3H-10000: 3H-10000 will be administered by infusion Q2W in 28-day cycles.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Dose Escalation Phase：Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) — Up to approximately 2 years Number of participants with AEs and SAEs as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version (NCI CTCAE 5.0)), including AEs that meet protocol-defined dose-limiting toxicity (DLT) criteria and AEs meeting protocol-defined adverse event of clinical interest (AECIs)
Dose Escalation Phase：Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of 3H-10000 — Up to approximately 2 years The MTD or MAD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to a target toxicity rate, or the highest dose administered, respectively.
Dose Escalation Phase：The recommended Phase 2 dose (RP2D) of 3H-10000 — Up to approximately 2 years The RP2D of 3H-10000 monotherapy will be determined based on relevant data, as available
Efficacy Expansion Phase：Overall Response Rate (ORR) — Up to approximately 2 years ORR is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) by Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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