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

3H Pharmaceuticals Co., Ltd.

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Lung Cancer; Stomach Cancer

Treatments: Drug: 3H-10000

Study type: Interventional

Funder types: Industry

Identifiers

NCT07354711

3H-10000-101

Details and patient eligibility

About

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 .

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Stage I - dose escalation

Experimental group

Description:

Dose escalation of 3H-10000 in patients with advanced solid tumors.

Treatment:

Drug: 3H-10000

stage II - expansion

Experimental group

Description:

Expansion evaluating the recommended dose and schedule of 3H-10000 identified from Stage I.

Treatment:

Drug: 3H-10000