Testing a new treatment for advanced solid tumors

A First-in-Human (FIH), Open-Label, Phase Ia/Ib Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SON-DP in Participants With Relapsed/Metastatic Solid Tumors

This study is testing a new treatment called SON-DP to see if it can turn cancer cells back into normal cells for people with advanced solid tumors that haven't responded to other treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Qurgen Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 5 sites (Gilbert, Arizona and 4 other locations)
• Trial ID: NCT05989724 on ClinicalTrials.gov

What this trial studies

This Phase I clinical trial evaluates the safety and effectiveness of SON-DP, a novel transcription factor protein designed to convert cancer cells into normal tissue cells. The study involves a dose escalation and expansion approach for participants with relapsed or refractory solid tumors who have not responded to standard therapies. By inducing pluripotent reprogramming within tumor tissues, SON-DP aims to transform cancer cells in situ, potentially offering a new therapeutic strategy against advanced metastatic cancers.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced solid tumors, specifically those with breast, pancreatic, ovarian, or colorectal cancer who have not responded to standard treatments.

Not a fit: Patients with early-stage cancers or those who have not yet undergone standard therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a groundbreaking alternative to traditional cancer therapies by reprogramming cancer cells into normal cells.

How similar studies have performed: While the approach of cell conversion is innovative, it remains largely untested in clinical settings, making this a novel endeavor.

Eligibility criteria

Inclusion Criteria:

1. Signed written informed consent;
2. Male or female participants aged ≥ 18 years;
3. For Phase Ia: Participants with histologic diagnosis and confirmed solid tumor; For Phase Ib: Participants with one of the four tumor types: breast cancer, pancreatic cancer, ovarian cancer or colorectal cancer;
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at study entry and an estimated life expectancy of at least 3 months;
5. Agree to the placement of drug infusion venous access;
6. For high dose group, agree for two biopsies, one at screening and one at 1st week of cycle 3;
7. Adequate hematological function;
8. Adequate hepatic/renal function;
9. Acceptable coagulation function;
10. Recovered from prior treatment Adverse Effect;
11. Effective contraception for female participant with child bearing potential participants and sexually active male participants.

Exclusion Criteria:

1. Participation in investigational study within 2 weeks or 5 half-lives, whichever is shorter of the first dose of study treatment.
2. Impaired cardiac function or clinically significant cardiac disease.
3. History of stroke or clinically significant intracranial hemorrhage within 6 months before first dose of study drug.
4. Malignant disease, other than that being treated in this study.
5. Anticancer therapy within 5 half-lives or 2 weeks (whichever is shorter) prior to study entry.
6. Active infection requiring intravenous systemic antibiotic or antiviral therapy within 14 days prior to the first dose of study drug.
7. Major surgery within 4 weeks of the first dose of study treatment.
8. Any medical condition that would, in the Investigator's judgment, prevent the participant's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results.
9. Active pneumonitis, the suspected pneumonitis that cannot be ruled out based on the imaging at Screening or based on the Investigator's judgement and a history of the (non-infectious) pneumonitis that required steroids within the past 12 months

Where this trial is running

Gilbert, Arizona and 4 other locations

• Banner MD Anderson Cancer Center (BMDACC) — Gilbert, Arizona, United States (Recruiting)
• Henry Ford Health System — Detroit, Michigan, United States (Recruiting)
• Carolina BioOncology Institute — Huntersville, North Carolina, United States (Recruiting)
• Stephenson Cancer Center, University of Oklahoma — Oklahoma City, Oklahoma, United States (Recruiting)
• MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Jianjun Wang

Conditions Solid Tumor; Breast Cancer; Pancreatic Cancer; Ovarian Cancer; Colorectal Cancer; SON-DP; Colorectal cancer