A Phase I Trial of SIM1811-03 in Subjects With Advanced Tumors

NCT05781386
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Phase
Phase 1
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Recruitment status
Unknown
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Participants
255
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Lead sponsor
Jiangsu Simcere Biologics Co., Ltd
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Start date
2022-03-06
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Number of sites
1
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Summary
This is a first in human, open-label, dose escalation and expansion Phase I study of SIM1811-03 in adult patients with advanced tumors. SIM1811-03 is a first-in-class IgG1-based humanized anti-tumor necrosis factor type 2 receptor (TNFR2) monoclonal antibody for the treatment of malignant tumors.
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Short title
A Phase I Trial of SIM1811-03 in Subjects With Advanced Tumors
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Official title
An Open-label, Phase I Trial of SIM1811-03 to Assess the Safety, Efficacy and Pharmacokinetics/Pharmacodynamics in Subjects With Advanced Tumors
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Unknown
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Phase
Phase 1
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Study type
Interventional
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Completion date
2025-12-30
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First posted
2023-03-23
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Registry last updated
2023-09-21
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Primary completion date
2025-06-30
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Start date
2022-03-06
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Participants
255
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Participant count basis
Estimated
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Planned participants
255
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Protocol amendments
1
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Jiangsu Simcere Biologics Co., Ltd
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05781386
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ClinicalTrials.gov ID
NCT05781386
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Registry record
Open registry record
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Allocation
Not applicable
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Part I The maximum tolerated dose (MTD) or recommended dose (RD)

    Timeframe: Within 28 days after the first dose in Q2W; Within 21 days after the first dose in Q3W

    Part I (dose escalation): To estimate the maximum tolerated dose (MTD) or recommended dose (RD) of SIM1811-03 Monotherapy or in combination with sintilimab

  2. Part II ORR for Solid Tumor

    Timeframe: Q2W: Participants will be evaluated every 8 weeks from baseline to Treatment Cycle 12 (an average of 1 year); Q3W:Participants will be evaluated every 6 weeks from baseline to Treatment Cycle 12 (an average of 1 year)

    Solid tumors: objective response rate (ORR) assessed by Investigator per RECIST 1.1 from baseline to disease progression

  3. Part II ORR for CTCL

    Timeframe: Q2W:Participants will be evaluated every 8 weeks from baseline to Treatment Cycle 12 (an average of 1 year); Q3W:Participants will be evaluated every 6 weeks from baseline to Treatment Cycle 12 (an average of 1 year)

    CTCL: ORR assessed by Investigator per global response score

  1. safety and tolerability (incidence of AE and SAE)

    Timeframe: All AEs/SAEs will be collected in this study from the time the subject signs the informed consent form until 90 days after the last dose

    Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

  2. Pharmacokinetics profile of SIM1811-03 and in combination with Sintilimab

    Timeframe: from Cycle 1 to Last dose (an average of 1 year)

    Serum concentrations of study drugs

  3. Pharmacokinetics profile of SIM1811-03 and in combination with Sintilimab

    Timeframe: from Cycle 1 to Last dose (an average of 1 year)

    Area under the concentration-time curve (AUC)

  4. Pharmacokinetics profile of SIM1811-03 and in combination with Sintilimab

    Timeframe: from Cycle 1 to Last dose (an average of 1 year)

    Maximum concentration (Cmax)

  5. Pharmacokinetics profile of SIM1811-03 and in combination with Sintilimab

    Timeframe: from Cycle 1 to Last dose (an average of 1 year)

    Pre-dose (trough) concentration (Ctrough)

  6. Pharmacokinetics profile of SIM1811-03 and in combination with Sintilimab

    Timeframe: from Cycle 1 to Last dose (an average of 1 year)

    Time to maximum concentration (Tmax)

  7. Pharmacokinetics profile of SIM1811-03 and in combination with Sintilimab

    Timeframe: Collection point would Predose, 0 hour, 24 hours, 168hours, 336 hours post-dose from Cycle 1 to Last dose (an average of 1 year)

    Half-life (T1/2)

  8. Antidrug antibodies of SIM1811-03 and Sintilimab

    Timeframe: before staring the treatment for the first 7 treatment cycles (each cycle would be 28 days/21 days)

    Incidence of serum antidrug antibodies.

  9. Neutralizing antibodies of SIM1811-03 and Sintilimab

    Timeframe: before staring the treatment for the first 7 treatment cycles (each cycle would be 28 days/21 days)

    Incidence of neutralizing antibodies to study drugs.

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

Key Inclusion Criteria:

  1. Written informed consent must be obtained prior to any procedures that are not considered standard of care.
  2. ≥18 years old on the day of signing informed consent, male or female;
  3. Histologically and/or cytologically documented advanced/metastatic solid tumors or histologically confirmed CTCL;
  4. Have relapsed or refractory advanced solid tumors or CTCL, whose disease has progressed during or after standard therapy
  5. At least one measurable tumor lesion (RECIST 1.1) for participants with solid tumors. Tumor lesions previously treated with radiotherapy or local therapy should not be considered as measurable unless progression is documented.
  6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
  7. Life expectancy of ≥ 12 weeks.
  8. Adequate organ and marrow functions 9） Provide archived or fresh biopsy tumor tissue samples or tissue sections

10) Females of childbearing potential require strict contraception during the study.

1) Participated in an interventional clinical trial or has used investigational devices within 28 days prior to first dose of study drug or received systemic anti-cancer treatments.

2）Toxicity due to previous antineoplastic therapy has not recovered to grade 0 or 1 unless such AEs are not considered to pose safety risks.

3) Required use of corticosteroids for more than 7 consecutive days within 14 days prior to the first dose of study treatment.

4) Participated with active or history of or risk of autoimmune disease 5) Major surgery (except biopsy) or unhealed wound within 4 weeks prior to first dose of study drug.

6) Other known malignancies within 2 years prior to enrollment. 7) Has known active central nervous system (CNS) metastases. 8) History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis, symptomatic interstitial lung disease or evidence of active pneumonia that is not considered appropriate by the investigator.

9) Participants with a history of active pulmonary tuberculosis infection within 1 year prior to first dose of study drug.

10) History of hemorrhagic disease requiring transfusion within the last 3 months.

Sources for eligibility
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  • Sun Yat-Sen University Cancer CenterGuanzhou, ChinaRecruiting
Sources for sites
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Sources for references
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Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)