A Study of Sirolimus for Injection (Albumin-bound) in Patients With Advanced Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, multi-center phase 1b study to evaluate the safety and efficacy of Sirolimus for injection (albumin-bound) in patients with malignant solid tumors with TSC1 or TSC2 genetic alterations.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Treatments: Sirolimus

Criteria

Inclusion Criteria:

• Patients must have histologically or cytologically confirmed diagnosis of malignant solid tumors, with TSC1 or TSC2 genetic alterations, and have no standard treatment or have failed standard treatments.

• Patients must have archival tumor tissues or agreed to have a tumor biopsy (if not, the sponsor's consent is required for enrollment).

• At least 1 measurable lesion as defined by RECIST 1.1.

• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.

• Life expectancy of ≥3 months.

• Adequate marrow and organ function.

• Fasting serum triglyceride must be <300 mg/dL or <3.42 mmol/L; fasting serum cholesterol must be<350 mg/dL or <9.07 mmol/L.

• Fasting blood glucose must be<6.1 mmol/L and HbA1c< 6.5% in dose escalation, in other stage must be < 7.8 mmol/L and be< 8% respectively.

• Women of child-bearing potential, or men whose partners are women of childbearing age must agree to use reliable contraceptive methods during the trial period and at least 6 months after the last administration; women of childbearing age must have a negative serum pregnancy test within 7 days prior to the first administration, should not be breast feeding.

• Patients should understand and willingness to sign a written informed consent form prior to study entry.

Exclusion Criteria:

• Prior treatment with an mTOR inhibitor.

• Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, target therapy, immune checkpoint inhibitor therapy and other anti-tumor treatments within 4 weeks prior to first dose of study treatment, except for the following items:Treatment with nitrosourea or Mitomycin C within 6 weeks prior to first dose of study treatment; Treatment with oral fluorouracil or targeted small molecule drugs within 2 weeks or approximately 5 half-lives, whichever is the longer, prior to the first dose of study treatment; Treatment with herbal medicine with anti-tumor indication within 2 weeks prior to the first dose of study treatment.

• Have received other therapy in another clinical study within 4 weeks prior to the first dose of study treatment.

• Have had major surgery within 4 weeks prior to starting study drug, or have not recovered adequately from any previous procedure.

• Have not recovered to ≤ grade 1 (CTCAE version 5.0) from adverse reactions of previous anti-tumor treatments (Except for alopecia or any other toxicity with no safety risk assessed by the investigator).

• Patients with primary brain tumors or PEComa.

• Central nervous system metastasis (CNS) or meningeal metastasis with clinical symptoms, or have any other evidence indicate it is uncontrolled, which is ineligible for enrollment assessed by investigator.

• History of serious cardiovascular disease.

• History of serious lung disease, such as interstitial lung disease and/or pneumonitis, or pulmonary hypertension, or pre-existing severely impaired lung function.

• Hydrothorax, ascities or pleural effusion with clinical symptoms or required treatment.

• Patients with hepatocellular carcinoma (HCC): Child-Pugh class B or C; or HCC with ≥50% liver occupation; or has a history or current evidence of hepatic encephalopathy; portal vein invasion at the main portal branch (Vp4).

• Have received a live vaccine (including live attenuated vaccine) within 30 days prior to the signature of ICF..

• Recent infection requiring systemic anti-infective treatment that was completed ≤14 days prior to enrollment.

• History of autoimmune disease or immunodeficiency disease, including HIV positive, or other acquired, congenital immunodeficiency, or organ transplant history.

• Active Hepatitis B or Hepatitis C.

• Have received a CYP3A4 strong inhibitor or inducer within 2 weeks prior to start of treatment initiation, or requiring concomitant treatment during the study.

• Other server disease (such as uncontrolled hypertension, active gastrointestinal bleeding) that may increase the risk of patients, or interfere the compliance of study procedures, or other reasons which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.