Clinical trial · Interventional
Study of HRS-1167 as Monotherapy in Patients With Advanced Solid Tumors
A Phase I, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HRS-1167 as Monotherapy in Patients With Advanced Solid Tumors
NCT05473624CI-TRIAL-00088532recruitingPhase 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 designed to determine if treatment with HRS-1167 alone is safe, tolerable, and has anti-cancer activity 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 |
|---|---|---|---|
| HRS-1167 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HRS-1167
- interventionNames
- Drug: HRS-1167
Primary outcomes (4)
- measure
- Dose-limiting toxicity (DLT) of HRS-1167
- timeFrame
- up to 24 days
- measure
- Maximum tolerated dose (MTD) of HRS-1167
- timeFrame
- up to 24 months
- measure
- Recommended Phase II Dose (RP2D) of HRS-1167
- timeFrame
- up to 24 months
- measure
- AEs+SAEs
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18； 2. ECOG performance status 0-1; 3. Life expectancy is not less than 12 weeks; 4. Dose escalation and PK expansion part: Subjects diagnosed with advanced solid malignancies who are refractory to standard therapies or for which no standard therapy exists； 5. Efficacy expansion part：Ovarian Cancer、Breast Cancer、Pancreatic Cancer、Prostate Cancer or other cancer types with HRR gene mutation； 6. At least one target lesion (except maintenance therapy); 7. Adequate organ and marrow function as defined by the protocol. Exclusion Criteria: 1. Surgery or chemotherapy within 4 weeks of the first dose of study treatment； 2. Subjects that are unable to swallow, or dysfunction of gastrointestinal absorption； 3. Active HBV/HCV/HIV infection; 4. Untreated and/or uncontrolled brain metastases.
References
Publications (0)
Data not yet available
No reference posted for this study.