Status:
RECRUITING
Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TGW101 in Participants With Advanced Solid Tumors
Lead Sponsor:
Tagworks Pharmaceuticals BV
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 pha...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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.
Key Trial Info
Start Date :
May 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06959706
Start Date
May 7 2025
End Date
September 1 2027
Last Update
December 23 2025
Active Locations (5)
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1
Honor Health
Scottsdale, Arizona, United States, 85258
2
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
3
NEXT Dallas
Irving, Texas, United States, 75039
4
NEXT San Antonio
San Antonio, Texas, United States, 78229