Clinical Trials

This study will evaluate the safety, efficacy, optimal dose, and pharmacokinetics (PK) of BNT326 as monotherapy (Part 1) and as combination treatment with immunotherapeutic agents (Part 2) in participants with histologically or cytologically confirmed solid tumors that are advanced (i.e., either metastatic or recurrent tumors with no further definitive treatment possible) and/or have relapsed/progressed after prior therapy.

The main purpose of this study is to evaluate the safety and tolerability of IBI3020 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RP2D) of IBI3020.

This is a FIH, multicenter, open-label Phase I study to investigate the safety, tolerability, preliminary antitumor activity, as well as PK and pharmacodynamics of XL309 (previously ISM3091) administered alone or in combination with olaparib in subjects with advanced solid tumors.

This is a Phase 1b/2, open-label, dose escalation study to evaluate the safety, tolerability, PK, and immunogenicity of ADG126-pembrolizumab combination regimens in patients with advanced/metastatic solid tumors.

This phase II trial evaluates the impact of cancer therapy in the patients' home compared to in the clinic on safety, side effects, patient preference, and satisfaction in Black men with prostate cancer that has spread to nearby tissue or lymph nodes (locally advanced), that has increasing prostate-specific antigen after treatment (biochemically recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Typically drug-related cancer care is conducted at a medical center which causes patients to have to spend considerable time away from family, friends, and familiar surroundings. This separation may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. Therapy administered to a patient in the patients' residence in the comfort of familiar surrounding using Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) may help reduce psychological and financial distress, increase access to care and improve treatment compliance. Giving cancer therapy in the home compared in the clinic may be safe, tolerable and improve patient satisfaction with overall cancer care in Black men with locally advanced, biochemically recurrent or metastatic prostate cancer.

The purpose of this study is to employ mixed methods approach to develop a prostate cancer survivorship care plan (CaP-SCP) tailored to US-born Black men (USbBM), Caribbean-born BM (CBBM) and African-born BM (ABBM) using clinicians’ key informant interviews and survey of CaP Black survivors and to develop a prototype of the digitalized CaP-SCP that integrates quantitative clinical, patient reported health-related quality of life (HRQOL) and population level data to assess the sensitivity and preliminary impact of the digitalized CaP-SCP  on Health Related Quality of Life (HRQOL) using community engagement research and behavioral precision medicine.

Augmented reality (AR) immersive technology in healthcare delivers unprecedented, intuitive, realistic visualization and interaction experience for patients in a synthetic and integrated fashion. AR can help patients to manage emotions, pain, combat anxiety or fears, and make better decisions. Combined with Artificial Intelligence (AI), with benefits of accurate machine-learning models, we propose to develop an integrated AI and AR technology Prostate Cancer (CaP) Survivorship Care Plan.

The digitalized CaP-SCP development will be led by the iCCaRE consortium’s Digital Health & Human Services core. They will develop a mobile app that integrates SDOH navigation, standard CaP psycho-oncology support and emotional support. The app’s content will be delivered through AI predictive analytic and recommender system and will be based on the previously conducted interviews and focus groups. 

The digitalized CaP-SRP when used by a patient, will present the following features: 
• A series of short survey questions, which is used by the AI model to predict or recommend a specific intervention(s), educative material(s), or AR interactions with personal CaP survival stories; 
• SDOH navigation that will appropriately connect them with relevant support services and resources in their communities; 
• An emotional support intervention that can establish an empathic rapport with a CaP survivor’s sharing of his story. This will be programmed based on one of the iCCaRe Consortium’s consumer advocates; 
• The psycho-oncology support will be programmed to provide psychoeducation about the PPCD experience, reify and concretize the PPCD experience, and foster hope; 
• Patients can choose to ignore the personalized recommendations and select from a drop-down menu list of contents. 

The app is expected to be downloaded to their mobile smartphone for introduction in the clinical setting and more in-depth use at home. The survivorship care plan can be taken with participants to follow-up appointments for reminders and updates to treatments. We anticipate participants acclimating to the app for approximately 30 minutes in the clinic

TARA-002-101-Ph2 is an open-label study to investigate the safety and anti-tumor activity of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta/T1). The purpose of this Phase 2 study (TARA-002-101-Ph2) is to further assess the safety and anti-tumor activity of TARA-002 at the RP2D which has been established in the Phase 1a dose finding study (TARA-002-101-Ph1a). This Phase 2 study includes participants with CIS NMIBC (± Ta/T1) with active disease (defined as disease present at last tumor evaluation prior to signing ICF). Participants will be enrolled into one of 2 cohorts: Cohort A: -Participants with CIS (± Ta/T1) who are BCG naive, or -Participants with CIS (± Ta/T1) who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis Cohort B: -Participants with persistent or recurrent CIS (± Ta/T1) who are BCG unresponsive within 12 months of completion of adequate BCG therapy (minimum 5/6 doses induction and 2/3 doses maintenance or 2/6 doses reinduction)

This phase III trial compares the effect of adding gemcitabine to intravesical Bacillus Calmette Guerin (BCG) versus intravesical BCG alone in patients with non-muscle invasive bladder cancer that has come back after a period of improvement (recurrent). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Intravesical BCG is a solution containing the live BCG bacteria that is placed in the bladder via a catheter (intravesical). When the solution comes into direct contact with the bladder wall, it stimulates the body's immune system which kills tumor cells. Giving gemcitabine with intravesical BCG may kill more tumor cells in patients with recurrent non-muscle invasive bladder cancer.

This is a multicenter, Phase 1b/2 trial. The purpose of phase 1b part of the trial aims to determine the  recommended phase II dose (RP2D) of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, and ribociclib. The Phase 2 part of the trial will evaluate the effectiveness and safety of the various combinations in patients with ER+/HER2- advanced/metastatic breast cancer.

The purpose of this study is to assess the impact of an Acceptance and Commitment Therapy and Compassion-Based virtual group intervention for diverse cancer patients at Mayo Clinic in Arizona.