Intratumoral N17350 in Advanced Solid Tumors

Conditions

• Breast Neoplasms, Triple-Negative
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Melanoma
• Neoplasms, Solid Tumor
• Squamous Cell Carcinoma of Skin

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• N17350 — BIOLOGICAL
  N17350 is a recombinant mutant porcine pancreatic elastase (PPE) developed to target the neutrophil elastase (ELANE) pathway.

Study Details

The goal of this clinical trial is to learn if N17350 works to treat advanced solid tumors in adults. It will also learn about the safety of N17350 and help determine the best dose to use in future studies. The main questions it aims to answer are: 1. Does N17350 cause tumors to shrink or stop growing in some participants with advanced solid tumors? 2. Are there any side effects for participants when taking N17350? 3. What is the safest dose of N17350 and the dose that should be used for further study? 4. Researchers will give N17350 directly into tumor lesions using a needle (intratumoral injection). This is an open-label study, meaning all participants will receive N17350 and there is no placebo. Participants will: 1. Receive injections of N17350 into tumor lesions every second week for 8 or 12 weeks 2. Visit the clinic regularly for checkups, blood tests, and monitoring for side effects 3. Have imaging scans (such as CT or MRI) to measure tumors and assess response 4. Provide blood samples and, when required, tumor samples to help researchers understand how N17350 affects the tumor and the immune system

Key Dates

First listed

Jan 14, 2026

Start date

May 25, 2026

Status verified

Jul 2026

Primary completion

Jul 31, 2028

Completion

Nov 30, 2029

Study Design

Enrollment

275 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: N17350 Intratumoral Injection 1 mg/ml superficial lesions
  Participants with superficial lesions will receive 1 mg/ml intratumoral N17350 injected into accessible tumor lesions every 2 weeks up to 12 weeks.
• Experimental: N17350 Intratumoral Injection 2 mg/ml superficial lesions
  Participants with superficial lesions will receive 2 mg/ml intratumoral N17350 injected into accessible tumor lesions every 2 weeks up to 12 weeks.
• Experimental: N17350 Intratumoral Injection 4 mg/ml superficial lesions
  Participants with superficial lesions will receive 4 mg/ml intratumoral N17350 injected into accessible tumor lesions every 2 weeks up to 12 weeks.
• Experimental: N17350 Intratumoral Injection 2 mg/ml visceral lesions
  Participants with visceral lesions will receive 2 mg/ml intratumoral N17350 injected into accessible tumor lesions every 2 weeks up to 12 weeks.
• Experimental: N17350 Intratumoral Injection 4 mg/ml visceral lesions
  Participants with visceral lesions will receive 4 mg/ml intratumoral N17350 injected into accessible tumor lesions every 2 weeks up to 12 weeks.
• Experimental: N17350 Intratumoral Injection for cuSCC
  Participants with cuSCC superficial or visceral lesions will receive intratumoral N17350 injected into tumor lesions every 2 weeks up to 12 weeks at the recommended phase two dose.
• Experimental: N17350 Intratumoral Injection for Melanoma
  Participants with Melanoma superficial or visceral lesions will receive intratumoral N17350 injected into tumor lesions every 2 weeks up to 12 weeks at the recommended phase two dose.
• Experimental: N17350 Intratumoral Injection for SCCHN
  Participants with SCCHN superficial or visceral lesions will receive intratumoral N17350 injected into tumor lesions every 2 weeks up to 12 weeks at the recommended phase two dose.
• Experimental: N17350 Intratumoral Injection for NSCLC
  Participants with NSCLC superficial or visceral lesions will receive intratumoral N17350 injected into tumor lesions every 2 weeks up to 12 weeks at the recommended phase two dose.
• Experimental: N17350 Intratumoral Injection for TNBC
  Participants with TNBC superficial or visceral lesions will receive intratumoral N17350 injected into tumor lesions every 2 weeks up to 12 weeks at the recommended phase two dose.

Primary Outcome Measure

Phase 1: Safety and tolerability of intratumoral N17350, including incidence of DLTs and adverse events [ Time Frame: DLTs: First 28 days; TEAEs/SAEs/laboratory abnormalities: From enrollment through 30 days after last dose assessed up to 4 months ]

Central Contacts

• Onchilles Pharma Clinical Trials
  650-270-0891
  [email protected]

Locations (4)

Find similar trials in Los Angeles, CA

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