A Trial of SHR-3792 Injection in Patients With Advanced Solid Tumors

NCT06907628
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
150
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Lead sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
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Start date
2025-04-02
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Number of sites
1
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Summary
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SHR-3792 injection monotherapy for patients with advanced solid tumors, and to explore the reasonable dosage of SHR-3792 injection monotherapy for patients with advanced solid tumors.
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Short title
A Trial of SHR-3792 Injection in Patients With Advanced Solid Tumors
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Official title
A Phase Ⅰ, Open Label, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-3792 in Patients With Advanced Solid 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
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-02-01
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First posted
2025-04-02
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Registry last updated
2025-04-25
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Primary completion date
2027-02-01
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Start date
2025-04-02
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Participants
150
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Participant count basis
Estimated
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Planned participants
150
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Protocol amendments
0
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Number of sites
1
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Registry sponsor category
Industry
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Lead sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06907628
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ClinicalTrials.gov ID
NCT06907628
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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. Maximum tolerated dose (MTD)

    Timeframe: From the first dose of study medication up to 21 days.

  2. Recommended phase Ⅱ dose (RP2D)

    Timeframe: From the first dose of study medication up to 21 days.

  3. Incidence of dose limited toxicity (DLT)

    Timeframe: From the first dose of study medication up to 21 days.

  4. Adverse events (AEs)

    Timeframe: Up to 24 weeks.

  5. Serious adverse events (SAEs)

    Timeframe: Up to 24 weeks.

  1. Objective response rate (ORR)

    Timeframe: Up to 6 months.

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

  1. Subjects with ability to understand and voluntarily agree to participate by giving written informed consent form for the study.
  2. Patients with unresectable recurrent or metastatic solid tumors.
  3. There is at least one lesion that could be measured.
  4. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
  5. Adequate organ functions as defined.
  6. Life expectancy ≥ 3 months.

  1. Patients with known active central nervous system (CNS) metastases.
  2. Subjects with other malignancy in five years before the first dose.
  3. Patients with tumor-related pain that cannot be controlled as determined.
  4. Patients with serious cardiovascular and cerebrovascular diseases.
  5. Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion.
  6. Patients with severe infections.
  7. History of immunodeficiency.
  8. History of autoimmune diseases.
  9. Active infection.
  10. Pregnant or nursing women.
  11. Known history of serious allergic reactions to the investigational product or its main ingredients.
Sources for eligibility
clinicaltrials.gov

  • Shandong First Medical University Affiliated Cancer HospitalJinan, ChinaRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)