Lung Cancer, Stomach Cancer
Conditions
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 .
Interventions
DRUG3H-10000
3H-10000 will be administered by infusion Q2W in 28-day cycles.
Sponsors
3H Pharmaceuticals Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dose Escalation Phase：ORR | Up to approximately 2 years | ORR is defined as the percentage of participants with CR or PR, as determined by RECIST v1.1 |
| Dose Escalation Phase and Efficacy Expansion Phase：Disease Control Rate (DCR) | Up to approximately 2 years | DCR is defined as the percentage of participants with best overall response of a CR, PR, and stable disease, as assessed by RECIST v1.1 |
| Dose Escalation Phase and Efficacy Expansion Phase：Duration of Response (DOR) | Up to approximately 2 years | DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of progression or death, whichever comes first, as assessed using RECIST v1.1 |
| Efficacy Expansion Phase：Progression Free Survival (PFS) | Up to approximately 2 years | PFS is defined as the time from the date of the first dose of study drug to the date of the first documentation of progressive disease assessed using RECIST v1.1 or death, whichever occurs first |
| Efficacy Expansion 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), and AEs meeting protocol-defined adverse event of clinical interest (AECI)s. |
| Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000 | Twice in the first 3 months | AUC0-last |
| Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000 | Up to approximately 2 years | AUC0-last |
Countries
China
Contacts
CONTACTShuchao Wu
Outcome results
None listed