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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage I - dose escalation | Experimental | Dose escalation of 3H-10000 in patients with advanced solid tumors. |
|
| stage II - expansion | Experimental | Expansion evaluating the recommended dose and schedule of 3H-10000 identified from Stage I. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3H-10000 | Drug | 3H-10000 will be administered by infusion Q2W in 28-day cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation Phase：Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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) | Up to approximately 2 years |
| Dose Escalation Phase：Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of 3H-10000 | 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. | Up to approximately 2 years |
| Dose Escalation Phase：The recommended Phase 2 dose (RP2D) of 3H-10000 | The RP2D of 3H-10000 monotherapy will be determined based on relevant data, as available | Up to approximately 2 years |
| Efficacy Expansion Phase：Overall Response Rate (ORR) | 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) | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation Phase：ORR | ORR is defined as the percentage of participants with CR or PR, as determined by RECIST v1.1 | Up to approximately 2 years |
| Dose Escalation Phase and Efficacy Expansion Phase：Disease Control Rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuchao Wu | Contact | 0086-21-50895559 | shuchao.wu@3hpharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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
| Up to approximately 2 years |
| Dose Escalation Phase and Efficacy Expansion Phase：Duration of Response (DOR) | 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 | Up to approximately 2 years |
| Efficacy Expansion Phase：Progression Free Survival (PFS) | 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 | Up to approximately 2 years |
| Efficacy Expansion Phase：Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | Up to approximately 2 years |
| Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000 | AUC0-last | Twice in the first 3 months |
| Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000 | AUC0-inf | Twice in the first 3 months |
| Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000 | Cmax | Twice in the first 3 months |
| Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000 | Tmax | Twice in the first 3 months |
| Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000 | Ctrough | Twice in the first 3 months |
| Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000 | CL | Twice in the first 3 months |
| Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000 | t1/2 | Twice in the first 3 months |
| Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000 | Vd | Twice in the first 3 months |
| Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000 | Vss | Twice in the first 3 months |
| Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000 | AUC0-last | Up to approximately 2 years |
| Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000 | AUC0-inf | Up to approximately 2 years |
| Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000 | Cmax | Up to approximately 2 years |
| Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000 | Tmax | Up to approximately 2 years |
| Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000 | Ctrough | Up to approximately 2 years |
| Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000 | CL | Up to approximately 2 years |
| Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000 | t1/2 | Up to approximately 2 years |
| Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000 | Vd | Up to approximately 2 years |
| Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000 | Vss | Up to approximately 2 years |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |