The Clinical Study of SHR-9839 for Injection in Patients With Advanced Solid Tumors

NCT05836948
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
174
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Lead sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
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Start date
2023-05-18
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Number of sites
1
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Summary
This study is an open-label, phase I clinical trial of SHR-9839 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion.
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Short title
The Clinical Study of SHR-9839 for Injection in Patients With Advanced Solid Tumors
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Official title
An Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-9839 for Injection 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
2026-06-01
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First posted
2023-05-01
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Registry last updated
2025-08-11
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Primary completion date
2026-05-01
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Start date
2023-05-18
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Participants
174
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Participant count basis
Estimated
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Planned participants
174
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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
NCT05836948
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ClinicalTrials.gov ID
NCT05836948
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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) or maximum administered dose (MAD)

    Timeframe: On the first day of each week,4 weeks is a treatment cycle

    Incidence and category of dose limiting toxicities (DLTs) during the first 4 week cycle of SHR-9839 treatment

  2. Recommended Phase 2 dose (RP2D)

    Timeframe: From Day 1 to 90 days after last dose

    RP2D will be determined on the basis of evaluation on MTD/MAD, PK, PD, efficacy data in dose escalation and dose expansion stages.

  3. Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) ([CTCAE] v5.0)

    Timeframe: From Day 1 to 90 days after last dose

    Assess safety and tolerability of SHR-9839 by way of adverse events (CTCAE v5.0).

  1. PK parameter: Tmax of SHR-9839

    Timeframe: approximately 10 months

    Time to maximum concentration of SHR-9839

  2. PK parameter: Cmax of SHR-9839

    Timeframe: approximately 10 months

    Maximum concentration of SHR-9839

  3. PK parameter: AUC0-t of SHR-9839

    Timeframe: Approximately 10 months

    Area under the concentration-time curve from time 0 to the last measurable concentration time point of SHR-9839

  4. PK parameter: AUC0-∞ of SHR-9839

    Timeframe: Approximately 10 months

    Area under the concentration-time curve from time 0 to infinity of SHR-9839

  5. Immunogenicity of SHR-9839

    Timeframe: Approximately 12 months

    Anti-SHR-9839 antibody (ADA)

  6. Overall response rate (ORR)

    Timeframe: Approximately within 36 months

    Evaluated using RECIST 1.1

  7. Duration of response (DoR)

    Timeframe: Approximately within 36 months

    Evaluated using RECIST 1.1

  8. Disease control rate (DCR)

    Timeframe: Approximately within 36 months

    Evaluated using RECIST 1.1

  9. Progression-free survival (PFS)

    Timeframe: Approximately within 36 months

    Evaluated using RECIST 1.1

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

  1. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently;
  2. Have at least one measurable tumor lesion per RECIST v1.1;
  3. ECOG performance status of 0-1;
  4. Life expectancy ≥ 12 weeks;
  5. Adequate bone marrow and organ function;
  6. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.

  1. Patients with active central nervous system metastases or meningeal metastases;
  2. Received anti-tumor treatment such as chemotherapy, biotherapy, targeted therapy, immunotherapy, radical radiotherapy, or other unlisted clinical research drugs or treatments within 4 weeks prior to the first use of the study drug;
  3. History of serious cardiovascular and cerebrovascular diseases;
  4. Subjects who received>30Gy of radiation therapy within 4 weeks before the first medication, and those who received ≤ 30Gy of palliative radiation therapy within 7 days before the first medication;
  5. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.
Sources for eligibility
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  • Zhejiang Tumor HospitalHangzhou, ChinaRecruiting
Sources for sites
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Related records

Drugs (1)

Lead sponsors (1)

Targets (2)