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

Trial Summary

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 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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of 177Lu-DOTATATE in Lung Neuroendocrine Tumors: A Bicenter study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Long-Term Efficacy, Survival, and Safety of [177Lu-DOTA0,Tyr3]octreotate in Patients with Gastroenteropancreatic and Bronchial Neuroendocrine Tumors. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

Individualized peptide-related-radionuclide-therapy concept using different radiolabelled somatostatin analogs in advanced cancer patients. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Quality of life in patients with gastroenteropancreatic tumors treated with [177Lu-DOTA0,Tyr3]octreotate. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Best Practices for the Coordinated Care of Patients With Neuroendocrine Tumors Undergoing Peptide Receptor Radionuclide Therapy. [2023]

6. Australia pubmed.ncbi.nlm.nih.gov

Anti-tumor effect of integrin targeted (177)Lu-3PRGD2 and combined therapy with Endostar. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Combined biology-guided radiotherapy and Lutetium PSMA theranostics treatment in metastatic castrate-resistant prostate cancer. [2023]

8. Australia 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. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

New Horizons in Radioligand Therapy: 161Tb-PSMA-617 in Advanced mCRPC. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Combined modality radioimmunotherapy for human prostate cancer xenografts with taxanes and 90yttrium-DOTA-peptide-ChL6. [2019]