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Solid TumorPhase 1DXP-106NCT07532018

DXP-106 in Solid Tumor Patients.

A Phase 1 study testing DXP-106 in people with Solid Tumor and Cancer, run by Singlomics Biopharmaceuticals Zhuhai Co., Ltd. at 4 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Solid Tumor, Cancer
What is being tested?
DXP-106
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
4 sitesChina
Study dates
23 Mar 2026to Mar 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Hepatic function: Total bilirubin (TBIL) ≤ 1.5 × ULN ); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; ALT and AST≤ 5.0 × ULN for patients with primary hepatocellular carcinoma (HCC) or hepatic metastases.
  • 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.

Who cannot join

  • 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).
  • The toxicity from previous treatments has not alleviated to the level specified in the inclusion/exclusion criteria or to NCI CTCAE ≤ Grade 1 (except for alopecia, pigmentation, Grade 2 peripheral neuropathy, adrenal insufficiency, and other toxicities deemed by the investigator to pose no safety risk to the participant).
  • 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.
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  • 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.
  • Presence of severe pulmonary disease at screening, such as pulmonary embolism or interstitial lung disease, with severely impaired pulmonary function as judged by the investigator.
  • Newly diagnosed brain metastases or brain metastases with central nervous system symptoms, or other evidence indicating uncontrolled metastases who are considered ineligible per investigator assessment. Participants with leptomeningeal metastases are not recommended for enrollment. Participants with brain metastases may be enrolled if they are clinically stable as assessed by the investigator following treatment and do not require steroid therapy for at least 28 days prior to the first study dose.
  • Seropositive for syphilis antibody; positive HIV test; presence of active hepatitis B [Active hepatitis B (HBV) is defined as positive HBsAg or positive HBcAb with HBV DNA greater than the upper limit of the site reference range (i.e., above the lower limit of detection). If HBV DNA is positive (above the lower limit of detection), participants may receive anti-HBV antiviral therapy and may be rescreened. Participants may be enrolled if HBV DNA falls below the lower limit of detection after treatment.] or active hepatitis C [Active hepatitis C is defined as positive HCV RNA (HCV RNA level 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;
  • Traditional Chinese 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.
  • Definitive radiotherapy < 4 weeks, limited-field local palliative radiotherapy < 2 weeks.
  • Endocrine anti-tumor therapy or small-molecule immunotherapy < 2 weeks or 5 half-lives, whichever is shorter.
  • 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.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

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

China4 sites, 4 recruiting

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

    Hangzhou, Zhejiang, 310009

    Yingzhi YZ Fang, +86-0571-86006987, gengweiran@foxmail.com

    Yong Fang, Doctor

    Not yet recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

    GCP officer, +86-0451-86298162, hmuccgcp@163.com

    Tongsen TS Zheng, Doctor

    Recruiting

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

    Yingzhi YZ GCP officer, +86-021-31587852, lcsyjg@zs-hospital.sh.cn

    Tianshu TS Liu, Doctor

    Recruiting

  • The First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

    Yusheng Wang, Doctor

    Not yet recruiting

Other trials in China

About this study

Official title: 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:

Read more
  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.

Read the 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
Being tested
DXP-106
Keywords
DXP-106, solid tumor, cancer, phase I
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DXP-106Drug

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

Study groups in NCT07532018
Study groupRoleWhat they receive
DXP-106ExperimentalThe 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.
Receives: Drug: DXP-106

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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.

  2. 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).

    Measured: From first administration of DXP-106 to safety follow up completion, assessed up to 13 months.

Secondary outcomes (7)

  1. 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, 6 hours after priming dose if any; within 1 hour before the start of infusion on Cycle1Day1 and Cycle2Day1, immediately after the end of infusion, 3 hours, 6 hours, 24 hours (Cycle1Day2 and Cycle2Day2) and 48 hours (Cycle1Day3 and Cycle2Day3) after the start of infusion ; 168 hours (within 1 hour before infusion on Cycle1Day8 and Cycle2Day8); immediately after the end of infusion on Cycle1Day8; within 1 hour before the start of infusion, immediately after the end of infusion on Cycle1Day15, Cycle1Day22, Cycle2Day15, each administration in Cycle 3 and 4; within 1 hour before administration on cycle 6 and every 4 cycles beyond and end of treatment visit.

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

  2. 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 priming dose if any, Cycle1Day1, Cycle1Day15, Cycle1Day22 (only for Part 1 monotherapy escalation and Part 2 PDAC patients; 4-week cycle); 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.

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

  3. Objective response rate (ORR and iORR)

    Tumor response is assessed according to Response Evaluation Criteria for Solid Tumors (RECIST) version 1.1 and iRECIST as per investigators' assessment. ORR/iORR 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/iCR) or partial response (PR/iPR) during study treatment. ORR/iORR = (Number of patients achieving CR/iCR + Number of patients achieving PR/iPR) / Total number of efficacy-evaluable patients × 100%

    Measured: 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.

  4. Disease Control Rate (DCR and iDCR)

    DCR is defined as the proportion of patients who is assessed as CR/iCR, PR/iPR, or stable disease (SD/iSD), where SD/iSD must be maintained for at least 6 weeks from the first documentation. DCR/iDCR = (CR/iCR + PR/iPR + SD/iSD [≥6 weeks]) / total number of evaluable patients for efficacy × 100%;

    Measured: 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.

  5. Overall Survival (OS)

    OS is defined as the time from the date of treatment to the date of death from any cause.

    Measured: 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.

  6. Progression-Free Survival (PFS) and iPFS

    PFS according to RECIST v1.1 and iRECIST as per the investigator's assessment. PFS 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. iPFS is defined as the time from the date of treatment to unconfirmed progressive disease (iUPD) or death from any cause, whichever occurs first, assessed per iRECIST v1.1 criteria.

    The event date for iPFS calculation shall be the date when progression criteria are first met (i.e., the date of iUPD), provided that iCPD (immune confirmed progressive disease) is confirmed at a subsequent assessment. If an assessment shows iUPD but subsequent assessment demonstrates iSD, iPR or iCR, this iUPD date shall NOT be used as the progression event date.

    If disease progression is not confirmed and no subsequent iSD, iPR or iCR is observed at later assessments, the date of the first iUPD shall still be used as the date meeting progression.

    Measured: 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.

  7. Duration of Response (DoR) and iDOR

    DoR assessed according to RECIST v1.1 and iRECIST, is defined as the time from the date of first documentation of overall response (CR/iCR or PR/iPR) to the date of first documented progressive disease (PD) or iUPD, or death from any cause, whichever occurs first. Calculated only for patients whose best overall efficacy is CR/iCR or PR/iPR.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2026
  2. Study start23 Mar 2026
  3. Primary completionFeb 2028 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07532018
Sponsor's protocol ID
DXP-106-101
Acronym
DXP-106
Status last verified
Sep 2026
First submitted
19 Mar 2026
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DXP-106 in people with Solid Tumor and Cancer, run by Singlomics Biopharmaceuticals Zhuhai Co., Ltd. at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mingli Guo ML Guo, Master (86-010-80765087, mingli.guo@singlomics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicities (DLTs) within the first cycle of administraton of DXP-106 (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07532018.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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