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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Tagworks Pharmaceuticals BV
Study ID
NCT06959706
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
May 7, 2025
Status verified
Apr 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to approximately 10 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Honor HealthScottsdaleArizona85258-
Massachusetts General HospitalBostonMassachusetts02114-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-
NEXT DallasIrvingTexas75039-
NEXT San AntonioSan AntonioTexas78229-
NEXT VirginiaFairfaxVirginia22031-

Find similar trials in Scottsdale, AZ

By research site
Honor Health· Scottsdale, AZMassachusetts General Hospital· Boston, MAFox Chase Cancer Center· Philadelphia, PAUniversity of Texas MD Anderson Cancer Center· Houston, TXNEXT Dallas· Irving, TXNEXT San Antonio· San Antonio, TX

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