Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Gland and Hormone Related Diseases

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Breast Neoplasms

Triple Negative Breast Neoplasms

Pancreatic Neoplasms

Carcinoma, Hepatocellular

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Cholangiocarcinoma

Melanoma

Sarcoma

Skin Neoplasms

Sarcoma, Synovial

Colonic Neoplasms

Breast Diseases

Skin Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms, Connective and Soft Tissue

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Neoplasms, Connective Tissue

Pancreatic Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Bile Duct Cancer

Soft Tissue Sarcoma

Synovial Sarcoma

Neuroendocrine Tumor

Neuroepithelioma

Herbal and Botanical

All Drugs and Chemicals

Cola

The dose cohorts will be 0.5, 1, 2, 4, and 8 mg/kg IV once weekly (QW)

Triple Negative Breast Cancer Expansion phase n=30

ST316

Steve Kaesshaefer

Xiomara Menendez, RN

Anthoney El-Khoueiry, MD

Josh Henninger, MD

Jason Henry, MD

Julie Burns, BSN

Nehal Lakhani, MD

JoAnna Gontarz, MSN

Niharika Mettu, MD PhD

Staci Vogel

Steven Powell, MD

Abi Vainstein-Haras

This is an open-label, two-part, phase 1-2 study designed to determine the safety, tolerability, PK, pharmacodynamics (PD), and proof-of-concept efficacy of ST316 administered IV in subjects with selected advanced solid tumors likely to harbor abnormalities of the WNT/β-catenin signaling pathway. The study consists of two phases: a phase 1 dose escalation/regimen exploration phase and a phase 2 expansion phase.

A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors

A Phase 1-2 Dose-escalation and Expansion Study of ST316 in Subjects With Selected Advanced Unresectable and Metastatic Solid Tumors

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Area under the concentration-time curve over the dosing interval

DOR is defined for participants achieving a confirmed CR+PR as the time from the initial response of CR+PR per investigator review according to RECIST 1.1 criteria to disease progression or death of any cause, whichever occurs earlier

Area under the concentration-time curve over the dosing interval time from time 0 extrapolated to infinite time

The time take to reach Maximum observed serum concentration

Overall survival (OS) is defined as time from first study treatment to death due to any cause.

Progression-free survival (PFS) is defined as time from first study treatment to a documented disease progression according to RECIST version 1.1, as determined by the investigator, or death due to any cause, whichever occurs earlier.

ORR defined as percentage of participants with confirmed best overall response of Confirmed complete response (CR) and partial response (PR) per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Sapience Therapeutics

Nervous System Diseases

Prostatic Neoplasms

Glioblastoma

Brain Neoplasms

Disease Attributes

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Antineoplastic Agents

Immune Checkpoint Inhibitors

Hormones

Temozolomide

Taxane

Antineoplastic Agents, Alkylating

Alkylating Agents

This cohort only patients diagnosed with locally advanced or metastatic melanoma, carcinoma or sarcoma of any tumor type who are refractory or intolerant to all available therapies. ST101 will be administered intravenously (IV), initially once per week.

This cohort must have progressed after 1-2 hormone based therapies. The starting dose of ST101 for Expansion will be derived from the maximum tolerated dose (MTD)/recommended dose for expansion (RDE) and the best dosing schedule determined during Dose Escalation.

This cohort must have Melanoma that has progressed after/or on treatment with an immune checkpoint inhibitor (CPI) and have received 1-2 prior lines of therapy for their advanced/metastatic disease. The starting dose of ST101 for Expansion will be derived from the maximum tolerated dose (MTD)/recommended dose for expansion (RDE) and the best dosing schedule determined during Dose Escalation.

Primary (de novo) GBM that has recurred or progressed (per modified RANO criteria) after 1 standard treatment regimen. Standard therapy is defined as maximal surgical resection, radiotherapy, and concomitant temozolomide with radiotherapy or adjuvant chemotherapy with temozolomide. The starting dose of ST101 for Expansion will be derived from the maximum tolerated dose (MTD)/recommended dose for expansion (RDE) and the best dosing schedule determined during Dose Escalation.

CRPC that has progressed after previous treatment with taxanes, abiraterone and enzalutamide/apalutamide. The starting dose of ST101 for Expansion will be derived from the maximum tolerated dose (MTD)/recommended dose for expansion (RDE) and the best dosing schedule determined during Dose Escalation.

Recurrent GBM patients must have completed radiation at least 3 months prior to minimize the inclusion of patients with pseudoprogression. Recurrent GBM patients must have unequivocal radiographic evidence of tumor progression by contrast-enhanced magnetic resonance imaging (MRI) scan within 21 days prior to registration. Patients must be able to delay surgery for 2 - 4 weeks per investigator decision

Newly diagnosed patients with a suboptimal resection or biopsy must be candidates for another surgical resection as determined by neurosurgical evaluation or multidisciplinary team based on the current standard of care that suggests that maximal safe resection is beneficial. Recurrent GBM patients must be candidates for tumor resection

ST101 will be administered intravenously (IV), initially once per week with a flat dose on the schedule described for each study arm

ST101

Radiation

Neuro Oncology Research Coordinator

Vinai Gondi, MD

Alyssa Schumpp

Fabio Iwamoto, MD

Katy Peters, MD

Abi Vainstein-Haras, MD

This is an open-label, two-part, phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 administered IV in patients with advanced solid tumors. The study consists of two phases: a phase 1 dose escalation/regimen exploration phase and a phase 2 expansion phase.

Dose escalation / regimen exploration phase During the dose escalation/regimen exploration phase, only patients diagnosed with locally advanced or metastatic melanoma, carcinoma or sarcoma of any tumor type who are refractory or intolerant to all available therapies that would impact survival will be enrolled.

ST101 will be administered intravenously (IV), initially once per week. The dose escalation cohorts will be recruited using a standard 3+3 design. At each new dosing cohort, there will be a 1-week observation period after dosing the first patient in order to assess safety prior to dosing the remainder of the patients in that cohort. The dose cohorts will be 0.5, 1, 2, 4, 8 and 16 mg/kg with once weekly (QW) dosing in all cohorts except for the highest dose level which will be dosed every other week (Q2W).

The expansion phase consists of 4 specific tumor-type cohorts, which each follow the same Simon 2-stage design. Fifteen (15) patients will be enrolled in each cohort and treated with the ST101 RP2D. If one or more responses is observed that cohort will be expanded to a total of 30 patients to further assess efficacy.

Responses will be graded using response evaluation criteria in solid tumors (RECIST) 1.1 (Eisenhauer 2009) for hormonal receptor positive (HRpos) locally advanced/metastatic breast cancer (LA/MBC) and melanoma, modified response assessment in neuro-oncology (RANO) (Ellingson 2017) for GBM and prostate cancer clinical trials working group 3 (PCWG3) (Scher 2016) for castration-resistant prostate cancer (CRPC).During the expansion phase, only patients diagnosed with the following tumor types will be allowed into this phase of the study:

* HRpos LA/MBC that has progressed after prior 1-2 hormone-based therapies. Previous treatment with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, mammalian target of rapamycin (mTOR) inhibitor or chemotherapy is allowed as monotherapy or in combination.
* Melanoma that has progressed after/or on treatment with an immune checkpoint inhibitor (CPI) and have received 1-2 prior lines of therapy for their advanced/metastatic disease. Patients that have BRAF mutated disease should also have received one line of appropriate targeted therapy.
* Primary (de novo) GBM that has recurred or progressed (per modified RANO criteria) after 1 standard treatment regimen. Standard therapy is defined as maximal surgical resection, radiotherapy, and concomitant temozolomide with radiotherapy or adjuvant chemotherapy with temozolomide. Patients that undergo tumor treating fields as an adjuvant to first line therapy are allowed.
* CRPC that has progressed after previous treatment with taxanes, abiraterone and enzalutamide/apalutamide.

The tumor types in the expansion phase may change based on emerging data from the dose escalation phase of this study. Additional mini cohorts of 10 patients may be added to the expansion phase based on efficacy signals during the dose escalation phase.

The study consists of two phases: a phase 1 dose escalation/regimen exploration phase and a phase 2 expansion phase.

A Phase 1-2 Study of ST101 in Patients With Advanced Solid Tumors

A Phase 1-2 Dose-escalation and Expansion Study of ST101 in Patients With Advanced Unresectable and Metastatic Solid Tumors

Number of Participants with a Dose-Limiting Toxicity (DLT)

Number of Participants with at Least One Adverse Event, Severity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)

Area under the plasma concentration time curve of ST101

Escalation and Expansion Evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

Expansion: Disease Control Rate, Assessed According to RECIST v1.1

Expansion: Duration of Response, Assessed According to RECIST v1.1

Expansion: Progression Free Survival, Assessed According to RECIST v1.1

Carcinoma, Squamous Cell

Carcinoma, Basal Cell

Neoplasms, Squamous Cell

Neoplasms, Basal Cell

R-5780

Janet Stephens, PhD

Christian Freguia, PhD

The goal of this study is determine the safety and tolerability of orally taken probiotic (R-5780) in patients currently on a PD-1 Pathway Checkpoint Inhibitor (checkpoint protein on immune cells called T cells) with Solid Tumors.

Patients will take an oral dosage of probiotic (R-3750 and provide patient reported overall feeling and physician scored measure of their tumors. Blood and fecal evaluations of inflammation and assessment of probiotic (R-5780) on fecal levels will also be measured.

R-5780-01 In Combination With PD-1 Checkpoint Inhibitors (Checkpoint Protein on Immune Cells Called T Cells) in Patients With Solid Tumors

A Single and Repeat Dosing and Expansion Study of the Safety, Drug Exposure and Clinical Activity of R-5780 in Combination With a PD-1 (Checkpoint Protein on Immune Cells Called T Cells) Pathway Checkpoint Inhibitor in Patients With Solid Tumors

To assess the number of participants with treatment-related adverse events after taking R-5780 (probiotic)

Collect how the patient is feeling on each study visit on the Quality of Life Scale of 30 questions. The Quality of Life scores are summed so that a higher score indicates higher quality of life.

Rise Therapeutics LLC

Pembrolizumab

Antineoplastic Agents, Immunological

Each participant will receive pembrolizumab every 21 days for up to 12 month or until confirmed disease progression on MRI or CT, unacceptable toxicity, confirmed.positive pregnancy test or withdrawal of consent.

pembrolizumab

This is an expanded access program (EAP) for patient with Melanoma and Glioblastoma who have progressed after prior Protocol therapy including Bevacizumab, Temozolomide ( TMZ ), Ipilimumab, BRAF and MEK inhibitors. The patients whose tumors are EGFR, MET or ALK positive should first receive an EFGR or ALK inhibitor, respectively, prior to treatment with pembrolizumab.

Pembrolizumab has been approved by the U.S. Food and Drug Administration for the treatment of patients with Glioblastoma and Melanoma The Expanded Access Program (EAP) for this medicine in the U.S. is closed. The EAP will continue outside the U.S.

Expanded Access for Pembrolizumab (MK-3475)

Expanded Access for Pembrolizumab (MK-3475) to Patients With Melanoma or Glioblastoma / Glioma After Failed Standart Therapy, at High Mutational Load Which is Confirmed by the Results of Molecular-genetic Analysis of Tumor Tissue.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors	NCT05848739	Breast Cancer M... Pancreatic Canc... NSCLC, Metastat... Synovial Sarcom... Colon Cancer Metastatic Colo... Melanoma Recurr... Metastatic Skin... Melanoma Stage ... Triple Negative... TNBC - Triple-N... Cholangiocarcin... Ovarian Cancer Metastatic Mela... Hepatocellular ...	ST316	18 Years -	Sapience Therapeutics
A Phase 1-2 Study of ST101 in Patients With Advanced Solid Tumors	NCT04478279	Glioblastoma Melanoma Stage ... Breast Cancer Prostate Cancer Glioblastoma Mu... GBM Brain Cancer Metastatic Brea... Metastatic Mela... Metastatic Pros... Melanoma Recurr... Prostate Cancer... Recurrent Gliob... Newly Diagnosed...	ST101 Temozolomide Radiation	18 Years -	Sapience Therapeutics
R-5780-01 In Combination With PD-1 Checkpoint Inhibitors (Checkpoint Protein on Immune Cells Called T Cells) in Patients With Solid Tumors	NCT06398418	Melanoma Basal Cell Carc... Squamous Cell C... Melanoma Recurr... Basal Cell Canc... Squamous Cell C...	R-5780	18 Years - 80 Years	Rise Therapeutics LLC
A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors	NCT05848739	Breast Cancer M... Pancreatic Canc... NSCLC, Metastat... Synovial Sarcom... Colon Cancer Metastatic Colo... Melanoma Recurr... Metastatic Skin... Melanoma Stage ... Triple Negative... TNBC - Triple-N... Cholangiocarcin... Ovarian Cancer Metastatic Mela... Hepatocellular ...	ST316	18 Years -	Sapience Therapeutics
Expanded Access for Pembrolizumab (MK-3475)	NCT03311542	Melanoma (Skin) Melanoma Recurr... Glioblastoma Mu... Glioblastoma by... Glioma of Brain	pembrolizumab	18 Years - 80 Years	Center Trials & Treatment
Expanded Access for Pembrolizumab (MK-3475)	NCT03311542	Melanoma (Skin) Melanoma Recurr... Glioblastoma Mu... Glioblastoma by... Glioma of Brain	pembrolizumab	18 Years - 80 Years	Center Trials & Treatment

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