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First-in-human Study of DB-1419 for Advanced/Metastatic Solid Tumors

PHASE1PHASE2RECRUITING

A Phase 1/2a First-in-Human Study of DB-1419 in Advanced/Metastatic Solid Tumors.

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Study details:

A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1419 in Participants with Advanced/Metastatic Solid Tumors.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Adults aged ≥ 18 years at the time of voluntarily signing informed consent.

Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or refused the standard treatment, or for which no standard treatment is available.

At least one measurable lesion as assessed by the Investigator according to RECIST v1.1 criteria (Only applicable to backfill participants in phase 1a and participants in phase 1b/2a). CRPC participants with bone-only disease may be eligible on a case-by-case basis after discussion with the Medical Monitor.

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.

Has adequate organ function within 7 days prior to the first dose of study treatment.

Has adequate treatment washout period prior to the first dose of study treatment.

Is willing to provide pre-existing resected tumor samples when available or undergo fresh tumor biopsy if feasible for the measurement of B7-H3/PD-L1 level and other biomarkers if no contraindication.

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 B7-H3 targeted therapy.

Has a medical history of symptomatic congestive heart failure (New York Heart Association [NYHA] classes II-IV or serious cardiac arrhythmia requiring treatment.

Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment.

Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to > 470 millisecond (ms) in males and females based on a 12-lead electrocardiogram (ECG) in triplicate.

Has a medical history of interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis which needs glucocorticoids and antibiotics) or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening.

Has a history of underlying pulmonary disorder including, but not limited to, pulmonary emboli within 3 months of the start of study treatment, severe asthma, severe COPD, restrictive lung disease, and other clinically significant pulmonary compromise or requirement for supplemental oxygen.

Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed.

Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals within 2 weeks before first dose of study treatment.

Know human immunodeficiency virus (HIV) infection.

Has spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Participants with asymptomatic CNS metastases who are radiologically and neurologically stable for at least 4 weeks following CNS-directed therapy (defined as 2 brain images, same imaging modality, both of which are obtained after treatment to the brain metastases; these imaging scans should be obtained at least 4 weeks apart and show no evidence of intracranial progression), and are on stable or decreasing doses of corticosteroids equivalent to ≤10 mg/day prednisone are eligible for study entry.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-09-03

Primary completion: 2027-02-01

Study completion finish: 2027-02-01

Study type

TREATMENT

Phase

PHASE1

PHASE2

Trial ID

NCT06554795

Intervention or treatment

DRUG: DB-1419

Conditions

• Solid Tumor, Adult

Condition: Solid Tumor, Adult
DRUG: DB-1419
North Ryde, New South Wales, Australia and more
Sponsor: DualityBio Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

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Find a site

Closest Location:

AUS03-0

Research sites nearby

Select from list below to view details:

AUS03-0
North Ryde, New South Wales, Australia
AUS01-0
Randwick, New South Wales, Australia
AUS02-0
Nedlands, Western Australia, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Dose Level 1 Enrolled subjects will receive DB-1419 at Dose Level 1	DRUG: DB-1419 Administered Injection of Vein (I.V.)
EXPERIMENTAL: Dose Level 2 Enrolled subjects will receive DB-1419 at Dose Level 2	DRUG: DB-1419 Administered Injection of Vein (I.V.)
EXPERIMENTAL: Dose Level 3 Enrolled subjects will receive DB-1419 at Dose Level 3	DRUG: DB-1419 Administered Injection of Vein (I.V.)
EXPERIMENTAL: Dose Level 4 Enrolled subjects will receive DB-1419 at Dose Level 4	DRUG: DB-1419 Administered Injection of Vein (I.V.)
EXPERIMENTAL: Dose Level 5 Enrolled subjects will receive DB-1419 at Dose Level 5	DRUG: DB-1419 Administered Injection of Vein (I.V.)
EXPERIMENTAL: Dose Level 6 Enrolled subjects will receive DB-1419 at Dose Level 6	DRUG: DB-1419 Administered Injection of Vein (I.V.)
EXPERIMENTAL: Dose Expansion 1 Not Specified	DRUG: DB-1419 Administered Injection of Vein (I.V.)
EXPERIMENTAL: Dose Expansion 2 Not Specified	DRUG: DB-1419 Administered Injection of Vein (I.V.)
EXPERIMENTAL: Dose Expansion 3 Not Specified	DRUG: DB-1419 Administered Injection of Vein (I.V.)
EXPERIMENTAL: Dose Expansion 4 Not Specified	DRUG: DB-1419 Administered Injection of Vein (I.V.)
EXPERIMENTAL: Dose Expansion 5 Not Specified	DRUG: DB-1419 Administered Injection of Vein (I.V.)
EXPERIMENTAL: Dose Expansion 6 Not Specified	DRUG: DB-1419 Administered Injection of Vein (I.V.)
EXPERIMENTAL: Dose Expansion 7 Not Specified	DRUG: DB-1419 Administered Injection of Vein (I.V.)
EXPERIMENTAL: Dose Expansion 8 Not Specified	DRUG: DB-1419 Administered Injection of Vein (I.V.)

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Phase 1/2a: Percentage of Participants with Adverse events (AE) serious AE (SAE)	Percentage of participants with TEAEs graded according to NCI CTCAE v5.0	Up to 30 days after last study treatment administration or before starting new anticancer treatment, whichever comes first
Phase 1/2a: Percentage of Participants with serious AE (SAE)	Percentage of participants with SAEs graded according to NCI CTCAE v5.0	Up to 30 days after last study treatment administration or before starting new anticancer treatment, whichever comes first
Phase 1a: Maximum Tolerated Dose (MTD)	MTD on the data collected during Part 1	From first study treatment administration until the initiation of Phase1b/2a, approximately up to 12 months.
Phase 1a: Recommended Phase 2 Dose (RP2D)	RP2D of DB-1419 based on the data collected during Part 1	From first study treatment administration until the initiation of Phase 1b/2a, approximately up to 12 months.
Phase 1b/2a: Objective Response Rate (ORR) determined by Investigator per RECIST v1.1	The percentage of subjects who had a best response rating of CR and PR	Up to disease progression or death or before starting new anticancer treatment or withdrawal from the trial, whichever comes first, approximately up to 12 months.

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Phase 1a: ORR determined from tumor assessments by Investigator per RECIST v1.1	The percentage of subjects who had a best response rating of CR and PR	Up to disease progression or death or before starting new anticancer treatment or withdrawal from the trial, whichever comes first, approximately up to 12 months.
Phase 1/2a: Progression free survival (PFS) determined from tumor assessments by Investigator per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1	PFS will be determined from tumor assessments by investigator per RECIST 1.1	Up to disease progression or death or before starting new anticancer treatment or withdrawal from the trial, whichever comes first, approximately up to 12 months
Phase 1/2a: OS	overall survival (OS)	From the start date of study drug to the date of death due to any cause, whichever occurs first, approximately up to 12 months after last patient first dose.
Phase 1/2a: AUC0-last	the area under the concentration-time curve from time zero to the last quantifiable concentration	within 8 cycles (each cycle is 21 days or 14 days)
Phase 1/2a: AUC0-tau	the area under the concentration-time curve from time zero to time tau	within 8 cycles (each cycle is 21 days or 14 days)
Phase 1/2a: AUCinf	the area under the concentration-time curve from time zero to infinite	within 8 cycles (each cycle is 21 days or 14 days)
Phase 1/2a: Cmax	peak observed concentration	within 8 cycles (each cycle is 21 days or 14 days)
Phase 1/2a: Tmax	Time to Cmax	within 8 cycles (each cycle is 21 days or 14 days)
Phase 1/2a: Ctrough	trough concentration	within 8 cycles (each cycle is 21 days or 14 days)
Phase 1/2a: ADA prevalence	the proportion of participants who are ADA positive at any point in time (at baseline and post-baseline)	within 8 cycles (each cycle is 21 days or 14 days)
Phase 1/2a: ADA incidence	the proportion of participants having treatment-emergent ADA.	within 8 cycles (each cycle is 21 days or 14 days)

Frequently Asked Questions

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References

Clinical Trials Gov: First-in-human Study of DB-1419 for Advanced/Metastatic Solid Tumors