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Advanced Solid TumorsPhase 1NCT06329206

A Phase Ia/Ib Study of GH2616 Tablet in Subjects With Advanced Solid Tumors

A Phase 1 study testing GH2616 Tablets in people with Advanced Solid Tumors, run by Suzhou Genhouse Bio Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a Phase Ia/Ib, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, pharmacodynamics (PD) and preliminary efficacy of GH2616 Tablet in subjects with advanced solid tumors. It includes two parts: the dose escalation study (Phase Ia) and the dose expansion study (Phase Ib). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
GH2616 Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
1 siteChina
Study dates
20 Mar 2024to 1 Sep 2026
Phase
Phase 1
Are there results?
None posted in the registry

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 meet all of the following inclusion criteria to be eligible for participation in this study:
  • Men or women ≥18 years old.
  • The following two points are evaluated by the Investigator and are deemed suitable to participate in the study: a. The subject fully understands the requirements of the study and voluntarily signs the written informed consent; b. Be able to comply with the medication requirements of the study and all study related procedures and evaluations.
  • Meeting the requirements of tumor types shown below:
  • Phase Ia Study:
  • Subjects with a histological or cytological diagnosis of recurrent or metastatic advanced solid tumors who have failed or are intolerant to standard treatment, or have no standard therapy. The specific tumor types include but not limited to high-grade serous ovarian cancer (HGSOC), uterine carcinosarcoma (UCS), lung adenocarcinoma (LUAD), lung squamous cell carcinoma (LUSC), triple-negative breast cancer (TNBC), bladder urothelial carcinoma (BLCA), colorectal cancer (CRC), etc.
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  • Phase Ib study:
  • Dose expansion study (Phase Ib): Subjects with a histological or cytological diagnosis of recurrent or metastatic advanced solid tumors harboring TP53 mutation and WGD+ who have failed or are intolerant to standard treatment, or have no standard therapy.
  • The specific tumor types include but not limited to high-grade serous ovarian cancer (HGSOC), uterine carcinosarcoma (UCS), lung adenocarcinoma (LUAD), lung squamous cell carcinoma (LUSC), triple-negative breast cancer (TNBC), bladder urothelial carcinoma (BLCA), colorectal cancer (CRC), etc.. Note: The specific tumor types/basket design with specific gene(s) will be determined by the principal Investigator and the Sponsor based on the Phase Ia study results.
  • Survival expectations are ≥ 12 weeks.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 (Appendix 1).
  • Subjects with advanced solid tumors have at least one evaluable lesion according to RECIST 1.1 (Appendix 2).
  • Subjects with adequate organ function at the time of screening (requiring no blood transfusion, no use of hematopoietic stimulating factor or human albumin within 14 days prior to screening), specifically defined as:
  • Blood routine: Absolute neutrophil count (ANC) ≥ 1.5×109/L; Platelet count (PLT) ≥100×109/L; Hemoglobin (HGB) ≥ 90 g/L (9 g/dL);
  • Liver function: Serum Total bilirubin (TBIL) ≤ 1.5 Upper limit of normal value (ULN), and serum TBIL≤ 3×ULN in patients with liver metastasis or confirmed Gilbert syndrome. Alanine aminotransferase (ALT) and Aspartate transferase (AST) ≤ 2.5×ULN in subjects without liver metastasis; ALT or AST≤ 5×ULN in subjects with liver metastasis;
  • Renal function: estimated creatinine clearance (CLcr) ≥ 60 mL/min as calculated using Cockcroft-Gault formula (Appendix 3);
  • Coagulation function: Activated Partial thromboplastin Time (APTT) and international normalized ratio (INR) ≤ 1.5×ULN (or within target range if on anticoagulation therapy);
  • Cardiac function: Echocardiography (ECHO) shows left ventricular ejection fraction (LVEF) > 50%.
  • Serum pregnancy test (for female of childbearing potential) negative within 7 days prior to first dosing of study treatment. Male and female subjects of childbearing potential must agree to use effective methods of contraception throughout the study and for 3 months (male) or 6 months (female) after the last dose of the investigational product. A subject is of childbearing potential if, in the opinion of the Investigator, he/she is biologically capable of having children and is sexually active.

Who cannot join

  • In Phase Ia and Ib studies, subjects will be excluded if they meet any of the following criteria:
  • Has received chemotherapy within 21 days prior to the first administration of GH2616 Tablet or has received radiation therapy, biologic therapy, endocrine therapy, targeted therapy, immunotherapy, or other anti-tumor drug treatments within 28 days prior to the first administration of GH2616 Tablet, or other anti-tumor drugs or treatments within the following interval before the first administration of GH2616 Tablet: Nitrosoureas or mitomycin C within 6 weeks prior to the first administration of the investigational drug. Oral fluoropyrimidines, small molecule targeted therapies, and Chinese herbal medicines with indications for anti-tumor within 14 days prior to the first administration of the investigational drug. Local palliative radiation therapy within 14 days prior to the first administration of the investigational drug.
  • Has received other investigational drugs or treatments not yet approved for marketing within 28 days prior to the first administration.
  • Acute toxic effects of prior anti-tumor therapy have not recovered to clinically significant NCI-CTCAE V5.0 grade ≤ 1 toxicity or baseline specified in the inclusion criteria within 28 days prior to the first administration of GH2616 Tablet (excluding toxicities such as alopecia and fatigue that the Investigator deems to have no safety risk).
  • At rest, the average Corrected QT interval (QTc, Fridericia's correction formula used) obtained by 12-lead Electrocardiograph (ECG) examination is > 450 ms for males or 470 ms for females (confirmed by repeated examinations). A variety of clinically significant arrhythmia, conduction, and resting ECG abnormalities, such as complete left bundle branch block, degree III, degree II, PR interval >250 ms. Various factors that may increase the risk of prolonged QTc or arrhythmia events, such as heart failure, hypokalemia, congenital long QT syndrome, a family history of long QT syndrome in a direct family member or sudden unexplained death before age 40, and use of any medications known to prolong QT intervals.
  • Has evidence of infectious diseases:
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  • Active hepatitis B (hepatitis B surface antigen (HbsAg) positive and hepatitis B virus deoxyribonucleic acid (HBV-DNA) > 500 IU/ml or 1000 cps/ml or lower limit of detection at the study site [only if lower limit of detection at the study site is higher than 500 IU/ml or 1000 cps/ml]), antiviral therapy other than interferon is allowed; active hepatitis C (subjects with hepatitis C virus (HCV) antibody positive but hepatitis C virus ribonucleic acid (HCVRNA) < lower limit of detection at the study site are allowed to be enrolled);
  • HIV infected patients (HIV 1/2 antibody positive detected by antigen/antibody test); Considering that HIV infections can be chronically managed, expanding cancer clinical trial eligibility to be more inclusive of patients with HIV infections is justified in many cases, and may accelerate the development of effective therapies in cancer patients with these chronic infections. Therefore, well-controlled HIV patients who have been on established antiretroviral therapy (ART) for at least four weeks and have an HIV viral load less than 400 copies/mL prior to enrollment should be included. Note: patients who are using ART drugs that are prohibited or cautious concomitant medications specified in the protocol (e.g. strong inhibitors or strong inducers of P-gp) could be switched to an alternate effective ART regimen (with minimal drug-drug interaction potential) before study participation or should be excluded from the study if their regimen cannot be altered.
  • Known active syphilis infection.
  • Has symptomatic or active central nervous system (CNS) metastases. Treated or untreated asymptomatic patients with CNS lesions are eligible only if all of the following criteria are met:
  • Presence of measurable lesions outside the CNS as determined by RECIST 1.1.
  • No history of intracranial or spinal hemorrhage.
  • No stereotactic radiation therapy or whole brain radiation therapy or neurosurgical resection within 28 days prior to initiation of study treatment.
  • No continuous use of corticosteroids during CNS disease treatment period.
  • Metastases limited to the cerebellum or supratentorial region (i.e., no metastases to the midbrain, pons, medulla, or spinal cord).
  • No evidence of intermediate progression between completion of CNSdirected therapy (if given) and initiation of study treatment.
  • Concurrent diseases that have not been controlled, such as:
  • Severe infection, including but not limited to hospitalization due to infection, bacteremia, or severe pneumonia complications, occurs within 28 days prior to initiation of study treatment; Or patients who received therapeutic oral or intravenous antibiotics within 14 days prior to starting study treatment; Subjects receiving prophylactic antibiotics for needle biopsy can be included.
  • Heart failure consistent with New York Heart Association Grades ≥ II within 6 months prior to initiation of study treatment.
  • Other malignancies (other than in situ cancers such as non-melanoma basal cell carcinoma or squamous cell carcinoma of the skin, breast/cervical carcinoma in situ, superficial bladder carcinoma that have received radical treatment and no evidence of disease recurrence, etc.) within 5 years prior to initiation of treatment.
  • Current subjects with cancerous meningitis, spinal cord compression, etc..
  • Has a history of poorly controlled hypertension within 28 days prior to initiation of study treatment, defined as systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg, despite treatment with multiple antihypertensive medications.
  • Any arterial thromboembolic event, including myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack, occurred within 6 months prior to initiation of study treatment.
  • Significant malnutrition, such as the need for intravenous nutrient supplementation. Those who were stable for more than 28 days after correction of malnutrition before treatment of first dose of investigational product could be included.
  • Tumor invasion of surrounding important organs or blood vessels (such as mediastinal great vessels, superior vena cava, trachea, esophagus, etc.), or at risk of esophagotracheal fistula or esophagopleural fistula.
  • After endoesophageal or tracheal stent implantation.
  • Has a history of gastrointestinal perforation and/or fistula 6 months prior to initiation of study treatment.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (monthly or more frequent).
  • Uncontrolled tumor-related pain, or no stable pain regimen.
  • Allergic to GH2616 Tablet or its components.
  • Significant impairment of oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction, etc..
  • Has severe lung disease or history, such as moderate to severe chronic obstructive pulmonary disease (COPD), evidence of interstitial lung disease (ILD)/pneumonitis on baseline imaging, history of ILD, drug-induced ILD, acute or chronic infectious pneumonia, lung transplantation, etc..
  • Use of strong inhibitors or inducers of P-glycoprotein (P-gp) within 14 days or 5 halflives (whichever is longer) before the first administration (refer to Appendix 5).
  • Use of sensitive narrow therapeutic index CYP3A4 substrate within 14 days or 5 halflives (whichever is longer) before the first administration (refer to Appendix 4).
  • Pregnant or lactating women.
  • Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
  • Has a major surgical procedure (craniotomy, thoracotomy, laparotomy, vascular intervention) within 28 days prior to the first administration, or had an unhealed wound, ulcer, or fracture. Note: For palliative care purposes, local surgical treatment of isolated lesions is acceptable.
  • Has a clear history of mental disorder with ongoing treatment.
  • Has a treatment history of KIF18A inhibitor.
  • Subjects with POLE gene hotspot mutated, or hypermutator phenotype.
  • In the opinion of the Investigator, there are other factors that the subject is unsuitable for participation in this clinical study.

Trial locations and contacts

1 site in 1 country.

SHIYA CHEN, bachelor contact

+8615618310761

chenshiya@genhousebio.com

ZHENGBO SONG, Doctorate contact

+8613857153345

zjccgcp_phase1@126.com

China1 site, 1 recruiting

  • Zhejiang Cancer Hospital

    Zhejiang

    ZHENGBO SONG, DOCTORATE, +8613857153345, zjccgcp_phase1@126.com

    Recruiting

Other trials in China

About this study

Official title: A Phase Ia/Ib Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of GH2616 Tablet in Subjects With Advanced Solid Tumors

This is a Phase Ia/Ib, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, pharmacodynamics (PD) and preliminary efficacy of GH2616 Tablet in subjects with advanced solid tumors. It includes two parts: the dose escalation study (Phase Ia) and the dose expansion study (Phase Ib).

Read the detailed description

Phase Ia: Dose Escalation Study This is a Phase Ia, open-label, multi-center, dose escalation study, aiming to investigate the safety, tolerability, PK, PD and preliminary anti-tumor activity of GH2616 Tablet in subjects with advanced solid tumors.

  • Dose Escalation Phase This study will consist of 8, sequential, ascending-dose cohorts (A1~ A8) and utilize a "3+3" dose escalation design.

Phase Ib: Dose Expansion Study The Phase Ib part is an open-label, multi-center, dose expansion study, aiming to further evaluate the safety, tolerability, PK, PD, and preliminary anti-tumor activity of GH2616 Tablet in subjects with advanced solid tumors harboring TP53 mutation and WGD+ at the RDEs.

Phase Ib study will consist of 2 to 3 dose level cohorts (B1 ~ B3) of RDEs identified by the safety, tolerability, PK/PD characteristics, and preliminary efficacy data obtained from Phase Ia study.

Being tested
GH2616 Tablets

What participants receive

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

  • GH2616 TabletsDrug

    GH2616 tablets will be given orally

Study groups in NCT06329206
Study groupRoleWhat they receive
GH2616 GROUPExperimentalDose Escalation: Dose Escalation Cohorts Subjects will be enrolled at various doses of GH2616. These Dose Escalation Cohorts will be utilized to To determine the maximum tolerated dose (MTD) and/or recommended dose for expansion(s) (RDEs) for Dose Expansion. Dose Escalation: Backfill Cohorts 2 ~ 3 dose cohorts are allowed to be backfilled.These Backfill Cohorts will be utilized to build additional data to support selection of doses and/or tumor types for further study in Dose Expansion. Dose Expansion: Expansion Cohorts 2 ~ 3 dose cohorts are planned.Subjects with advanced solid tumors harboring TP53 mutation and whole genome duplication (WGD+) will be enrolled.These Cohorts will be utilized to to determine the recommended Phase II dose (RP2D) of GH2616 Tablet.
Receives: Drug: GH2616 Tablets

What is being measured

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

  1. Number of Participants Reporting Adverse Events (AEs) or Serious Adverse Events (SAEs)

    Adverse events (AE), serious adverse events (SAE), and severity of AE using the NCI-CTCAE version 5.0.

    Measured: 2 years

  2. Dose-limiting Toxicities Incidence Count Among Study Participant

    DLT refers to Dose-Limiting Toxicity. It is defined as a side effect or adverse reaction of a drug or treatment that is severe enough to prevent an increase in dosage. Identifying DLT is crucial in clinical trials for determining the maximum tolerated dose (MTD) of a new drug.

    Measured: 2 years

Secondary outcomes (7)

  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). (phase I)

    Measured: 2 years

  2. 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. (phase I)

    Measured: 2 years

  3. Duration of Response (DOR) based on RECIST 1.1 criteria

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

    Measured: 2 years

  4. Plasma Concentration (Cmax)

    Highest observed plasma concentration of GH2616. (phase I)

    Measured: 2 years

  5. Area Under the plasma Concentration-Time Curve (AUC)

    Area under the plasma concentration time curve of GH2616. (phase I)

    Measured: 2 years

  6. Time to CAchieve Cmax (Tmax)

    Time of highest observed plasma concentration of GH2616. (phase I)

    Measured: 2 years

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

    DCR refers to Disease Control Rate. It is a measure used in clinical trials to indicate the proportion of patients whose cancer shrinks or remains stable over a specified period.

    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 posted25 Mar 2024
  2. Study start20 Mar 2024
  3. Primary completion25 Apr 2026 (estimated)
  4. Study completion1 Sep 2026 (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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
156 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06329206
Sponsor's protocol ID
GH2616-101
Status last verified
Jul 2024
First submitted
12 Mar 2024
Last updated
8 Jul 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GH2616 Tablets in people with Advanced 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 19 inclusion and 41 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: status not confirmed, as of the sponsor's last update on 8 Jul 2024. 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 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?

Results are not available in the source record.

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

Contact SHIYA CHEN, bachelor (+8615618310761, chenshiya@genhousebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Reporting Adverse Events (AEs) or Serious Adverse Events (SAEs) (time frame: 2 years). The study lists 2 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 NCT06329206.

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 8 Jul 2024.

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