Clinical trial · Interventional
SHR-1701 in Metastatic or Locally Advanced Solid Tumors
A Phase I, Open-label Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of SHR-1701 in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications
NCT03710265CI-TRIAL-00055157unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main purpose of this Phase I study is to access the safety and tolerability of SHR-1701 at different dose levels. It is hoped to find out the recommended dose for Phase II/III.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-1701 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHR-1701
- interventionNames
- Drug: SHR-1701
Primary outcomes (2)
- measure
- Safety and tolerability profile of SHR-1701
- timeFrame
- Up to week 3
- description
- Number of Subjects who occurs dose-limiting toxicity (DLTs)
- measure
- Objective Response Rate (ORR) assessed by site investigator as per RECIST 1.1
- timeFrame
- Screening up to study completion, an average of 1 year
Secondary outcomes (15)
- measure
- Area under the plasma concentration versus time curve (AUC) of SHR-1701
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female subjects aged between 18 and 75 years * Life expectancy \>= 12 weeks as judged by the Investigator * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Has measurable disease per RECIST 1.1 * Subjects with confirmed metastatic or locally advanced solid tumor (histologically or cytologically) and there is no known effective anti-tumor treatment (refractory or relapsed from standard treatment). * Adequate hematological, hepatic and renal function as defined in the protocol * Females of childbearing potential (FOCBP), who are not surgically sterile or postmenopausal, must conduct pregnancy test (serum or urine) within 7 days before enrollment, and must not be pregnant or breast-feeding women. If the result is negative, she must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs. And non-sterilized males who are sexually active must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs. * Able to understand and sign an informed consent, and able to comply with all procedures Exclusion Criteria: * Anticancer treatment within 28 days before the first dose of study drug * Major surgery within 28 days before start of trial treatment (prior diagnostic biopsy is permitted) * Systemic therapy with immunosuppressive agents within 7 days prior to the first dose of study drug; or use any investigational drug within 28 days before the start of trial treatment * With any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded * Subjects with active central nervous system (CNS) metastases causing clinical symptoms or metastases that require therapeutic intervention are excluded * Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class \> 2), or ventricular arrhythmia which need medical intervention. * History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or any active systemic viral infection requiring therapy, e.g., hepatitis B or C * Previous malignant disease (other than the target malignancy to be investigated in the trial) within the last 2 years. Subjects with history of cervical carcinoma in situ, superficial or non-invasive bladder cancer or basal cell or squamous cell cancer in situ previously treated with curative intent are NOT excluded. * Receipt of any organ transplantation, including allogeneic stem-cell transplantation
References
Publications (2)
- DERIVEDPeng H, Jiang L, Yuan J, Wu X, Chen N, Liu D, Liang Y, Xie Y, Jia K, Li Y, Feng X, Li J, Zhang X, Shen L, Chen Y. Single-cell characterization of differentiation trajectories and drug resistance features in gastric cancer with peritoneal metastasis. Clin Transl Med. 2024 Oct;14(10):e70054. doi: 10.1002/ctm2.70054. PMID 39422697
- DERIVEDLiu D, Zhou J, Wang Y, Li M, Jiang H, Liu Y, Yin X, Ge M, Xiang X, Ying J, Huang J, Zhang YQ, Cheng Y, Huang Z, Yuan X, Han W, Yan D, Wang X, Liu P, Wang L, Zhang X, Luo S, Liu T, Shen L. Bifunctional anti-PD-L1/TGF-betaRII agent SHR-1701 in advanced solid tumors: a dose-escalation, dose-expansion, and clinical-expansion phase 1 trial. BMC Med. 2022 Oct 25;20(1):408. doi: 10.1186/s12916-022-02605-9. PMID 36280870