Clinical Study of SM3321 With Solid Tumors

NCT06087770 | Unknown Phase 1 FDA Drug

• 1 other identifier: SM3321-CN-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Locally Advanced or Metastatic Solid Tumors

Keywords

locally advanced; solid tumors; metastatic

Outcome Measures

Primary Outcomes (9)

• 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

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

• 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

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

• 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)

  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)

• Safety evaluation-2

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

  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)

• Safety evaluation-3

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

  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

• 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)

  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)

• Safety evaluation-5

  electrocardiogram (ECG)

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

• Safety evaluation-6

  echocardiography (ECHO)

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

• Safety evaluation-7

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

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

Study Arms (1)

Phase Ia Dose escalation

EXPERIMENTAL

Phase Ia Dose escalation： A maximum of 48 patients will be enrolled in this phase and are planned to be divided into eight dose groups: 0.3 mg/kg, 1mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg, 30 mg/kg, 40 mg/kg and 50 mg/kg

Drug: SM3321

Interventions

SM3321 DRUG

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

Phase Ia Dose escalation

Eligibility Criteria

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

You may qualify if:

• 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
• 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:
• a) 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.

You may not qualify if:

• 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);
• 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.
• 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.,

Sponsors & Collaborators

• Beijing StarMab Biomed Technology Ltd: lead

Study Sites (3)

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

Guangzhou, Guangdong, 510120, China

NOT YET RECRUITING

Shanghai General Hospital

Shanghai, Shanghai Municipality, 201210, China

RECRUITING

The second affiliated hospital Zhejiang university School of Medicine

Hangzhou, Zhejiang, 310009, China

NOT YET RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Qi Li, Dr.

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Zhang, Dr.

CONTACT

+86 183 1012 7099; lei.zhang@starmab.com.cn

Study Design

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

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: October 18, 2023
• Study Start: December 7, 2023
• Primary Completion: August 19, 2025
• Study Completion: October 14, 2025
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)