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Lung CancerPhase 1/2NCT07354711

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

A Phase 1/2 study testing 3H-10000 in people with Lung Cancer and Stomach Cancer, run by 3H Pharmaceuticals Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 . Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Stomach Cancer
What is being tested?
3H-10000
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
1 siteChina
Study dates
4 Jan 2026to Jan 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shuchao Wu contact

0086-21-50895559

shuchao.wu@3hpharma.com

China1 site, 1 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Lin Shen, MD

    Recruiting

Other trials in China

About this study

Official title: 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 .

Being tested
3H-10000
Medical subject headings
Lung Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3H-10000Drug

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

Study groups in NCT07354711
Study groupRoleWhat they receive
Stage I - dose escalationExperimentalDose escalation of 3H-10000 in patients with advanced solid tumors.
Receives: Drug: 3H-10000
stage II - expansionExperimentalExpansion evaluating the recommended dose and schedule of 3H-10000 identified from Stage I.
Receives: Drug: 3H-10000

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Up to approximately 2 years

  2. 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.

    Measured: Up to approximately 2 years

  3. 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

    Measured: Up to approximately 2 years

  4. 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)

    Measured: Up to approximately 2 years

Secondary outcomes (23)

  1. Dose Escalation Phase：ORR

    ORR is defined as the percentage of participants with CR or PR, as determined by RECIST v1.1

    Measured: Up to approximately 2 years

  2. 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

    Measured: Up to approximately 2 years

  3. 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

    Measured: Up to approximately 2 years

  4. 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

    Measured: Up to approximately 2 years

  5. 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.

    Measured: Up to approximately 2 years

  6. Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    AUC0-last

    Measured: Twice in the first 3 months

  7. Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    AUC0-inf

    Measured: Twice in the first 3 months

  8. Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Cmax

    Measured: Twice in the first 3 months

  9. Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Tmax

    Measured: Twice in the first 3 months

  10. Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Ctrough

    Measured: Twice in the first 3 months

  11. Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    CL

    Measured: Twice in the first 3 months

  12. Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    t1/2

    Measured: Twice in the first 3 months

  13. Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Vd

    Measured: Twice in the first 3 months

  14. Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Vss

    Measured: Twice in the first 3 months

  15. Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    AUC0-last

    Measured: Up to approximately 2 years

  16. Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    AUC0-inf

    Measured: Up to approximately 2 years

  17. Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Cmax

    Measured: Up to approximately 2 years

  18. Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Tmax

    Measured: Up to approximately 2 years

  19. Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Ctrough

    Measured: Up to approximately 2 years

  20. Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    CL

    Measured: Up to approximately 2 years

  21. Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    t1/2

    Measured: Up to approximately 2 years

  22. Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Vd

    Measured: Up to approximately 2 years

  23. Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Vss

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2026
  2. Study start4 Jan 2026
  3. Primary completionJan 2028 (estimated)
  4. Study completionJan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07354711
Sponsor's protocol ID
3H-10000-101
Status last verified
Dec 2025
First submitted
13 Jan 2026
Last updated
21 Jan 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 3H-10000 in people with Lung Cancer and Stomach Cancer, run by 3H Pharmaceuticals Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shuchao Wu (0086-21-50895559, shuchao.wu@3hpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Escalation Phase：Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to approximately 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07354711.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.

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