RecruitingPhase 1/2

A Study of DB-1310 in Advanced/Metastatic Solid Tumors

United States1,000 participantsStarted 2023-08-17

Plain-language summary

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1310 in subjects with advanced solid tumors.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent).
✓. Have relapsed or progressed on or after standard systemic treatments, or intolerable with standard treatment, or for which no standard treatment is available. Documented radiological disease progression during/after most recent treatment regimen for advanced/unresectable, or metastatic disease.
✓. At least one measurable lesion as assessed by the investigator according to response evaluation criteria in solid tumors (RECIST) version 1.1 criteria.
✓. Has a life expectancy of ≥ 3 months.
✓. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
✓. Has LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment.
✓. Is willing to provide archived tumor tissue or undergo fresh tumor biopsy for the retrospective measurement of human epidermal growth factor receptor 3 (HER3) level and other biomarkers if no contraindication. For HER2 IHC 0 breast cancer subjects, it is highly recommended to collect additional tumor sample (Refer to Lab Manual).
✓. Is capable of comprehending study procedures and risks outlined in the informed consent and able to provide written consent and agree to comply with the requirements of the study and the schedule of assessments.

Exclusion criteria

✕. Prior treatment with HER3 targeted therapy.
✕. Prior treatment with antibody drug conjugate with topoisomerase I inhibitor (except topoisomerase I inhibitor HER2 ADC for backfilled subjects in Combo A of Phase 1 and subjects in Cohort 2e of Phase 2a, and not applicable for subjects enrolled for DLT observation in Phase 1).
✕. Has a medical history of symptomatic congestive heart failure (CHF) (New York Heart Association \[NYHA\] classes II-IV) or serious cardiac arrhythmia requiring treatment.
✕. Has a medical history of myocardial infarction or unstable angina or cerebrovascular accident including transient ischemic attack (TIA) within 6 months before first dose. Or has uncontrolled hypertension (defined as systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg).
✕. Has any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiogram (ECG), e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, or PR interval \> 250 milliseconds (ms).
✕. Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to \> 470 millisecond (ms) based on a 12-lead electrocardiogram (ECG) in triplicate.
✕. Unable or unwilling to discontinue concomitant drugs that are known to prolong the QT interval.
✕. Has a history of (non-infectious) ILD/pneumonitis and/or radiation pneumonitis that required glucocorticoids, or has current ILD/pneumonitis and/or radiation pneumonitis, or where suspected ILD/pneumonitis and/or radiation pneumonitis cannot be ruled out by imaging at screening.

What they're measuring

Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0. Percentage of participants in Part 1 with DLTs

Timeframe: up to 21 days after Cycle 1 Day 1

Phase 1: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0.

Timeframe: Up to follow-up period, approximately 1 year post-treatment

Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.

Timeframe: Up to follow-up period, approximately 1 year post-treatment

Maximum Tolerated Dose (MTD) of DB-1310

Timeframe: 12 months

Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1310

Timeframe: 12 months

Phase 2a: Percentage of Participants with Treatment Emergent adverse events (TEAEs) as assessed by CTCAE v5.0.

Timeframe: Up to follow-up period, approximately 1 year post-treatment

Phase 2a: Percentage participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.

Timeframe: Up to follow-up period, approximately 1 year post-treatment

Trial details

NCT IDNCT05785741

SponsorDualityBio Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-30

Contact for this trial

Tiana Zhao

1-626-433-3820 tiana.zhao@dualitybiologics.com

View on ClinicalTrials.gov More Advanced Solid Tumor trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent).
✓. Have relapsed or progressed on or after standard systemic treatments, or intolerable with standard treatment, or for which no standard treatment is available. Documented radiological disease progression during/after most recent treatment regimen for advanced/unresectable, or metastatic disease.
✓. At least one measurable lesion as assessed by the investigator according to response evaluation criteria in solid tumors (RECIST) version 1.1 criteria.
✓. Has a life expectancy of ≥ 3 months.
✓. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
✓. Has LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment.
✓. Is willing to provide archived tumor tissue or undergo fresh tumor biopsy for the retrospective measurement of human epidermal growth factor receptor 3 (HER3) level and other biomarkers if no contraindication. For HER2 IHC 0 breast cancer subjects, it is highly recommended to collect additional tumor sample (Refer to Lab Manual).
✓. Is capable of comprehending study procedures and risks outlined in the informed consent and able to provide written consent and agree to comply with the requirements of the study and the schedule of assessments.

Exclusion criteria

✕. Prior treatment with HER3 targeted therapy.
✕. Prior treatment with antibody drug conjugate with topoisomerase I inhibitor (except topoisomerase I inhibitor HER2 ADC for backfilled subjects in Combo A of Phase 1 and subjects in Cohort 2e of Phase 2a, and not applicable for subjects enrolled for DLT observation in Phase 1).
✕. Has a medical history of symptomatic congestive heart failure (CHF) (New York Heart Association \[NYHA\] classes II-IV) or serious cardiac arrhythmia requiring treatment.
✕. Has a medical history of myocardial infarction or unstable angina or cerebrovascular accident including transient ischemic attack (TIA) within 6 months before first dose. Or has uncontrolled hypertension (defined as systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg).
✕. Has any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiogram (ECG), e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, or PR interval \> 250 milliseconds (ms).
✕. Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to \> 470 millisecond (ms) based on a 12-lead electrocardiogram (ECG) in triplicate.
✕. Unable or unwilling to discontinue concomitant drugs that are known to prolong the QT interval.
✕. Has a history of (non-infectious) ILD/pneumonitis and/or radiation pneumonitis that required glucocorticoids, or has current ILD/pneumonitis and/or radiation pneumonitis, or where suspected ILD/pneumonitis and/or radiation pneumonitis cannot be ruled out by imaging at screening.

What they're measuring

Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0. Percentage of participants in Part 1 with DLTs

Timeframe: up to 21 days after Cycle 1 Day 1

Phase 1: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0.

Timeframe: Up to follow-up period, approximately 1 year post-treatment

Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.

Timeframe: Up to follow-up period, approximately 1 year post-treatment

Maximum Tolerated Dose (MTD) of DB-1310

Timeframe: 12 months

Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1310

Timeframe: 12 months

Phase 2a: Percentage of Participants with Treatment Emergent adverse events (TEAEs) as assessed by CTCAE v5.0.

Timeframe: Up to follow-up period, approximately 1 year post-treatment

Phase 2a: Percentage participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.

Timeframe: Up to follow-up period, approximately 1 year post-treatment