RiMO-401 with Radiation for Advanced Cancer

Overseen By Ze-Qi Xu, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Coordination Pharmaceuticals, Inc.

Must not be taking: Chemotherapy, Immunotherapies, others

Disqualifiers: Lymphomas, Leukemias, Significant infections, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 45 days

24 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a single arm study of RiMO-401 with radiation in patients with advanced tumors. A single escalation dose of RiMO-401 is intratumorally injected in a 3+3 study design to identify the recommended dose.

Will I have to stop taking my current medications?

The trial requires that you have not received chemotherapy, targeted therapies, immunotherapies, biologic response modifiers, or hormonal therapy within the last 14 days before starting the study. It does not specify about other medications, so you may need to discuss your specific situation with the trial team.

What data supports the effectiveness of the treatment RiMO-401 with Radiation for Advanced Cancer?

The use of intensity-modulated radiotherapy (IMRT), a component of the treatment, has shown effectiveness in improving outcomes in various cancers, such as reducing toxicity in breast cancer and improving survival in pancreatic cancer. This suggests that IMRT, when combined with other treatments like RiMO-401, may enhance treatment effectiveness for advanced cancer. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults with advanced or metastatic cancer that can't be cured by standard treatments. They should have a tumor suitable for injection and radiation, not previously treated in the last six months. Participants need to be relatively healthy (ECOG score 0-1), have recovered from past cancer therapies, expect to live at least 12 weeks, and have good organ function.

Inclusion Criteria

Have a life expectancy of at least 12 weeks

Patients must sign a study-specific informed consent form prior to study entry

My bone marrow and liver are functioning well.

Exclusion Criteria

Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that would make the patient inappropriate for enrollment in this study

Pregnant and nursing women

I have been diagnosed with lymphoma or leukemia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Single intratumoral injection of RiMO-401 followed by radiation

45 days

Pharmacokinetics

Plasma concentrations of RiMO-401 measured to evaluate Cmax and AUC

8 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• RiMO-401

Trial Overview The study tests RiMO-401 combined with radiation on patients with advanced tumors. It's a single-arm trial where everyone gets the same treatment. The dose of RiMO-401 is increased step-by-step in groups of patients to find the safest and most effective level.

Participant Groups

Group I: RiMO-401 Experimental Treatment 1 Intervention

• Single intratumoral injection followed by radiation

Who Is Running the Clinical Trial?

Coordination Pharmaceuticals, Inc.

Lead Sponsor

Trials

6

Recruited

130+

Findings from Research

Intensity Modulated Radiation Therapy (IMRT) for treating locally advanced cervical cancer has an incremental cost-effectiveness ratio (ICER) of $182,777 per quality-adjusted life year (QALY) gained, which is above the commonly accepted threshold of $100,000/QALY.

However, for patients requiring extended-field radiation therapy (EFRT), IMRT becomes cost-effective with an ICER of $91,580/QALY, suggesting that IMRT may be a viable option in specific patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upfront treatment of locally advanced cervical cancer with intensity modulated radiation therapy compared to four-field radiation therapy: a cost-effectiveness analysis. Lesnock, JL., Farris, C., Beriwal, S., et al.[2013]

The study aimed to evaluate the safety and efficacy of preoperative hypofractionated radiotherapy combined with capecitabine in patients with locally advanced rectal cancer, but it was discontinued due to high toxicity, with 38% of patients experiencing severe side effects.

Despite the treatment, no patients achieved a pathologically complete response, indicating that this regimen may not be effective and highlighting the need for further research to find safer alternatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I trial of preoperative hypofractionated intensity-modulated radiotherapy with incorporated boost and oral capecitabine in locally advanced rectal cancer. Freedman, GM., Meropol, NJ., Sigurdson, ER., et al.[2022]

In a study of 200 patients with locally advanced pancreatic cancer, those receiving dose-escalated intensity modulated radiation therapy (IMRT) with a biologically effective dose (BED) greater than 70 Gy showed significantly improved overall survival (OS) of 17.8 months compared to 15.0 months for those with lower doses.

The higher radiation dose also led to better local-regional recurrence-free survival (RFS) of 10.2 months versus 6.2 months, without increasing toxicity, indicating that dose escalation can be a safe and effective strategy in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focal Radiation Therapy Dose Escalation Improves Overall Survival in Locally Advanced Pancreatic Cancer Patients Receiving Induction Chemotherapy and Consolidative Chemoradiation. Krishnan, S., Chadha, AS., Suh, Y., et al.[2022]

The management of locally advanced rectal cancer involves a complex combination of surgery, chemotherapy, and radiation, with treatment tailored based on tumor risk factors identified through MRI and clinical evaluation.

For high-risk patients, preoperative chemoradiation significantly increases the chances of successful surgical resection, while the ongoing PROSPECT trial aims to refine treatment approaches by selectively using chemoradiation based on tumor response, potentially reducing unnecessary treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolving role of neoadjuvant therapy in rectal cancer. Schrag, D.[2022]

A longitudinal study involving 727 breast cancer patients found that while patients initially reported worse toxicity symptoms at 6 months post-radiotherapy, these symptoms improved significantly over time, indicating a positive trend in patient-reported outcomes (PROMs).

Despite using intensity-modulated radiotherapy (IMRT), the study did not find significant benefits in PROMs compared to standard radiotherapy at 5 years, suggesting that factors such as breast volume, age, and surgical outcomes play a crucial role in patient experiences post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient reported outcome measures (PROMs) following forward planned field-in field IMRT: results from the Cambridge Breast IMRT trial. Mukesh, MB., Qian, W., Wilkinson, JS., et al.[2022]

References

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

Upfront treatment of locally advanced cervical cancer with intensity modulated radiation therapy compared to four-field radiation therapy: a cost-effectiveness analysis. [2013]

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

Phase I trial of preoperative hypofractionated intensity-modulated radiotherapy with incorporated boost and oral capecitabine in locally advanced rectal cancer. [2022]

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

Focal Radiation Therapy Dose Escalation Improves Overall Survival in Locally Advanced Pancreatic Cancer Patients Receiving Induction Chemotherapy and Consolidative Chemoradiation. [2022]

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

Evolving role of neoadjuvant therapy in rectal cancer. [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

Patient reported outcome measures (PROMs) following forward planned field-in field IMRT: results from the Cambridge Breast IMRT trial. [2022]