Symptoms and General Pathology

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KSH01 injection

clinical trials ksh

Jie Ma

1) Safety and efficacy of TCR-T cells in subjects with refractory/relapsed solid tumors. 2) The activation and proliferation of TCR-T cells in the subject, and the survival time.

KSH01-TCRT Solid Tumors

A Single-arm, Prospective Clinical Study of KSH01-TCR-T in the Treatment of Refractory/Recurrent Solid Tumors

Pharmacokinetic Values of blood test values

Biomarker Features values of blood test values

TCRx Therapeutics Co.Ltd

KSX01-TCRT cell therapy

Ning Li

Shuhang Wang

This trial is a single arm, open phase I clinical study to investigate the safety and efficacy of personalized KSX01-TCRT in patients with advanced solid tumors. This experiment is divided into two parts: the dose increasing stage (Part A) and the dose expanding stage (Part B). For those enrolled in the planned expansion phase, the dose should have passed the safety assessment during the dose escalation phase.

Single Arm Clinical Study on the Safety and Efficacy of Personalized KSX01-TCRT in Patients With Advanced Solid Tumors

Number of participants with treatment-related adverse events assessed by CTCAE v4.0.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Participants will receive escalating doses of PYX-106 to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of PYX-106, and to determine the recommended dose(s).

PYX-106

Chalyse Bush

The primary objective of this study is to determine the recommended dose(s) of PYX-106 in participants with relapsed/refractory solid tumors.

Study of PYX-106 in Solid Tumors

A First-in-Human, Open-label, Multicenter, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PYX-106 in Subjects With Advanced Solid Tumors

Type, incidence, seriousness and causality of AEs based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Any clinically significant changes in clinical laboratory parameters, vital signs, and electrocardiogram (ECG) parameters will be recorded as AEs.

Pyxis Oncology, Inc

Neoplasms

Blood and Lymph Conditions

Leukemia

Neoplasms by Histologic Type

Hematologic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Etoposide

Cyclophosphamide

Etoposide phosphate

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Enzyme Inhibitors

Carfilzomib in combination with cyclophosphamide and etoposide

Carfilzomib in combination with cyclophosphamide and etoposide for children with relapsed and refractory solid tumors and leukemias

Carfilzomib

This study evaluates the use of carfilzomib in combination with cyclophosphamide and etoposide for children with relapsed/refractory solid tumors or leukemia. The medications cyclophosphamide and etoposide are standard drugs often used together for the treatment of cancer in children with solid tumors or leukemia.

Carfilzomib is FDA (Food and Drug Administration) approved in the United States for adults with multiple myeloma (a type of cancer). However, this drug is not approved to treat children with relapsed/refractory solid tumors or leukemia. With this research, we plan to determine the DLTs and MTD of Carfilzomib given in combination with cyclophosphamide and etoposide in pediatric patients with relapsed/refractory leukemias and solid tumors.

Part 1 of the study will include a dose escalation based on Dose limiting toxicities (DLTs) until the MTD or highest dose level is reached, whichever comes first.

At the MTD or highest dose level (if no MTD is reached), an additional 6 patients will be enrolled to further evaluate safety of the regimen (Part 2).

Part 2 of this study will enroll additional patients at the highest tolerable dose found in Part 1 in order to get more information on side effects and make sure the dose is tolerable

Once an MTD is determined for Strata A or B, if the Study Principal Investigator determines that the study treatment should not be further pursued due to safety or enrollment barriers, the expansion Part or the study will be discontinued.

Carfilzomib in Combination With Cyclophosphamide and Etoposide for Children

Phase I Study of Carfilzomib in Combination With Cyclophosphamide and Etoposide for Children With Relapsed and Refractory Solid Tumors and Leukemias

Pediatric Oncology Experimental Therapeutics Investigators' Consortium

Amgen

Stanford University

Principal Investigator

Drug: KSX01 injection individualization TCR-T cell injection

KSX01-TCRT injection

KSX01-TCRT Injection Project in Solid Tumors

IIT Clinical Trial on Tolerance, Safety, and Preliminary Efficacy of KSX01-TCRT Injection in Solid Tumor Subjects

Immune System Diseases

Rare Diseases

Lymphoma

Lymphoma, Non-Hodgkin

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Sequential cohorts of participants will receive escalating doses of KB-0742.

Following identification of the contingent recommended Phase 2 dose (RP2D) in Part 1, the following expansion cohorts will be enrolled:

Cohort A: Participants with R/R non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), and ovarian cancer.

Cohort B: Participants with R/R small cell lung cancer (SCLC), NUT midline carcinomas (NMC), adenoid cystic carcinoma (ACC), chordoma and soft tissue sarcomas associated with transcription factor fusion.

KB-0742

Director of Clinical Operations

Part 1: Dose Escalation. The primary objective of Part 1 of this study is to evaluate the safety and tolerability of KB-0742 in participants with relapsed or refractory (R/R) solid tumors or non-Hodgkin lymphoma (NHL).

Part 2: Cohort Expansion. The primary objective of Part 2 of this study is to further evaluate the safety and tolerability of KB-0742 in defined participant cohorts.

A Dose Escalation and Cohort Expansion Study of KB-0742 in Participants With Relapsed or Refractory Solid Tumors or Non-Hodgkin Lymphoma

Phase 1, First-in-human, Open-label Dose Escalation and Cohort Expansion Study of KB-0742 in Patients With Relapsed or Refractory Solid Tumors or Non-Hodgkin Lymphoma

Type, incidence, severity, causality and outcome of adverse events (AEs), including serious AEs and AEs at Grade 3 or above, based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.

Kronos Bio

Topotecan

Topoisomerase I Inhibitors

Two courses of cyclophosphamide at 50 mg/m2/dose and topotecan 0.8 mg/m2/dose by mouth every morning for 14 days each.

Cyclophosphamide and Topotecan

Daniel C Bowers, MD

The purposes of this study include:

* Determination of the change in clearance of topotecan and topotecan lactone between day 1 and day 14 for patients receiving treatment with p.o. topotecan and p.o. cyclophosphamide x 14 days.
* Determination of the correlation between the activity of CYP3A4, as measured by the 14C- Erythromycin Breath Test (ERMBT), and topotecan/topotecan lactone clearance for patients receiving treatment with p.o. topotecan and p.o. cyclophosphamide x 14 days.
* Determination of the response rate to oral cyclophosphamide and oral topotecan in recurrent and/or refractory pediatric solid tumors.
* Obtain additional safety data for the chemotherapy regimen, p.o. topotecan and p.o. cyclophosphamide x 14 days.
* Report the frequency of severe toxicities associated with the level of CYP3A4 activity, as measured by the ERMBT, for patients receiving treatment with p.o. topotecan and p.o. cyclophosphamide x 14 days.

Upon obtaining informed consent, patients will begin two courses of oral cyclophosphamide and topotecan x 14 days. During the first of two courses, patients will perform the 14C-Erythromycin Breath Test and have topotecan pharmacokinetics performed on day 1 and 14. The subjects will also have various medical tests and procedures performed that are part of regular cancer care which include: Medical history and physical examination to be done weekly, blood tests to be done weekly, heart and kidney function tests, various scans to be done after two courses of treatment, and a pregnancy test for females of childbearing age to be done prior to starting treatment.

Patients may continue to receive additional courses of oral cyclophosphamide and topotecan provided that they do not experience tumor progression or intolerable side effects.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
KSH01-TCRT Solid Tumors	NCT05539833	TCR-T Cells Refractory Soli... Relapsed Solid ...	KSH01 injection	18 Years - 70 Years	TCRx Therapeutics Co.Ltd
Single Arm Clinical Study on the Safety and Efficacy of Personalized KSX01-TCRT in Patients With Advanced Solid Tumors	NCT06150365	Refractory Soli... Relapsed Solid ...	KSX01-TCRT cell...	18 Years - 70 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study of PYX-106 in Solid Tumors	NCT05718557	Solid Tumor	PYX-106	18 Years -	Pyxis Oncology, Inc
Carfilzomib in Combination With Cyclophosphamide and Etoposide for Children	NCT02512926	Relapsed Solid ... Refractory Soli... Relapsed Leukem... Refractory Leuk...	Carfilzomib Cyclophosphamid... Etoposide	6 Months - 29 Years	Stanford University
KSX01-TCRT Injection Project in Solid Tumors	NCT05811975	TCR-T Cells Refractory Soli... Relapsed Solid ...	KSX01-TCRT inje...	18 Years - 70 Years	TCRx Therapeutics Co.Ltd
KSX01-TCRT Injection Project in Solid Tumors	NCT05811975	TCR-T Cells Refractory Soli... Relapsed Solid ...	KSX01-TCRT inje...	18 Years - 70 Years	TCRx Therapeutics Co.Ltd
A Dose Escalation and Cohort Expansion Study of KB-0742 in Participants With Relapsed or Refractory Solid Tumors or Non-Hodgkin Lymphoma	NCT04718675	Relapsed Solid ... Refractory Soli... Non-Hodgkin Lym...	KB-0742	12 Years -	Kronos Bio
A Dose Escalation and Cohort Expansion Study of KB-0742 in Participants With Relapsed or Refractory Solid Tumors or Non-Hodgkin Lymphoma	NCT04718675	Relapsed Solid ... Refractory Soli... Non-Hodgkin Lym...	KB-0742	12 Years -	Kronos Bio
A Pharmacokinetic Study of Oral Cyclophosphamide and Topotecan in Children With Recurrent Solid Tumors	NCT00628732	Solid Tumors	Cyclophosphamid...	- 21 Years	Children's Medical Center Dallas

Spots Global Cancer Trial Database for relapsed solid tumors