Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Breast Neoplasms

Adenocarcinoma

Triple Negative Breast Neoplasms

Pancreatic Neoplasms

Breast Diseases

Skin Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

All Drugs and Chemicals

Antibodies

Immunoglobulins

AGX-101, initial 90-minute IV infusion, second 60-minute IV infusion and 30 minute subsequent IV infusions on Day 1 of every 3-week cycle in Dose Escalation Phase. Dose escalation will be carried out in sequential cohorts of escalating doses.

AGX-101, initial 90-minute IV infusion, second 60-minute IV infusion and 30 minute subsequent IV infusions on Day 1 of every 3-week cycle in Dose Escalation Phase. Dose expansion will be carried out with a selected dose and selected cancer type.

AGX101

Paul Jaminet, PhD

Rebecaa Beaman

Meredith P Pelster, MD

Amanda Betancourt

Ismael Rodriguez Rivera, MD

Glen Weiss, MD

AGX101 is an antibody-drug conjugate (ADC) therapy for tumor-forming cancers. The purpose of this study is to learn about AGX101 effects and safety at various dose levels in an all-comers advanced solid cancer patient population. AGX101will be administered intravenously.

Dosing of AGX101 will be repeated once every 3 weeks. Participants may continue study treatment until disease progression, unacceptable toxicity, or consent withdrawal. Subjects will attend an end of treatment visit and will receive two safety follow-up telephone contacts up to 90 days following the last dose of study drug.

A mTPI-2 design (Guo et al, 2017) with a target DLT rate of at most 30% will be applied for dose-escalation and expansion to determine the AGX101 RP2D.

A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors

A Phase 1, Open-Label, Dose-Escalation and Expansion Study of AGX101, a TM4SF1 Directed Antibody Drug Conjugate in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors Including Triple-Negative Breast Cancer and Pancreatic Adenocarcinoma

Maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) of AGX101 will be characterized

Evaluation of the incidence, severity, and duration of adverse events

Determination of the terminal elimination half-life (t½)

Determination of the AUC in 1 dosing interval

Determination of the Cmax concentration over a dosing interval, systemic clearance, volume of distribution at steady-state (Vss), and accumulation ratio from first dose to steady-state

Incidence and titers of ADA will be measured

Determination the objective response rate (ORR)

Determination of the duration of response (DoR)

Determination of the disease control rate (DCR)

Determine progression-free survival (PFS)/PFS assessed per immune-related response evaluation criteria (iPFS).

Angiex, Inc.

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Neoplasms, Squamous Cell

Esophageal Neoplasms

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

Fluorouracil

Tislelizumab

Cisplatin

Antineoplastic Agents, Immunological

In the single experimental arm, patients with locally nonresectable disease were subjected to receive neoadjuvant tislelizumab (200mg) plus chemotherapy (FP regimen) for conversion therapy. If conversion therapy succeeds, patients would proceed to surgery and adjuvant therapy. Otherwise, if patients were still not resectable after the conversion therapy, they will be treated by tislelizumab plus chemotherapy with or without palliative radiotherapy .

The 1st to 3rd doses were administered concurrently with FP regimen chemotherapy, 200 mg Tislelizumab each, on D1, D22 and D43 by intravenous infusion. In patients with successful conversion, one dose of 200 mg was administered 21 days after surgery in concurrent with the 4th to 6th cycles of 5-Fu, then 6 cycles of 200 mg Tislelizumab as adjuvant therapy; in patients with failed conversion, chemotherapy combined with tislelizumab were administered, with or without radiation therapy.

A FP regimen with 5-Fu 850mg/m\^2 d1-4 + cis-platinum 850mg/m\^2 d1-4 was used, on D1, D22 and D43 infused intravenously. 3 cycles of 5-Fu 850mg/m\^2 d1-4 adjuvant chemotherapy were started at 21 days after surgery in patients with a successful conversion. In patients with failed conversion, chemotherapy combined with tislelizumab were administered, with or without radiation therapy.

5-FU

A FP regimen with 5-Fu 850mg/m\^2 d1-4 + cis-platinum 850mg/m\^2 d1-4 was used, on D1, D22 and D43 infused intravenously. In patients with failed conversion, chemotherapy combined with tislelizumab were administered, with or without radiation therapy.

cis Platinum

Tongpeng Xu, PhD

This is a single-arm，open-label study to evaluate the efficacy and safety of tislelizumab plus chemotherapy for conversion therapy of patients with locally nonresectable ESCC.

Tislelizumab in Combination With Chemotherapy for Conversion Therapy of Locally Nonresectable ESCC

The Safety and Efficacy of Tislelizumab in Combination With Chemotherapy for Conversion Therapy of Locally Nonresectable ESCC，A Single-arm Study

Translational treatment-related AEs resulted in rates of surgery that were more than 30 days late or inoperable than originally planned

The proportion of patients whose primary tumor cell residual was less than 10% in the total number of patients enrolled after transformation therapy

Pathological complete response refers to that no tumor component or a small amount of carcinoma in situ component can be found on the horizontal line of pathological section after systemic treatment and surgical resection of the lesion.

The proportion of patients who completed R0 resection through 3 cycles of immunotherapy combined with chemotherapy in the total enrolled population.R0 finger resection margin under microscope was negative.

The time from randomization to disease recurrence or death due to disease progression

The First Affiliated Hospital with Nanjing Medical University

Symptoms and General Pathology

Neoplasm Metastasis

Disease Progression

Liquid biopsies of all 200 study patients will be analysed with FoundationOne®Liquid CDx.

Tissue biopsies from all study patients for whom a tissue biopsy is available will be analysed with FoundationOne® CDx and IHC (approximately 50% of the enrolled patients).

Biomarker Monitoring of study patients receiving matched therapy with AVENIO ctDNA Surveillance Kit.

Next Generation Sequencing

Biomarker Monitoring of study patients receiving matched therapy.

Biomarker Monitoring

Armin Gerger, AssocProf.Priv.Doz.Dr.MD,MBA

Sarah Steinlechner, BSc, MSc, MSc

Holger Rumpold, AssPr PD MD

Thomas Winder, PD M.D. PhD

Armin Gerger, AssocProf.MD

Richard Greil, Prof. M.D.

Jakob Michael Riedl, Priv.Doz.Dr.scient.,MD.

The aims of this study are

* to evaluate the efficacy of comprehensive genomic tumour profiling (CGP) from liquid and/or tissue biopsy in patients with locally advanced and/or metastatic carcinoma.
* to evaluate and describe the impact of treatment decisions based on CGP on individual progression free survival in patients with locally advanced and/or metastatic carcinoma
* to evaluate and describe similarities and differences between the treatment suggestions based on CGP/IHC (immuno-histochemistry) of tissue biopsy and liquid biopsy.

In patients with locally advanced and/or metastatic carcinoma the primary efficacy objective of the study is, to observe and describe the PFS (progression-free survival) of the matched treatment compared to the PFS of the most recent therapy.

The SOUND study will be exploring the treatment rates and outcomes of CGP-driven targeted treatment in patients with advanced or metastasized cancer. It will use a substantially larger gene-panel than previous studies in Austria. Departing from the routine clinical practice, study patients will have the opportunity to have CGP from liquid and/or tissue biopsy. The treatment decision will be discussed within a molecular tumour board consisting of experts in clinical oncology, human genetics and pathology. The treatment decision process will be supported and documented by a software.

Data from the SOUND study will cover the whole analysis process, the reasons for the treatment decision, reasons for getting or not-getting a matched treatment as well as the outcome, treatment and hospitalisation costs. The SOUND study will give valuable insights into the clinical practice of CGP-driven therapy in Austria and describe the experience and the possible restrictions. Considering the differing conditions in Austria, the SOUND study will generate data that might be useful for best practice sharing with other countries in the future.

Open, Prospective, Multicentre IVD (in vitro diagnostic device) Study

Evaluation of Efficacy of Comprehensive Genomic Tumour Profiling (CGP) From Liquid and/or Tissue Biopsy in Patients With Locally Advanced and/or Metastatic Carcinoma

To observe and describe the PFS of the matched treatment compared to the PFS of the most recent therapy, PFS = number of calendar days from start treatment to progression of disease

To evaluate the number of targets identified with NGS (next-generation sequencing) and IHC, that are potentially actionable with an approved drug on-label, off-label or an experimental drug per patient

To investigate the proportion of patients with targets actionable by an approved drug on-label, off-label or an experimental drug.

To observe and describe overall survival (OS)

To observe and describe objective response rate (ORR), Response will be evaluated by the investigator as defined by RECIST 1. or irRECIST

To investigate the proportion of patients with successful molecular profiling

Medical University of Graz

Neoplastic Processes

Lattice radiation therapy (LRT) : 5 fractions

Lattice therapy (LRT)

UCCC Clinical Trials Office

Andrew Frankart, MD

The purpose of this research study is to determine if lattice radiation therapy (LRT) will provide better treatment for bulky (large) tumors than current standard of care radiotherapy.

This will be a single-institution, single-arm Phase II trial with an anticipated total of 37 patients enrolled. Treatment will consist of 5 fractions of lattice radiation therapy delivered every other day. The primary endpoints will include the efficacy of lattice therapy as evaluated by ORR (CR or PR per RECIST criteria) at 60 days (2 months) post-treatment and safety. Toxicity will be evaluated at day 5 (+/- 2 days), day 15 (+/- 5 days), day 30 (+/- 5 days), and day 60 (+/- 7 days) post-completion of lattice therapy. This study will also include a translational analysis of the impact of lattice therapy on systemic immune responses.

Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors

A Phase 2 Study of Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors

Blood will be collected pre-treatment, after the last lattice fraction, and at 5 days post-lattice therapy for analysis via flow cytometry. Differences in immune anti-tumor responses be assessed between timepoints/tumor types. Increased immune anti-tumor responses after therapy compared to baseline are anticipated.

To evaluate the efficacy of lattice therapy in patients with bulky tumors, as measured by objective response rate (ORR) at 60 days post-treatment.

To characterize the safety profile and adverse events (AEs) of lattice therapy.

To assess overall survival (OS) following lattice therapy. Overall survival will be assessed via review of medical and vital records.

To determine patient-reported quality of life outcomes after lattice therapy via the Functional Assessment of Cancer Therapy - General - 7 Item Version (FACT-G7) tool as a measure of global quality of life. This is measured on 5 point Likert-type scale ranging from 0-4. Higher scores reflect better QOL.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors	NCT06440005	Cancer Advanced Cancer Locally Advance... Metastatic Soli... Triple Negative... Pancreas Cancer Pancreatic Aden...	AGX101	18 Years -	Angiex, Inc.
Tislelizumab in Combination With Chemotherapy for Conversion Therapy of Locally Nonresectable ESCC	NCT05469061	Esophageal Squa... Locally Advance...	Tislelizumab 5-FU cis Platinum	18 Years - 75 Years	The First Affiliated Hospital with Nanjing Medical University
Evaluation of Efficacy of Comprehensive Genomic Tumour Profiling (CGP) From Liquid and/or Tissue Biopsy in Patients With Locally Advanced and/or Metastatic Carcinoma	NCT05032092	Locally Advance... Metastatic Canc...	Next Generation... Next Generation... Biomarker Monit...	18 Years -	Medical University of Graz
Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors	NCT06416007	Cancer Metastatic Canc... Locally Advance... Locally Advance... Locally Advance...	Lattice therapy...	18 Years -	University of Cincinnati
Evaluation of Efficacy of Comprehensive Genomic Tumour Profiling (CGP) From Liquid and/or Tissue Biopsy in Patients With Locally Advanced and/or Metastatic Carcinoma	NCT05032092	Locally Advance... Metastatic Canc...	Next Generation... Next Generation... Biomarker Monit...	18 Years -	Medical University of Graz

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