NCT07354711 A First-in-human Study of 3H-10000 in Patients With Unresectable or Metastatic Solid Tumors
| NCT ID | NCT07354711 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | 3H Pharmaceuticals Co., Ltd. |
| Condition | Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 170 participants |
| Start Date | 2026-01-04 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 170 participants in total. It began in 2026-01-04 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 .
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07354711 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07354711 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07354711 currently recruiting?
Yes, NCT07354711 is actively recruiting participants. Contact the research team at shuchao.wu@3hpharma.com for enrollment information.
Where is the NCT07354711 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07354711 clinical trial?
NCT07354711 is sponsored by 3H Pharmaceuticals Co., Ltd.. The trial plans to enroll 170 participants.
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