Clinical trial · Interventional
A Trial of SHR-1701 in Subjects With Advanced Solid Tumors
A Phase 1, Open-Label, Multi-Center, Non-Randomized, Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of SHR-1701 in Subjects With Advanced Solid Tumors.
NCT04324814CI-TRIAL-00064069completedPhase 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)
This is a dose-escalation and dose-expansion Phase 1 trial to evaluate the safety and tolerability of SHR-1701 in subjects with 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 |
|---|---|---|---|
| Advanced 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 (7)
- type
- EXPERIMENTAL
- label
- Dose level 1
- description
- Subjects will receive a single dose of SHR-1701 at Dose level 1 on Day 1 of each cycle
- interventionNames
- Drug: SHR-1701
- type
- EXPERIMENTAL
- label
- Dose level 2
- description
- Subjects will receive a single dose of SHR-1701 at Dose level 2 on Day 1 of each cycle
- interventionNames
- Drug: SHR-1701
- type
- EXPERIMENTAL
- label
- Dose level 3
- description
- Subjects will receive a single dose of SHR-1701 at Dose level 3 on Day 1 of each cycle
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed (histologically or cytologically) with solid tumors * ECOG Performance Status of 0 or 1 at both the screening and baseline visits * Life expectancy ≥12 weeks * Adequate laboratory parameters * Willing and able to comply with clinic visits and study-related procedures * Provide signed informed consent Exclusion Criteria: * Known history of hypersensitivity to the study drug * Prior malignancy active within the previous 2 years * Any investigational or concurrent cancer therapy * History of immunodeficiency including seropositivity * Systemic antibiotics treatment for ≥ 7 days before the first dose * A known history of allogeneic organ transplantation
References
Publications (0)
Data not yet available
No reference posted for this study.