Intra-Lymphatic STI-3031 Using the Sofusa DoseConnect Device for Treatment of In-Transit Melanoma, The Sofusa-2 Study

NCT05393713 | Terminated Phase 1 DMC FDA Drug

• 3 other identifiers: MC210705NCI-2022-0344021-010150
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief Summary

This phase Ib trial tests the safety, side effects, and best dose of STI-3031 given directly into the into the lymph nodes or the lymph vessels (intra-lymphatic) using the Sofusa DoseConnect device in treating patients with melanoma that has spread through a lymph vessel and begins to grow more than 2 centimeters away from the primary tumor but before it reaches the nearest lymph node (in-transit). Immunotherapy with monoclonal antibodies, such as STI-3031, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Conditions

Melanoma; Clinical Stage III Cutaneous Melanoma AJCC v8; Metastatic Melanoma; Recurrent Metastatic Melanoma

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD) of STI-3031 that can be administered through the DoseConnect device

  MTD is the dose level where at most 1 of the 6 patients treated at that dose level develops a dose limiting event (DLE) during the first cycle of treatment and neither a Grade 3 or worse AE attributable to either drug or device or a Grade 2 or worse adverse event (AE) lasting \>= 1 week and attributable to device is reported after the first cycle of treatment.

  Up to 42 days (Cycle 1)

• Incidence of adverse events

  The maximum grade of each type of adverse event will be recorded for each patient. For each adverse event reported by dose level, the percentage of patients developing any degree of that adverse event as well as the percentage of patients developing a severe degree (Grade 3 or higher) will be determined.

  Up to 2 years

Secondary Outcomes (3)

• Clinical benefit rate

  Up to the end of cycle 3 (126 days)

• Progression-free survival (PFS)

  From study entry to the documentation of disease progression, assessed up to 2 years

• Response rate

  Up to 2 years

Other Outcomes (2)

• Lymphatic flow rate

  Baseline and prior to cycle 3

• Indocyanine green (ICG) lymphography classification

  Up to 2 years

Study Arms (1)

Treatment (STI-3031)

EXPERIMENTAL

Patients receive STI-3031 intra-lymphatically via the DoseConnect device over 1-8 hours QW on days 1, 8, 15, 22, 29, and 36 of cycle 1, and Q2W on days 1, 15, and 29 of cycle 2. Treatment repeats every 42 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR at the end of cycle 2 receive 1-2 additional cycles in the absence of disease progression or unacceptable toxicity. Patients with PR or SD at the end of cycle 2 continue treatment for a total of 9 cycles in the absence of disease progression or unacceptable toxicity.

Biological: Anti-PD-L1 Monoclonal Antibody IMC-001; Procedure: Punch Biopsy

Interventions

Anti-PD-L1 Monoclonal Antibody IMC-001 BIOLOGICAL

Given intra-lymphatically via DoseConnect device

Also known as: IMC 001, IMC-001, IMC001, STI 3031, STI-3031, STI3031

Treatment (STI-3031)

Punch Biopsy PROCEDURE

Undergo punch biopsy

Also known as: BIOPSY, PUNCH, Punch Biopsy of Skin

Treatment (STI-3031)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>= 18 years
• Disease characteristics:
• Newly diagnosed, recurrent, or previously treated in-transit metastatic melanoma (ITM) confined to a single limb with or without regional lymph node involvement
• For patients with ITM, one of the following must be true:
• A visible superficial ITM, non-nodal lesion with longest diameter \>= 1.0 cm in diameter as assessed using a ruler (e.g., skin nodules) NOTE: Documentation by color photography, including a ruler is required OR
• A malignant regional lymph node with short axis \> 1.0 cm as assessed by computed tomography (CT) scan (CT scan slice thickness recommended to be no greater than 5 mm) OR
• A non-visible, non-nodal soft tissue mass of the involved extremity with longest diameter \>= 1.0 cm as measured with CT scan, CT component of a positron emission tomography (PET)/CT, or magnetic resonance imaging (MRI)
• Newly diagnosed, recurrent or previously treated metastatic melanoma of the lymph nodes in lymphatic beds accessible to limb-lymphatic infusion (Example: lower limb lymphatic accessible femoral, inguinal pelvic and/or retroperitoneal lymph node metastases; upper limb: axillary, infraclavicular and/or subclavian lymph node metastases)
• For patients with lymph node metastases only (non ITM) the following must be true:
• At least one tumor involved lymph nodes must be \>= 15 mm as assessed by CT, PET or MRI (target lesion by Response Evaluation Criteria in Solid Tumors \[RECIST\])
• Hemoglobin \>= 8.0 g/dL (obtained =\< 15 days prior to registration)
• Absolute neutrophil count (ANC) \>= 1500/mm\^3 (obtained =\< 15 days prior to registration)
• Platelet count \>= 75,000/mm\^3 (obtained =\< 15 days prior to registration)
• Total bilirubin =\< 1.5 x upper limit of normal (ULN) (obtained =\< 15 days prior to registration)
• Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\< 3.0 x ULN (obtained =\< 15 days prior to registration)

You may not qualify if:

• Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown:
• Pregnant persons
• Nursing persons
• Persons of childbearing potential who are unwilling to employ adequate contraception
• Persons expecting to conceive or father children during the study or within 180 days (6 months) after the last treatment on this study
• Metastatic melanoma beyond in-transit metastases (ITM) and regional lymph nodes (LNs) that cannot be accessed by intralymphatic infusion by DoseConnect (example: visceral or active central nervous system \[CNS\] metastatic disease)
• ITM involving the hands and feet (not accessible to DoseConnect infusion)
• ITM NOT involving a limb (i.e., head, neck, or trunk)
• Prior radiation of ITM that are being evaluated as measurable lesions
• Any of the following prior therapies:
• Allogeneic hematopoietic stem cell transplantation (HSCT)
• Solid organ transplantation
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy.
• NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Melanoma

Interventions

IMC-001; Biopsy

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Anastasios Dimou, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 26, 2022
• Study Start: October 17, 2022
• Primary Completion: February 16, 2025
• Study Completion: February 16, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

US (2)