RGT-61159 for Cancer

Recruiting at 10 trial locations

Overseen By Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Rgenta Therapeutics Inc

Must not be taking: Nitrosoureas, Mitomycin C

Disqualifiers: Active malignancy, Cardiac disease, HIV, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

105 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, RGT-61159, for safety and effectiveness in treating two types of cancer: ACC and CRC. Researchers aim to assess the drug's impact on tumors and determine the optimal dose. Suitable candidates have ACC or CRC that cannot be treated with surgery or radiation and have not responded to other available treatments. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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.

Is there any evidence suggesting that RGT-61159 is likely to be safe for humans?

Research shows that RGT-61159 remains in the early stages of human testing, so detailed safety information is limited. However, researchers are testing the treatment for safety and tolerance in patients with adenoid cystic carcinoma (ACC) or colorectal cancer (CRC).

Early-phase trials like this one aim to find the optimal dose that works effectively with minimal side effects. Researchers closely monitor the treatment for any negative reactions, which could include serious issues like hospitalization or life-threatening conditions.

Earlier lab studies have shown promising results in targeting cancer cells, but the full effects on humans are still being studied. Prospective participants should discuss potential risks and benefits with the trial team. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard cancer treatments, which often involve chemotherapy that targets rapidly dividing cells indiscriminately, RGT-61159 is designed to offer a more precise approach. Researchers are excited about RGT-61159 because it involves dose escalation and optimization, which means they are fine-tuning the amount of drug given to maximize its effectiveness while minimizing side effects. This personalized dosing strategy could potentially provide better outcomes for patients by targeting cancer cells more effectively with fewer adverse effects. Additionally, the Simon's two-stage design in Cohort B allows researchers to assess the drug's efficacy quickly and efficiently, potentially speeding up the process of making this treatment available to those who need it.

What evidence suggests that RGT-61159 might be an effective treatment for cancer?

Research has shown that RGT-61159, the investigational treatment in this trial, has strong potential in fighting cancer. In early lab studies, it slowed tumor growth by up to 90% in certain cancer models, effectively stopping tumors from enlarging. This compound targets and blocks a gene called c-MYB, which plays a role in cancer development. RGT-61159 also demonstrated strong anti-tumor effects in other cancer types, such as AML, a type of blood cancer. These early results suggest that RGT-61159 might effectively treat some types of cancer. ^{1 2 4 6 7}

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.

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.

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?

Group I: Dose expansion Cohort B Experimental Treatment 1 Intervention

Simon's 2 stage, RGT-61150 at optimized dose from Part A

Group II: Dose expansion Cohort A Experimental Treatment 1 Intervention

Dose optimization; RGT-61159, 2 doses, randomized allocation

Group III: Dose escalation Experimental Treatment 1 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)

Who Is Running the Clinical Trial?

Rgenta Therapeutics Inc

Lead Sponsor

Trials

1

Recruited

110+

Published Research Related to This Trial

The study demonstrated that (177)Lu-3PRGD2 effectively targets integrin αvβ3 in U87MG tumors, showing significant tumor uptake and clear visualization through gamma imaging, indicating its potential for targeted radiotherapy.

Using a two-dose regimen of (177)Lu-3PRGD2, combined with anti-angiogenic therapy, significantly delayed tumor growth without the need for daily injections, suggesting a more convenient treatment option for patients that could be quickly adapted for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-tumor effect of integrin targeted (177)Lu-3PRGD2 and combined therapy with Endostar. Shi, J., Fan, D., Dong, C., et al.[2021]

In a study of 75 patients with metastatic prostate cancer, 6 were excluded from Lutetium-177 [177Lu]-PSMA-617 treatment due to PSMA-negative/FDG-positive discordance, but 89 suitable targets for biology-guided radiotherapy (BgRT) were identified.

The research suggests that combining BgRT with Lutetium-177 [177Lu]-PSMA-617 is feasible for treating patients with discordant metastases, particularly highlighting that bone and lung metastases are the most suitable candidates for this combined therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined biology-guided radiotherapy and Lutetium PSMA theranostics treatment in metastatic castrate-resistant prostate cancer. Gaudreault, M., Chang, D., Hardcastle, N., et al.[2023]

The study successfully demonstrates that pretargeted radioimmunotherapy (DOTA-PRIT) can effectively target the internalizing HER2 antigen in breast cancer, achieving a high therapeutic index and complete tumor responses in mice with established tumors.

The treatment regimen was well tolerated, resulting in 100% complete responses and minimal damage to critical organs, suggesting that DOTA-PRIT can be a safe and effective option for targeting internalizing antigens in cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Theranostic pretargeted radioimmunotherapy of internalizing solid tumor antigens in human tumor xenografts in mice: Curative treatment of HER2-positive breast carcinoma. Cheal, SM., Xu, H., Guo, HF., et al.[2020]

An 85-year-old man with advanced metastatic castration-resistant prostate cancer showed significant improvement after receiving a single cycle of 161 Tb-PSMA radioligand therapy, resulting in a 53.4% decline in PSA levels and reduced tumor burden on imaging.

This case suggests that 161 Tb-PSMA RLT may be an effective alternative treatment for patients who have progressed after conventional 177 Lu-PSMA therapy, highlighting its potential therapeutic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Horizons in Radioligand Therapy: 161Tb-PSMA-617 in Advanced mCRPC. Rosar, F., Maus, S., Schaefer-Schuler, A., et al.[2023]

In a study using nude mice with human prostate cancer, combining the radiation therapy 90Y-DOTA-peptide-ChL6 with docetaxel resulted in a 67% cure rate, while the combination with paclitaxel achieved a 100% response rate with 20% cures, indicating significant therapeutic synergy.

The addition of these chemotherapy drugs did not increase toxicity compared to radiation therapy alone, suggesting that this combined treatment approach could be safely translated to clinical settings for improved prostate cancer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined modality radioimmunotherapy for human prostate cancer xenografts with taxanes and 90yttrium-DOTA-peptide-ChL6. O'Donnell, RT., DeNardo, SJ., Miers, LA., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized peptide-related-radionuclide-therapy concept using different radiolabelled somatostatin analogs in advanced cancer patients. Gabriel, M., Andergassen, U., Putzer, D., et al.[2016]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of 177Lu-DOTATATE in Lung Neuroendocrine Tumors: A Bicenter study. Zidan, L., Iravani, A., Oleinikov, K., et al.[2022]

In a study of 50 patients with metastatic gastroenteropancreatic tumors treated with (177)Lu-octreotate therapy, there was a significant improvement in overall quality of life (QoL) six weeks after treatment, with scores rising from 69.0 to 78.2 (P <.01).

Patients who experienced tumor regression showed the most notable improvements in QoL, but even those with progressive disease reported better global health scores, indicating that (177)Lu-octreotate therapy may enhance patient well-being regardless of tumor response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life in patients with gastroenteropancreatic tumors treated with [177Lu-DOTA0,Tyr3]octreotate. Teunissen, JJ., Kwekkeboom, DJ., Krenning, EP.[2013]

[177Lu]Lu-DOTA-TATE is an effective treatment for adult patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (NETs) who have not responded to first-line somatostatin analogs, addressing a critical need in advanced cases.

The treatment process for PRRT is complex but manageable, with care coordinators ensuring smooth communication and scheduling between primary oncologists and specialists, which is essential for patient care continuity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Best Practices for the Coordinated Care of Patients With Neuroendocrine Tumors Undergoing Peptide Receptor Radionuclide Therapy. Hendifar, AE., Mehr, SH., McHaffie, DR.[2023]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.6107

Effect of RGT-61159 on inhibition of oncogene c-MYB ... In addition, RGT-61159 single agent showed a remarkable anti-tumor activity (up to 90% TGI) at tolerated doses in the four ACC PDX models ...

2. prnewswire.com prnewswire.com/news-releases/rgenta-therapeutics-presents-preclinical-data-on-rgt-61159-a-potent-selective-oral-small-molecule-inhibitor-of-myb-demonstrating-robust-anti-tumor-activity-in-several-monotherapy-models-of-aml-and-synergistic-activity-when-comb-302438452.html

Rgenta Therapeutics Presents Preclinical Data on RGT ... The data demonstrate robust anti-tumor activity of RGT-61159 in several cell-derived xenograft (CDX) models of AML and synergistic benefit when combined with ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06462183

NCT06462183 | Study of Safety and Efficacy of RGT-61159 ... It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

4. firstwordpharma.com firstwordpharma.com/story/5919990

Rgenta Therapeutics Presents Preclinical Data ... The data presented at ASH demonstrate that RGT-61159 potently eliminates MYB RNA and protein in a dose-dependent manner in AML cancer cell lines ...

5. withpower.com withpower.com/trial/rgt-61159-for-cancer-8e887

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 ...

6. clin.larvol.com clin.larvol.com/trial-detail/NCT06462183

Study of Safety and Efficacy of RGT-61159 in Adults with ... "RGT-61159...is currently being evaluated in a Phase 1a/b clinical trial in patients with advanced relapsed or refractory ACC or colorectal cancer.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06462183?cond=Adenoid%20cystic%20carcinoma%20OR%20%22adenocystic%20carcinoma%22%20OR%20%22%20adenoid%20cystic%20cancer%22%20OR%20%22%20cylindroid%20adenocarcinoma%22&aggFilters=status:not%20rec&viewType=Table&rank=9

Study of Safety and Efficacy of RGT-61159 in Adults with ... This first-in-human, Phase 1, multi-center, open-label, non-randomized study, is designed to evaluate safety, tolerability, and anti-tumor activity of once- ...