NCT07532018

DXP-106 in Solid Tumor Patients.

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of DXP-106 as Monotherapy or in Combination With Standard of Care Chemotherapy in Patients With Advanced Solid Tumors.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Singlomics Biopharmaceuticals Zhuhai Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

To accurately assess DLT, DLT-evaluable subjects are defined as one who meets any of the following criteria during the DLT evaluation period: 1. The patient experiences a DLT at any time after DXP-106 infusion during the DLT observation period. 2. The patient completes at least 75% of the planned total dose of DXP-106 infusion during the DLT evaluation period and have fulfilled the safety evaluation requirements during the DLT observation period. For Part 1 (monotherapy dose escalation) and Part 2 (combination therapy dose escalation) of this study, patients who discontinue prior to completion of the DLT evaluation period in the first cycle after the first dose for reasons other than DLT, or who do not meet any of the above criteria, will be considered non-evaluable for DLT. Subjects who are not evaluable for DLT due to non-DLT reasons will be replaced, leading to an increase in the actual sample size.

Conditions

• Solid Tumor
• Cancer

Interventions

Type	Name	Description
DRUG	DXP-106	DXP-106 as monotherapy or in combination with standard of care chemotherapy

Timeline

• Start date: 2026-03-23
• Primary completion: 2028-02-01
• Completion: 2028-03-01
• First posted: 2026-04-15
• Last updated: 2026-04-15

Locations

3 sites across 1 country: China