Clinical trial · Interventional
Phase I/II Clinical Study of FH-006 for Injection in Patients With Malignant Solid Tumors
A Multicenter, Open Label Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of FH-006 for Injection in Patients With Malignant Solid Tumors
NCT06735144CI-TRIAL-00098501recruitingPhase 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)
Evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FH-006 in subjects with advanced malignant solid tumors, and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), recommended dose for phase II clinical trials (RP2D), and preliminary efficacy.
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 |
|---|---|---|---|
| Malignant Solid Tumor | Malignant Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FH-006 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Queue A
- interventionNames
- Drug: FH-006
- type
- EXPERIMENTAL
- label
- Queue B
- interventionNames
- Drug: FH-006
Primary outcomes (5)
- measure
- DLT: 21or28 days after the first administration of each subject
- timeFrame
- 21or28 days after the first administration of each subject
- measure
- AE: from Day1 to 30 days after last dose
- timeFrame
- from Day1 to 30 days after last dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women aged 18 to 75 (inclusive) 2. Subjects with histologically or cytologically confirmed recurrent or metastatic solid tumors who experience disease progression after standard treatment, or who do not have a standard treatment plan or are not suitable for standard treatment. 3. ECOG score is 0 or 1 4. An expected survival of ≥3 months 5. At least one target lesion according to RECIST v1.1 criteria 6. Has a good level of organ function 7. Patients voluntarily joined the study and signed informed consent Exclusion Criteria: 1. Have other malignancies within the past 5 years 2. Active central nervous system metastasis without surgery or radiotherapy 3. Presence with uncontrollable third space effusion 4. Have undergone other anti-tumor treatment within 4 weeks before the first dose 5. Has severe infection within 4 weeks before the first medication 6. Any active autoimmune disease or a history of autoimmune disease 7. A history of immune deficiency 8. Has serious cardiovascular and cerebrovascular diseases 9. Clinically significant history of lung disease 10. The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I 11. Having undergone surgery on important organs within 4 weeks prior to the first use of medication 12. Used attenuated live vaccine within 28 days prior to the first use of the investigational drug 13. Presence of other serious physical or mental diseases or laboratory abnormalities
References
Publications (0)
Data not yet available
No reference posted for this study.