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Locally Advanced or Metastatic Solid Tumors With PIK3CA-mutatedPhase 1NCT07407504

GenSci145 as Monotherapy or in Combination Therapy, in Participants With PIK3CA-mutated, Locally Advanced or Metastatic Solid Tumors.

A Phase 1 study testing GenSci145 tablets in people with Locally Advanced or Metastatic Solid Tumors With PIK3CA-mutated, run by Changchun GeneScience Pharmaceutical 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
Search all trials

Trial summary

An international, multicenter, open-label, Phase 1/2 clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of GenSci145, as monotherapy or in combination therapy, in participants with PIK3CA-mutated, locally advanced or metastatic solid tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
GenSci145 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
186 participants
Where
1 siteChina
Study dates
1 Apr 2026to 21 Feb 2029
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General inclusion criteria for all participants
  • Participants should be able to understand and voluntarily sign a written ICF (before participating in any trial-related procedures of this study).
  • Participants are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other specified study procedures.
  • At the time of signing the ICF: aged between 18 and 75 years (inclusive). If the legal age of consent in the jurisdiction in which the study is taking place is > 18 years, then the legal age of consent should be reached.
  • Central or local test results are required to confirm the presence of eligible PIK3CA mutations in tumor tissue or blood samples. Eligible PIK3CA mutations include: R88Q, G106A/D/R/S/V, K111N/R/E, G118D, N345D/H/I/K/S/T/Y, C420R, E453A/D/G/K/Q/V, E542A/D/G/K/Q/R/V, E545A/D/G/K/L/Q/R/V, Q546E/H/K/L/P/R, T1025A/I/S, M1043I/T/V, N1044H/I/K/S/T/Y, H1047D/I/L/N/P/Q/R/T/Y, G1049A/C/D/R/S, or other pathogenic PIK3CA mutations.
  • Fresh tumor tissue (preferred) or archived tumor tissue sections are required (participants planning to be enrolled in Part 1 Dose Level 1 or Dose Level 2 who cannot provide tumor samples or provide insufficient samples can be screened after communicating with the sponsor).
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  • At least one measurable lesion as assessed according to RECIST v1.1.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1 (refer to Appendix 1 for details).
  • Life expectancy ≥ 3 months.
  • Has adequate hematologic and organ function within 7 days prior to the first dose of GenSci145 as follows:
  • Hematology:Neutrophil count ≥ 1,500/µL (1.5 × 109/L);Hemoglobin ≥ 9 g/dL;Platelet count ≥ 100,000/µL (100 × 109/L); Liver function:Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN) (TBIL ≤ 3 × ULN for patients with Gilbert's syndrome); AST and ALT ≤ 2.5 × ULN; for participants with documented liver metastases: AST and/or ALT ≤ 5.0 × ULN; Renal function:Creatinine clearance rate (CLcr) ≥ 60 mL/min (Calculated by using the Cockcroft-Gault formula, refer to Appendix 3 for details); Glucose metabolism:•Fasting blood glucose ≤ 140 mg/dL (7.7 mmol/L);HbA1c ≤ 7.0%;Fasting blood amylase ≤ 2.0 × ULN;Fasting blood lipase ≤ 1.0 × ULN; Coagulation function:•International normalized ratio or prothrombin time (PT) ≤ 1.5 × ULN, or PT within the therapeutic range of intended anticoagulant treatment if the participant is receiving anticoagulant therapy;Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN, or aPTT within the therapeutic range of intended anticoagulant treatment if the participant is receiving anticoagulant therapy;
  • Women of childbearing potential (WOCBP) must be willing to use adequate contraception from signing the ICF until at least 30 days after the last dose of study treatment (or extended to 2 years if in combination with fulvestrant in accordance with the local prescribing information) and have a negative serum human chorionic gonadotropin (HCG) test within 7 days prior to the first dose of GenSci145.
  • Men able to father a child must be willing to use adequate contraception from signing the ICF until at least 30 days after the last dose.
  • Inclusion criteria only applicable to specific study part/cohort
  • Part 1:
  • Participants with histologically or cytologically confirmed locally advanced or metastatic solid tumors;
  • Participants with progressive disease following standard of care, or for whom, in the opinion of the investigator, no effective standard treatment regimen is available.
  • Part 2:
  • Female participants with histologically or cytologically confirmed HR+/HER2- locally advanced or metastatic breast cancer [HR+ in this protocol is defined as estrogen receptor (ER) positive and/or progesterone receptor (PR) positive (positive nuclear staining in ≥ 10% tumor cells); HER2- is defined as immunohistochemistry (IHC) 0, 1+, or IHC 2+ and in situ hybridization (ISH) negative];
  • Participants with progressive disease following standard of care, or for whom, in the opinion of the investigator, no effective standard treatment regimen is available.
  • Part 3 (Doublet), Part 4 Cohort A:
  • Female participants with histologically or cytologically confirmed HR+/HER2- locally advanced or metastatic breast cancer;
  • Participants who meet any of the following:
  • Participants with progressive disease during (neo)adjuvant endocrine therapy or within 12 months after completing the therapy and have not received any endocrine therapy for metastatic disease;
  • Progressive disease more than 12 months after completing adjuvant endocrine therapy, followed by progression again after one line of endocrine therapy (for metastatic disease);
  • Newly diagnosed advanced breast cancer with disease progresses following first-line endocrine therapy;
  • Have received ≤ 1 line of chemotherapy or antibody-drug conjugate therapy in the advanced stage;
  • Prior use of CDK4/6 inhibitors that meets any of the following:
  • Received a CDK4/6 inhibitor in the advanced stage and experienced progressive disease while on treatment or used a CDK4/6 inhibitor in the (neo)adjuvant setting and experienced progressive disease while on treatment; or within 12 months after the end of treatment;
  • Discontinuation of treatment due to intolerance to adverse reactions (e.g., hyperglycemia, rash, etc.);
  • If no prior use of CDK4/6 inhibitors, a plausible explanation (e.g., drug unavailability) is required.
  • Part 3 (Triplet), Part 4 Cohort C:
  • Female participants with histologically or cytologically confirmed HR+/HER2- locally advanced or metastatic breast cancer;
  • Progression while on or within 12 months of completing adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen; if a CDK4/6 inhibitor is included in the (neo)adjuvant setting, the progression event must have occurred > 12 months after completing (neo)adjuvant therapy with CDK4/6 inhibitors.
  • Part 4 Cohort B:
  • Female participants with histologically or cytologically confirmed HR+/HER2- locally advanced or metastatic breast cancer with brain metastases. The diagnostic and treatment requirements are the same as those for Part 3 (doublet) and Part 4 Cohort A;
  • No immediate CNS-specific treatment (e.g., radiation therapy or surgery) is required, as evaluated by the investigator.
  • Additional inclusion criteria applicable only to participants with breast cancer participating in combination therapy
  • Female participants with breast cancer participating in combination therapy should meet one of the following:
  • 1)Postmenopausal, defined as:
  • Have undergone bilateral oophorectomy ≥14 days and have recovered to baseline status; or
  • Age ≥ 60 years; or
  • Age < 60 years, and amenorrheic for ≥ 12 months, and the levels of follicle-stimulating hormone (FSH) and estradiol (E2) within the local reference range and consistent with menopause criteria when no oral contraceptive pills, hormone replacement therapy, or gonadotropin-releasing hormone agonist/antagonist are used.
  • Premenopausal or perimenopause (perimenopausal is defined as age ≥ 50 and < 60 years with amenorrhea for less than 12 months or FSH and/or E2 not in the postmenopausal range): ovarian function suppression with a luteinizing hormone-releasing hormone agonist such as goserelin or leuprorelin beginning ≥ 2 weeks prior to Day 1 of Cycle 1 and continuing for the duration of the study is require.

Who cannot join

  • Any active malignancy ≤ 2 years prior to the first dose of GenSci145, except for the cancer under study and any locally recurrent cancers that have been cured (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, or breast carcinoma in situ)
  • Symptomatic, treatment-naïve, or progressing central nervous system (CNS) metastases; CNS metastases that have been treated with CNS treatment (e.g., surgery/radiotherapy) is allowed if all of the following conditions are met:
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  • The disease is stable for at least 3 months, with no progressive disease as confirmed by imaging examination within 4 weeks prior to the first dose of the study treatment, and all neurological symptoms have recovered to baseline;
  • Treatment with radiation, surgery, or steroids has been discontinued for at least 4 weeks prior to the first dose of study treatment.
  • 3.History of metastases to meninges, spinal cord compression, or leptomeningeal disease.
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  • 4.Prior history of acute pancreatitis (within the past 1 year) or chronic pancreatitis, or imaging evidence of metastases to pancreas.
  • 5.Stroke, transient ischemic attack, or other clinically significant cerebrovascular events within 6 months prior to the first dose of GenSci145.
  • 6.Active infections requiring IV antibiotics or other uncontrolled intercurrent illnesses requiring hospitalization. Participants with minor infections, such as periodontal infection or urinary tract infection that may be treated with a short course of oral antibiotics, are allowed to be enrolled.
  • 7.Type I diabetes mellitus, or history of gestational diabetes, or type II diabetes mellitus that is uncontrolled as evaluated by the Investigator.
  • 8.Uncontrolled hypertension (defined as blood pressure ≥ 150/90 mmHg despite optimal medical intervention).
  • 9.Clinically significant cardiac disorder, including but not limited to:
  • 1)A history of myocardial infarction or unstable angina within 6 months prior to the first dose of GenSci145; 2)New York Heart Association (NYHA) Class III or higher within 4 weeks prior to the first dose of GenSci145 ; 3)Left ventricular ejection fraction < 50% as evaluated by cardiac echocardiography within 4 weeks prior to the first dose of GenSci145; 4)Mean QT interval corrected by Fridericia's method (QTcF) > 450 ms, based on 3 consecutive resting 12-lead ECGs collected at screening; 5)Any factors that increase the risk of torsades de pointes (e.g., persistent hypokalemia despite standard treatment, family history of long QT syndrome); 6)Any clinically significant abnormalities in heart rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, grade 2/3 atrioventricular block).
  • 10.Interstitial pneumonitis, drug-induced pneumonitis, radiation pneumonitis requiring glucocorticoids, or other significant pulmonary disorder affecting lung function.
  • 11.Gastrointestinal diseases that may interfere with the oral absorption of GenSci145 as evaluated by the investigator, such as peptic ulcer, uncontrolled nausea and vomiting, malabsorption syndrome, history of small intestinal resection, active inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), etc.
  • 12.Serous effusion that is not well controlled, including pleural effusion, ascites, and pericardial effusion (participants can be enrolled if it is controlled and stable for ≥ 2 weeks after treatment).
  • 13.Prior treatment with PI3K, mTOR, or AKT inhibitors. 14.Prior treatment with fulvestrant (excluding Phase Ia and Part 4 Cohort D). 15.Inoculation of live attenuated vaccines within 4 weeks prior to the first dose of GenSci145.
  • 16.Treatment with the following anti-tumor therapies prior to the first dose of GenSci145:
  • Herbal medicines or Chinese patent medicines with anti-tumor activity within 2 weeks;
  • Endocrine therapy with anti-tumor indications within 2 weeks or 5 half-lives (whichever is shorter);
  • Radiotherapy within 4 weeks;
  • Chemotherapy within 4 weeks (6 weeks for nitrosourea or mitomycin; 14 days or 5 half-lives for oral fluorouracil agents, whichever is longer);
  • Small molecule targeted agents, biologics, or immunotherapy within 4 weeks or 5 half-lives (whichever is shorter).
  • 17.Patients who have undergone major surgery within 4 weeks prior to the first dose of GenSci145, have not adequately recovered from the surgery, or are expected to undergo major surgery during the study.
  • 18.Participants who have received strong or moderate inducers or inhibitors of cytochrome P450 family 3 subfamily A (CYP3A) enzyme , or received strong inducers or inhibitors of CYP2C8 enzyme and CYP2C9 enzyme, or received sensitive substrates of CYP3A, CYP2C8, CYP2C9, CYP2C19, and CYP2B6 enzyme , or medications with a known risk of QT/QTc interval prolongation within 5 half-lives or 14 days (whichever is longer) prior to the first dose of GenSci145.
  • 19.Current or recent treatment with systemic glucocorticoids or not fully recovered from side effects of systemic glucocorticoids (topical drugs, such as topical administration for rash, aerosol inhalation for chronic obstructive pulmonary disease, eye drops, and intra-articular local injection are allowed).
  • 20.Prior history of organ transplantation or allogeneic stem cell transplantation.
  • 21.Unable to swallow oral medications (e.g., tablets, capsules) without chewing, breaking, crushing, opening, or otherwise altering the form of the product.
  • 22.Positive hepatitis B test [defined as hepatitis B surface antigen (HBsAg) positive, further testing with hepatitis B virus DNA (HBV DNA) is required, and participants with a result above the assey upper limit of normal will be excluded]; positive hepatitis C virus antibody (HCV Ab) [further testing with hepatitis C virus RNA (HCV RNA) is required, and participants with a result above the assay upper limit of normal will be excluded]; or positive human immunodeficiency virus antibody (HIV Ab).
  • 23.Persistent toxicity of grade ≥ 2 from prior anti-tumor therapy as per CTCAE v6.0, except for alopecia, stable Grade 2 peripheral neuropathy, or adequately controlled endocrine toxicities.
  • 24.Known serious allergy to GenSci145 and/or any of its excipients. Participants with hypersensitivity to fulvestrant or palbociclib will also be excluded if entering the combination therapy group (applicable to Part 3 triplet combination and Part 4 Cohort C).
  • 25.Pregnant or breastfeeding women, or women who plan to breastfeed during the study or within 30 days after the last dose of GenSci145 (may be extended to 2 years if in combination with fulvestrant as per local prescribing information).
  • 26.Participation in other clinical studies within 4 weeks prior to the first dose (except for observational non-interventional studies or during the follow-up period in interventional studies).
  • 27.Any other condition that, in the investigator's opinion, would make the participant unsuitable for the study.

Trial locations and contacts

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

Binhe Xu contact

+8613501028690

xubingheBM@163.com

China1 site, 1 recruiting

  • The Cancer Hospital of the Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Binhe Xu, +8613501028690, xubingheBM@163.com

    Recruiting

Other trials in China

About this study

Official title: An International, Multicenter, Open-label, Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of GenSci145, as Monotherapy or in Combination Therapy, in Participants With PIK3CA-mutated, Locally Advanced or Metastatic Solid Tumors.

An international, multicenter, open-label, Phase 1/2 clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of GenSci145, as monotherapy or in combination therapy, in participants with PIK3CA-mutated, locally advanced or metastatic solid tumors.

Read the detailed description

An international, multicenter, open-label, Phase 1/2 clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of GenSci145, as monotherapy or in combination therapy, in participants with PIK3CA-mutated, locally advanced or metastatic solid tumors.

Being tested
GenSci145 tablets

What participants receive

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

  • GenSci145 tabletsDrug

    Participants will receive GenSci145 as stipulated in the research protocol

Study groups in NCT07407504
Study groupRoleWhat they receive
GenSci145 tabletsExperimentalNot described
Receives: Drug: GenSci145 tablets

What is being measured

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

  1. Phase Ia :Incidence and severity of treatment-emergent adverse events (TEAEs)

    Measured: Collect the adverse events (AES) that occurred in the subjects from the signing of the ICF to 30 days after the last administration of the investigational drug or the initiation of a new anti-tumor treatment (whichever occurs first).

  2. Part1:Dose limiting toxicities(DLTs)

    Measured: At the end of Cycle 1 (each cycle is 28 days).

Secondary outcomes (8)

  1. To determine the maximum tolerated dose (MTD) (if applicable) and recommended dose for expansion (RDE) of GenSci145.

    Measured: Approximately form time of first dose of GenSci145 up to 12 months.

  2. Peak concentration (Cmax) of GenSci145

    Measured: Approximately 12 months.

  3. Peak time (Tmax) of GenSci145

    Measured: Approximately 12 months.

  4. The area under the drug-time curve from time 0 to the last measurable concentration time point (AUC0-last) of GenSci145

    Measured: Approximately 12 months.

  5. Half-life (t1/2) of GenSci145

    Measured: Approximately 12 months.

  6. Apparent clearance rate (CL/F) of GenSci145

    Measured: Approximately 12 months.

  7. The apparent distribution volume (Vd/F) and the area under the drug-time curve from time 0 to infinity (AUC0-inf) of GenSci145.

    Measured: Approximately 12 months.

  8. ORR,the best overall response (BOR) is achieved at complete response (CR) or partial response (PR) Proportion of subjects.

    Measured: Approximately 12 months.

Timeline

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

  1. First posted12 Feb 2026
  2. Study start1 Apr 2026
  3. Primary completion8 Nov 2028 (estimated)
  4. Study completion21 Feb 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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
186 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07407504
Sponsor's protocol ID
GenSci145-101
Status last verified
Jan 2026
First submitted
3 Feb 2026
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GenSci145 tablets in people with Locally Advanced or Metastatic Solid Tumors With PIK3CA-mutated, run by Changchun GeneScience Pharmaceutical 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 44 inclusion and 34 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 25 Sep 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 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 Binhe Xu (+8613501028690, xubingheBM@163.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 treatment-emergent adverse events (TEAEs) (time frame: Collect the adverse events (AES) that occurred in the subjects from the signing of the ICF to 30 days after the last administration of the investigational drug or the initiation of a new anti-tumor treatment (whichever occurs first).). 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 NCT07407504.

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 25 Sep 2026.

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