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

Purpose

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 anti-tumor activity.

Condition

Advanced Solid Tumors

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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 (triple negative, estrogen receptor and/or progesterone receptor positive, and/or human epidermal growth factor receptor 2 positive). 2. Castrate-resistant prostate cancer. 3. Cervical cancer. 4. Endometrial cancer. 5. Esophageal, adenocarcinoma only. 6. Gastric. 7. Non-squamous cell carcinoma of the head and neck, e.g., salivary gland neoplasms. 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

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

Phase: Phase 1
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
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.	Drug: 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.
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 a Safety Oversight Committee (SOC), enrollment in enrichment cohorts may be limited to specific tumor type(s).	Drug: 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.

Recruiting Locations

NEXT Dallas
Irving, Texas 75039

NEXT San Antonio
San Antonio, Texas 78229

NEXT Virginia
Fairfax, Virginia 22031

More Details

NCT ID: NCT06959706
Status: Recruiting
Sponsor: Tagworks Pharmaceuticals BV

Study Contact

Tagworks Pharmaceuticals
Please email
clinicaltrials@tagworkspharma.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.