Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TGW101 in Participants With Advanced Solid Tumors
Research Study on Investigational Medication for Advanced Solid Tumors
Brief description of study
The primary objectives of this study are to evaluate the safety and tolerability of TGW101 and determine the recommended dosing regimen(s) for further study. The secondary objectives are to assess pharmacokinetics and preliminary anti-tumor activity.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Advanced Solid Tumors
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Age: 18 years or above
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Gender: All
Inclusion Criteria:
- Written informed consent prior to any study procedures.
- Males or females 18 years or older.
Histologically or cytologically confirmed diagnosis of a solid tumor malignancy listed below, with radiographic evidence of disease progression based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or for castration resistant prostate cancer (CRPC), Prostate Cancer Clinical Trials Working Group 3, after most recent treatment and locally advanced or metastatic disease at Screening:
- Breast cancer (triple negative, estrogen receptor and/or progesterone receptor positive, and/or human epidermal growth factor receptor 2 positive).
- Castrate-resistant prostate cancer.
- Cervical cancer.
- Endometrial cancer.
- Esophageal, adenocarcinoma only.
- Gastric.
- Non-squamous cell carcinoma of the head and neck, e.g., salivary gland neoplasms.
- Non-small cell lung cancer, adenocarcinoma only.
- Ovarian.
- Refractory disease, intolerance to, or documented refusal of available standard therapy(ies) known to provide clinical benefit for the participant's solid tumor malignancy per Investigator judgment.
- At least 1 measurable lesion per RECIST v1.1 except for participants with bone-only metastatic disease.
- Biopsy pretreatment; if not possible, archival tissue block (preferred) or unstained formalin-fixed paraffin-embedded slides required.
- Eastern Cooperative Oncology Group Performance Status 0-1.
- Life expectancy of > 3 months in the opinion of the Investigator.
- Adequate hepatic, hematologic, and renal function.
Exclusion Criteria:
- Active second malignancy or history of another malignancy within the last 2 years, with the exception of: treated non-melanoma skin cancers; treated carcinoma in situ (e.g., breast and cervix); controlled superficial carcinoma of the urinary bladder; T1a or b carcinoma of the prostate; papillary thyroid carcinoma Stage I treated surgically for cure.
- Known symptomatic brain metastases.
- Significant cardiovascular disease within 6 months prior to starting study drug.
- Evidence of an active systemic bacterial, fungal, or viral infection requiring treatment.
- Grade ≥ 2 peripheral neuropathy.
- Major surgery within 4 weeks prior to starting study drug.
- Prior solid organ or bone marrow progenitor cell transplantation.
- Prior high-dose chemotherapy requiring stem cell rescue.
- Anticancer therapy within 28 days or within 5 half-lives (whichever is shorter) prior to starting study drug.
- Palliative radiation therapy within 14 days prior to starting study drug.
- Live vaccine within 28 days prior to starting study drug.
- Pregnant or a breastfeeding postpartum female.
This study investigates the effects of an investigational medication on patients with advanced solid tumors. Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. This study focuses on various types of solid tumors, including breast cancer, prostate cancer, cervical cancer, and others, to understand how the investigational medication impacts tumor growth and progression.
Participants in this study will undergo specific procedures to evaluate the effects of the investigational medication. These procedures may include imaging tests, blood tests, and biopsies, which involve taking a small sample of tissue for examination. The study aims to gather data on the safety and efficacy of the investigational medication, which is not yet approved for general use.
- Who can participate: Adults 18 years or older with a confirmed diagnosis of certain types of advanced solid tumors, such as breast or prostate cancer, may be eligible. Participants must have disease progression after recent treatment and meet specific health criteria, including a performance status of 0-1 and measurable lesions.
- Study details: Participants will receive an investigational medication to assess its effects on tumor growth. Some participants may receive a placebo, an inactive substance that looks like the investigational medication but does not contain any medicine. The study will include various tests and assessments to monitor health and tumor response.
