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Locally Advanced or Metastatic Solid TumorsPhase 2NCT07318649

Phase 2 Clinical Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GH21 Capsules Combined With D-1553 Tablets in Subjects With Locally Advanced or Metastatic Solid Tumors With the KRASG12C Mutation

A Phase 2 study testing GH21，D-1553 in people with Locally Advanced or Metastatic Solid Tumors, run by Suzhou Genhouse Bio Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The study is divided into 2 cohorts, Cohort 1 is patients with KRASG12C mutated non-small cell lung cancer who have failed standard therapy or no standard therapy and have been treated with KRASG12C inhibitor; Cohort 2 is patients with KRASG12C mutated solid tumors (except non-small cell lung cancer) who have failed… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
GH21，D-1553
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
30 Dec 2025to 30 Jun 2027
Phase
Phase 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

  • 1)Patients or their legal representatives can understand and voluntarily sign a written informed consent form (before starting this study and any study procedures); 2)Age ≥ 18 years, male or female; 3)Cohort 1: Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer with KRASG12C mutation who have failed standard therapy or no standard therapy and have been treated with KRASG12C inhibitors; Cohort 2: Histologically or cytologically confirmed locally advanced or metastatic solid tumors (except non-small cell lung cancer) with KRASG12C mutation who have failed standard therapy or have no standard therapy and have been treated with KRASG12C inhibitors.
  • 4)Patients must have at least one measurable lesion that meets the definition of RECISTv1.1 (tumor lesions located in previously irradiated areas or other locoregional treatment sites are generally not considered measurable unless there is definite progression of the lesion); 5)Expected survival ≥ 3 months; 6)ECOG performance score: 0-1; 7)Patients must have adequate organ function, defined as follows: Blood
  • Absolute neutrophil count (ANC) ≥ 1.5 × 109/L without granulocyte colony-stimulating factor support within 14 days;
  • Platelets≥100×109/L without thrombopoietin (TPO) and interleukin-11 (IL-11) transfusion within 14 days;
  • Hemoglobin ≥ 90 g/L without transfusion within 14 days and without erythropoietin (EPO); Renal
  • Serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 60 ml/min calculated using the modified Cockcroft-Gault equation or eGFR ≥ 60 ml/min estimated by the MDRD equation; Liver
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  • Albumin ≥ 3.0 g/dL;
  • Total bilirubin ≤ 1.5 × ULN; in case of liver metastasis, total bilirubin ≤ 2.5 × ULN;
  • AST/ALT ≤ 2.5 × ULN; in case of liver metastasis, AST/ALT ≤ 5 × ULN; Coagulation
  • International normalized ratio (INR) and prothrombin time (PT) ≤ 1.5 × ULN unless the patient is receiving anticoagulant therapy (INR < 2.5 × ULN) and PT or PTT is within the therapeutic range of the intended use of anticoagulants;
  • Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN unless the patient is receiving anticoagulant therapy (APTT < 2.5 × ULN) and PT or PTT is within the therapeutic range of the intended use of anticoagulants.
  • 8)Men of childbearing potential and women of childbearing potential must agree to practice reliable contraception (hormonal or barrier methods or abstinence) from signing of informed consent until 6 months after the last dose of study drug. Females of childbearing potential must have a negative pregnancy test ≤ 7 days prior to the first dose of study drug.

Who cannot join

  • 1)Patients who have received chemotherapy, biological agents for anti-tumor therapy within 3 weeks before the first dose, radiotherapy, endocrine therapy and other anti-tumor drugs within 4 weeks before the first dose, except for the following:
  • nitrosourea or mitomycin C within 6 weeks before the first use of study drugs;
  • oral fluorouracil, small molecule targeted drugs and Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 5 half-lives or 2 weeks before the first use of study drugs (whichever is shorter);
  • Local palliative radiotherapy within 2 weeks before the first use of study drugs; 2)Receiving other unmarketed investigational drugs or treatments within 5 half-lives or 4 weeks (whichever is shorter) before the first dose; 3)Patients who underwent major organ surgery (excluding needle biopsy) or had significant trauma within 4 weeks before the first dose, or required elective surgery during the trial; 4)Use of strong inhibitors or strong inducers of CYP3A4 or P-gp within 2 weeks or 5 half-lives before the first dose; 5)Previous treatment with other SHP2 inhibitors. 6)Evidence of the following cardiac diseases: acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, cerebrovascular accident or transient ischemic attack within 6 months prior to the first dose;
  • Grade III-IV heart failure according to New York Heart Association functional classification at screening;
  • left ventricular ejection fraction (LVEF)≤50% by echocardiography (ECHO) at screening;
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  • Fridericia-corrected QT interval (QTcF)≥450 ms (male) and≥470 ms (female) at screening;
  • poorly controlled hypertension (systolic blood pressure≥160 mmHg and/or diastolic blood pressure≥100 mmHg) after drug therapy at screening; 7)Dysphagia or gastrointestinal diseases or other malabsorption conditions affecting drug absorption, such as intestinal obstruction, Crohn 's disease, ulcerative colitis, short bowel syndrome, gastric emptying disorder or severe gastrointestinal related toxicity before the first dose and not recovered to less than grade 2; or confirmed to have clinically significant or acute gastrointestinal diseases; 8)Uncontrolled pleural effusion, pericardial effusion or pleural effusion requiring repeated drainage (once a month or more frequently); 9)Patients with active brain metastases or with symptoms of active central nervous system metastases including headache, vomiting and vertigo are eligible only if all of the following criteria are met, and asymptomatic patients with CNS lesions treated or untreated are eligible: • Measurable lesions located outside the CNS as determined by RECISTv1.1;
  • Stable brain metastases after treatment are defined as no evidence of disease progression or bleeding within 28 days before the start of treatment, and steroid hormones and other therapeutic agents are discontinued for at least 14 days before enrollment; 10)patients with interstitial pneumonia within 6 months before the first dose, or any evidence of clinically active interstitial lung disease; 11)Hyperarterial/venous thrombotic events within 6 months before the first dose, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis and pulmonary embolism; 12)Patients with a history of other malignant tumors (cured skin squamous cell carcinoma in situ, basal cell carcinoma and cervical carcinoma in situ that have not recurred for 5 years, unless the investigator believes that they can be enrolled; in the dose escalation stage, unless the investigator believes that they can be enrolled); 13)Patients who have a history of severe allergy, or have a history of allergy to test drugs/any excipients/combination therapy drugs, or have a history of allergy to multiple drugs; 14)Hepatitis B virus infection (HBsAg positive and DNA copy number > 1000 IU/ml); or hepatitis C virus infection (HCV antibody positive, HCV RNA > upper limit of normal); or human immunodeficiency virus infection (HIV antibody positive); 15)Active infection (≥ Grade 2) requiring anti-infective treatment or fever of unknown origin exceeding 38℃ within 28 days before the first dose; 16)autoimmune diseases in the active stage as judged by the investigator within 28 days prior to the first dose; 17)Any toxicity caused by previous anti-tumor treatment before the first dose has not recovered CTCAE 5.0 grade evaluation ≤ 1 (unless alopecia, grade 2 peripheral neuropathy and/or other adverse events ≤ grade 2 that do not pose a safety risk); 18)Pregnant or lactating women; 19)The investigator considers that there are any clinical or laboratory abnormalities or other reasons that make the subject unsuitable to participate in this clinical study.

Trial locations and contacts

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

SHIYA CHEN, BACHELOR contact

15618310761

chenshiya@genhousebio.com

China1 site

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

    Zhenbo Song, DOCTORATE, 13857153345, songzb@zjcc.org.cn

Other trials in China

About this study

The study is divided into 2 cohorts, Cohort 1 is patients with KRASG12C mutated non-small cell lung cancer who have failed standard therapy or no standard therapy and have been treated with KRASG12C inhibitor; Cohort 2 is patients with KRASG12C mutated solid tumors (except non-small cell lung cancer) who have failed standard therapy or have no standard therapy and have been treated with KRASG12C inhibitor. Each cohort consists of two stages, and 10 subjects are planned to be enrolled in the first stage of each cohort. According to the preliminary efficacy and safety data, each party will discuss and decide whether to continue the second stage. Twenty to fifty subjects were planned to be enrolled in Stage II of each cohort. A total of 20-120 subjects were enrolled.

Screened eligible subjects received GH21 in combination with D-1553 in 21-day cycles until the investigator considered the subject no longer benefiting, or the subject developed intolerable toxicity, or the subject withdrew consent, or the subject died, or was lost to follow-up, or received a new anticancer treatment, whichever came first.

Being tested
GH21，D-1553

What participants receive

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

  • GH21，D-1553Drug

    • D-1553 tablet, BID, orally. Each cycle lasts 3 weeks.
    • GH21 Capsule: QD, oral, Each treatment cycle lasts 3 weeks.
Study groups in NCT07318649
Study groupRoleWhat they receive
Subjects received treatment with GH21 combined with D-1553, with 21 days as one cycleExperimentalD-1553 tablet, BID, orally. Each cycle lasts 3 weeks. GH21 Capsule: QD, oral, Each treatment cycle lasts 3 weeks.
Receives: Drug: GH21，D-1553

What is being measured

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

  1. Objective response rate (ORR) based on RECIST 1.1 criteria

    ORR is defined as the proportion of participants with complete response or partial response (CR+PR)

    Measured: 2 years

Secondary outcomes (6)

  1. Safety and tolerability

    All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs , etc

    Measured: 2 years

  2. Duration of response (DOR) based on RECIST 1.1 criteria

    DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first.

    Measured: 2 years

  3. Disease Control Rate (DCR) based on RECIST 1.1 criteria

    DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD).

    Measured: 2 years

  4. Progression-free survival (PFS) based on RECIST 1.1 criteria

    PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first.

    Measured: 2 years

  5. Overall survival (OS)

    OS is defined as the interval of time between the date of first treatment until death, loss to follow up or termination of the study by the sponsor

    Measured: 2 years

  6. Plasma concentration (Cmax)

    Peak Plasma concentration

    Measured: 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 posted6 Jan 2026
  2. Study start30 Dec 2025 (estimated)
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07318649
Sponsor's protocol ID
GH21C204
Status last verified
Dec 2025
First submitted
19 Dec 2025
Last updated
6 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GH21，D-1553 in people with Locally Advanced or Metastatic Solid Tumors, 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 12 inclusion and 9 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 6 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 phase mean?

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 SHIYA CHEN, BACHELOR (15618310761, chenshiya@genhousebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) based on RECIST 1.1 criteria (time frame: 2 years). 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 NCT07318649.

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 6 Jan 2026.

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