Is NCT05684965 recruiting in Cleveland, OH?

Yes, NCT05684965 is currently recruiting participants at its Cleveland, OH location. This advanced solid tumors clinical trial is actively enrolling qualified participants.

How do I join the advanced solid tumors clinical trial in Cleveland?

To join this clinical trial in Cleveland, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Cleveland clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Advanced Solid Tumors Clinical Trial in Cleveland, OH

Who Can Participate

Inclusion Criteria

• Disease Criteria: Part 1A - Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard therapy, standard therapy does not confer survival benefit, or standard therapy is not available. Part 1B- Any histologically or cytologically confirmed solid tumor malignancy among the tumor types outlined below, that is locally advanced or metastatic and has failed standard therapy, standard therapy does not confer survival benefit, or standard therapy is not available. Patients with the following tumor types are eligible for Part 1B: melanoma, NSCLC, HNSCC, TNBC, cervical cancer, microsatellite instability high/mismatch repair deficient (MSI-H/dMMR) colorectal cancer, or MSI-H/dMMR endometrial cancer. Note: Based on evolving internal and external data, the Sponsor may decide to open a "backfill cohort" in Part 1B for patients with any of the following solid tumors: prostate cancer, ovarian cancer, pancreatic cancer, microsatellite stable colorectal cancer, T-cell lymphoma. Phase 2 - All patients must have measurable disease at baseline per RECIST 1.1, except patients with CPRC/APMR-PC. Additional disease-specific criteria per cohort are as follows: i. Cohort 2A: head and neck squamous cell carcinoma (HNSCC). Must have histologically or cytologically confirmed locally recurrent or metastatic HNSCC previously treated with 1 to 2 lines of therapy (therapy given in the curative setting or radiotherapy alone would not be counted as a line of therapy). Unless contraindicated, prior therapy must have included PD-1/PD-L1 inhibitor and/or platinum-based chemotherapy per local and institutional standard of care. Patients who received prior PD-1/PD-L1 inhibitor must have derived clinical benefit, i.e. either achieved a partial response (PR) or CR or have remained stable on PD-1/PD-L1 therapy (alone or in combination) without progression for at least 6 months. Patients must have a known human papillomavirus (HPV) status (either HPV-positive or HPV-negative). Patients with known or suspected invasion or encasement of major vessel or with active or imminent airway obstruction are excluded. ii. Cohort 2B: melanoma. Must have unresectable or metastatic melanoma previously treated with 1 to 2 lines of therapy in the recurrent or metastatic setting. Unless contraindicated, prior therapy must have included a PD-1/PD-L1 inhibitor alone or in combination. Patients with known BRAF V600-activating mutation must have previously received targeted therapy per local and institutional standard of care. Note: patients with uveal melanoma are excluded. iii. Cohort 2C: non-small cell lung cancer (NSCLC). Must have histologically confirmed locally advanced or metastatic NSCLC previously treated with 1 to 2 lines of therapy. Unless contraindicated, prior therapy must have included a PD1/PD-L1 inhibitor and a platinum-based regimen, given either concurrently or separately per local and institutional standard of care. Patients with known genomic alteration for which a targeted therapy is approved (e.g. ROS1 fusion, NTRK fusion, BRAF V600E mutation, EGFR mutation, or ALK fusion) must have been previously treated with relevant targeted therapy per local and institutional standard of care. iv. Cohort 2D: ovarian cancer. Must have histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with current platinum-resistant disease per investigator's assessment (e.g. patient is not eligible for further platinum-containing treatment). Patients must have previously experienced a response lasting at least 180 days to first-line platinum-based therapy. Patients who have been unable to tolerate platinum therapy are also eligible. Unless contraindicated, patients with known BRCA mutation must have received a poly(ADP-ribose) polymerase (PARP) inhibitor. v. Cohort 2E: castrate-resistant prostate cancer (CRPC)/androgen pathway modulation-resistant prostate cancer (APMR-PC). Histopathologically or cytopathologically confirmed adenocarcinoma without neuroendocrine differentiation or small cell features. Must have metastatic disease either on bone scan and/or in soft tissue by CT or MRI. Patients without measurable extra-skeletal lesions must have prostate-specific antigen (PSA) levels ≥ 2 ng/mL at screening. Must have been previously treated with an androgen receptor pathway inhibitor (e.g. abiraterone, enzalutamide, darolutamide, or apalutamide) and/or chemotherapy per local and institutional standard of care. Baseline total testosterone must be ≤ 50 ng/dL (≤ 2.0 nM), and surgical or ongoing medical castration must be maintained throughout the duration of the study. Patients receiving anti-resorptive agent (e.g. bisphosphonate, denosumab) therapy must have been on stable regimen prior to study entry. vi. Cohort 2F: triple-negative breast cancer (TNBC). Must have metastatic TNBC with disease relapse after 2 to 4 previous lines of therapy per local and institutional standard of care. Neoadjuvant and/or adjuvant chemotherapy will count as 1 prior line of therapy only if recurrence during or within 6 months of completing adjuvant systemic therapy. Unless contraindicated, patients with known actionable mutations (e.g. BRCA1 or BRCA2) must have received prior therapy with the corresponding targeted agent per local and institutional standard of care

ECOG performance status of 0-2 for Phase 1

ECOG performance status of 0 or 1 for Phase 2

Adequate organ function

Tumor tissue samples: Part 1B: patients must have lesions amenable to biopsy and be willing and able to provide fresh tumor biopsies before and after initiation of treatment

Patients with recent major surgery must have adequately recovered with no ongoing complications from the surgery before receiving study drug

Exclusion Criteria

Prior treatment with IL-12 therapy (any form, e.g. recombinant human, prodrug, intratumoral, etc.)

Known liver metastasis based on imaging

Possible area of ongoing necrosis (non-disease-related), such as active ulcer, nonhealing wound, or intercurrent bone fracture

Active primary central nervous system (CNS) malignancy, CNS metastases, and/or carcinomatous meningitis

Active autoimmune disease

History of Grade ≥ 3 immune-related adverse events associated with prior immunotherapy unless these were adequately resolved with therapy within 14 days

A diagnosis of immunodeficiency; receiving chronic systemic therapy exceeding prednisone 10 mg daily or equivalent or any other form of immunosuppressive therapy within 7 days before the first dose of study drug

Active hepatitis B or active hepatitis C infection

Prior treatment with gene therapy, organ transplant, or hematopoietic stem-cell transplant

Known malignancy (other than disease under study) that is progressing or has required active treatment within the past 3 years

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Cleveland?

Yes, this clinical trial (NCT05684965) has an active research site in Cleveland, OH that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Advanced Solid Tumors Treatment Options in Cleveland, OH

If you're searching for advanced solid tumors treatment options in Cleveland, OH, this clinical trial (NCT05684965) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Cleveland research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced advanced solid tumors specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all advanced solid tumors clinical trials near you to find additional studies recruiting in your area.

Advanced Solid Tumors Clinical Trial in Cleveland, OH

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About This Advanced Solid Tumors Study in Cleveland