NCT06959706 · Tagworks Pharmaceuticals BV
Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TGW101 in Participants With Advanced Solid Tumors
What this study is about
The primary objectives of this study are to evaluate the safety and how well patients handle the treatment of TGW101 and determine the recommended dosing regimen(s) for further study. The secondary objectives are to assess how the drug moves through the body and preliminary antitumor activity.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 (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.
- 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.
Where
- Scottsdale, Arizona
- Boston, Massachusetts
- Philadelphia, Pennsylvania
- Houston, Texas
- Irving, Texas
- San Antonio, Texas
- Fairfax, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 16, 2026 · Source of record for eligibility and locations