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Locally Advanced or Metastatic Solid TumorsPhase 1NCT06087770

Clinical Study of SM3321 With Solid Tumors

A Phase 1 study testing SM3321 in people with Locally Advanced or Metastatic Solid Tumors, run by Beijing StarMab Biomed Technology Ltd at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the Safety and Tolerability of SM3321 in patients with locally advanced or metastatic solid tumors Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SM3321
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
3 sitesChina
Study dates
7 Dec 2023to 29 Oct 2024
Phase
Phase 1
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female aged 18 years or older.
  • Subjects with histologically or cytologically confirmed unrespectable locally advanced or metastatic solid tumors.
  • The subject's disease progresses after receiving adequate standard treatment or is intolerant to standard treatment or has no effective standard treatment options available.
  • Subjects in this study must have at least one evaluable lesion (based on RECIST v1.1).
  • Expected survival ≥12 weeks
  • ECOG PS score 0-2 points
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  • The function of the major organs is basically normal, and the laboratory examination within 7 days or less before the first administration meets the following standards:
  • Liver function:
  • AST/ALT ≤ 2.5 × ULN (ULN= upper limit of normal);If liver metastasis occurs, AST/ALT≤5×ULN;
  • Serum total bilirubin ≤ 1.5 × ULN;Or in cases of Gilbert syndrome ≤3×ULN; b) Blood routine (no hematopoietic growth factor or blood transfusion was used within 2 weeks before enrollment) :
  • Hemoglobin ≥ 90 g/L;
  • Platelet count ≥100×10^9/L;
  • Absolute neutrophil count ≥1.5×10^9/L. c) Kidney function:
  • Creatinine clearance ≥50 mL/min (calculated by Cockcroft-Gault formula). d) Coagulation function:
  • International normalized ratio (INR) ≤1.5×ULN.
  • Female subjects of reproductive age must have a negative blood pregnancy test within 3 days prior to the first use of the study drug; Eligible subjects (men and women) who are fertile (defined as sexually mature and biologically fertile) must agree to use a reliable contraceptive method (hormonal or barrier method or abstinence, etc.) with their partner during the study period and for at least 6 months after the last dose.
  • Willing to participate in clinical research, understand and sign informed consent, and follow up and abide by research procedures on time.

Who cannot join

  • Known allergy to SM3321 or its formulation components.
  • Previously received the following anti-tumor therapy:
  • Chemotherapy, targeted therapy, immunotherapy, or other anticancer therapy within 28 days or 5 half-lives (whichever is shorter) prior to initial administration of the investigational therapy, except for the following:
  • anti-programmed death receptor-1 / programmed death receptor-ligand 1 antibodies used within 1.5 months;
  • nitrosourea or mitomycin eluting period ≤6 weeks;
  • Washout period of fluoropyrimidine or small molecule targeted drugs ≤5 half-lives or 2 weeks (whichever is longer);
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  • The washout period for herbal treatments with anticancer indications is ≤2 weeks.
  • Radiotherapy received within 4 weeks prior to the first dosing of the study treatment, allowing a single fractionated radiotherapy for symptom relief.
  • The subject has participated in any other clinical study and received the trial drug within 28 days prior to the first administration of the study drug.
  • Major surgery within 28 days before dosing or major surgery expected during the study period.
  • There was acute toxicity from prior antitumor therapy that had not returned to ≤ grade 1 or baseline levels specified by the inclusion criteria prior to first administration (based on NCI-CTCAE v5.0).
  • Uncontrolled or severe cardiovascular disease, including but not limited to any of the following:
  • Prolonged QTc (using Fridericia's correction formula), male >450 ms/ female >470 ms, or congenital long QT syndrome;
  • Left ventricular ejection fraction (LVEF) <50% was assessed by Multiple-gated acquisition (MUGA) or ECHO;
  • any of the following in the 6 months prior to screening: > Grade 2 ventricular arrhythmia, severe/unstable angina, congestive heart failure (New York heart association (NYHA) III orGrade IV), coronary artery bypass grafting, myocardial infarction, cerebrovascular accident, or transient ischemic attack;
  • Uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg).If blood pressure can be controlled within the above limits by antihypertensive therapy, subjects with a history of hypertension will be admitted to the study.,
  • Concurrent history of severe chronic or active infection:
  • The subject has active hepatitis B, defined as:If HepatitisB surface antigen (HBsAg) is positive, hepatitisB virus (HBV) Deoxyribonucleic acid (DNA) should be tested for HepatitisB virus (HBV).HBV DNA was higher than the lower limit of quantitative value.
  • The subject has active Hepatitis C, defined as: if Hepatitis C virus (HCV) antibodies are positive, HCV Ribonucleic acid (RNA) should be tested, and HCVRNA is positive;
  • Known to have Acquired immune deficiency syndrome (AIDS) or Human immunodeficiency viru (Human immunodeficiency viru)Hiv-infected subjects may be eligible for study participation if the CD4+ T cell count is ≥350 cells /µL and there is no history of opportunistic infection as defined by AIDS.
  • other severe chronic infections, including but not limited to hospitalization for infectious complications, bacteremia, severe pneumonia, or active tuberculosis complications, within 4 weeks prior to initial administration of SM3321;Or an uncontrolled active infection or unexplained fever >38 ° C occurred within 7 days prior to first administration of SM3321.
  • Uncontrolled co-morbidities such as:
  • Subjects with known active primary tumors or metastases of the Central nervous system (CNS);Note: Subjects with previously treated primary CNS tumors/metastases may participate in the study, provided that they are clinically stable for at least 2 weeks, have no evidence of new BMS or BMS enlargement, and were first dosed with SM3321 The steroid dose was not increased during the first 14 days to manage CNS symptoms.Subjects with cancerous meningitis or pia spread or spinal cord compression were excluded from this study even if clinically stable.
  • known to have other malignancies that are currently advanced or have required aggressive treatment within the past 5 years (except for non-melanoma skin basal cell carcinoma or squamous cell carcinoma, breast/cervical carcinoma in situ, superficial bladder carcinoma and other in situ cancers that have been treated radically and have no evidence of disease recurrence);
  • A history of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment;
  • Significant malnutrition, such as the need for intravenous nutritional solutions. Patients with stable malnutrition for more than 4 weeks after correction before the first dose of the study drug could be enrolled;
  • Other acute or chronic medical conditions or abnormalities in laboratory testing that may increase the risks associated with participation in the study or use of the study product, or interfere with the interpretation of the study results and, in the judgment of the investigator, render the subject ineligible for participation in the study.
  • Pregnant or lactating women.
  • Have a history of active autoimmune disease, such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, or have received long-term systemic steroid therapy (at doses greater than 10 mg prednisone daily equivalent) or any other form of immunosuppressive therapy within 14 days prior to the first administration of the study drug. Exceptions include: clinically stable autoimmune thyroid disease; Receive inhaled or topical corticosteroid therapy, such as intraocular, intraarticular, and intranasal administration of prednisone equivalent ≤10 mg daily; Short-term use of corticosteroids (no more than 7 days) for preventive treatment (for example, to prevent hypersensitivity to contrast agents or non-autoimmune allergic diseases);As well as replacement therapy (e.g., thyroxine for hypothyroidism, insulin for diabetes, physiocorticoid replacement for adrenal or pituitary insufficiency).
  • Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
  • Received systemic immunomodulatory drugs, such as thymosin, IL-2, and IFN, within 14 days prior to the first administration of the study drug.
  • People who have a clear history of mental disorders and take medication for treatment.
  • People with a history of drug abuse or use.
  • Receive or will receive live vaccine within 30 days prior to the first dose of the study drug, or plan to receive any live vaccine during the study.
  • The Investigator believes that the subject may have other factors that could affect the study results and interfere with the subject's participation in the overall study process, including previous or existing medical conditions, abnormal treatments or laboratory tests, and the subject's unwillingness to comply with all procedures, study restrictions and requirements.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510120

  • The second affiliated hospital Zhejiang university School of Medicine

    Hangzhou, Zhejiang, 310009

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 201210

Other trials in China

About this study

Official title: An Open-label, Dose-escalation Phase Ia Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of SM3321 in Patients With Locally Advanced or Metastatic Solid Tumors

The purpose of this study is to evaluate the Safety and Tolerability of SM3321 in patients with locally advanced or metastatic solid tumors

Read the detailed description

The goal of this clinical trial is to test patients with locally advanced or metastatic solid tumors. The main questions it aims to answer are:

  • To evaluate the safety and tolerability of SM3321 in patients with locally advanced or metastatic solid tumors.
  • To determine dose-limiting toxicities (DLTs) , Maximum tolerated dose(MTD) and Recommended phase 2 dose (RP2D)of SM3321 in the treatment of patients with locally advanced or metastatic solid tumors. .
  • To evaluate the Pharmacokinetics (PK) profile of SM3321 in patients with locally advanced or metastatic solid tumors after single and multiple administration.
  • To evaluate the immunogenicity of single and multiple administration of SM3321 in patients with locally advanced or metastatic solid tumors.
  • To evaluate the initial antitumor activity of SM3321 in patients with locally advanced or metastatic solid tumors.
  • To further evaluate serum biomarkers and explore the potential relationship between these markers and the antitumor activity and safety of SM3321.
  • To explore the relationship between dose and/or PK exposure and effects(including anti-tumor activity and safety).
Being tested
SM3321
Keywords
locally advanced, solid tumors, metastatic
Medical subject headings
Neoplasm Metastasis

What participants receive

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

  • SM3321Drug

    Intravenous infusion, once a week, 28 days for a dosing cycle

Study groups in NCT06087770
Study groupRoleWhat they receive
Phase Ia Dose escalationExperimentalUp to 48 patients will be enrolled in this phase. SM3321 will be administered using a sequential dose-escalation design to determine the safety profile, tolerability, pharmacokinetic characteristics, and recommended dose for further clinical development.
Receives: Drug: SM3321

What is being measured

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

  1. Maximum tolerated dose

    The highest dose when the proportion of subjects with DLT events during the DLT observation period was less than 1/3 or 2/6 of

    Measured: DLT observation period: 28 days after the first dose [i.e., 1 Cycle ]

  2. Phase II recommended dose（RP2D)

    RP2D will be determined based on safety, tolerability, PK, and PD study results, and may be at MTD/MAD or lower dose levels.

    The RP2D cohort will include at least six evaluable subjects to further clarify safety and tolerability.

    Adverse events in subjects that meet the definition of DLT outside the DLT observation period will not be used as a basis for dose escalation, but will be used as a reference for subsequent dose design and for evaluating the overall safety of future recommended doses

    Measured: DLT observation period: 28 days after the first dose [i.e., 1 Cycle ]

  3. Safety evaluation-1

    Incidence and severity of DLT, adverse events (AE), serious adverse events (SAE), and immune-related adverse events (irAE)(evaluated per [National Cancer Institute-Common Terminology Criteria for Adverse Events，NCI-CTCAE] v5.0)

    Measured: Screen Period(Day-28~Day-1),Cycle 1 (Day1, 2, 3, 4, 6, 8, 15,22, 23, 24, 25,27） (Cycle 2~Cycle N) Day 1±3 Days, within 7 days after stop dosing, 30±5 days after last dosing, 90±5 days after last dosing (1 Cycle=28 Days)

  4. Safety evaluation-2

    Clinically significant abnormalities in laboratory tests, including blood routine examination, coagulation function, blood biochemistry, urine analysis, viral serology

    Measured: Screen Period(Day-28~Day-1),Cycle 1 (Day1, 8, 15,22） (Cycle 2~Cycle N) Day 1±3 Days, within 7 days after stop dosing, 30±5 days after last dosing, 90±5 days after last dosing (1 Cycle=28 Days)

  5. Safety evaluation-3

    vital signs, including respiratory rate, heart rate, body temperature and blood pressure

    Measured: On the day of dosing, within 1 hour before dosing, every 15±5 minutes during dosing, at the end of dosing (within 5 minutes), and every 30±5 minutes after dosing. within 4 hours after the end of the first dosing

  6. Safety evaluation-4

    physical examination, examination of the entire human system/organ (skin, head, eyes, ears, nose, mouth/throat/neck, thyroid, lymph nodes, respiratory, cardiovascular, gastrointestinal, limbs, abdomen, back, musculoskeletal, nervous system and mental state)

    Measured: Screen Period(Day-28~Day-1),Cycle 1 (Day1, 8, 15,22） (Cycle 2~Cycle N) Day 1±3 Days, within 7 days after stop dosing, 30±5 days after last dosing, 90±5 days after last dosing (1 Cycle=28 Days)

  7. Safety evaluation-5

    electrocardiogram (ECG)

    Measured: Within 1 hour before dosing, 30 minutes after ending dosing, and 30 minutes after starting dosing 4 hours

  8. Safety evaluation-6

    echocardiography (ECHO)

    Measured: Scans or examinations are performed during the screening period and when clinically indicated

  9. Safety evaluation-7

    physical status (PS) in the Eastern United States Oncology Consortium (ECOG)

    Measured: Screen Period(Day-28~Day-1), (Cycle 2~Cycle N) Day 1±3 Days, within 7 days after stop dosing (1 Cycle=28 Days)

Timeline

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

  1. First posted18 Oct 2023
  2. Study start7 Dec 2023
  3. Primary completion29 Oct 2024
  4. Study completion29 Oct 2024

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
Sequential
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06087770
Sponsor's protocol ID
SM3321-CN-001
Status last verified
Jul 2026
First submitted
3 Aug 2023
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SM3321 in people with Locally Advanced or Metastatic Solid Tumors, run by Beijing StarMab Biomed Technology Ltd at 3 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 17 inclusion and 35 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: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (time frame: DLT observation period: 28 days after the first dose [i.e., 1 Cycle ]). The study lists 9 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 NCT06087770.

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 23 Jul 2026.

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