Clinical trial · Interventional
A Phase 1 Study of SHR-A2102 in Subjects With Advanced Solid Tumors.
Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A2102, In Subjects With Locally Advanced Or Metastatic Solid Tumor Malignancies: A Phase I Open-Label, One-Arm, Multicenter Study.
- 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 first in human, open-label, single-arm, multicenter dose escalation and expansion Phase 1 study of SHR-A2102 in patients with advanced or metastatic solid tumors. The purpose of this study is to assess the tolerability, safety, pharmacokinetics and immunogenicity of SHR-A2102 and preliminary anti-tumor efficacy
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 Or Metastatic Solid Tumor Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-A2102 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHR-A2102 Does Escalation and Expansion
- interventionNames
- Drug: SHR-A2102
Primary outcomes (3)
- measure
- Dose Limited Toxicity (DLT)
- timeFrame
- 21 Days (first cycle)
- measure
- Maximum tolerable dose (MTD)
- timeFrame
- 21 Days (first cycle)
- measure
- Recommended dose for phase II (RP2D)
- timeFrame
- Up to 8 months
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Ability to understand and the willingness to sign a written informed consent document； 2. Aged ≥18 years old; 3. Histologically or cytologically confirmed advanced or metastatic malignant tumor; 4. Presence of at least one measurable lesion in agreement to RECIST criteria; 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1; 6. Life expectancy ≥3 months; 7. Adequate organ performance based on laboratory blood tests; 8. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Exclusion Criteria: 1. Previous received anti-cancer systemic therapy including chemo-therapy, radiation therapy, target therapy or immuno-therapy within 4 weeks before the first dose; 2. Previous received experimental medication or therapy within 4 weeks before the first dose; 3. Previous therapeutic surgery within 4 weeks; 4. Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1. 5. Known allergic to any compound of SHR-A2102; 6. Patients with uncontrolled or active brain metastasis； 7. Patients with clinical significant lung disease; 8. Patients with history of autoimmune diseases; 9. Known active hepatitis B or C infection; 10. Other serious accompanying illnesses, which, in the investigator's assessment, could seriously adversely affect the safety of the treatment.
References
Publications (0)
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