Solid TumorPhase 1NCT05989724
A First-in-Human Study of SON-DP in Participants With Relapsed/Refractory Intolerant to Standard of Care Therapies for Advanced/Metastatic Solid Tumors
A Phase 1 study testing SON-DP in people with Solid Tumor and Breast Cancer, run by Qurgen Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Breast Cancer, Pancreatic Cancer
- What is being tested?
- SON-DP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 5 sitesUnited States
- Study dates
- 19 Sep 2023to Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Henry Ford Health System
Detroit, Michigan, 48202
Cesar Figueras, 313-433-8915, cfiguer1@hfhs.org
Amy Weise
- Recruiting
Banner MD Anderson Cancer Center (BMDACC)
Gilbert, Arizona, 85234
Katt Mackin, 480-256-3425, Katt.Mackin@bannerhealth.com
Jason Niu
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Siqing Fu, 877-632-6789, siqingfu@mdanderson.org
Jing Peng, 713-792-2208, jingpeng@mdanderson.org
- Recruiting
Carolina BioOncology Institute
Huntersville, North Carolina, 28078
Ashley McClain Wallace, 980-441-1021, awallace@carolinabiooncology.org
John Powderly
- Recruiting
Stephenson Cancer Center, University of Oklahoma
Oklahoma City, Oklahoma, 73104
Christina Caldwell, 405-271-8001 ext. 48171, Christina-Caldwell@ouhsc.edu
Susanna Ulahannan
About this study
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
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.
Read the detailed description
- In an effort to overcome the major challenges of the conventional cancer cell-killing therapy for high side effect, drug resistance, cancer recurrence and tumor heterogenicity, Qurgen Inc. is developing a novel transcription factor (TF) protein anticancer drug, named SON-DP, to treat the Participants with relapsed and advanced metastatic solid tumors. Proposed as an effective therapeutic drug product for a cell-converting cancer therapy, SON-DP is expected to transform cancer cells in situ into normal tissue cells via a SON-DP induced cancer cell reprogramming and re-differentiation process as an innovative rationale.
- SON-DP is developed based on the rationale of cancer cell conversion into normal tissue cells as the primary mechanism of actions of a new cancer therapy, not by cancer cell-killing, the traditional goals of chemotherapy, radiation therapy, targeted therapy and immune therapy. Cancer cell conversion is achieved by the SON-DP induced pluripotent re-programming in situ inside tumor tissue into transient iPSCs (tiPSCs) that quickly re-differentiate into normal tissue cells induced by the differentiating resident tissue environment. The in situ generated tiPSCs either secrete exosomes, providing the embryonic stem cells (ESC)-like microenvironments to transform the surrounding cancer cells into normal tissue cells for an overall malignant phenotype reversion (OMPR) (an effect named as a bystander effect), or display a targeting effect that enables the in situ generated tiPSCs to track down the distant metastatic cancer cells for OMPR (an effect named as a tropism effect). The SON-DP-induced cell reprogramming also restored the mutation-caused and compromised p53 checkpoint in cancer cells to re-establish cell quality control system that ensures the downstream re-differentiation of the in situ generated tiPSCs into normal tissue cells. Overall, this SON-DP-induced re-programming and re-differentiation process is capable of transforming both primary and metastatic cancer cells into normal tissue cells.
- Preclinical studies demonstrated that treatment of tumors with SON-DP resulted in eradication of late-stage cancers and long term (over 3 years) survival without teratoma formation and cancer recurrence in multiple tumor-bearing mouse/rat (syngeneic) or human xenograft rodent models, providing high treatment efficacy of this cell-converting cancer therapy. Thus, the cell-converting cancer therapy rationale represents a new cancer therapeutic strategy. SON-DP was tolerated in tumor-bearing rodents, as well as in naïve rats, dogs, and monkeys as demonstrated by GLP-enabled (rats and dogs) and non-GLP (monkey) toxicity study and after repeated IV administrations at higher doses compared with the planned clinical dose range. Therefore, the current nonclinical studies, including pharmacodynamics (PD), pharmacokinetics (PK) and toxicology studies, support the safety and efficacy of SON-DP TF protein drug product to be used in clinical studies of human participants. This first-in-human (FIH) clinical study will be conducted in selected types of relapsed/refractory advanced/metastatic solid tumors as a step in demonstrating the utility of this anticancer agent.
- In this SON-DP-A001-ST clinical trial, SON-DP is given to the participants with late stage solid tumors through 90-minutes IV infusion either once a week or twice a week at first 4 dose levels during the first Phase I dose escalation stage with the purpose to identify the final schedule (either once a week or twice a week) for the last 3 higher dose levels and the recommended phase II dose (RP2D) for the second Phase Ib does expansion stage that will focus on 4 cancer types including breast cancer, pancreatic cancer, ovarian cancer and colorectal cancer.
- During Phase Ia dose escalation stage, an accelerated 3+3 design will be followed. A Safety Monitoring Committee (SMC) will be formed to evaluate all the safety, efficacy, pharmacokinetic and pharmacodynamic data of each dose level cohort to decide if the SON-DP dose level should be either escalated to the next dose level or de-escalated to one level below or determination of maximum tolerated dose (MTD) or RP2D confirmation or others. Phase Ia will enroll the participants with various types of solid tumors that metastasized and not response to standard treatment.
- During Phase Ib dose expansion stage, SON-DP will be used, at RP2D dose level, to treat the participants with 4 specific cancer types including breast cancer, pancreatic cancer, ovary cancer or colorectal cancer. Four groups of cancer cohorts will be opened with eligible participants who have relapsed/refractory/intolerant to standard of care therapies of these four advanced/metastatic solid tumors. Participants will be followed for safety, confirmation of the RP2D, PK, PD, and anti-tumor activity as measured by standard assessment tools.
- Conditions
- Solid Tumor, Breast Cancer, Pancreatic Cancer, Ovarian Cancer, Colorectal Cancer
- Being tested
- SON-DP
- Keywords
- SON-DP, Solid Tumor, Breast Cancer, Pancreatic Cancer, Ovarian Cancer, Colorectal cancer
- Medical subject headings
- Breast Neoplasms, Pancreatic Neoplasms, Ovarian Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SON-DPDrug
Solution for IV administration
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: SON-DP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 7 months after the first dose
MTD (Maximum tolerable dose) / RP2D (Recommended dose for phase II)
Measured: During 28-day DLT observation period
Secondary outcomes (11)
ORR
Objective response rate (ORR)
Measured: Up to 6 months after the first dose
DCR
Disease control rate (DCR)
Measured: Up to 6 months after the first dose
DOR
Duration of response (DoR)
Measured: Up to 6 months after the first dose
TTP
Time-to-event endpoints of time to disease progression (TTP)
Measured: Up to 6 months after the first dose
PFS
Progression-free survival (PFS)
Measured: Up to 6 months after the first dose
OS
Overall Survival (OS)
Measured: Time Frame: Up to 12 months after the first dose
Cmax
Maximum serum concentration (Cmax) of 3 proteins from SON-DP will be investigated.
Measured: Up to 6 months after the first dose
Tmax
Time to maximum serum concentration (Tmax) of 3 proteins from SON-DP will be investigated.
Measured: Up to 6 months after the first dose
T1/2
Half-life (T1/2) of 3 proteins from SON-DP will be investigated.
Measured: Up to 6 months after the first dose
AUC0-t
AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration.
Measured: Up to 6 months after the first dose
CL
Clearance (CL) in the serum of 3 proteins from SON-DP per unit of time will be investigated.
Measured: Up to 6 months after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start19 Sep 2023
- Primary completionSep 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qurgen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Britney Winterberger, Study director, Tigermed America LLC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989724
- Sponsor's protocol ID
- SON-DP-A001-ST
- Status last verified
- Apr 2024
- First submitted
- 19 Jul 2023
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05989724
- Acronym / sponsor ID
- SON-DP-A001-ST
- Conditions
- Solid Tumor, Breast Cancer, Pancreatic Cancer, Ovarian Cancer, Colorectal Cancer
- Keywords
- SON-DP, Solid Tumor, Breast Cancer, Pancreatic Cancer, Ovarian Cancer, Colorectal cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Qurgen Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- In an effort to overcome the major challenges of the conventional cancer cell-killing therapy for high side effect, drug resistance, cancer recurrence and tumor heterogenicity, Qurgen Inc. is developing a novel transcription factor (TF) protein anticancer drug, named SON-DP, to treat the Participants with relapsed and advanced metastatic solid tumors. Proposed as an effective therapeutic drug product for a cell-converting cancer therapy, SON-DP is expected to transform cancer cells in situ into normal tissue cells via a SON-DP induced cancer cell reprogramming and re-differentiation process as an innovative rationale.
- SON-DP is developed based on the rationale of cancer cell conversion into normal tissue cells as the primary mechanism of actions of a new cancer therapy, not by cancer cell-killing, the traditional goals of chemotherapy, radiation therapy, targeted therapy and immune therapy. Cancer cell conversion is achieved by the SON-DP induced pluripotent re-programming in situ inside tumor tissue into transient iPSCs (tiPSCs) that quickly re-differentiate into normal tissue cells induced by the differentiating resident tissue environment. The in situ generated tiPSCs either secrete exosomes, providing the embryonic stem cells (ESC)-like microenvironments to transform the surrounding cancer cells into normal tissue cells for an overall malignant phenotype reversion (OMPR) (an effect named as a bystander effect), or display a targeting effect that enables the in situ generated tiPSCs to track down the distant metastatic cancer cells for OMPR (an effect named as a tropism effect). The SON-DP-induced cell reprogramming also restored the mutation-caused and compromised p53 checkpoint in cancer cells to re-establish cell quality control system that ensures the downstream re-differentiation of the in situ generated tiPSCs into normal tissue cells. Overall, this SON-DP-induced re-programming and re-differentiation process is capable of transforming both primary and metastatic cancer cells into normal tissue cells.
- Preclinical studies demonstrated that treatment of tumors with SON-DP resulted in eradication of late-stage cancers and long term (over 3 years) survival without teratoma formation and cancer recurrence in multiple tumor-bearing mouse/rat (syngeneic) or human xenograft rodent models, providing high treatment efficacy of this cell-converting cancer therapy. Thus, the cell-converting cancer therapy rationale represents a new cancer therapeutic strategy. SON-DP was tolerated in tumor-bearing rodents, as well as in naïve rats, dogs, and monkeys as demonstrated by GLP-enabled (rats and dogs) and non-GLP (monkey) toxicity study and after repeated IV administrations at higher doses compared with the planned clinical dose range. Therefore, the current nonclinical studies, including pharmacodynamics (PD), pharmacokinetics (PK) and toxicology studies, support the safety and efficacy of SON-DP TF protein drug product to be used in clinical studies of human participants. This first-in-human (FIH) clinical study will be conducted in selected types of relapsed/refractory advanced/metastatic solid tumors as a step in demonstrating the utility of this anticancer agent.
- In this SON-DP-A001-ST clinical trial, SON-DP is given to the participants with late stage solid tumors through 90-minutes IV infusion either once a week or twice a week at first 4 dose levels during the first Phase I dose escalation stage with the purpose to identify the final schedule (either once a week or twice a week) for the last 3 higher dose levels and the recommended phase II dose (RP2D) for the second Phase Ib does expansion stage that will focus on 4 cancer types including breast cancer, pancreatic cancer, ovarian cancer and colorectal cancer.
- During Phase Ia dose escalation stage, an accelerated 3+3 design will be followed. A Safety Monitoring Committee (SMC) will be formed to evaluate all the safety, efficacy, pharmacokinetic and pharmacodynamic data of each dose level cohort to decide if the SON-DP dose level should be either escalated to the next dose level or de-escalated to one level below or determination of maximum tolerated dose (MTD) or RP2D confirmation or others. Phase Ia will enroll the participants with various types of solid tumors that metastasized and not response to standard treatment.
- During Phase Ib dose expansion stage, SON-DP will be used, at RP2D dose level, to treat the participants with 4 specific cancer types including breast cancer, pancreatic cancer, ovary cancer or colorectal cancer. Four groups of cancer cohorts will be opened with eligible participants who have relapsed/refractory/intolerant to standard of care therapies of these four advanced/metastatic solid tumors. Participants will be followed for safety, confirmation of the RP2D, PK, PD, and anti-tumor activity as measured by standard assessment tools.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 15
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dose escalation, Cohort 1 | Experimental | Drug: SON-DPDrug: 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. |
| Dose escalation, Cohort 2 | Experimental | Drug: SON-DPDrug: 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. |
| Dose escalation, Cohort 3 | Experimental | Drug: SON-DPDrug: 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. |
| Dose escalation, Cohort 4 | Experimental | Drug: SON-DPDrug: 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. |
| Dose escalation, Cohort 5 | Experimental | Drug: SON-DPDrug: 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. |
| Dose escalation, Cohort 6 | Experimental | Drug: SON-DPDrug: 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. |
| Dose escalation, Cohort 7 | Experimental | Drug: SON-DPDrug: 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. |
| Dose escalation, Cohort 8 | Experimental | Drug: SON-DPDrug: 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. |
| Dose escalation, Cohort 9 | Experimental | Drug: SON-DPDrug: 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. |
| Dose escalation, Cohort 10 | Experimental | Drug: SON-DPDrug: 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. |
| Dose escalation, Cohort 11 | Experimental | Drug: SON-DPDrug: 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. |
| Dose expansion, Arm 1 | Experimental | Drug: SON-DPDrug: 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. |
| Dose expansion, Arm 2 | Experimental | Drug: SON-DPDrug: 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. |
| Dose expansion, Arm 3 | Experimental | Drug: SON-DPDrug: 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. |
| Dose expansion, Arm 4 | Experimental | Drug: SON-DPDrug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SON-DPSolution for IV administration | Drug | 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 |
Primary outcome
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.
Time frame: Up to 7 months after the first dose
MTD (Maximum tolerable dose) / RP2D (Recommended dose for phase II)
Time frame: During 28-day DLT observation period
11 secondary outcomes
ORR
Time frame: Up to 6 months after the first dose
DCR
Time frame: Up to 6 months after the first dose
DOR
Time frame: Up to 6 months after the first dose
TTP
Time frame: Up to 6 months after the first dose
PFS
Time frame: Up to 6 months after the first dose
OS
Time frame: Time Frame: Up to 12 months after the first dose
Cmax
Time frame: Up to 6 months after the first dose
Tmax
Time frame: Up to 6 months after the first dose
T1/2
Time frame: Up to 6 months after the first dose
AUC0-t
Time frame: Up to 6 months after the first dose
CL
Time frame: Up to 6 months after the first dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Britney Winterberger study director
Tigermed America LLC.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SON-DP in people with Solid Tumor and Breast Cancer, run by Qurgen Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianjun Wang (+1（248）607 8451, wangjianjun@qurgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Up to 7 months after the first dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.