Clinical trial · Interventional
SHR-1701 in Subjects With 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 With Expansion to Selected Indications
NCT03774979CI-TRIAL-00062031unknownPhase 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 study is to assess the safety and tolerability of SHR-1701 at different dose levels. Study consists of dose-escalation part and an expansion part in subjects with metastatic or locally advanced solid tumors.
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
- description
- intravenous infusion
- interventionNames
- Drug: SHR-1701
Primary outcomes (2)
- measure
- Dose escalation part： Safety and tolerability of SHR-1701 in advanced malignancies.
- timeFrame
- Up to 3/4 weeks.
- description
- Number of Subjects who occurs dose-limiting toxicity (DLTs).
- measure
- Clinical expansion Part: Objective Response Rate（ORR）
- timeFrame
- Up to 6 weeks
- description
- ORR is define as the percentage of participants in the analysis population who havea Complete Response(CR:Disappearance of all target lesions)or a Partial Response(PR :30% decrease in the sum of diameter of target lesions) per RECIST 1.1.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Able and willing to provide signed informed consent form, and able to comply with all procedures. * Histologically or cytologically proven metastatic or locally advanced solid tumors. * Male or female subjects aged 18-75 years. * Life expectancy \>= 12 weeks as judged by the Investigator. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry. * Disease must be measurable with at least 1 uni dimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. * Adequate hematological, hepatic and renal function as defined in the protocol Other protocol-defined inclusion criteria could apply. Exclusion Criteria: * Prior therapy with an anti-PD1, anti-PD-L1, anti-CTLA-4 or a TGFb inhibitor. * Anticancer treatment within 28 days before the first dose of study drug. * Major surgery within 28 days before start of trial treatment. * 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. * With active central nervous system (CNS) metastases causing clinical symptoms or requiring therapeutic intervention. * Clinically significant cardiovascular and cerebrovascular diseases * History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immunedeficient disease, or any active systemic viral infection requiring therapy. * 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 Other protocol-defined exclusion criteria could apply
References
Publications (0)
Data not yet available
No reference posted for this study.