Clinical trial · Interventional
Multicenter Phase I Study of HRS-6208 in Patients With Solid Tumors
A Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HRS-6208 Monotherapy in Patients With Advanced Solid Tumors
NCT06727812CI-TRIAL-00099188recruitingPhase 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 an open, multicenter Phase I study to evaluate the safety and tolerability of HRS-6208 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 |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HRS-6208 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental arm
- interventionNames
- Drug: HRS-6208
Primary outcomes (4)
- measure
- Incidence and severity of adverse events (AEs)
- timeFrame
- From Day 1 to 30 days after the last dose.
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- From Day 1 to 21 days after the first dose.
- measure
- Dose limiting toxicity (DLT)
- timeFrame
- From Day 1 to 21 days after the first dose.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with unresectable locally advanced or metastatic solid tumors confirmed by histology or cytology who have relapsed or progressed after standard treatment, or have no standard treatment options, or do not apply standard treatment at this stage; 2. Age 18\~75 years old; 3. At least one measurable lesion per RECIST v1.1 criteria; 4. ECOG PS score: 0-1. Exclusion Criteria: 1. History of other malignancies within the past 5 years, excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; 2. The adverse reactions of previous anti-tumor therapy have not recovered to NCI-CTCAE v5.0 grade evaluation ≤ 1; 3. He has severe cardiovascular and cerebrovascular diseases; 4. Severe infection within 4 weeks prior to the first dose.
References
Publications (0)
Data not yet available
No reference posted for this study.