105 Participants Needed

RGT-61159 for Cancer

Recruiting at 10 trial locations
CO
Overseen ByClinical Operations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

Phase 1 study to evaluate safety, tolerability and anti-tumor activity of RGT-61159 in patients with ACC or CRC

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot have had chemotherapy within 14 days, certain other treatments within specific time frames, or ongoing infections requiring treatment before starting the trial.

What makes the drug RGT-61159 unique for cancer treatment?

RGT-61159 is unique because it may involve a targeted radiotherapy approach, similar to treatments like 177Lu-3PRGD2, which targets specific proteins on cancer cells to deliver radiation directly to the tumor, potentially increasing effectiveness while minimizing damage to healthy tissues.12345

What data supports the effectiveness of the drug RGT-61159 for cancer?

The research on a similar treatment, 177Lu-DOTATATE, shows it is effective and safe for treating certain types of neuroendocrine tumors, with good response rates and survival times. This suggests that RGT-61159, if similar, might also be effective for cancer.678910

Are You a Good Fit for This Trial?

Adults with Adenoid Cystic Carcinoma (ACC) or Colorectal Cancer (CRC) that has come back or hasn't responded to treatment can join this trial. Specific details about who can and cannot participate are not provided, but typically these would include health status and prior treatments.

Inclusion Criteria

My cancer is confirmed to be either adrenal cortical carcinoma or colorectal cancer.
I have recovered from the side effects of my previous treatments.
My cancer can be measured on scans and has grown after any previous radiation.
See 3 more

Exclusion Criteria

I have not had radiation therapy in the last 3 weeks.
I have another active cancer besides the one being treated.
I have had an organ transplant.
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of RGT-61159 to determine the optimal dose

8-12 weeks

Dose Expansion

Participants receive RGT-61159 at the optimized dose to further assess safety and efficacy

12-16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • RGT-61159
Trial Overview The study is testing RGT-61159's safety, how well it's tolerated by patients, and its effectiveness in fighting ACC or CRC tumors. This early-phase trial will help determine the appropriate dosage and gather preliminary data on its impact.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Dose expansion Cohort BExperimental Treatment1 Intervention
Simon's 2 stage, RGT-61150 at optimized dose from Part A
Group II: Dose expansion Cohort AExperimental Treatment1 Intervention
Dose optimization; RGT-61159, 2 doses, randomized allocation
Group III: Dose escalationExperimental Treatment1 Intervention
RGT-61159 in escalating doses

RGT-61159 is already approved in United States for the following indications:

🇺🇸
Approved in United States as RGT-61159 for:
  • Adenoid cystic carcinoma (ACC)
  • Colorectal cancer (CRC)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rgenta Therapeutics Inc

Lead Sponsor

Trials
1
Recruited
110+

Published Research Related to This Trial

In a study of 48 patients with advanced progressive lung neuroendocrine tumors, treatment with 177Lu-DOTATATE showed a median progression-free survival of 23 months and an overall survival of 59 months, indicating its efficacy in managing these tumors.
The treatment was found to be safe, with most adverse events being reversible; the most common severe side effect was lymphopenia, occurring in 14% of patients, and there were no cases of myelodysplasia or leukemia.
Efficacy and Safety of 177Lu-DOTATATE in Lung Neuroendocrine Tumors: A Bicenter study.Zidan, L., Iravani, A., Oleinikov, K., et al.[2022]
Peptide receptor radionuclide therapy (PRRT) with 177Lu-DOTATATE has shown a 39% objective response rate and a 43% rate of stable disease in over 1,200 patients with neuroendocrine tumors, indicating its efficacy in treating these slow-growing tumors.
The therapy is considered safe, with only a small percentage of patients experiencing long-term toxicities, such as acute leukemia (0.7%) and myelodysplastic syndrome (1.5%), while no significant renal or hepatic failures were reported.
Long-Term Efficacy, Survival, and Safety of [177Lu-DOTA0,Tyr3]octreotate in Patients with Gastroenteropancreatic and Bronchial Neuroendocrine Tumors.Brabander, T., van der Zwan, WA., Teunissen, JJM., et al.[2022]
In a study of 100 patients with somatostatin receptor-positive tumors, receptor-mediated radionuclide therapy (PRRT) showed promising results, with 23% achieving partial remission and 10% showing minor remission, indicating its efficacy in treating these tumors.
The therapy was well tolerated, with only 6% of patients experiencing severe side effects, and no severe long-term kidney damage observed, suggesting a favorable safety profile for PRRT using either (90)Y-DOTA-TOC or (177)Lu-DOTA-TATE.
Individualized peptide-related-radionuclide-therapy concept using different radiolabelled somatostatin analogs in advanced cancer patients.Gabriel, M., Andergassen, U., Putzer, D., et al.[2016]

Citations

Efficacy and Safety of 177Lu-DOTATATE in Lung Neuroendocrine Tumors: A Bicenter study. [2022]
Long-Term Efficacy, Survival, and Safety of [177Lu-DOTA0,Tyr3]octreotate in Patients with Gastroenteropancreatic and Bronchial Neuroendocrine Tumors. [2022]
Individualized peptide-related-radionuclide-therapy concept using different radiolabelled somatostatin analogs in advanced cancer patients. [2016]
Quality of life in patients with gastroenteropancreatic tumors treated with [177Lu-DOTA0,Tyr3]octreotate. [2013]
Best Practices for the Coordinated Care of Patients With Neuroendocrine Tumors Undergoing Peptide Receptor Radionuclide Therapy. [2023]
Anti-tumor effect of integrin targeted (177)Lu-3PRGD2 and combined therapy with Endostar. [2021]
Combined biology-guided radiotherapy and Lutetium PSMA theranostics treatment in metastatic castrate-resistant prostate cancer. [2023]
Theranostic pretargeted radioimmunotherapy of internalizing solid tumor antigens in human tumor xenografts in mice: Curative treatment of HER2-positive breast carcinoma. [2020]
New Horizons in Radioligand Therapy: 161Tb-PSMA-617 in Advanced mCRPC. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Combined modality radioimmunotherapy for human prostate cancer xenografts with taxanes and 90yttrium-DOTA-peptide-ChL6. [2019]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security