Recruiting
Phase 1

TGW101

Sponsor:

Tagworks Pharmaceuticals BV

Code:

NCT06959706

Conditions

Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TGW101

Study Details

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 pharmacokinetics and preliminary antitumor activity.

Conditions

Advanced Solid Tumors

Study ID

NCT06959706

Start date

May 7, 2025

Status verified date

Apr, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

Interventions

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.

Primary outcome measure

  • Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to approximately 10 months ]
  • Number of Participants Experiencing Dose-limiting Toxicities (DLTs) [ Time Frame: Up to Day 21 ]
  • Number of Participants Experiencing Cycle Delay [ Time Frame: Up to approximately 10 months ]
  • Number of Participants Experiencing Dose Reduction [ Time Frame: Up to approximately 10 months ]
  • RDE of TGW101 [ Time Frame: Up to approximately 10 months ]

Central Contacts and Locations

Central contacts

Locations

Honor Health

Recruiting

Scottsdale, Arizona, United States, 85258

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

NEXT Dallas

Recruiting

Irving, Texas, United States, 75039

NEXT San Antonio

Recruiting

San Antonio, Texas, United States, 78229

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Tagworks Pharmaceuticals BV

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Keywords

  • Antibody-drug conjugates
  • Carcinoma
  • TGW101
  • TGW101-ADC
  • TRG001
  • TAG-72
  • Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Tagworks Pharmaceuticals BV on 2026-04-16.