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

A Phase I/II Study of 3H-10000 (an Anti-FGFR2b Antibody-Drug Conjugate) in Subjects With Unresectable or Metastatic Advanced Solid Tumors

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 .

Study Overview

• Status: Recruiting
• Conditions: Stomach Cancer; Lung Cancer
• Intervention / Treatment: Drug: 3H-10000

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Shuchao Wu; Phone Number: 0086-21-50895559; Email: shuchao.wu@3hpharma.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Recruiting
      • Beijing Cancer Hospital
      • Contact: Lin Shen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stage I - dose escalation; Dose escalation of 3H-10000 in patients with advanced solid tumors.	Drug: 3H-10000; 3H-10000 will be administered by infusion Q2W in 28-day cycles.
Experimental: stage II - expansion; Expansion evaluating the recommended dose and schedule of 3H-10000 identified from Stage I.	Drug: 3H-10000; 3H-10000 will be administered by infusion Q2W in 28-day cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: 3H Pharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: January 18, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 18, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Stomach Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 3H-10000-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No