A First-in-Human Study of SON-DP in Participants With Relapsed/Refractory Intolerant to Standard of Care Therapies for Advanced/Metastatic Solid Tumors

Description

This proposed Phase I clinical trial of SON-DP is an FIH, open-label, Phase Ia/Ib dose escalation and expansion study to evaluate the safety, tolerability, PK, and PD of SON-DP in participants with relapsed/refractory/intolerant to standard of care therapies, for advanced/ metastatic solid tumors.

Conditions

Solid Tumor, Breast Cancer, Pancreatic Cancer, Ovarian Cancer, Colorectal Cancer

Study Overview

Study Details

Study overview

This proposed Phase I clinical trial of SON-DP is an FIH, open-label, Phase Ia/Ib dose escalation and expansion study to evaluate the safety, tolerability, PK, and PD of SON-DP in participants with relapsed/refractory/intolerant to standard of care therapies, for advanced/ metastatic 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

A First-in-Human Study of SON-DP in Participants With Relapsed/Refractory Intolerant to Standard of Care Therapies for Advanced/Metastatic Solid Tumors

Condition
Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Gilbert

Banner MD Anderson Cancer Center (BMDACC), Gilbert, Arizona, United States, 85234

Detroit

Henry Ford Health System, Detroit, Michigan, United States, 48202

Huntersville

Carolina BioOncology Institute, Huntersville, North Carolina, United States, 28078

Oklahoma City

Stephenson Cancer Center, University of Oklahoma, Oklahoma City, Oklahoma, United States, 73104

Houston

MD Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Qurgen Inc.,

Britney Winterberger, STUDY_DIRECTOR, Tigermed America LLC.

Study Record Dates

2026-03