Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TGW101 in Participants With Advanced Solid Tumors
NCT ID: NCT06959706
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
50 participants
INTERVENTIONAL
2025-05-07
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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TGW101: Dose Escalation Cohorts
Escalating doses of TGW101-anti-drug conjugate (ADC) will be administered via intravenous (IV) infusion followed by administration of TRG001. The treatment period continues until a reason for permanent discontinuation of treatment occurs.
TGW101
TGW101 is a combination product comprising a chemically cleavable diabody drug conjugate (TGW101-ADC) and a corresponding small molecule chemical trigger (TRG001) administered separately.
TGW101: Enrichment Cohorts
During Dose Escalation, additional participants may be enrolled to permit further evaluation of TGW101 to support selection of the optimal recommended dosing regimen(s) for expansion (RDE\[s\]). At the discretion of the Safety Oversight Committee (SOC), enrollment in enrichment cohorts may be limited to specific tumor type(s) based on assessment of clinical activity by the Sponsor in the dose escalation portion, and other nonclinical, translational, and clinical data.
TGW101
TGW101 is a combination product comprising a chemically cleavable diabody drug conjugate (TGW101-ADC) and a corresponding small molecule chemical trigger (TRG001) administered separately.
Interventions
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TGW101
TGW101 is a combination product comprising a chemically cleavable diabody drug conjugate (TGW101-ADC) and a corresponding small molecule chemical trigger (TRG001) administered separately.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Tagworks Pharmaceuticals BV
INDUSTRY
Responsible Party
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Locations
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Honor Health
Scottsdale, Arizona, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
NEXT Dallas
Irving, Texas, United States
NEXT San Antonio
San Antonio, Texas, United States
NEXT Virginia
Fairfax, Virginia, United States
Countries
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Central Contacts
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Other Identifiers
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TGW101-101
Identifier Type: -
Identifier Source: org_study_id