NCT07532018 DXP-106 in Solid Tumor Patients.

Trial Parameters

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

Brief Summary

The goal of this clinical trial is to evaluate the safety and tolerability of DXP-106 in Chinese patients with advanced solid tumors. The main questions it aims to answer are: For Part I: 1. The safety and tolerability of DXP-106 monotherapy in patients with advanced solid tumors; 2. The dose-limiting toxicities (DLTs) and determine the maximum tolerated dose (MTD) and/or the recommended Phase II dose (RP2D); 3. The pharmacokinetics (PK) profile, the immunogenicity of DXP-106 following administration in patients with advanced solid tumors; 4. The preliminary efficacy of DXP-106 in patients with advanced solid tumors; 5. The pharmacodynamic (PD) profiles of DXP-106 following administration in patients with advanced solid tumors as exploratory objective; For Part2: 1. The safety and tolerability of DXP-106 in combination with standard of care chemotherapy in patients with advanced solid tumors; 2. The recommended dose of DXP-106 in combination with standard of care chemotherapy and/or potential responsive tumor types; 3. The efficacy of DXP-106 in combination with standard of care chemotherapy in patients with advanced solid tumors; 4. The PK profile and immunogenicity of DXP-106 in combination with standard of care chemotherapy in patients with advanced solid tumors; 5. The PD profiles of DXP-106 in combination with standard of care chemotherapy in patients with advanced solid tumors. The dose escalation is designed with five cohorts, including Cohort 1 (1.0 mg/kg), Cohort 2 (2.0 mg/kg), Cohort 3 (4.0 mg/kg), Cohort 4 (6.0 mg/kg), and Cohort 5 (8.0 mg/kg) in part 1. Each treatment cycle consists of 4 weeks, with administration once weekly (QW) in the first cycle and once every two weeks (Q2W) in subsequent cycles. Treatment will continue until disease progression, unacceptable toxicity, death, loss to follow-up, withdrawal of consent, or discontinuation due to other reasons. Based on the continuously obtained data from Part 1 monotherapy dose escalation, the Part 2 combination therapy exploration will be scheduled to commence. The combination therapy dose-escalation is planned to include three dose levels, tentatively designated as Dose Level 1 (DL1), DL2, and DL3 in PDAC patients. Dose escalation will follow the "traditional 3+3" rule, proceeding sequentially from DL1 to DL3. Safety Review Committee (SRC) will determine whether to proceed with escalation to higher doses based on available data, including but not limited to safety, tolerability, PK/PD, and preliminary efficacy. The SRC will discuss and make appropriate decisions when any other unanticipated circumstances occur during the clinical trial.

Eligibility Criteria

Inclusion criteria: * Participants who fully understand the trial objectives, nature, procedures, and potential adverse reactions, and who voluntarily agree to participate in the study and provide signed informed consent. * Patients aged 18 to 75 years (inclusive, based on the date of signing the informed consent form), both male and female. * Measurable disease as assessed by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST criteria within 4 weeks prior to screening. * Study Population * Part 1: Patients with histologically or cytologically confirmed locally advanced or metastatic solid tumors who are ineligible for surgery or curative radiotherapy and have experienced disease progression after standard treatment or are intolerant to such therapy. Target tumor types include but are not limited to colorectal cancer, pancreatic ductal adenocarcinoma (PDAC), head and neck squamous cell carcinoma, lung cancer (LC), Ewing sarcoma (ES), and triple-negative breast canc

Related Trials