Clinical trial · Interventional
A Trial of HRS-6768 in Patients With Advanced Solid Tumors
A Phase I/II Clinical Trial to Evaluate the Pharmacokinetics, Radiation Dosimetry, Safety and Preliminary Efficacy of HRS-6768 in the Treatment of Patients With Advanced Solid Tumors
NCT06925581CI-TRIAL-00098311recruitingPhase 1 / Phase 2ClinicalTrials.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)
The study is being conducted to evaluate the pharmacokinetics, radiation dosimetry, safety and preliminary efficacy of HRS-6768. To explore the reasonable dosage of HRS-6768 in the treatment of 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 |
|---|---|---|---|
| HRS-6768 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HRS-6768
- interventionNames
- Drug: HRS-6768
Primary outcomes (4)
- measure
- Phase 1:Dose-limiting toxicity (DLTs)
- timeFrame
- From first dose of study drug through at least 6 weeks
- description
- To evaluate the safety and tolerability of HRS-6768 and determine the RP2D.
- measure
- Phase 1: recommended Phase 2 dose (RP2D)
- timeFrame
- From first dose of study drug to end of phase 1 treatment (up to approximately 1 years)
- description
- To evaluate the safety and tolerability of HRS-6768 and determine the RP2D.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Able and willing to provide a written informed consent 2. subjects with solid tumors who have been histologically or cytologically diagnosed with advanced - stage (unresectable or metastatic) disease, have failed standard treatment (disease progression or intolerance), or lack effective treatment methods. 3. There must be at least one evaluable lesion . 4. ECOG 0-1 5. The functions of major organs are in good condition. Exclusion Criteria: 1. The patient has experienced significant weight loss within 28 days prior to signing the informed consent form. 2. The patient has previously received radiopharmaceutical therapy or radioactive embolization, or has previously undergone any external beam radiotherapy (EBRT) involving more than 25% of the bone marrow, or has previously had EBRT directly applied to the kidneys, or has received any EBRT within 2 weeks before the first dose. 3. The patient has received anti - tumor treatments such as surgery (excluding diagnostic biopsy and serous cavity effusion drainage), checkpoint inhibitor therapy, other antibody therapies, chemotherapy, targeted therapy, gene therapy, and vaccine therapy within 4 weeks before the first dose. 4. The patient has had a severe infection (CTCAE \> Grade 2) within 4 weeks before the first dose, such as severe pneumonia requiring hospitalization, bacteremia, and infectious complications. The patient has had symptoms and signs of infection within 2 weeks before the first dose that require intravenous antibiotic treatment (excluding cases of prophylactic antibiotic use).
References
Publications (0)
Data not yet available
No reference posted for this study.