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

Nutritional and Metabolic Diseases

Wasting Syndrome

Cachexia

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Body Weight

Weight Loss

Body Weight Changes

Thinness

Manfred Welslau, MD

Evaluation of patient reported outcomes (PRO) with tumor cachexia in a real life setting.

The PRO Xie project will recruit a representative cohort of patients with advanced lung or advanced pancreatic cancer with a high risk for the development of cancer cachexia.

Patient Reported Outcomes (PRO) are assessed in a real life setting by a questionnaire consisting of 20 questions: QoL is measured by SF12, fatigue by FACIT-F and cachexia by FAACT questionnaires, respectively.

These data will determine the potential need for anti-cachexia treatment in those patients, as well as the number of underweight patients, the evaluation of general QoL, fatigue and cachexia and the evaluation of malnutrition.

Patient Reported Outcomes Registry in Patient With Cancer Cachexia

Tablet-based Prospective Patient Reported Outcomes (PRO) Registry in Patients With Advanced NSCLC or Advanced Pancreatic Cancer With Focus on Cancer Cachexia

BMI \< 20 kg/qm at start or during observation.

At baseline, throughout and at the end of the study with SF 12 questionnaire.

At baseline, throughout and at the end of the study with FACIT-F (short version of fatigue subscale).

At baseline, throughout and at the end of the study with FAACT (short version of anorexia / cachexia subscale).

Chugai Pharma Europe Ltd.

iOMEDICO AG

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
Patient Reported Outcomes Registry in Patient With Cancer Cachexia	NCT02983500	Metastatic Panc... NSCLC, Metastat...		18 Years -	iOMEDICO AG
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

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