A Trial of SHR-A2102 With Other Antitumor Therapies in Advanced Solid Tumors

NCT06895928
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Phase
Phase 2
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Recruitment status
Recruiting
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Participants
400
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Lead sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
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Start date
2025-03-28
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Number of sites
1
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Summary
The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 with other antitumor therapies in advanced solid tumors to explore the reasonable dosage, safety and efficacy of SHR-A2102 for advanced solid tumors.
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Short title
A Trial of SHR-A2102 With Other Antitumor Therapies in Advanced Solid Tumors
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Official title
A Phase II, Multicenter, Open-Label Study of Safety, Tolerability and Efficacy of SHR-A2102 for Injection in Combination With Other Antitumor Therapies 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 2
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Study type
Interventional
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Completion date
2028-12-01
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First posted
2025-03-26
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Registry last updated
2025-04-22
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Primary completion date
2028-12-01
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Start date
2025-03-28
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Participants
400
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Participant count basis
Estimated
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Planned participants
400
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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
Shanghai Hengrui Pharmaceutical Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06895928
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ClinicalTrials.gov ID
NCT06895928
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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. Adverse events (AEs)

    Timeframe: From day 1 to 90 days after the last dose.

  2. Serious adverse events (SAEs)

    Timeframe: From day 1 to 90 days after the last dose.

  3. Objective response rate (ORR)

    Timeframe: About 2 years.

  1. Disease control rate (DCR)

    Timeframe: About 2 years.

  2. Duration of response (DOR)

    Timeframe: About 2 years.

  3. Progression free survival (PFS)

    Timeframe: About 2 years.

  4. Overall survival (OS)

    Timeframe: About 2 years.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
70 Years
Healthy volunteers
No

  1. The age of signing the informed consent is 18 -70 years, regardless of gender.
  2. At least one measurable lesion according to RECIST v1.1 criteria.
  3. The ECOG score is 0 or 1.
  4. Expected survival ≥12 weeks.
  5. Good level of organ function.
  6. Have the ability to give informed consent and to comply with the treatment plan.
  7. Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods.

  1. Inadequately treated central nervous system metastases or the presence of uncontrolled or symptomatic active central nervous system metastases.
  2. Spinal cord compression not cured by surgery and/or radiotherapy.
  3. Subjects with uncontrolled tumor-related pain.
  4. Received antitumor therapy within 4 weeks before the start of the study.
  5. Subjects with severe cardiovascular and cerebrovascular disease.
  6. History of immunodeficiency, including a positive HIV test.
Sources for eligibility
clinicaltrials.gov

  • Shanxi Cancer hospitalTaiyuan, ChinaRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (4)

Lead sponsors (1)

Targets (4)