perturbed cancers, including synovial sarcoma and SMARCB1-null tumors.

  Phase 1 only: To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for CFT8634 in subjects with locally advanced or metastatic SMARCB1-perturbed cancers.

  Phase 2 only: To assess preliminary antitumor activity by overall response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in subjects with locally advanced or metastatic synovial sarcoma (Cohort 1) or SMARCB1-null tumors (Cohort 2).

   

• A Phase 3 Randomized, Open-Label, Multicenter Clinical Study of CGT9486+Sunitinib vs. Sunitinib in Subjects With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors (CGT9486-21-301) Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

  The purpose of this study is to compare CGT9486 in combination with sunitinib to treat gastrointestinal stromal tumors.

• A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional Chondrosarcoma Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

  The purpose of this study is to evaluate INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.

• Brightline-1: A Phase II/III, Randomized, Open-label, Multi-center Study of Brigimadlin BI 907828 Compared to Doxorubicin as First Line Treatment of Patients With Advanced Dedifferentiated Liposarcoma Rochester, Minn., Jacksonville, Fla.

  The purpose of this study is to compare a medicine called BI 907828 with doxorubicin in people with liposarcoma. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer.

  Doxorubicin is a medicine already used to treat cancer including liposarcoma. During the study, participants get either BI 907828 or doxorubicin. Every 3 weeks, participants take BI 907828 as tablets or doxorubicin as an infusion into a vein. Participants can switch to BI 907828 treatment if they did not benefit from doxorubicin treatment. Participants can continue treatment in the study as long as they benefit from it and can tolerate it. Doctors regularly check the size of the tumour and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.

• Brightline-4: A Phase III open-label, single-arm, multi-center study to assess the safety and efficacy of brigimadlin (BI 907828) treatment in patients with treatment-naïve or pre-treated advanced dedifferentiated liposarcoma Rochester, Minn., Scottsdale/Phoenix, Ariz., Jacksonville, Fla.

  The purpose of this study is to evaluate the safety of brigimadlin in patients with advanced or metastatic DDLPS by assessing the incidence of treatment-emergent adverse events (TEAEs) and to characterise the severity, frequency, seriousness, relationship, and outcome of TEAEs.

• Clinical and laboratory tools to evaluate treatment tolerability in older patients with sarcoma Rochester, Minn.

  Sarcomas are rare, encompass multiple subtypes, and have few established guidelines. Geriatric assessments and screening tools are recommended as part of multi-disciplinary care for older patients with cancer, but they are not widely used in clinical practice. This pilot study will prospectively evaluate older patients (age 65 years and above) with sarcoma who are followed in the medical oncology sarcoma clinic in Rochester MN; this will include patients who are newly diagnosed or receiving systemic therapy. Patients will undergo geriatric screening as well as laboratory testing. Laboratory testing will include routine complete blood counts (CBC) that are associated with poor outcomes in sarcoma, as well as circulating senescence-associated secretory phenotype (SASP) proteins, which are associated with frailty.

  This prospective, observational pilot study will examine factors which may affect tolerability of systemic therapy (chemotherapy, immunotherapy, and targeted therapy) in older patients with sarcoma. The study will combine clinical and laboratory monitoring of older patients (age 65 and above).  Data (including screening tools and laboratory studies) will be collected at two timepoints – when patient consents to study and at the subsequent clinic visit with imaging assessment. Review of electronic medical record will be performed to evaluate clinically significant outcomes such as adverse events, hospitalizations, as well as treatment changes (delay or dose reductions) or discontinuation.

  We hypothesize that clinical screening tools and laboratory tests can help evaluate older patients (age 65 years and above) with advanced/metastatic sarcoma who may develop toxicity with therapy.