Evaluating TGW101 for advanced solid tumors
Phase 1, First-in-Human, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TGW101 in Patients With Advanced Solid Tumors
This study is testing a new drug called TGW101 to see if it is safe and effective for people with advanced solid tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tagworks Pharmaceuticals BV Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 7 sites (Scottsdale, Arizona and 6 other locations) |
| Trial ID | NCT06959706 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and tolerability of TGW101, an antibody-drug conjugate, in patients with advanced solid tumors. It will also determine the recommended dosing regimen for future studies and evaluate the pharmacokinetics and preliminary anti-tumor activity of the treatment. Participants will be closely monitored for any adverse effects and the effectiveness of the drug in halting disease progression.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed advanced solid tumors that have shown disease progression after previous treatments.
Not a fit: Patients with early-stage tumors or those who have not progressed after standard treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors.
How similar studies have performed: Other studies involving antibody-drug conjugates have shown promising results, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Written informed consent prior to any study procedures. 2. Males or females 18 years or older. 3. 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: 1. Breast cancer (all subtypes). 2. Castrate-resistant prostate cancer. 3. Cervical cancer. 4. Endometrial cancer. 5. Esophageal, adenocarcinoma only. 6. Gastric/gastroesophageal junction (GEJ). 7. Non-squamous cell carcinoma of the head and neck, e.g., salivary gland neoplasms, with the exception of adenoid cystic carcinoma. 8. Non-small cell lung cancer, adenocarcinoma only. 9. Ovarian. 4. 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. 5. At least 1 measurable lesion per RECIST v1.1 except for participants with bone-only metastatic disease. 6. Biopsy pretreatment; if not possible, archival tissue block (preferred) or unstained formalin-fixed paraffin-embedded slides required. 7. Eastern Cooperative Oncology Group Performance Status 0-1. 8. Life expectancy of \> 3 months in the opinion of the Investigator. 9. Adequate hepatic, hematologic, and renal function. Exclusion Criteria: 1. 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. 2. Known symptomatic brain metastases. 3. Significant cardiovascular disease within 6 months prior to starting study drug. 4. Evidence of an active systemic bacterial, fungal, or viral infection requiring treatment. 5. Grade ≥ 2 peripheral neuropathy. 6. Major surgery within 4 weeks prior to starting study drug. 7. Prior solid organ or bone marrow progenitor cell transplantation. 8. Prior high-dose chemotherapy requiring stem cell rescue. 9. Anticancer therapy within 28 days or within 5 half-lives (whichever is shorter) prior to starting study drug. 10. Palliative radiation therapy within 14 days prior to starting study drug. 11. Live vaccine within 28 days prior to starting study drug. 12. Pregnant or a breastfeeding postpartum female.
Where this trial is running
Scottsdale, Arizona and 6 other locations
- Honor Health — Scottsdale, Arizona, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- NEXT Dallas — Irving, Texas, United States (Recruiting)
- NEXT San Antonio — San Antonio, Texas, United States (Recruiting)
- NEXT Virginia — Fairfax, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Tagworks Pharmaceuticals
- Email: clinicaltrials@tagworkspharma.com
- Phone: Please email
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.