Menu
Recruiting NCT07354711

A First-in-human Study of 3H-10000 in Patients With Unresectable or Metastatic Solid Tumors

Phase I / Phase II Interventional Lung Cancer Stomach Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 3H-10000.
Who it may be relevant to
Registry conditions: Lung Cancer, Stomach Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase I/II Study of 3H-10000 (an Anti-FGFR2b Antibody-Drug Conjugate) in Subjects With Unresectable or Metastatic Advanced Solid Tumors

Overview

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 .

Interventions

  • Drug 3H-10000
    3H-10000 will be administered by infusion Q2W in 28-day cycles.

Primary outcome measures

  • Dose Escalation Phase：Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: Up to approximately 2 years]
  • Dose Escalation Phase：Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of 3H-10000 [Time frame: Up to approximately 2 years]
  • Dose Escalation Phase：The recommended Phase 2 dose (RP2D) of 3H-10000 [Time frame: Up to approximately 2 years]
  • Efficacy Expansion Phase：Overall Response Rate (ORR) [Time frame: Up to approximately 2 years]
Secondary outcome measures (12)
  • Dose Escalation Phase：ORR [Time frame: Up to approximately 2 years]
  • Dose Escalation Phase and Efficacy Expansion Phase：Disease Control Rate (DCR) [Time frame: Up to approximately 2 years]
  • Dose Escalation Phase and Efficacy Expansion Phase：Duration of Response (DOR) [Time frame: Up to approximately 2 years]
  • Efficacy Expansion Phase：Progression Free Survival (PFS) [Time frame: Up to approximately 2 years]
  • Efficacy Expansion Phase：Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: Up to approximately 2 years]
  • Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000 [Time frame: Twice in the first 3 months]
  • Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000 [Time frame: Twice in the first 3 months]
  • Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000 [Time frame: Twice in the first 3 months]
  • Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000 [Time frame: Twice in the first 3 months]
  • Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000 [Time frame: Twice in the first 3 months]
  • Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000 [Time frame: Twice in the first 3 months]
  • Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000 [Time frame: Twice in the first 3 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Cancer Hospital — Beijing

Identifiers

NCT: NCT07354711 · 3H-10000-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗