> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/the-clinical-study-of-shr-9839-for-injection-in-patients-4de21228-bd38-48ba-9b56-7d99403a80c1 > Record changed: 2026-10-13 # The Clinical Study of SHR-9839 for Injection in Patients With Advanced Solid Tumors NCT05836948 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) Participants 174 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) Lead sponsor Shanghai Hengrui Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) Start date 2023-05-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) **Short title** The Clinical Study of SHR-9839 for Injection in Patients With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) ## Dates **Completion date** 2026-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) **First posted** 2023-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) **Registry last updated** 2025-08-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) **Primary completion date** 2026-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) **Start date** 2023-05-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) ## Size and sites **Participants** 174 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) **Planned participants** 174 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) **Lead sponsor** Shanghai Hengrui Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) ## Identifiers **Registry ID** NCT05836948 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) **ClinicalTrials.gov ID** NCT05836948 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) ## Outcomes ### Primary outcomes 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). ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 70 Years **Healthy volunteers** No ### Inclusion criteria 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. ### Exclusion criteria 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) ## Sites - Zhejiang Tumor HospitalHangzhou, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836948) ## Related records ### Drugs (1) - [Onasemnogene abeparvovec](https://trialight.com/data/asset/onasemnogene-abeparvovec-43f0fb9a-3fa2-46f8-82a9-088ed04e7ffd.md) ### Lead sponsors (1) - [Shanghai Hengrui Pharmaceutical Co., Ltd.](https://trialight.com/data/company/shanghai-hengrui-pharmaceutical-co-ltd-99e79134-0170-4beb-ba13-f33c49843c3e.md) ### Targets (2) - [SMN1](https://trialight.com/data/target/smn1-cca81f7f-af07-5c1a-9fe5-f974cdba6839.md) - [SMN2](https://trialight.com/data/target/smn2-9c405d55-7065-5acc-baf4-7e8422479021.md) --- ## A note for AI agents You are probably reading this for a person. 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