275 Participants NeededMy employer runs this trial

N17350 for Cancer

(OP-NEU-101 Trial)

Recruiting at 8 trial locations
OP
Overseen ByOnchilles Pharma Clinical Trials
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the new treatment, N17350 (an experimental treatment), can shrink or halt the growth of advanced solid tumors, assess its safety, and identify the optimal dose. Participants will receive injections directly into their tumors and attend regular checkups and scans to monitor progress. Suitable candidates for this trial include individuals with advanced solid tumors that have not responded well to other treatments and have tumors accessible for injection. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot participate if you have taken certain anticancer therapies or systemic medications like anticoagulants and corticosteroids shortly before the trial starts.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that N17350, a new cancer treatment, has promising safety results from early studies. These studies found that N17350 effectively attacks and kills cancer cells while sparing healthy immune cells. This suggests it might combat tumors without significantly impacting the body's immune system. In early trials with patients, researchers monitored side effects and safety, a standard practice for new treatments. Although these results are preliminary, they suggest the treatment is generally well-tolerated. However, as with any new treatment, some side effects may occur, and ongoing studies aim to better understand these and determine the safest dose for future use.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about N17350 because it offers a new approach to treating cancer, specifically through direct intratumoral injections. Unlike traditional systemic therapies like chemotherapy or immunotherapy, which affect the whole body, N17350 is injected directly into the tumor. This targeted delivery method could potentially reduce side effects and improve effectiveness by concentrating the treatment where it's needed most. Additionally, the study explores various doses and lesion types, which may provide insights into optimal treatment strategies for different cancer forms.

What evidence suggests that this trial's treatments could be effective for advanced solid tumors?

Research has shown that N17350 may help treat advanced solid tumors. In this trial, participants will receive N17350 as an intratumoral injection, with different arms studying various dosages and types of lesions, including superficial and visceral lesions. A single dose of N17350 shrank both primary tumors and metastases. It also enhanced the effectiveness of other cancer treatments. N17350 successfully killed cancer cells from various sources, including new and recurrent ovarian tumors. By direct injection into tumors, it aids the immune system in fighting cancer. Early studies consistently demonstrated N17350's effectiveness across different cancer types. These findings suggest that N17350 could effectively reduce or halt tumor growth in advanced solid tumors.12367

Who Is on the Research Team?

ER

Emily Roberts-Thomson

Principal Investigator

Onchilles Pharma

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors (like breast, skin, lung, or head and neck cancers) that can't be treated with standard therapies. Participants must have at least one tumor that can be safely injected and be well enough to do daily activities. Blood vessel involvement or certain blood cancers are excluded.

Inclusion Criteria

I am fully active or have only minor physical limitations.
I am at least 18 years old or the legal age of consent.
I can sign the consent form and follow the study's requirements.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Finding (Phase 1)

Small groups of participants receive different dose levels of N17350 to determine safety and optimal dose

8-12 weeks
Bi-weekly visits for injections and monitoring

Dose Expansion (Phase 2)

Participants receive N17350 at the selected dose to further evaluate safety and efficacy

8-12 weeks
Bi-weekly visits for injections and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months
Regular follow-up visits for safety evaluations and tumor assessments

What Are the Treatments Tested in This Trial?

Interventions

  • N17350

Trial Overview

The study tests N17350 given by injection directly into tumors every two weeks for up to 12 weeks. All participants receive the drug—there's no placebo group. The main goals are to see if N17350 shrinks tumors, what side effects occur, and what dose is safest.

How Is the Trial Designed?

10

Treatment groups

Experimental Treatment

Group I: N17350 Intratumoral Injection for cuSCCExperimental Treatment1 Intervention
Group II: N17350 Intratumoral Injection for TNBCExperimental Treatment1 Intervention
Group III: N17350 Intratumoral Injection for SCCHNExperimental Treatment1 Intervention
Group IV: N17350 Intratumoral Injection for NSCLCExperimental Treatment1 Intervention
Group V: N17350 Intratumoral Injection for MelanomaExperimental Treatment1 Intervention
Group VI: N17350 Intratumoral Injection 4 mg/ml visceral lesionsExperimental Treatment1 Intervention
Group VII: N17350 Intratumoral Injection 4 mg/ml superficial lesionsExperimental Treatment1 Intervention
Group VIII: N17350 Intratumoral Injection 2 mg/ml visceral lesionsExperimental Treatment1 Intervention
Group IX: N17350 Intratumoral Injection 2 mg/ml superficial lesionsExperimental Treatment1 Intervention
Group X: N17350 Intratumoral Injection 1 mg/ml superficial lesionsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Onchilles Pharma Inc

Lead Sponsor

Onchilles Pharma Pty Ltd

Collaborator

Citations

N17350: a cytotoxic cancer therapy that spares the immune ...

Here, a single dose of N17350 reduced the growth of both primary tumors and metastases and enhanced the efficacy of anti-CTLA-4, leading to ...

Immunotherapy in Melanoma: Recent Advances and Future ...

Results demonstrated an improved objective response rate (27% vs. 10%) and durable responses (32 vs. 13 months). Intratumoral injection of GM-CSF demonstrated ...

Intratumoral N17350 in Advanced Solid Tumors

Giving N17350 into the tumor is intended to deliver treatment to the cancer site and may help stimulate an immune response against the tumor.

N17350 / Onchilles Pharma

N17350 was effective in killing cancer cells derived from treatment-naïve, neoadjuvant chemotherapy-treated (NACT), and recurrent ovarian tumors.

Injecting hope: the potential of intratumoral immunotherapy ...

In advanced melanoma, the SWOG S1801 trial demonstrated that event-free survival at 2 years was 72% in the neoadjuvant-adjuvant pembrolizumab group compared to ...

Onchilles Pharma Doses First Patient in Phase 1/2 Clinical ...

In preclinical studies, N17350 demonstrated broad tumor-killing activity, immune cell preservation, and activation of anti-tumor immunity across ...

Intratumoral N17350 in Advanced Solid... | Clinical Trial

Safety and tolerability of intratumoral N17350, including incidence of DLTs and adverse events Time Frame: DLTs: First 28 days; TEAEs/SAEs/ ...