Clinical trial · Interventional
Safety, Tolerability and Pharmacokinetics/Pharmacodynamics (PK/PD) of SHR-1603 in Subjects With Advanced Malignancies
An Open-label, Single-arm, Phase I Study of the Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of SHR-1603 in Subjects With Advanced Solid Tumor or Relapsed/Refractory Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business Decision
Summary
Brief summary (as posted)
SHR-1603-I-101 is an single-arm, open-label, dose finding phase I clinical trial of SHR-1603 in subjects with advanced solid tumor or relapsed/refractory malignant lymphoid diseases. The study drug will be administered by intravenous infusion.
Conditions
Conditions (6)
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 Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Hematologic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Immunotherapy | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Neoplasms by Histologic Type | — | UNRESOLVED | — |
| Physiological Effects of Drugs | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-1603 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHR-1603
- description
- Multiple escalating doses of SHR-1603
- interventionNames
- Drug: SHR-1603
Primary outcomes (3)
- measure
- Adverse events(AE) of SHR-1603
- timeFrame
- 18 months (anticipated)
- description
- Assessment of the incidence of treatment-emergent AEs
- measure
- Dose-limited toxicity (DLT) of SHR-1603
- timeFrame
- 18 months(anticipated)
- description
- Assessment of the incidence of DLT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Ages 18 years or older; 2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 3. Life expectancy no less than 12 weeks; 4. Pathologically confirmed advanced solid tumor or relapsed/refractory lymphoma with measurable target lesions; 5. Adequate bone marrow, haptic, renal and coagulation function. Exclusion Criteria: 1. Evidence of central nervous system (CNS) involvement; 2. Previously treated with similar agents; 3. History of anticancer treatment within 4 weeks of enrollment (6 weeks for subjects treated with nitrosoureas or mitomycins); 4. Anticipated to be involved in other anti-cancer treatments expect for palliative care during the trial; 5. History of anti-cancer vaccination; or history of vaccination using attenuated vaccines within 4 weeks of enrollment; 6. History of Red blood cell (RBC) transfusion within or treatment with erythropoitin(EPO) within 3 months of enrollment; 7. History of grade 3 or higher thrombolic incidence within 2 years of enrollment, or using antithrombotic/anticoagulant agents; 8. With confirmed immunodeficiency, uncontrolled auto-immune disease, uncontrolled cardiovascular disease, uncontrolled or active infection; 9. Substance abuse.
References
Publications (0)
Data not yet available