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

NCT05989724 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: SON-DP-A001-ST
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 5

Brief Summary

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Number of participants with AEs, with abnormal vital signs, abnormal ECG readings, abnormal clinical laboratory tests results, abnormal physical examinations and abnormal ECOG performance status.

  Up to 7 months after the first dose

• MTD (Maximum tolerable dose) / RP2D (Recommended dose for phase II)

  During 28-day DLT observation period

Secondary Outcomes (11)

• ORR

  Up to 6 months after the first dose

• DCR

  Up to 6 months after the first dose

• DOR

  Up to 6 months after the first dose

• TTP

  Up to 6 months after the first dose

• PFS

  Up to 6 months after the first dose

Other Outcomes (1)

• SON-DP concentration in tumor biopsy tissue

  Up to 5 weeks after the first dose

Study Arms (15)

Dose escalation, Cohort 1

EXPERIMENTAL

Drug: SON-DP 1 participant or 3 participants with solid tumor will be treated with SON-DP by 90-minute IV infusion in the cohort 1 at dose level 1 once per week in 28-day cycle, for up to 6 cycles.

Drug: SON-DP

Dose escalation, Cohort 2

EXPERIMENTAL

Drug: SON-DP 1 participant or 3 participants with solid tumor will be treated with SON-DP by 90-minute IV infusion in the cohort 2 at dose level 2 once per week in 28-day cycle, for up to 6 cycles.

Drug: SON-DP

Dose escalation, Cohort 3

EXPERIMENTAL

Drug: SON-DP 3 participants with solid tumor will be treated with SON-DP by 90-minute IV infusion in the cohort 3 at dose level 3 once per week in 28-day cycle, for up to 6 cycles.

Drug: SON-DP

Dose escalation, Cohort 4

EXPERIMENTAL

Drug: SON-DP 3 participants with solid tumor will be treated with SON-DP by 90-minute IV infusion in the cohort 4 at dose level 4 once per week in 28-day cycle, for up to 6 cycles.

Drug: SON-DP

Dose escalation, Cohort 5

EXPERIMENTAL

Drug: SON-DP 3 participants with solid tumor will be treated with SON-DP by 90-minute IV infusion in the cohort 5 at dose level 3 twice per week in 28-day cycle, for up to 6 cycles.

Drug: SON-DP

Dose escalation, Cohort 6

EXPERIMENTAL

Drug: SON-DP 3 participants with solid tumor will be treated with SON-DP by 90-minute IV infusion in the cohort 6 at dose level 4 twice per week in 28-day cycle, for up to 6 cycles.

Drug: SON-DP

Dose escalation, Cohort 7

EXPERIMENTAL

Drug: SON-DP 3 participants with solid tumor will be treated with SON-DP by 90-minute IV infusion in the cohort 7 at dose level 5 either once per week or twice per week (FINAL SCHEDULE) in 28-day cycle, for up to 6 cycles.

Drug: SON-DP

Dose escalation, Cohort 8

EXPERIMENTAL

Drug: SON-DP 3 participants with solid tumor will be treated with SON-DP by 90-minute IV infusion in the cohort 8 at dose level 6 either once per week or twice per week (FINAL SCHEDULE) in 28-day cycle, for up to 6 cycles.

Drug: SON-DP

Dose escalation, Cohort 9

EXPERIMENTAL

Drug: SON-DP 3 participants with solid tumor will be treated with SON-DP by 90-minute IV infusion in the cohort 9 at dose level 7 either once per week or twice per week (FINAL SCHEDULE) in 28-day cycle, for up to 6 cycles.

Drug: SON-DP

Dose escalation, Cohort 10

EXPERIMENTAL

Drug: SON-DP Up to 12 participants with solid tumor will be treated with SON-DP by 90-minute IV infusion at the RP2D-1 dose level using either once per week or twice per week (FINAL SCHEDULE), for up to 6 cycles.

Drug: SON-DP

Dose escalation, Cohort 11

EXPERIMENTAL

Drug: SON-DP Up to 12 participants with solid tumor will be treated with SON-DP by 90-minute IV infusion at the RP2D dose level using either once per week or twice per week (FINAL SCHEDULE), for up to 6 cycles.

Drug: SON-DP

Dose expansion, Arm 1

EXPERIMENTAL

Drug: SON-DP Up to 18 participants with breast cancer will be treated with SON-DP by 90-minute IV infusion at the RP2D dose level using the Final Schedule, for up to 6 cycles.

Drug: SON-DP

Dose expansion, Arm 2

EXPERIMENTAL

Drug: SON-DP Up to 18 participants with pancreatic cancer will be treated with SON-DP by 90-minute IV infusion at the RP2D dose level, for up to 6 cycles.

Drug: SON-DP

Dose expansion, Arm 3

EXPERIMENTAL

Drug: SON-DP Up to 18 participants with ovarian cancer will be treated with SON-DP by 90-minute IV infusion at the RP2D dose level, for up to 6 cycles.

Drug: SON-DP

Dose expansion, Arm 4

EXPERIMENTAL

Drug: SON-DP Up to 18 participants with colorectal cancer will be treated with SON-DP by 90-minute IV infusion at the RP2D dose level, for up to 6 cycles.

Drug: SON-DP

Interventions

SON-DP DRUG

Solution for IV administration

Dose escalation, Cohort 1; Dose escalation, Cohort 10; Dose escalation, Cohort 11; Dose escalation, Cohort 2; Dose escalation, Cohort 3; Dose escalation, Cohort 4; Dose escalation, Cohort 5; Dose escalation, Cohort 6; Dose escalation, Cohort 7; Dose escalation, Cohort 8; Dose escalation, Cohort 9; Dose expansion, Arm 1; Dose expansion, Arm 2; Dose expansion, Arm 3; Dose expansion, Arm 4

Eligibility Criteria

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

You may qualify if:

• Signed written informed consent;
• Male or female participants aged ≥ 18 years;
• 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;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at study entry and an estimated life expectancy of at least 3 months;
• Agree to the placement of drug infusion venous access;
• For high dose group, agree for two biopsies, one at screening and one at 1st week of cycle 3;
• Adequate hematological function;
• Adequate hepatic/renal function;
• Acceptable coagulation function;
• Recovered from prior treatment Adverse Effect;
• Effective contraception for female participant with child bearing potential participants and sexually active male participants.

You may not qualify if:

• Participation in investigational study within 2 weeks or 5 half-lives, whichever is shorter of the first dose of study treatment.
• Impaired cardiac function or clinically significant cardiac disease.
• History of stroke or clinically significant intracranial hemorrhage within 6 months before first dose of study drug.
• Malignant disease, other than that being treated in this study.
• Anticancer therapy within 5 half-lives or 2 weeks (whichever is shorter) prior to study entry.
• Active infection requiring intravenous systemic antibiotic or antiviral therapy within 14 days prior to the first dose of study drug.
• Major surgery within 4 weeks of the first dose of study treatment.
• 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.
• 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

Sponsors & Collaborators

• Qurgen Inc.: lead

Study Sites (5)

Banner MD Anderson Cancer Center (BMDACC)

Gilbert, Arizona, 85234, United States

RECRUITING

Henry Ford Health System

Detroit, Michigan, 48202, United States

RECRUITING

Carolina BioOncology Institute

Huntersville, North Carolina, 28078, United States

RECRUITING

Stephenson Cancer Center, University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Pancreatic Neoplasms; Ovarian Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Gonadal Disorders; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Britney Winterberger

  Tigermed America LLC.

  STUDY DIRECTOR

Central Study Contacts

Jianjun Wang

CONTACT

+1（248）607 8451; wangjianjun@qurgen.com

Yingyi zhang

CONTACT

+1-248-862-1598; zhangyingyi@qurgen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a first-in-human and first-in-class, open-label, Phase I clinical trial including a Phase Ia dose escalation stage for the participants with all solid tumor types using seven dose levels of SON-DP to determine the RP2D, MTD and DLT; and a Phase Ib dose expansion stage for the participants of four arms including breast cancer, pancreatic cancer, ovary cancer or colorectal cancer using the RP2D of SON-DP obtained from Phase Ia.

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: August 14, 2023
• Study Start: September 19, 2023
• Primary Completion: September 1, 2025
• Study Completion: March 1, 2026
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)