DXP-106 in Solid Tumor Patients. (DXP-106)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Solid Tumor
• Intervention / Treatment: Drug: DXP-106

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.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Mingli Guo ML Guo, Master; Phone Number: 86-010-80765087; Email: mingli.guo@singlomics.com
• Study Contact Backup: Name: Huilian HL Zeng, Bachlor; Phone Number: China: 86-010-80765087; Email: huilian.zeng@singlomics.com

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Not yet recruiting
      • Harbin Medical University Cancer Hospital
      • Contact: GCP officer; Phone Number: +86-0451-86298162; Email: hmuccgcp@163.com
      • Principal Investigator: Tongsen TS Zheng, Doctor
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Recruiting
      • Zhongshan Hospital, Fudan University
      • Contact: Yingzhi YZ GCP officer; Phone Number: +86-021-31587852; Email: lcsyjg@zs-hospital.sh.cn
      • Principal Investigator: Tianshu TS Liu, Doctor
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Not yet recruiting
      • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
      • Contact: Yingzhi YZ Fang; Phone Number: +86-0571-86006987; Email: gengweiran@foxmail.com
      • Principal Investigator: Yong Fang, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 cancer (TNBC).

  • Part 2: If the participant received adjuvant/neoadjuvant therapy before or after completing prior curative treatment, and the participant's disease has recurred, the interval between the end of adjuvant/neoadjuvant therapy and the first dose in this study must exceed 6 months.

    • LC patients: Patients with locally advanced/metastatic lung cancer confirmed by histology or cytology, who relapsed after first-line treatment and must meet the criteria for receiving platinum-based chemotherapy as first-line or second-line standard treatment;
    • PDAC Patients: Patients with newly diagnosed histologically or cytologically confirmed, unresectable or radiotherapeutically ineligible locally advanced or metastatic PDAC, who have not received previous treatment and are eligible for standard of care chemotherapy regimens.
    • ES patients: Patients with pathologically confirmed unresectable or locally advanced or metastatic Ewing's sarcoma that has failed standard treatment, and a detailed pathological report must be provided. Patients have received at least 1 but no more than 2 lines of systemic therapy previously, and must be eligible for standard chemotherapy regimens.
    • TNBC patients (for patients with bilateral breast cancer, both sides must be TNBC): Patients with histologically or cytologically confirmed, inoperable locally advanced or metastatic breast cancer, with ER, PR, and HER-2 all negative. The definition of ER and PR negativity is: IHC ER < 1%, IHC PR < 1%. The definition of HER-2 negativity is: IHC HER-2 (-) or (1+); for those with HER-2 (2+), FISH testing must be performed and the result must be negative. Patients must be eligible for standard chemotherapy regimens;
• Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1.
• Life expectancy > 3 months.

• Adequate organ function meeting the following criteria:

  • Hematology (without transfusion, hematopoietic growth factors, or medication to correct blood cell counts within 14 days prior to first dose): absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, hemoglobin ≥ 9.0 g/dL.
  • Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × upper limit of normal (ULN) (for patients not receiving anticoagulant therapy); patients on oral anticoagulants with an INR between 2 and 3 were eligible.
  • Hepatic function: Total bilirubin (TBIL) ≤ 1.5 × ULN ); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN.
  • Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance > 50 mL/min (calculated using the Cockcroft-Gault formula).
• Both female and male patients of reproductive potential must have agreed to use reliable contraceptive methods during the trial and for 6 months after the last dose.

Exclusion criteria

• Participants with a history of hypersensitivity, particularly those allergic to the investigational drug or its excipients, or those who have previously experienced severe allergic reactions to macromolecular protein preparations/monoclonal antibodies.
• Participants who have received live vaccines, etanercept or other TNF-α inhibitors, or any other investigational drug during or prior to participation in this study (within 4 weeks before the first dose of the investigational drug or within 5 half-life of the investigational drug, whichever is longer).
• In Part 2, LC patients have received other anti-tumor drug treatments in addition to first-line treatment medications; patients with gene mutations that can be used as targets for targeted therapy (including but not limited to EGFR, ALK, ROS, KRAS) (excluding patients who have progressed on standard targeted therapy and whose next-line standard treatment is a platinum-based dual-drug regimen).
• The toxicity from previous treatments has not alleviated to the level specified in the inclusion/exclusion criteria of NCI CTCAE ≤ Grade 1 (except for alopecia and pigmentation).
• Presence of other active malignancies besides the primary tumor within the past 5 years. Excluding participants who have been cured through radical treatment, such as basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix, or carcinoma in situ of the breast, etc.
• History of active autoimmune disease requiring systemic immunosuppressive therapy, including but not limited to systemic lupus erythematosus, psoriasis, etc.
• Active infection requiring treatment or unexplained body temperature >38.5°C during the screening period.
• Major surgery, cytotoxic chemotherapy, immunotherapy, or biologic therapy within 4 weeks prior to the first dose of the investigational drug.
• Prior cell therapy within 3 months before the first dose of the investigational drug.
• Immunocompromised individuals requiring systemic treatment.
• Patients with significant cardiovascular diseases (e.g., congestive heart failure, unstable angina, atrial fibrillation, arrhythmias, uncontrolled hypertension, etc.) : history of acute myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months prior to enrollment; congestive heart failure classified as New York Heart Association (NYHA) Class ≥ III; left ventricular ejection fraction (LVEF) < 50%; congenital long QT syndrome; or any other clinically significant cardiac condition.
• Presence of severe pulmonary diseases at screening, such as pulmonary embolism or interstitial lung disease.
• Central nervous system (CNS) metastasis or meningeal metastasis with clinical symptoms, or other evidence that such metastases have not been controlled, and the investigator judges it to be unsuitable for inclusion;
• Positive syphilis antibody test; active HIV-related opportunistic infection; active hepatitis B or hepatitis C; Active HBV is defined as positivity for HBsAg or HBcAb with HBV DNA above the central laboratory upper limit of reference (i.e., above the lower limit of detection); participants who are HBsAg-positive or HBcAb-positive but have HBV DNA below the lower limit of detection may be included if they have received stable and effective antiviral therapy for at least 2 weeks prior to enrollment and have normal liver function; Active HCV is defined as positivity for HCV RNA (HCV RNA test result above the lower limit of detection).
• History of allogeneic tissue/solid organ transplantation requiring immunosuppressive therapy.
• Patients who experienced immune-related toxicity during prior antitumor immunotherapy and permanently discontinued treatment as a result.
• Severe hereditary or acquired bleeding tendency or coagulation disorder.
• Inability to undergo venipuncture and/or tolerate venous access.
• Pregnant or lactating women.

• Before the first administration of the study drug, the washout period for previous systemic anti-tumor treatments is insufficient, including:

  • Chemotherapy < 3 weeks, except for oral fluorouracil (such as tegafur and capecitabine), which requires 2 weeks or within 5 half-lives before the first administration, whichever is shorter;
  • Small molecule targeted therapy < 2 weeks or 5 half-lives, whichever is shorter;
  • Antibody therapy (including ADC) or biological therapy < 3 weeks;
  • Chinese herbal medicines with anti-tumor indications or non-specific immunomodulators (such as thymosin, interferon, interleukin, and traditional Chinese medicines with clear immunomodulatory indications, etc.) < 2 weeks.
• Any other condition considered by the investigator as potentially affecting the participant's ability to provide informed consent or comply with the trial protocol, or that may influence the trial results or participant safety.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: DXP-106; The study includes Part 1 (monotherapy dose escalation) and Part 2 (combination therapy dose escalation). In Part 1, five cohorts are planned. The first cohort is expected to enroll approximately 1 to 6 patients, and the remaining cohorts are planned to enroll approximately 3 to 6 patients each. In Part 2, the PDAC, LC, TNBC, EWS tumor types are tentatively selected, with approximately 3-6 patients planned for enrollment. Backfilling may be considered at dose levels in some indications deemed safe and demonstrating efficacy signals, with approximately 6-12 subjects to be enrolled via backfilling. A total of approximately 24 subjects are expected to be enrolled in Part 2. Overall, the study plans to enroll approximately 40 to 54 subjects.

Drug: DXP-106; DXP-106 as monotherapy or in combination with standard of care chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose-limiting toxicities (DLTs) within the first cycle of administraton of DXP-106	The severity of adverse events will be assessed and graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 6.0 (United States). A DLT is defined as any of the following adverse events occurring during the first cycle (starting from the first intravenous infusion of DXP-106, including priming dose if any) in either Part 1 (monotherapy dose escalation) or Part 2 (combination therapy dose escalation), including but not limited to: hematologic Toxicity; hepatic toxicity; other Grade ≥3 non-Hematologic toxicity; delays in subsequent treatment cycles exceeding 14 days due to persistent toxicity; any death clearly unrelated to the underlying disease or external causes.	From the first administration of DXP-106 on Cycle1Day1, including priming dose if any to the end of cycle1, assessed up to 4 weeks.
Adverse events(AE) and serious adverse events(SAE)	It will be assessed by the frequency, severity and nature of AEs, serious adverse event (SAE), changes in vital signs, physical examination, 12-lead ECG, infusion-related reactions and laboratory tests (haematology, serum chemistry, and urine), etc. The severity of AEs will be graded by the NCI CTCAE version 6.0 and the AE terms will be coded by the current version of the Medical Dictionary for Regulatory Activities (MedDRA).	From first administration of DXP-106 to safety follow up completion, assessed up to 13 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exposure levels of DXP-106 when administered in participants (Pharmacokinetics)	PK collected from all participants receiving DXP-106 within 1 hour before the start of infusion, immediately after the end of infusion, 3 hours, 6 hours, 24 hours and 48 hours after the start of infusion on Cycle1Day1 and Cycle2Day1; 168 hours after the start of first infusion; within 1 hour before infusion and immediately after the end of infusion on Cycle1Day8, Cycle1Day15,Cycle1Day22, Cycle2Day15 and each administration in Cycle 3 and 4. For cycle 6 and beyond, PK samples should be collected within 1 hour before administration and end of treatment.	From the first administration of DXP-106 to the end of treatment, assessed up to 12 months.
Anti-drug antibodies (ADAs) against DXP-106 (Immunogenicity)	Blood samples will be collected from all participants in this study at the following time points to detect ADA and neutralizing antibodies (Nab, if applicable) for immunogenicity evaluation. The blood time points include: within 1 hour prior to infusion on Cycle1Day1, Cycle1Day15, Cycle1Day22 (only for Part 1 monotherapy escalation and Part 2 PDAC patients; cycles of 4 weeks); within 1 hour prior to each infusion in Cycle 2; within 1 hour prior to infusion on Cycle6 Day1and beyond, D1 (every 4 cycles ± 1 cycle) and at the end of treatment (EOT). The timing of immunogenicity blood sample collection may be appropriately adjusted based on accumulating human immunogenicity data.	From the first administration of DXP-106 to the end of treatment, assessed up to 12 months.
Objective response rate (ORR)	Tumor response is assessed according to Response Evaluation Criteria for Solid Tumors (RECIST) version 1.1 as per investigators' assessment. ORR is defined the proportion of patients who receive at least one dose of treatment and have measurable disease and is assessed as complete response (CR) or partial response (PR) during study treatment.	From date of first administration until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months.
Disease Control Rate (DCR)	DCR is defined as the proportion of patients who is assessed as CR, PR, or stable disease (SD), where SD must be maintained for at least 4 weeks from the first documentation. DCR = (CR + PR + SD [≥4 weeks]) / total number of evaluable patients for efficacy × 100%;	From date of first administration until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months.
Overall Survival (OS)	OS is defined as the time from the date of treatment to the date of death from any cause.	survival follow-up will be conducted once every 12 weeks (±4 weeks) after end of treatment visit until death, withdrawal of informed consent, loss to follow-up, or the data cutoff date, whichever comes first. assessed up to 12 months.
Progression-Free Survival (PFS)	PFS according to RECIST v1.1 as per the investigator's assessment. It is defined as the time from the date of treatment to the date of progressive disease (PD) or death from any cause, whichever occurs first.	From date of first administration until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months.
Duration of Response (DoR)	DoR assessed according to RECIST v1.1, is defined as the time from the date of first documentation of overall response (CR or PR) to the date of first documented progressive disease (PD), or death from any cause, whichever occurs first. Calculated only for patients whose best overall efficacy is CR or PR.	From date of first administration until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacodynamic (PD) after DXP-106 administration	All participants in this study will have blood samples collected at the following time points for PD analysis. Peripheral blood sample collection time points for receptor occupancy of IL-1RAP on monocytes and neutrophils: Within 1 hour before the start of infusion, immediately after the end of infusion, 6 hours, 24 hours after the start of infusion on Cycle1Day1; within 1 hour before the start of infusion and immediately after the end of infusion for each subsequent dose in Cycle 1 and each dose in Cycle 2 to measure receptor occupancy of IL-1RAP on monocytes and neutrophils in peripheral whole blood.	From the first administration of DXP-106 to the end of cycle2, assessed up to 8 weeks.

Collaborators and Investigators

• Sponsor: Singlomics Biopharmaceuticals Zhuhai Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: cancer; solid tumor; phase I; DXP-106
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: DXP-106-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data will be made available to researchers whose proposed research aims are consistent with the study objectives, following publication of the primary results in an ICMJE-approved journal, after approval by the study sponsor/investigator and upon reasonable request.
• IPD Sharing Time Frame: Mar 2028-Dec 2028
• IPD Sharing Access Criteria: De-identified individual participant data will be accessible to qualified researchers following publication in an ICMJE journal, after review of a research proposal and execution of a data use agreement. Access will be provided via reasonable request to the study sponsor or principal investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No