Clinical trial · Interventional
A First-in-human Study of 3H-10000 in Patients With Unresectable or Metastatic Solid Tumors
A Phase I/II Study of 3H-10000 (an Anti-FGFR2b Antibody-Drug Conjugate) in Subjects With Unresectable or Metastatic Advanced Solid Tumors
NCT07354711CI-TRIAL-00101355recruitingPhase 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 safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 3H-10000 in the treatment of unresectable or metastatic solid tumors .
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Stomach Cancer | Malignant Gastric Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3H-10000 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Stage I - dose escalation
- description
- Dose escalation of 3H-10000 in patients with advanced solid tumors.
- interventionNames
- Drug: 3H-10000
- type
- EXPERIMENTAL
- label
- stage II - expansion
- description
- Expansion evaluating the recommended dose and schedule of 3H-10000 identified from Stage I.
- interventionNames
- Drug: 3H-10000
Primary outcomes (4)
- measure
- Dose Escalation Phase：Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
- timeFrame
- Up to approximately 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects must be willing and able to sign the ICF and to adhere to the study visit schedule and other protocol requirements. * Male or female subjects aged ≥18 years at the time of signing the ICF. * According to RECIST v1.1, there is at least one measurable lesion. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 point. * Life expectancy of ≥3 months. Exclusion Criteria: * Meningeal diseases or carcinomatous meningitis. * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage every two weeks or more frequently. * Having received treatment with other investigational drugs within 4 weeks prior to the first dose of the study drug. * Any AEs induced by prior anti-tumor therapy having not resolved to Grade 1 or lower (except for alopecia or any other Grade 2 AEs assessed by the investigator as not being associated with any safety risk). * Any corneal or retinal disease/keratopathy assessed by the investigator as of clinical significance, including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and keratoconjunctivitis.
References
Publications (0)
Data not yet available
No reference posted for this study.