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Advanced Solid TumorsPhase 1NCT06959706

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

A Phase 1 study testing TGW101 in people with Advanced Solid Tumors, run by Tagworks Pharmaceuticals BV at 7 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
TGW101
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
7 sitesUnited States
Study dates
7 May 2025to Dec 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 and have evidence of disease progression on or after (within 3 months of discontinuation) the most recent treatment regimen:
  • Endometrial cancer.
  • Esophageal, adenocarcinoma only.
  • Gastric/gastroesophageal junction (GEJ).
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  • 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.
  • Eastern Cooperative Oncology Group Performance Status 0-1.
  • Life expectancy of > 3 months in the opinion of the Investigator.
  • Adequate hepatic, hematologic, and renal function.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Tagworks Pharmaceuticals contact

Please email

clinicaltrials@tagworkspharma.com

7 sites in 1 country

United States7 sites, 7 recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Recruiting

  • NEXT Virginia

    Fairfax, Virginia, 22031

    Recruiting

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • NEXT Dallas

    Irving, Texas, 75039

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Recruiting

  • NEXT San Antonio

    San Antonio, Texas, 78229

    Recruiting

  • Honor Health

    Scottsdale, Arizona, 85258

    Recruiting

Other trials in United States

About this study

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

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.

Being tested
TGW101
Keywords
Antibody-drug conjugates, Carcinoma, TGW101, TGW101-ADC, TRG001, TAG-72, Cancer
Medical subject headings
Carcinoma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TGW101Drug

    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 groups in NCT06959706
Study groupRoleWhat they receive
TGW101: Dose Escalation CohortsExperimentalEscalating 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.
Receives: Drug: TGW101
TGW101: Enrichment CohortsExperimentalDuring 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.
Receives: Drug: TGW101

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Experiencing Adverse Events (AEs)

    Measured: Up to approximately 10 months

  2. Number of Participants Experiencing Dose-limiting Toxicities (DLTs)

    Measured: Up to Day 28

  3. Number of Participants Experiencing Cycle Delay

    Measured: Up to approximately 10 months

  4. Number of Participants Experiencing Dose Reduction

    Measured: Up to approximately 10 months

  5. RDE of TGW101

    Measured: Up to approximately 10 months

Secondary outcomes (15)

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

    Measured: Up to approximately 10 months

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

    Measured: Up to approximately 10 months

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

    Measured: Up to approximately 10 months

  4. Maximum Concentration (Cmax) of TGW101-ADC and TRG001

    Measured: Up to approximately 10 months

  5. Trough Concentration (Ctrough) of TGW101-ADC and TRG001

    Measured: Up to approximately 10 months

  6. Time to Maximum Concentration (Tmax) of TGW101-ADC and TRG001

    Measured: Up to approximately 10 months

  7. Apparent Terminal Elimination Half-life (t1/2) of TGW101-ADC and TRG001

    Measured: Up to approximately 10 months

  8. Steady-state Volume of Distribution (Vss) of TGW101-ADC and TRG001

    Measured: Up to approximately 10 months

  9. Clearance (CL) of TGW101-ADC and TRG001

    Measured: Up to approximately 10 months

  10. Accumulation Index of TGW101-ADC and TRG001

    Measured: Up to approximately 10 months

  11. Overall Response Rate (ORR)

    Measured: Up to approximately 10 months

  12. Duration of Response (DOR)

    Measured: Up to approximately 10 months

  13. Progression-free Survival (PFS)

    Measured: Up to approximately 10 months

  14. Overall Survival (OS)

    Measured: Up to approximately 10 months

  15. Number of Participants Experiencing Antidrug Antibodies (ADAs) Against TGW101-ADC

    Measured: Up to approximately 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2025
  2. Study start7 May 2025
  3. Primary completionOct 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06959706
Sponsor's protocol ID
TGW101-101
Status last verified
Oct 2026
First submitted
28 Apr 2025
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TGW101 in people with Advanced Solid Tumors, run by Tagworks Pharmaceuticals BV at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tagworks Pharmaceuticals (Please email, clinicaltrials@tagworkspharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Experiencing Adverse Events (AEs) (time frame: Up to approximately 10 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06959706.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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