Clinical trial · Interventional
A Phase I Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid Tumors
A Phase I, Open-Label, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A2009 for Injection in Patients With Advanced Solid Tumors
NCT05114759CI-TRIAL-00118140active not recruitingPhase 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 study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-A2009 for injection in patients 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 Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-A2009 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHR-A2009 for Injection will be administrated per dose level in which the patients are assigned.
- interventionNames
- Drug: SHR-A2009
Primary outcomes (3)
- measure
- Maximum tolerated dose (MTD) or maximum administered dose (MAD).
- timeFrame
- From Day 1 to Day 21
- description
- Incidence and category of dose limiting toxicities (DLTs) during the first 21-day cycle of SHR-A2009 treatment.
- measure
- Recommended Phase 2 dose (RP2D)
- timeFrame
- From Day 1 to 90 days after last dose
- description
- RP2D will be determined on the basis of evaluation on MTD/MAD, PK, efficacy data in dose escalation and dose expansion stages.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently; 2. Have at least one measurable tumor lesion per RECIST v1.1 (patients with only non-target lesions are allowed to be enrolled in dose escalation stage); 3. ECOG performance status of 0-1; 4. Life expectancy ≥ 12 weeks; 5. Adequate bone marrow and organ function . 6. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form. Exclusion Criteria: 1. Patients with symptomatic central nervous system metastases or meningeal metastases; 2. Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug; 3. Prior treatment with antibody-drug conjugate (ADC) consisting of topoisomerase I inhibitors; 4. History of serious cardiovascular and cerebrovascular diseases; 5. Severe infection within 4 weeks prior to the first dose; 6. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.
References
Publications (0)
Data not yet available
No reference posted for this study.