Actively Recruiting
Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TGW101 in Participants With Advanced Solid Tumors
Led by Tagworks Pharmaceuticals BV · Updated on 2026-04-16
50
Participants Needed
7
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TGW101 in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent before any study procedures
- Male or female aged 18 years or older
- Histologically or cytologically confirmed diagnosis of specified advanced solid tumors with evidence of disease progression
- Breast cancer (all subtypes), castrate-resistant prostate cancer, cervical cancer, endometrial cancer, esophageal adenocarcinoma, gastric/gastroesophageal junction cancer, non-squamous head and neck carcinoma (excluding adenoid cystic carcinoma), non-small cell lung adenocarcinoma, or ovarian cancer
- Disease refractory to, intolerant of, or refusal of available standard therapies
- At least one measurable lesion per RECIST v1.1 (except for bone-only metastatic disease)
- Available pretreatment biopsy or archival tissue block or unstained slides
- Eastern Cooperative Oncology Group Performance Status 0-1
- Life expectancy greater than 3 months as judged by the investigator
- Adequate liver, blood, and kidney function
You will not qualify if you...
- Active second malignancy or history of another malignancy within 2 years, except certain treated cancers
- Known symptomatic brain metastases
- Significant cardiovascular disease within 6 months before study drug start
- Active systemic bacterial, fungal, or viral infection requiring treatment
- Grade 2 or higher peripheral neuropathy
- Major surgery within 4 weeks before starting study drug
- Prior solid organ or bone marrow transplant
- Prior high-dose chemotherapy needing stem cell rescue
- Anticancer therapy within 28 days or 5 half-lives before study drug start
- Palliative radiation therapy within 14 days before study drug start
- Live vaccine within 28 days before study drug start
- Pregnant or breastfeeding females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Honor Health
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
3
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
4
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
5
NEXT Dallas
Irving, Texas, United States, 75039
Actively Recruiting
6
NEXT San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
7
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
T
Tagworks Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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