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

NCT06959706 | Recruiting Phase 1 FDA Drug

• 1 other identifier: TGW101-101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 7

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Number of Participants Experiencing Adverse Events (AEs)

  Up to approximately 10 months

• Number of Participants Experiencing Dose-limiting Toxicities (DLTs)

  Up to Day 21

• Number of Participants Experiencing Cycle Delay

  Up to approximately 10 months

• Number of Participants Experiencing Dose Reduction

  Up to approximately 10 months

• RDE of TGW101

  Up to approximately 10 months

Secondary Outcomes (15)

• Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of TGW101-ADC and TRG001

  Up to approximately 10 months

• Area Under the Concentration-time Curve From Time Zero to the end of the Dosing Interval (AUCtau) of TGW101-ADC and TRG001

  Up to approximately 10 months

• Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of TGW101-ADC and TRG001

  Up to approximately 10 months

• Maximum Concentration (Cmax) of TGW101-ADC and TRG001

  Up to approximately 10 months

• Trough Concentration (Ctrough) of TGW101-ADC and TRG001

  Up to approximately 10 months

Study Arms (2)

TGW101: Dose Escalation Cohorts

EXPERIMENTAL

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: Enrichment Cohorts

EXPERIMENTAL

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.

Drug: TGW101

Interventions

TGW101 DRUG

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: Dose Escalation Cohorts; TGW101: Enrichment Cohorts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tagworks Pharmaceuticals BV: lead

Study Sites (7)

Honor Health

Scottsdale, Arizona, 85258, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

NEXT Dallas

Irving, Texas, 75039, United States

RECRUITING

NEXT San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

NEXT Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Tagworks Pharmaceuticals

CONTACT

Please email; clinicaltrials@tagworkspharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 6, 2025
• Study Start: May 7, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)