RECRUITING

A First-in-Human Study 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 SON-DP

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-09-19

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05989724

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Jianjun Wang

CONTACT

+1（248）607 8451

wangjianjun@qurgen.com

Yingyi zhang

CONTACT

+1-248-862-1598

zhangyingyi@qurgen.com

Principal Investigator

Britney Winterberger

STUDY_DIRECTOR

Tigermed America LLC.

Study Locations (Sites)

Banner MD Anderson Cancer Center (BMDACC)

Gilbert, Arizona, 85234

United States

Henry Ford Health System

Detroit, Michigan, 48202

United States

Carolina BioOncology Institute

Huntersville, North Carolina, 28078

United States

Stephenson Cancer Center, University of Oklahoma

Oklahoma City, Oklahoma, 73104

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Qurgen Inc.

Britney Winterberger, STUDY_DIRECTOR, Tigermed America LLC.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-19

Study Completion Date2026-03

Study Record Updates

Study Start Date2023-09-19

Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Solid Tumor
Breast Cancer
Pancreatic Cancer
Ovarian Cancer
Colorectal Cancer