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

NCT07354711 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 3H-10000-101
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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 .

Conditions

Lung Cancer; Stomach Cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (23)

• Dose Escalation Phase：ORR

  Up to approximately 2 years

• Dose Escalation Phase and Efficacy Expansion Phase：Disease Control Rate (DCR)

  Up to approximately 2 years

• Dose Escalation Phase and Efficacy Expansion Phase：Duration of Response (DOR)

  Up to approximately 2 years

• Efficacy Expansion Phase：Progression Free Survival (PFS)

  Up to approximately 2 years

• Efficacy Expansion Phase：Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Up to approximately 2 years

Study Arms (2)

Stage I - dose escalation

EXPERIMENTAL

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

Drug: 3H-10000

stage II - expansion

EXPERIMENTAL

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

Drug: 3H-10000

Interventions

3H-10000 DRUG

3H-10000 will be administered by infusion Q2W in 28-day cycles.

Stage I - dose escalation; stage II - expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• 3H Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Shuchao Wu

CONTACT

0086-21-50895559; shuchao.wu@3hpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 21, 2026
• Study Start: January 4, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: January 21, 2026

Record last verified: 2025-12

Locations

CN (1)