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Clinical Trials associated with SYS-6090Open-Label, Multicenter Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of JMT108 Injection in Participants With Unresectable or Metastatic Melanoma
This is an open-label, multicenter Phase I/II clinical study conducted in participants with unresectable locally advanced or metastatic melanoma, aiming to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of JMT108 Injection in this population. The study consists of Phase I and Phase II (including Phase IIa and Phase IIb), where Phase I is the dose-escalation stage, Phase IIa is the dose-expansion stage, and Phase IIb is the cohort-expansion stage.
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of JMT108 Injection in Participants With Advanced Malignant Tumors
The goal of this clinical trial is to test JMT108, a type of drug called a bispecific antibody in adult patients with locally advanced or metastatic solid tumors.
The main questions it aims to answer are:
* To assess the safety and tolerability of JMT108 at increasing doses and determine the dose and schedule to be used in the second part of the study (Phase 1a)
* To assess effectiveness of JMT108 in participants with locally advanced or metastatic tumors (Phase 1b)
* To evaluate how quickly JMT108 is metabolized by the body (pharmacokinetics or PK)
* To evaluate if antibodies to the study drug develop (immunogenicity)
* To evaluate preliminary efficacy to the drug
* To explore the pharmacodynamic (PD) characteristics of JMT108
* To explore the correlation between biomarker levels and preliminary efficacy
Participants will:
* Provide written informed consent
* Undergo screening tests to ensure they are eligible for study treatment
* Attend all required study visits and receive JMT108 by intravenous injection every 2 weeks until the study doctor determines study treatment should be stopped, based on how well a participant is doing on treatment
* Be followed for progression every 3 months for up to 2 years
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of JMT108 Injection in Participants With Advanced Malignant Tumors.
This study is designed as an open-label, multi-center Phase 1 clinical study in participants with advanced malignant tumors to evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor activity of JMT108 injection, and to determine the RP2D/schedule for subsequent studies.
100 Clinical Results associated with SYS-6090
100 Translational Medicine associated with SYS-6090
100 Patents (Medical) associated with SYS-6090
100 Deals associated with SYS-6090