/ Enrolling by invitationPhase 1 A Phase I, Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Sequential Treatment With P1101 and P1801 in Patients With Advanced Solid Tumors
The goal of this clinical trial is to learn the safety of sequential treatment with P1101 and P1801 in advanced solid tumors. It will also learn the maximum tolerated dose (MTD) of P1801. The main questions it aims to answer are:
To evaluate the safety and tolerability of sequential treatment with P1101 and P1801 in patients with advanced solid tumors.
To determine the maximum tolerated dose (MTD) of P1801.
Participants will:
Ttreated by 6 doses of P1101 once per 2 weeks (Q2W) at 450 mcg and then followed by the treatment with P1801 Q2W at the pre-determined dose level by cohort during each 28-day treatment cycle in the Dose Escalation Phase (Cohort 1-5).
Once the MTD have been declared and for further characterize safety and clinical activity, additional patients with RCC or CRC will be enrolled into the tumor-specific expansion cohorts to receive the sequential administration of 6 doses of P1101 Q2W at 450 ug followed by P1801 Q2W at MTD.
Patients will visit the clinic every two weeks during the treatment period for drug administration and physical examinations.
All patients must complete the safety follow-up visits at the 30-, 90-, and 150-day after the last dose of study treatment.
Upon completion of the safety follow up, patients will be followed for survival every 12 weeks until death or until the end of the study is reached, unless they withdraw consent or are lost to follow-up.
A Phase I Open-label Dose-finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of LXP1788 Injection in Patients with Advanced Solid Tumors.
A Phase I, open-label, first-in-human study to determine the MTD, recommended phase 2 dose (RP2D), assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of LXP1788 Injection in patients with advanced solid tumor.
Patients with advanced solid tumors that are refractory to currently available therapies or for whom no effective treatment is available will be selected.
The main questions it aims to answer are:
1. To determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of LXP1788 Injection
2. To evaluate the pharmacokinetics (PK) of LXP1788 Injection
Phase 2 Study of Orally Administrated JBM-TC4 for the Prevention of Acute Radiation-induced Dermatitis in Breast Cancer Patients
This trial is designed as a multicenter, double-blinded, randomized, placebo controlled study to assess the safety and efficacy of JBM-TC4 for the prevention and treatment of acute radiation-induced dermatitis in breast cancer patients receiving radiotherapy.
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