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New Two-Part cancer drug enters first human tests

NCT ID NCT06959706

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial is testing a new drug called TGW101 in people with advanced solid tumors that have not responded to other treatments. TGW101 is given in two parts: an antibody-drug conjugate and a chemical trigger that activates it. The main goal is to check safety and find the right dose, while also looking at how the drug moves through the body and whether it shrinks tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TGW101 (a two-part drug: an antibody-drug conjugate and a chemical trigger)
What this could lead to
If it works, this could point toward a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
What could go wrong
This is a very early Phase 1 trial with only 50 participants, focused mainly on safety. It is too soon to know if TGW101 will be effective, and side effects are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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. Exclusion Criteria: 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    7 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Fox Chase Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19111, United States

  • Honor Health

    RECRUITING

    Scottsdale, Arizona, 85258, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • NEXT Dallas

    RECRUITING

    Irving, Texas, 75039, United States

  • NEXT San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

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