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Tests treatment safety and results for Advanced Solid Tumors
Official title Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TGW101 in Participants With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06959706
What this study is testing
What is TGW101?
TGW101 is an investigational medicine, being studied as a potential treatment for advanced solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 antitumor activity.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Breast cancer (all subtypes).
- Castrate-resistant prostate cancer.
You likely can't join if
- Active second malignancy or history of another malignancy within the last 2 years, with the exception of: treated non-melanoma skin cancers; treated...
- 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.
See the full eligibility 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...
- Breast cancer (all subtypes).
- Castrate-resistant prostate cancer.
- Cervical cancer.
- Endometrial cancer.
- Esophageal, adenocarcinoma only.
- Gastric/gastroesophageal junction (GEJ).
- Non-squamous cell carcinoma of the head and neck, e.g., salivary gland neoplasms, with the exception of adenoid cystic carcinoma.
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Boston, Massachusetts, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Irving, Texas, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Boston, Massachusetts, United States; Philadelphia, Pennsylvania, United States; Houston, Texas, United States; Irving, Texas, United States; San Antonio, Texas, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.