Advanced Solid Tumor CancerPhase 1/2NCT07446725
A Study to Evaluate Safety, PK and Efficacy of GH55 in Combination With GH21 in Patients With Solid Tumors
A Phase 1/2 study testing Phase I dose escalation, Phase I: Dose Expansion and phase II in people with Advanced Solid Tumor Cancer, run by Suzhou Genhouse Bio Co., Ltd. at 1 site in China.
Trial summary
GH55 Capsule is a novel, highly selective small molecule dual mechanism ERK1/2 inhibitor. GH21 Capsule is a potent, orally active human SHP2 allosteric inhibitor. The combination of an ERK1/2 inhibitor and an SHP2 inhibitor achieves a dual effect: synergistic upstream and downstream blockade of the aberrantly… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Solid Tumor Cancer
- What is being tested?
- Phase I dose escalation, Phase I: Dose Expansion and phase II
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteChina
- Study dates
- 24 Feb 2026to 31 Dec 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Aged 18-80 years (inclusive), regardless of gender.
- 2. Histologically or cytologically confirmed locally advanced or metastatic solid tumor with aberrantly activated MAPK signaling pathway (RAS/RAF/MEK/ERK).
- 3. Failed standard treatment, has no standard treatment options, refuses standard treatment, or is not eligible for standard treatment at the current stage.
- 4. Has at least one measurable tumor lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- 6. Estimated survival time ≥ 3 months.
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- 7. Essential organ function is basically normal, with screening laboratory results meeting the following criteria:
- Hematological system (no blood transfusion or hematopoietic stimulants within 14 days)
- Absolute Neutrophil Count (ANC) ≥1.5×109/L
- Platelet (PLT) ≥75×109/L
- Hemoglobin (Hb) ≥90g/L
- Liver function
- Albumin (ALB) ≥3.0g/dL
- Total Bilirubin (TBIL) ≤1.5×Upper Limit of Normal (ULN); <br/>For patients with --Gilbert syndrome: ≤3×ULN
- Alanine Aminotransferase (ALT) ≤2.5×ULN; <br/>For patients with liver metastasis or liver cancer: ≤5×ULN
- Aspartate Aminotransferase (AST) ≤2.5×ULN; <br/>For patients with liver metastasis or liver cancer: ≤5×ULN
- Renal function
- Creatinine (Cr) ≤1.5×ULN
- Creatinine Clearance (Ccr) ≥50ml/min (calculated by Cockcroft-Gault formula)
- Coagulation function
- Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN
- International Normalized Ratio (INR) ≤1.5×ULN
- Cardiac function
- Left Ventricular Ejection Fraction (LVEF) ≥50%
- Fridericia-corrected QT interval (QTcF) Male<450ms; Female<470ms
- 8. Eligible patients of childbearing potential (male and female) must agree to use reliable contraceptive methods (hormonal, barrier, or abstinence) with their partners during the trial and for at least 3 months after the last dose; female patients of childbearing potential must have a negative serum pregnancy test within 1 week before the first dose.
- 9. Must understand the study requirements, voluntarily sign a written informed consent form before the trial.
Who cannot join
- 1. Received chemotherapy within 3 weeks, or radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, or other anti-tumor treatments within 4 weeks before the first dose, except:
- - Nitrosourea or mitomycin C: within 6 weeks before the first dose;
- - Oral fluoropyrimidines, small-molecule targeted drugs, or traditional Chinese medicine with anti-tumor indications: within 2 weeks before the first dose;
- - Local palliative radiotherapy: within 2 weeks before the first dose.
- 2. Received other unmarketed clinical research drugs or treatments within 4 weeks before the first dose.
- 3. Underwent major organ surgery (excluding needle biopsy) or suffered significant trauma within 4 weeks before the first dose.
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- 4. Used strong inhibitors or inducers of CYP3A4 or P-gp within 1 week before the first dose.
- 5. Previously received other selective ERK inhibitors and/or SHP2 inhibitors.
- 6. Previously received hematopoietic stem cell transplantation or organ transplantation.
- 7. Adverse reactions from previous anti-tumor treatment have not recovered to NCI CTCAE v5.0 Grade ≤ 1 (except for toxicities judged by investigators to be safe, such as alopecia, Grade 2 peripheral neuropathy, or hypothyroidism stabilized with hormone replacement therapy).
- 8. Symptomatic parenchymal brain metastasis or meningeal metastasis, deemed unsuitable for enrollment by investigators.
- 9. Has an active infection requiring intravenous anti-infective treatment.
- 10. Has a history of immunodeficiency, including positive HIV antibody test.
- 11. Active hepatitis B (HBsAg positive and HBV-DNA > 500 IU/ml, 1000 cps/ml, or the study center's lower limit of detection [if higher]); antiviral therapy (excluding interferon) is allowed. Active hepatitis C (patients with positive HCV antibody but HCV-RNA < the study center's lower limit of detection are eligible).
- 12. Has a history of severe cardiovascular and cerebrovascular diseases, including but not limited to:
- - Severe cardiac arrhythmia or conduction abnormalities requiring clinical intervention (e.g., ventricular arrhythmia, third-degree atrioventricular block);
- - Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade ≥ 3 cardiovascular and cerebrovascular events within 6 months before the first dose;
- - New York Heart Association (NYHA) cardiac function class ≥ III;
- - Clinically uncontrolled hypertension;
- - Any factors increasing the risk of QTc prolongation or arrhythmia (e.g., heart failure, intractable hypokalemia, congenital long QT syndrome, family history of long QT syndrome, use of any known drugs that prolong the QT interval [see Appendix 8]).
- 13. Has a history of other malignant tumors (except cured in situ cancers with no recurrence for 5 years, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix, as deemed eligible by investigators; eligible in the dose escalation phase at the discretion of investigators).
- 14. Has a history of retinal vein occlusion or central serous chorioretinopathy.
- 15. Unable to swallow oral medications, or has conditions severely affecting gastrointestinal absorption (e.g., chronic diarrhea, intestinal obstruction) as judged by investigators.
- 16. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently).
- 17. Has a history of interstitial pneumonia within 6 months before the first dose, or any evidence of clinically active interstitial lung disease.
- 18. Has aberrantly activated PI3K-mTOR pathway (including PI3K activating mutations, AKT activating mutations, and PTEN deletion or inactivation).
- 19. Has known alcohol or drug dependence.
- 20. Has a mental disorder or poor compliance.
- 21. Has a history of severe allergies or allergies to multiple drugs.
- 22. Is pregnant or lactating.
- 23. Deemed unsuitable for the study by investigators for other reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Goboard Cancer Hospital
Shanghai, Shanghai Municipality, 200000
JIN LI, DOCTORATE, +8613761222111, lijin@csco.org.cn
About this study
Official title: Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Efficacy of GH55 Capsule in Combination With GH21 Capsule in Subjects With Locally Advanced or Metastatic Solid Tumors Harboring Aberrantly Activated MAPK Signaling Pathway.
GH55 Capsule is a novel, highly selective small molecule dual mechanism ERK1/2 inhibitor. GH21 Capsule is a potent, orally active human SHP2 allosteric inhibitor. The combination of an ERK1/2 inhibitor and an SHP2 inhibitor achieves a dual effect: synergistic upstream and downstream blockade of the aberrantly activated RTK MAPK signaling pathway, as well as complementation of resistance mechanisms.
This study will evaluate the safety, tolerability and pharmacokinetic (PK) characteristics of GH55 Capsule in combination with GH21 Capsule in patients with advanced solid tumors with aberrantly activated MAPK signaling pathway, and investigate the efficacy of this combination regimen in the same patient population.
- Conditions
- Advanced Solid Tumor Cancer
- Being tested
- Phase I dose escalation, Phase I: Dose Expansion, phase II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase I dose escalationDrug
Drug: GH55 Drug: GH21 Treatment Group: Subjects will receive oral GH55 and GH21 following a dose-escalation design until confirmed disease progression, unacceptable toxicity, or fulfillment of any study withdrawal criterion.
Phase I: Dose ExpansionDrug
Drug: GH55 Drug: GH21 Treatment Group: Subjects will receive oral GH55 and GH21 at two dose levels established in the Dose Escalation phase until confirmed disease progression, unacceptable toxicity, or fulfillment of any study withdrawal criterion.
phase IIDrug
Drug: GH55 Drug: GH21 Treatment Group: Subjects will receive oral GH55 and GH21 at the fixed dose established during the Phase I portion until confirmed disease progression, unacceptable toxicity, or fulfillment of any study withdrawal criterion.
| Study group | Role | What they receive |
|---|---|---|
| GH55 Capsule in combination with GH21 Capsule | Experimental | Not described Receives: Drug: Phase I dose escalation; Drug: Phase I: Dose Expansion; Drug: phase II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ia: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (according to NCI CTCAE 5.0).
Evaluated at each dose level GH55 and GH21, as graded by National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 5.0.
Measured: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Phase Ia: Dose Limited Toxicity (DLT)
Evaluated at each dose level GH55 and GH21, as graded by National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 5.0.
Measured: 28 Days (first cycle)
Phase Ib and Phase II: Progression-Free Survival (PFS)
Antitumor activity was evaluated by assessing tumor response using RECIST 1.1 criteria.
Measured: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Phase Ib and Phase II: Objective response rate (ORR)
The number (%) of patients with a best overall response of complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by investigator.
Measured: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Secondary outcomes (13)
Phase Ia, Phase Ib and Phase II: Evaluation of pharmacokinetics
Area under the concentration-time curve (AUC) from time 0 to time of last concentration measured and from time 0 extrapolated to infinity and from time 0 to time of the dosing interval at steady state
Measured: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Phase Ib and Phase II: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (according to NCI CTCAE 5.0).
Graded by National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 5.0.
Measured: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Phase Ia, Phase Ib and Phase II: Evaluation of pharmacokinetics
Maximum plasma concentration
Measured: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Phase Ia, Phase Ib and Phase II: Evaluation of pharmacokinetics
Time to maximum observed concentration
Measured: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Phase Ia, Phase Ib and Phase II: Evaluation of pharmacokinetics
Terminal half-life
Measured: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Phase Ia, Phase Ib and Phase II: Evaluation of pharmacokinetics
Apparent clearance and apparent volume of distribution
Measured: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Phase Ia, Phase Ib and Phase II: Evaluation of pharmacokinetics
Mean residence time
Measured: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Phase Ia, Phase Ib and Phase II: Evaluation of pharmacokinetics
Trough concentration at steady state
Measured: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Phase Ia, Phase Ib and Phase II: Evaluation of pharmacokinetics
Maximum concentration at steady state
Measured: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Phase Ia, Phase Ib and Phase II: Evaluation of pharmacokinetics
Accumulation ratio
Measured: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Phase Ia, Phase Ib and Phase II: Duration of Response (DOR)
Antitumor activity was evaluated by assessing tumor response using RECIST 1.1 criteria.
Measured: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Phase Ia, Phase Ib and Phase II: Disease Control Rate (DCR)
Antitumor activity was evaluated by assessing tumor response using RECIST 1.1 criteria.
Measured: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Phase Ia: Progression-Free Survival (PFS)
Antitumor activity was evaluated by assessing tumor response using RECIST 1.1 criteria.
Measured: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start24 Feb 2026 (estimated)
- Primary completion30 Oct 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumor CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Genhouse Bio Co., Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Goboard Cancer Hospital
- Responsible party
- Sponsor
- Investigators
- JIN LI, DOCTORATE, Principal investigator, Shanghai Goboard Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446725
- Sponsor's protocol ID
- GH55C201
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Efficacy of GH55 Capsule in Combination With GH21 Capsule in Subjects With Locally Advanced or Metastatic Solid Tumors Harboring Aberrantly Activated MAPK Signaling Pathway.
- ClinicalTrials.gov ID
- NCT07446725
- Acronym / sponsor ID
- GH55C201
- Conditions
- Advanced Solid Tumor Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Suzhou Genhouse Bio Co., Ltd.University, hospital or other
- Collaborators
- Shanghai Goboard Cancer Hospital
- Study start
- 24 Feb 2026 (estimated)
- Primary completion
- 30 Oct 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 3 Mar 2026 (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.
GH55 Capsule is a novel, highly selective small molecule dual mechanism ERK1/2 inhibitor. GH21 Capsule is a potent, orally active human SHP2 allosteric inhibitor. The combination of an ERK1/2 inhibitor and an SHP2 inhibitor achieves a dual effect: synergistic upstream and downstream blockade of the aberrantly activated RTK MAPK signaling pathway, as well as complementation of resistance mechanisms.
This study will evaluate the safety, tolerability and pharmacokinetic (PK) characteristics of GH55 Capsule in combination with GH21 Capsule in patients with advanced solid tumors with aberrantly activated MAPK signaling pathway, and investigate the efficacy of this combination regimen in the same patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GH55 Capsule in combination with GH21 Capsule | Experimental | Drug: Phase I dose escalation, Drug: Phase I: Dose Expansion, Drug: phase II |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- 1. Aged 18-80 years (inclusive), regardless of gender.
- 2. Histologically or cytologically confirmed locally advanced or metastatic solid tumor with aberrantly activated MAPK signaling pathway (RAS/RAF/MEK/ERK).
- 3. Failed standard treatment, has no standard treatment options, refuses standard treatment, or is not eligible for standard treatment at the current stage.
- 4. Has at least one measurable tumor lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Key exclusion criteria (31 listed)
- 1. Received chemotherapy within 3 weeks, or radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, or other anti-tumor treatments within 4 weeks before the first dose, except:
- - Nitrosourea or mitomycin C: within 6 weeks before the first dose;
- - Oral fluoropyrimidines, small-molecule targeted drugs, or traditional Chinese medicine with anti-tumor indications: within 2 weeks before the first dose;
- - Local palliative radiotherapy: within 2 weeks before the first dose.
- 2. Received other unmarketed clinical research drugs or treatments within 4 weeks before the first dose.
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 |
|---|---|---|
| Phase I dose escalationDrug: GH55 Drug: GH21 Treatment Group: Subjects will receive oral GH55 and GH21 following a dose-escalation design until confirmed disease progression, unacceptable toxicity, or fulfillment of any study withdrawal criterion. | Drug | GH55 Capsule in combination with GH21 Capsule |
| Phase I: Dose ExpansionDrug: GH55 Drug: GH21 Treatment Group: Subjects will receive oral GH55 and GH21 at two dose levels established in the Dose Escalation phase until confirmed disease progression, unacceptable toxicity, or fulfillment of any study withdrawal criterion. | Drug | GH55 Capsule in combination with GH21 Capsule |
| phase IIDrug: GH55 Drug: GH21 Treatment Group: Subjects will receive oral GH55 and GH21 at the fixed dose established during the Phase I portion until confirmed disease progression, unacceptable toxicity, or fulfillment of any study withdrawal criterion. | Drug | GH55 Capsule in combination with GH21 Capsule |
Primary outcome
Phase Ia: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (according to NCI CTCAE 5.0).
Time frame: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Evaluated at each dose level GH55 and GH21, as graded by National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 5.0.
Phase Ia: Dose Limited Toxicity (DLT)
Time frame: 28 Days (first cycle)
Evaluated at each dose level GH55 and GH21, as graded by National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 5.0.
Phase Ib and Phase II: Progression-Free Survival (PFS)
Time frame: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Antitumor activity was evaluated by assessing tumor response using RECIST 1.1 criteria.
Phase Ib and Phase II: Objective response rate (ORR)
Time frame: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
The number (%) of patients with a best overall response of complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by investigator.
13 secondary outcomes
Phase Ia, Phase Ib and Phase II: Evaluation of pharmacokinetics
Time frame: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Phase Ib and Phase II: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (according to NCI CTCAE 5.0).
Time frame: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Phase Ia, Phase Ib and Phase II: Evaluation of pharmacokinetics
Time frame: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Phase Ia, Phase Ib and Phase II: Evaluation of pharmacokinetics
Time frame: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Phase Ia, Phase Ib and Phase II: Evaluation of pharmacokinetics
Time frame: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Phase Ia, Phase Ib and Phase II: Evaluation of pharmacokinetics
Time frame: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Phase Ia, Phase Ib and Phase II: Evaluation of pharmacokinetics
Time frame: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Phase Ia, Phase Ib and Phase II: Evaluation of pharmacokinetics
Time frame: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Phase Ia, Phase Ib and Phase II: Evaluation of pharmacokinetics
Time frame: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Phase Ia, Phase Ib and Phase II: Evaluation of pharmacokinetics
Time frame: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Phase Ia, Phase Ib and Phase II: Duration of Response (DOR)
Time frame: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Phase Ia, Phase Ib and Phase II: Disease Control Rate (DCR)
Time frame: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Phase Ia: Progression-Free Survival (PFS)
Time frame: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
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 3 Mar 2026.
- Individual participant dataSharing planned: No
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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.
JIN LI, DOCTORATE principal investigator
Shanghai Goboard Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Phase I dose escalation, Phase I: Dose Expansion and phase II in people with Advanced Solid Tumor Cancer, run by Suzhou Genhouse Bio 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 27 inclusion and 31 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 3 Mar 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 QIAN DONG, MASTER (+8615221908116, dongqian@genhousebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ia: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (according to NCI CTCAE 5.0). (time frame: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. 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?
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 3 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.