RECRUITING

Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TGW101 in Participants With Advanced Solid Tumors

Conditions

Advanced Solid Tumors Antibody-drug conjugates Carcinoma TGW101 TGW101-ADC TRG001 TAG-72 Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase 1, First-in-Human, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TGW101 in Patients With Advanced Solid Tumors

Quick Facts

Study Start:2025-05-07

Study Completion:2027-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06959706

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Tagworks Pharmaceuticals

CONTACT

Please email

clinicaltrials@tagworkspharma.com

Study Locations (Sites)

Honor Health

Scottsdale, Arizona, 85258

United States

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

United States

NEXT Dallas

Irving, Texas, 75039

United States

NEXT San Antonio

San Antonio, Texas, 78229

United States

NEXT Virginia

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: Tagworks Pharmaceuticals BV

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-07

Study Completion Date2027-09

Study Record Updates

Study Start Date2025-05-07

Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Advanced Solid Tumors