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

NCT07407504 | Not Yet Recruiting Phase 1

• 1 other identifier: GenSci145-101
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Locally Advanced or Metastatic Solid Tumors With PIK3CA-mutated

Outcome Measures

Primary Outcomes (2)

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

  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).

• Part1:Dose limiting toxicities(DLTs)

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

Secondary Outcomes (8)

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

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

• Peak concentration (Cmax) of GenSci145

  Approximately 12 months.

• Peak time (Tmax) of GenSci145

  Approximately 12 months.

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

  Approximately 12 months.

• Half-life (t1/2) of GenSci145

  Approximately 12 months.

Other Outcomes (6)

• DOR,from the first assessment of CR or PR to the first assessment of disease progression (PD) or death The duration of (whichever occurs first).

  Approximately 12 months.

• DCR,the proportion of subjects whose BOR reached CR, PR or disease stability (SD).

  Approximately 12 months.

• CBR,the proportion of subjects whose BOR reached CR, PR or SD (duration ≥6 months).

  Approximately 12 months.

Study Arms (1)

GenSci145 tablets

EXPERIMENTAL

Drug: GenSci145 tablets

Interventions

GenSci145 tablets DRUG

Participants will receive GenSci145 as stipulated in the research protocol

GenSci145 tablets

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and voluntarily provide written ICF.
• Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other protocol-specified procedures.
• Age 18-75 years (inclusive) at the time of providing informed consent.
• Disease diagnosis requirements:
• Part 1:
• Histologically or cytologically confirmed locally advanced or metastatic solid tumors.
• Disease progression after standard therapy, or, in the opinion of the investigator, no available and effective standard therapy.
• Part 2:
• Histologically or cytologically confirmed HR+/HER2- locally advanced or metastatic breast cancer \[HR+ is defined as estrogen receptor (ER) positive and/or progesterone receptor (PR) positive (≥10% of tumor cell nuclei showing positive staining); HER2- is defined as immunohistochemistry (IHC) 0 or 1+, or IHC 2+ with a negative in situ hybridization (ISH) result\].
• Disease progression after standard therapy, or, in the opinion of the investigator, no available and effective standard therapy.
• Part 3 (doublet) and Part 4 Cohort 1:
• Histologically or cytologically confirmed HR+/HER2- locally advanced or metastatic breast cancer.
• Patients must meet one of the following:
• Disease progression during (neo)adjuvant endocrine therapy or within 12 months after completion of such therapy, without having received any prior therapy for metastatic disease.
• Disease progression occurring more than 12 months after completion of adjuvant endocrine therapy, followed by first-line endocrine therapy for metastatic disease, with subsequent progression on that therapy.

You may not qualify if:

• History of any active malignancy within ≤2 years prior to the first dose of GenSci145, except for the malignancy under investigation in this study and any curatively treated locally recurrent malignancies
• Presence of symptomatic, untreated, or progressing CNS metastases. Participants with previously treated CNS metastases (e.g., by surgery or radiotherapy) are eligible only if all of the following conditions are met:
• Disease stable for at least 3 months, with no evidence of progression on imaging within 4 weeks prior to first dose of study treatment, all neurologic symptoms recovered to baseline, and no evidence of new or enlarging brain metastases.
• At least 4 weeks have elapsed since completion of CNS-directed radiotherapy, surgery, or corticosteroid therapy prior to the first dose of study treatment.
• History of leptomeningeal metastases, spinal cord compression, or leptomeningeal disease.
• History of acute pancreatitis (within 1 year) or chronic pancreatitis, or radiologic evidence of pancreatic metastases.
• History of stroke, transient ischemic attack, or other clinically significant cerebrovascular events within 6 months prior to the first dose of GenSci145.
• Active infection requiring intravenous antibiotics, or other uncontrolled intercurrent illness requiring hospitalization. Minor infections such as periodontal infection or urinary tract infection manageable with short-course oral antibiotics are permitted.
• Confirmed diagnosis of uncontrolled diabetes mellitus, defined as HbA1c ≥8% and/or fasting plasma glucose ≥140 mg/dL (7.7 mmol/L).
• Uncontrolled hypertension, defined as blood pressure ≥150/90 mmHg despite optimal medical management.
• Clinically significant cardiovascular disease, including but not limited to:
• Myocardial infarction or unstable angina within 6 months prior to the first dose of GenSci145.
• New York Heart Association (NYHA) Class III or higher within 4 weeks prior to the first dose.
• Left ventricular ejection fraction (LVEF) \<50%, assessed by echocardiogram within 4 weeks prior to the first dose.
• Based on three consecutive resting ECGs collected during the screening, the average QT interval corrected by Fridericia's formula (QTcF) is \>450 ms for males and \>470 ms for females.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Cancer Hospital of the Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Central Study Contacts

Binhe Xu

CONTACT

+8613501028690; xubingheBM@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 12, 2026
• Study Start: March 14, 2026
• Primary Completion (Estimated): November 8, 2028
• Study Completion (Estimated): February 21, 2029
• Last Updated: February 12, 2026

Record last verified: 2026-01

Locations

CN (1)