TSN084 Treating Patients With Advanced Malignant Tumors

NCT06386705 | Recruiting Phase 1

• 1 other identifier: TSN084-101CH
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 2

Brief Summary

TSN084 is a novel type II kinase inhibitor with demonstrated anti-tumor effects in vitro and in vivo and targets multiple tyrosine kinases, such as c-MET, FLT3, TRK and serine/threonine kinase CDK8/19. This phase 1a/1b study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of TSN084 in advanced or metastatic malignancies in China.

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (2)

• Dose limiting toxicity (DLT)

  Number of patients with dose limiting toxicity, to determine the MTD and/or RP2D

  28 days

• Incidence of Treatment-Emergent Adverse Events (TEAE)

  Incidence of TEAE, Serious Adverse Event (SAE), their relationship with the investigational product and severity. Adverse events will be graded according to NCI-CTCAE V5.0.

  Up to 3 years

Secondary Outcomes (9)

• Maximum plasma concentration (Cmax)

  28 days

• Time to Cmax (Tmax)

  28 days

• Area under the concentration versus time curve from time 0 to the last measurable concentration (AUC 0-t)

  28 days

• Objective response rate (ORR)

  Up to 3 years

• Duration of response (DoR)

  Up to 3 years

Study Arms (2)

Experimental: Phase 1a

EXPERIMENTAL

Dose Escalation/Evaluation

Drug: TSN084

Experimental: Phase 1b

EXPERIMENTAL

TSN084 recommended Phase 2 dose administered to separate cohorts of patients with selected malignancies harboring mutations including but not limited to MET exon14 skipping mutation and MET amplification.

Drug: TSN084

Interventions

TSN084 DRUG

TSN084 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.

Experimental: Phase 1a; Experimental: Phase 1b

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women ≥18 years old.
• The subject fully understands the requirements of the study and voluntarily signs the written informed consent.
• Be able to comply with the medication requirements of the study and all study related procedures and evaluations; not deemed as potentially unreliable and/or uncooperative.
• Meeting the requirements of tumor types shown below. Phase Ia Study: Histological or cytological diagnosis of locally advanced, relapsed, or metastatic malignancies, not amenable to standard therapy or for which no standard therapy is available.
• Phase Ib study: Histological or cytological diagnosis of the locally advanced, relapsed, or metastatic selected malignancies not amenable to standard therapy (disease progression or intolerance), or unable to receive standard therapy/no standard therapy is available. Malignancies with targeted mutations are preferred, including but not limited to MET exon 14 skipping mutation and MET amplification.
• Survival expectations are ≥ 12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 for Phase Ia, while 0 to 2 for Phase Ib.
• Patients with adequate organ function at the time of screening.
• Male and female patients of childbearing potential must agree to use effective methods of contraception.

You may not qualify if:

• Patients with active brain metastases, except that their central nervous system (CNS) tumor metastases are confined to the supratentorial or cerebellum, have been adequately treated (surgery or radiotherapy), have maintained radiographic stability for at least 4 weeks, and do not require corticosteroids to control symptoms.
• Other malignancies (other than non-melanoma basal cell carcinoma or squamous cell carcinoma of the skin, breast/cervical carcinoma in situ, superficial bladder carcinoma that have received radical treatment and no evidence of disease recurrence) within 5 years prior to initiation of TSN084 treatment;
• Any arterial thromboembolic event, including myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack, occurred within 6 months prior to enrolment;
• Uncontrolled third space effusion requiring repeated drainage, such as pleural effusion, ascites, pericardial effusion, etc. (Patients who do not need drainage effusion or have no significant increase in effusion after 3 days of cessation of drainage can be included).
• Has active gastrointestinal disease or other disease, or other factors such as surgical resection that may significantly affect drug absorption, metabolism, or excretion.
• Pregnant or lactating women.
• Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
• HIV infected patients (HIV 1/2 antibody positive).
• Known active syphilis infection, or active tuberculosis.
• A history of drug abuse or drug use.

Sponsors & Collaborators

• Tyligand Bioscience (Shanghai) Limited: lead

Study Sites (2)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Peking university cancer hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jie Wang, MD, PhD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tyligand Clinical Trial Info

CONTACT

+86-021-50720081; clinical_trial@tyligand.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 26, 2024
• Study Start: July 20, 2022
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)