TGW101 for Cancer
Recruiting at 2 trial locations
TP
Overseen ByTagworks Pharmaceuticals
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Tagworks Pharmaceuticals BV
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
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.
What data supports the effectiveness of the drug TGW101 for cancer?
How does the drug TGW101 differ from other cancer treatments?
What is the purpose of this trial?
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.
Eligibility Criteria
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
See 5 more
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.
See 9 more
Timeline
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
Treatment Details
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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: TGW101: Enrichment CohortsExperimental Treatment1 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 CohortsExperimental Treatment1 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tagworks Pharmaceuticals BV
Lead Sponsor
Findings from Research
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]
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]
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]
References
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. [2023]
Prognostic Impact of An Integrative Landscape of Clinical, Immune, and Molecular Features in Non-Metastatic Rectal Cancer. [2023]
PD-L1 Status in Tenosynovial Giant Cell Tumors. [2022]
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. [2022]
Tiragolumab Impresses in Multiple Trials. [2021]
[Expression and significance of TSG101, P21 and P300/CBP in squamous cell carcinoma and adenocarcinoma of the lung]. [2010]
Aberrant expression of TSG101 in Taiwan Chinese breast cancer. [2019]
Identification of cellular TSG101 protein in multiple human breast cancer cell lines. [2009]
[Changing of TSG101 expression on the invasion and metastasis of gastric cancer cells]. [2013]
[The action of TSG101 on HIV-1 budding and related inhibitors]. [2009]
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