Actively Recruiting
DXP-106 in Solid Tumor Patients.
Led by Singlomics Biopharmaceuticals Zhuhai Co., Ltd. · Updated on 2026-04-15
54
Participants Needed
3
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
DXP-106 in Solid Tumor Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 75 years who understand the study and consent to participate
- Measurable disease confirmed by CT or MRI within 4 weeks prior to screening
- Histologically or cytologically confirmed advanced or metastatic solid tumors not eligible for surgery or curative radiotherapy
- Patients with disease progression after standard treatment or intolerance to such therapy
- Specific tumor types include colorectal cancer, pancreatic ductal adenocarcinoma, head and neck squamous cell carcinoma, lung cancer, Ewing sarcoma, and triple-negative breast cancer
- ECOG performance status of 0 or 1
- Life expectancy greater than 3 months
- Adequate organ function as defined by blood counts, coagulation, liver and kidney function criteria
- Agreement to use reliable contraception during the trial and for 6 months after last dose
You will not qualify if you...
- History of hypersensitivity or severe allergic reactions to the study drug or similar proteins
- Use of live vaccines, TNF-alpha inhibitors, or investigational drugs within 4 weeks prior to study drug
- Lung cancer patients who received other anti-tumor drugs beyond first-line treatment or have targetable gene mutations (unless progressed on standard targeted therapy)
- Toxicity from prior treatments not resolved to Grade 1 or lower (except alopecia and pigmentation)
- Other active malignancies within 5 years except certain treated cancers
- Active autoimmune diseases requiring immunosuppressive therapy
- Active infections or fever above 38.5°C
- Major surgery or cytotoxic/immunologic therapy within 4 weeks before study drug
- Prior cell therapy within 3 months before study drug
- Immunocompromised patients needing systemic treatment
- Significant cardiovascular or severe pulmonary diseases
- Uncontrolled central nervous system metastases
- Positive for active hepatitis B or C, active HIV infection
- History of allogeneic transplant needing immunosuppression
- Prior immune-related toxicity requiring treatment discontinuation
- Severe bleeding or coagulation disorders
- Pregnant or breastfeeding women
- Insufficient washout period from prior systemic anti-tumor treatments
- Any condition impairing consent or compliance or affecting safety or study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
2
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
3
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310009
Not Yet Recruiting
Research Team
M
Mingli Guo ML Guo, Master
CONTACT
H
Huilian HL Zeng, Bachlor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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