Solid Tumors With FGFR2 Alterations, AdultPhase 1NCT06287918
A First-in-human Study of 3HP-2827 in Patients With Unresectable or Metastatic Solid Tumors With FGFR2 Alterations
A Phase 1 study testing 3HP-2827 in people with Solid Tumors With FGFR2 Alterations, Adult, run by 3H (Suzhou) Pharmaceuticals Co., Ltd. at 2 sites in United States.
Trial summary
The study is being conducted to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 3HP-2827 in the treatment of unresectable or metastatic solid tumors with FGFR2 alterations. Patients will be enrolled in two stages: dose escalation stage (Stage I) and expansion stage (Stage II). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors With FGFR2 Alterations, Adult
- What is being tested?
- 3HP-2827
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2026to Jun 2028
- Phase
- Phase 1
- 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
- The patient is willing and able to provide written informed consent and has the ability to comply with the study protocol
- Men or women, age ≥ 18 years at the time of signing informed consent.
- Histologically or cytologically confirmed surgically unresectable, locally advanced, metastatic solid tumor.
- ECOG score is 0 or 1.
- An expected survival of ≥ 12 weeks.
- Evaluable or measurable disease per RECIST v1.1.
- Adequate organ function, as measured by laboratory values.
Who cannot join
- Active brain metastases.
- Have other malignancies within the past 3 years.
- The toxicity from previous anti-tumor treatment has not recovered to ≤ grade 1.
- Clinically significant corneal or retinal disease/keratopathy.
- Clinically significant cardiovascular disorders.
- Failure to swallow, chronic diarrhea, or presence of other factors affecting drug absorption.
- Known to be allergic to any study drug or any of its excipients.
- Any other diseases or clinical laboratory, etc that may affect the interpretation of the results, or renders the patients at high risk from treatment complications.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic
Phoenix, Arizona, 85054
About this study
Official title: A First-in-human, Open-label, Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Activity of 3HP-2827 in Patients With Unresectable or Metastatic Solid Tumors With FGFR2 Alterations
The study is being conducted to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 3HP-2827 in the treatment of unresectable or metastatic solid tumors with FGFR2 alterations. Patients will be enrolled in two stages: dose escalation stage (Stage I) and expansion stage (Stage II).
- Being tested
- 3HP-2827
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3HP-2827Drug
3HP-2827 will be administered orally once daily in 28-day cycles.
| Study group | Role | What they receive |
|---|---|---|
| Stage I - dose escalation | Experimental | Dose escalation of 3HP-2827 in patients with advanced solid tumors. Receives: Drug: 3HP-2827 |
| Stage II - expansion | Experimental | Expansion evaluating the recommended dose and schedule of 3HP-2827 identified from Stage I. Receives: Drug: 3HP-2827 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation Stage- incidence of adverse events (AEs)
Measured: From baseline up until 28 days after the final dose
Dose Escalation Stage- incidence of dose-limiting toxicities (DLTs)
Measured: Days 1-28 of Cycle 1 (a cycle is 28 days)
Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs
Measured: From baseline up until 28 days after the final dose
Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results
Measured: From baseline up until 28 days after the final dose
Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters
Measured: From baseline up until 28 days after the final dose
Dose Escalation Stage -determine the maximum tolerated dose (MTD) and/or the recommended dose (RD) for expansion stage or recommended Phase II dose (RP2D) of 3HP-2827
Measured: Initiation of study drug until study discontinuation, (up to approximately 24 months)
Expansion stage -Objective response rate（ORR）
Measured: Initiation of study drug until disease progression (up to approximately 36 months)
Secondary outcomes (9)
Plasma Concentration of 3HP-2827 and/or its major metabolites
Measured: Initiation of study drug until study discontinuation（up to 45 months）
Duration of Response (DOR) as assessed by RECIST v1.1
Measured: Up to 45 months
Progression-free survival (PFS) as assessed by RECIST v1.1
Measured: Up to 45 months
Overall survival
Measured: Up to 48 months
Dose escalation stage - Objective Response Rate (ORR)
Measured: Up to 45 months
Expansion Stage- incidence of adverse events (AEs)
Measured: From baseline up until 28 days after the final dose
Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs
Measured: From baseline up until 28 days after the final dose
Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results
Measured: From baseline up until 28 days after the final dose
Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters
Measured: From baseline up until 28 days after the final dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study startJun 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumors With FGFR2 Alterations, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 3H (Suzhou) Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287918
- Sponsor's protocol ID
- 3HP-2827-101
- Status last verified
- Jan 2026
- First submitted
- 22 Feb 2024
- Last updated
- 27 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Open-label, Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Activity of 3HP-2827 in Patients With Unresectable or Metastatic Solid Tumors With FGFR2 Alterations
- ClinicalTrials.gov ID
- NCT06287918
- Acronym / sponsor ID
- 3HP-2827-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- 3H (Suzhou) Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being conducted to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 3HP-2827 in the treatment of unresectable or metastatic solid tumors with FGFR2 alterations. Patients will be enrolled in two stages: dose escalation stage (Stage I) and expansion stage (Stage II).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage I - dose escalation | Experimental | Drug: 3HP-2827Dose escalation of 3HP-2827 in patients with advanced solid tumors. |
| Stage II - expansion | Experimental | Drug: 3HP-2827Expansion evaluating the recommended dose and schedule of 3HP-2827 identified from Stage I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient is willing and able to provide written informed consent and has the ability to comply with the study protocol
- Men or women, age ≥ 18 years at the time of signing informed consent.
- Histologically or cytologically confirmed surgically unresectable, locally advanced, metastatic solid tumor.
- ECOG score is 0 or 1.
- An expected survival of ≥ 12 weeks.
Key exclusion criteria (8 listed)
- Active brain metastases.
- Have other malignancies within the past 3 years.
- The toxicity from previous anti-tumor treatment has not recovered to ≤ grade 1.
- Clinically significant corneal or retinal disease/keratopathy.
- Clinically significant cardiovascular disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3HP-28273HP-2827 will be administered orally once daily in 28-day cycles. | Drug | Stage I - dose escalation, Stage II - expansion |
Primary outcome
Dose Escalation Stage- incidence of adverse events (AEs)
Time frame: From baseline up until 28 days after the final dose
Dose Escalation Stage- incidence of dose-limiting toxicities (DLTs)
Time frame: Days 1-28 of Cycle 1 (a cycle is 28 days)
Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs
Time frame: From baseline up until 28 days after the final dose
Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results
Time frame: From baseline up until 28 days after the final dose
Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters
Time frame: From baseline up until 28 days after the final dose
Dose Escalation Stage -determine the maximum tolerated dose (MTD) and/or the recommended dose (RD) for expansion stage or recommended Phase II dose (RP2D) of 3HP-2827
Time frame: Initiation of study drug until study discontinuation, (up to approximately 24 months)
Expansion stage -Objective response rate（ORR）
Time frame: Initiation of study drug until disease progression (up to approximately 36 months)
9 secondary outcomes
Plasma Concentration of 3HP-2827 and/or its major metabolites
Time frame: Initiation of study drug until study discontinuation（up to 45 months）
Duration of Response (DOR) as assessed by RECIST v1.1
Time frame: Up to 45 months
Progression-free survival (PFS) as assessed by RECIST v1.1
Time frame: Up to 45 months
Overall survival
Time frame: Up to 48 months
Dose escalation stage - Objective Response Rate (ORR)
Time frame: Up to 45 months
Expansion Stage- incidence of adverse events (AEs)
Time frame: From baseline up until 28 days after the final dose
Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs
Time frame: From baseline up until 28 days after the final dose
Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results
Time frame: From baseline up until 28 days after the final dose
Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters
Time frame: From baseline up until 28 days after the final dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 3HP-2827 in people with Solid Tumors With FGFR2 Alterations, Adult, run by 3H (Suzhou) Pharmaceuticals Co., Ltd. at 2 sites in United States.
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 7 inclusion and 8 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: opening soon, as of the sponsor's last update on 27 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 2 sites in United States. 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 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.
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 (+86-21-50895559, 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 Stage- incidence of adverse events (AEs) (time frame: From baseline up until 28 days after the final dose). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2026.