Clinical trial · Interventional
Clinical Trial of HRS-4642 Plus SHR-A2102 in Patients With Advanced Solid Tumors
An Exploratory Clinical Study of HRS-4642 in Combination With SHR-A2102 for the Treatment of Advanced Solid Tumors
NCT06955390CI-TRIAL-00089243not yet recruitingPhase 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 purpose of this study is to observe and evaluate the efficacy and safety of HRS-4642 combined with SHR-A2102 in the treatment of 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 |
|---|---|---|---|
| SHR-A2102+HRS-4642 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment group
- description
- SHR-A2102+HRS-4642
- interventionNames
- Drug: SHR-A2102+HRS-4642
Primary outcomes (2)
- measure
- Dose Limited Toxicity(DLT)
- timeFrame
- At the end of Cycle 1 (each cycle is 14 days)
- description
- one or more unacceptable toxic reactions that occur after administration, leading to an inability to further increase the dose or extend the dosing cycle.
- measure
- Objective Response Rate (ORR)
- timeFrame
- up to 1 year
- description
- the proportion of patients with a confirmed complete response or partial response on two consecutive occasions≥4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements 2. The age of signing the informed consent is from 18 to 75 years old, regardless of gender 3. Subjects with pathologically confirmed locally advanced unresectable or metastatic solid tumors 4. The ECOG score is 0 or 1 5. Expected survival ≥12 weeks 6. At least one measurable lesion according to RECIST v1.1 criteria 7. Good level of organ function 8. Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods Exclusion Criteria: 1. subjects with uncontrolled or active brain metastasis； 2. subjects with clinical significant lung disease; 3. subjects with history of autoimmune diseases; 4. Known active hepatitis B or C infection; 5. Subjects with severe cardiovascular and cerebrovascular diseases 6. Uncontrolled tumor-related pain 7. Severe infections that require intravenous antibiotic, antiviral or antifungal control 8. Clinically symptomatic moderate to severe ascites; Uncontrollable or moderate or above pleural effusion, pericardial effusion 9. Received anti-tumor therapy 4 weeks prior to initiation of study treatment. 10. Known allergic to any compound of SHR-A2102 or HRS-4642 11. Other serious accompanying illnesses, which, in the investigator's assessment, could seriously adversely affect the safety of the treatment
References
Publications (0)
Data not yet available
No reference posted for this study.