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

  • STATUS
    Recruiting
  • End date
    Sep 7, 2027
  • participants needed
    50
  • sponsor
    Tagworks Pharmaceuticals BV
Send
Updated on 7 May 2025
See if I qualify

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 anti-tumor activity.

Details
Condition Advanced Solid Tumors
Age 18years or above
Clinical Study IdentifierNCT06959706
SponsorTagworks Pharmaceuticals BV
Last Modified on7 May 2025

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

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
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
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Preferred way of contact
Race
Ethnicity
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.