TGW101 for Cancer

Recruiting at 4 trial locations

Overseen By Tagworks Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Tagworks Pharmaceuticals BV

Disqualifiers: Active second malignancy, Brain metastases, Cardiovascular disease, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Until discontinuation criteria are met

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called TGW101, an experimental therapy, to determine its safety and optimal dosage. It targets individuals with specific cancers, such as breast, prostate, or lung cancer, who have not responded to standard treatments. Participants will receive TGW101 through an IV, and researchers will monitor its effects and any side effects. Those with measurable tumors who have tried other treatments without success might be suitable for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not have had anticancer therapy within 28 days or within 5 half-lives of the drug (whichever is shorter) before starting the study drug.

Is there any evidence suggesting that TGW101 is likely to be safe for humans?

Research shows that TGW101 is being tested for safety and tolerability. This study aims to determine the right dose for future tests. As a Phase 1 trial, it is among the first times TGW101 is tried in humans, so information on its safety is currently limited.

Phase 1 trials primarily focus on safety, with researchers closely monitoring for side effects. They aim to find the highest dose that people can tolerate without significant issues. If TGW101 is well-tolerated, participants do not experience severe side effects. However, as an early-stage trial, detailed information about potential negative side effects is not yet available.

In summary, TGW101 is in the early testing stages, and researchers are assessing its safety for people. This trial will provide more information about potential risks and tolerability. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cancer?

Unlike the standard treatments for cancer, which often involve chemotherapy or radiation, TGW101 offers a novel approach by using an anti-drug conjugate (ADC). This method targets cancer cells more precisely, potentially reducing side effects typically associated with broader treatment methods. Researchers are particularly excited because TGW101 is administered intravenously, allowing for controlled and escalating doses that can be fine-tuned for optimal effectiveness. Additionally, the inclusion of TRG001 as part of the treatment regimen may enhance the therapy's impact, offering hope for more personalized and effective cancer treatment options.

What evidence suggests that TGW101 might be an effective treatment for cancer?

Research has shown that TGW101 could help treat certain types of cancer. In this trial, participants will receive TGW101 in various dosing regimens. TG01, a component of TGW101, successfully targets KRAS mutations, common in many cancers, including pancreatic cancer. Earlier lab studies demonstrated that a similar drug worked well against ovarian cancer with specific markers. This suggests that TGW101 might also be effective for cancers with similar traits. Although more human studies are necessary, these early results offer hope for its potential in cancer treatment. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with advanced solid tumors, including uterine tumors. Participants should be adults who have tried other treatments that didn't work or aren't suitable. Specific eligibility details are not provided but typically include factors like overall health status and absence of certain medical conditions.

Inclusion Criteria

At least 1 measurable lesion per specified criteria

Life expectancy of > 3 months in the opinion of the Investigator

Written informed consent prior to any study procedures

Exclusion Criteria

I have had a solid organ or bone marrow transplant.

Pregnant or a breastfeeding postpartum female

I am currently being treated for a serious infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive escalating doses of TGW101 via IV infusion, followed by administration of TRG001

Until discontinuation criteria are met

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TGW101

Trial Overview The study is testing TGW101, a new potential treatment for solid tumors. It aims to find out how safe it is, what side effects it has, the best dose to use, and if it might help against cancer. The trial will start with small doses and increase them slowly to see what's tolerable.

How Is the Trial Designed?

Group I: TGW101: Enrichment Cohorts Experimental Treatment 1 Intervention

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 a Safety Oversight Committee (SOC), enrollment in enrichment cohorts may be limited to specific tumor type(s).

Group II: TGW101: Dose Escalation Cohorts Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Tagworks Pharmaceuticals BV

Lead Sponsor

Published Research Related to This Trial

Tiragolumab, a TIGIT inhibitor, shows promise in treating solid cancers, particularly non-small cell lung cancer, based on results from phase I and II trials.

The combination of tiragolumab with the PD-L1 inhibitor atezolizumab has demonstrated statistically significant efficacy in multiple solid tumors, suggesting a potential new treatment strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tiragolumab Impresses in Multiple Trials. [2021]

In a systematic review of 24 trials involving over 14,860 patients, PD-1/PD-L1 inhibitors significantly reduced the risk of death compared to conventional treatments, with a hazard ratio of 0.72, indicating a strong efficacy across various tumor types.

Patients with positive PD-L1 expression (≥1%) showed improved overall survival when treated with anti-PD-1/PD-L1 monotherapy, particularly in nonsmall cell lung cancer, suggesting that PD-L1 expression can be a useful biomarker for selecting patients for this type of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Value of PD-L1 Expression in Predicting the Efficacy of Anti-PD-1 or Anti-PD-L1 Therapy in Patients with Cancer: A Systematic Review and Meta-Analysis. Chen, XJ., Yuan, SQ., Duan, JL., et al.[2022]

TG01, an immunotherapy targeting KRAS mutations, was found to be well tolerated in patients with resected pancreatic adenocarcinoma, with a high immune response rate of 95% in the main cohort and 92% in the modified cohort.

The study reported favorable median overall survival (33.1 months for the main cohort and 34.3 months for the modified cohort) and disease-free survival (13.9 months and 19.5 months, respectively), suggesting TG01/GM-CSF combined with gemcitabine may enhance treatment outcomes compared to standard gemcitabine alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TG01/GM-CSF and adjuvant gemcitabine in patients with resected RAS-mutant adenocarcinoma of the pancreas (CT TG01-01): a single-arm, phase 1/2 trial. Palmer, DH., Valle, JW., Ma, YT., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06959706

NCT06959706 | Study Evaluating the Safety, Tolerability, ... TGW101 is a combination product comprising a chemically cleavable diabody drug conjugate (TGW101-ADC) and a corresponding small molecule chemical trigger ( ...

2. targetedonc.com targetedonc.com/view/fda-clears-phase-1-study-of-tgw101-for-advanced-solid-tumor-treatment

FDA Clears Phase 1 Study of TGW101 for Advanced Solid ... TGW101 has the potential to offer an improved antitumor effect and safety profile which may lead to better clinical outcomes. I am excited to ...

3. withpower.com withpower.com/trial/phase-1-neoplasms-4-2025-ad648

TGW101 for Cancer TG01, a component of TGW101, has shown safety and effectiveness in treating pancreatic cancer by targeting KRAS mutations, which are common in many cancers.

4. tagworkspharma.com tagworkspharma.com/wp-content/uploads/2025/04/20250407_AACR-poster-presentation-1794_Rossin.pdf

Preclinical development of TGW101, a first in class click- ... TGW101 pharmacologic effect. Previously, 4 cycles of 1st generation ADC tc-ADC + trigger afforded pronounced therapeutic efficacy in TAG72+ ovarian cancer ...

5. trialx.com trialx.com/clinical-trials/listings/320730/study-evaluating-the-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-of-tgw101-in-participants-with-advanced-solid-tumors/

Study Evaluating the Safety, Tolerability, Pharmacokinetics ... Overview. The primary objectives of this study are to evaluate the safety and tolerability of TGW101 and determine the recommended dosing regimen(s) for ...

6. tagworkspharma.com tagworkspharma.com/tagworks-pharmaceuticals-announces-initiation-of-third-dose-level-in-ongoing-phase-1-clinical-trial-of-tgw101-for-the-treatment-of-solid-tumors

Tagworks Pharmaceuticals Announces Initiation of Third ... TGW101 is being studied in an open-label, multicenter, Phase 1 dose-escalation clinical trial designed to evaluate safety, tolerability, ...

7. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_1/1794/756427/Abstract-1794-Preclinical-development-of-TGW101-a

Abstract 1794: Preclinical development of TGW101, a first in ... Preclinical development of TGW101, a first in class click-cleavable ADC with MMAE against non-internalizing pan-carcinoma marker TAG72.