DXP-106 in Solid Tumor Patients.

NCT07532018 | Recruiting Phase 1

• 1 other identifier: DXP-106-101
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 4

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. 1.The safety and tolerability of DXP-106 monotherapy in patients with advanced solid tumors;
2. 2.The dose-limiting toxicities (DLTs) and determine the maximum tolerated dose (MTD) and/or the recommended Phase II dose (RP2D);
3. 3.The pharmacokinetics (PK) profile, the immunogenicity of DXP-106 following administration in patients with advanced solid tumors;
4. 4.The preliminary efficacy of DXP-106 in patients with advanced solid tumors;
5. 5.The pharmacodynamic (PD) profiles of DXP-106 following administration in patients with advanced solid tumors as exploratory objective;
6. 6.The safety and tolerability of DXP-106 in combination with standard of care chemotherapy in patients with advanced solid tumors;
7. 7.The recommended dose of DXP-106 in combination with standard of care chemotherapy and/or potential responsive tumor types;
8. 8.The efficacy of DXP-106 in combination with standard of care chemotherapy in patients with advanced solid tumors;
9. 9.The PK profile and immunogenicity of DXP-106 in combination with standard of care chemotherapy in patients with advanced solid tumors;
10. 10.The PD profiles of DXP-106 in combination with standard of care chemotherapy in patients with advanced solid tumors.

Conditions

Solid Tumor; Cancer

Keywords

DXP-106; solid tumor; cancer; phase I

Outcome Measures

Primary Outcomes (2)

• 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 4 weeks following C1D1 administration.

• 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 Outcomes (7)

• Exposure levels of DXP-106 when administered in participants (Pharmacokinetics)

  From the first administration of DXP-106, including priming dose if any, to the end of treatment, assessed up to 12 months.

• Anti-drug antibodies (ADAs) against DXP-106 (Immunogenicity)

  From the first administration of DXP-106, including priming dose if any, to the end of treatment, assessed up to 12 months.

• Objective response rate (ORR and iORR)

  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 and iDCR)

  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)

  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.

Other Outcomes (1)

• Pharmacodynamic (PD) after DXP-106 administration

  From the first administration of DXP-106 to the end of cycle2, assessed up to 8 weeks.

Study Arms (1)

DXP-106

EXPERIMENTAL

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

Interventions

DXP-106 DRUG

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

DXP-106

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 80 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 ≥ 75 × 109/L (part1) or platelet count ≥ 100 × 109/L (part2), 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.

You may not qualify if:

• 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/live attenuated 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).
• Presence of other active malignancies besides the primary tumor within the past 2 years, with the following exceptions: participants cured with curative-intent therapy and without evidence of recurrence, such as basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder carcinoma, papillary thyroid carcinoma, carcinoma in situ of the cervix, or breast carcinoma in situ.
• History of active autoimmune disease requiring treatment with systemic immunosuppressive agents, or participants requiring systemic immune-related therapy due to immunocompromise from any cause, including but not limited to autoimmune conditions such as systemic lupus erythematosus and active psoriasis.
• Active infection requiring intravenous treatment or unexplained body temperature \>38.5°C during the screening period.
• Major surgery 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.
• Participants with significant cardiovascular disease, defined as any of the following:
• Congestive heart failure with New York Heart Association (NYHA) Class ≥ 3; left ventricular ejection fraction (LVEF) \< 50%;
• History of acute myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months prior to enrollment;
• Malignant arrhythmias requiring pharmacotherapy, second- or third-degree atrioventricular block; congenital long QT syndrome, or prolongation of QT/QTc interval on screening electrocardiogram (QTcF: \>450 ms for males and \>470 ms for females, calculated using Fridericia's method. If QTc is abnormal, up to 3 consecutive measurements may be obtained at intervals ≤5 minutes and the average value used);
• Uncontrolled hypertension despite pharmacologic management (hypertension inadequately controlled with medications, with systolic blood pressure ≥150 mmHg and diastolic blood pressure ≥100 mmHg);
• Other cardiac abnormalities judged by the investigator to be clinically significant and likely to compromise study safety.

Sponsors & Collaborators

• Singlomics Biopharmaceuticals Zhuhai Co., Ltd.: lead

Study Sites (4)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

NOT YET RECRUITING

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

NOT YET RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Mingli Guo ML Guo, Master

CONTACT

86-010-80765087; mingli.guo@singlomics.com

Huilian HL Zeng, Bachlor

CONTACT

China: 86-010-80765087; huilian.zeng@singlomics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: April 15, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Mar 2028-Dec 2028
• 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.

Locations

CN (4)