DB-1305 for Solid Tumors, Advanced Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The Oncology Institute of Hope and Innovation, Downey, CA
Solid Tumors, Advanced Solid Tumors+1 More
DB-1305 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1305 in subjects with advanced solid tumors.

Eligible Conditions

  • Solid Tumors, Advanced Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Solid Tumors, Advanced Solid Tumors

Study Objectives

8 Primary · 4 Secondary · Reporting Duration: Up to follow-up period, approximately 1 year post-treatment

12 months
Maximum Tolerated Dose (MTD) of DB-1305
Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1305
Year 1
Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Phase 1: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0.
Phase 2a: Percentage of Objective Response Rate (ORR) as assessed by RECIST 1.1.
Phase 2a: Percentage of Participants with Treatment Emergent adverse events (TEAEs) as assessed by CTCAE v5.0.
Phase 2a: Percentage participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Day 21
Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0.
Day 21
Phase 1 & Phase 2a: Pharmacokinetic-AUC
Phase 1 & Phase 2a: Pharmacokinetic-Cmax
Phase 1 & Phase 2a: Pharmacokinetic-T1/2
Phase 1 & Phase 2a: Pharmacokinetic-Tmax

Trial Safety

Safety Progress

1 of 3

Other trials for Solid Tumors, Advanced Solid Tumors

Trial Design

10 Treatment Groups

DB-1305 Dose Level 2
1 of 10
DB-1305 Dose Expansion 1
1 of 10
DB-1305 Dose Level 1
1 of 10
DB-1305 Dose Level 3
1 of 10
DB-1305 Dose Level 5
1 of 10
DB-1305 Dose Level 4
1 of 10
DB-1305 Dose Expansion 2
1 of 10
DB-1305 Dose Expansion 4
1 of 10
DB-1305 Dose Expansion 3
1 of 10
DB-1305 Dose Expansion 5
1 of 10
Experimental Treatment

235 Total Participants · 10 Treatment Groups

Primary Treatment: DB-1305 · No Placebo Group · Phase 1 & 2

DB-1305 Dose Level 2
Drug
Experimental Group · 1 Intervention: DB-1305 · Intervention Types: Drug
DB-1305 Dose Expansion 1
Drug
Experimental Group · 1 Intervention: DB-1305 · Intervention Types: Drug
DB-1305 Dose Level 1
Drug
Experimental Group · 1 Intervention: DB-1305 · Intervention Types: Drug
DB-1305 Dose Level 3
Drug
Experimental Group · 1 Intervention: DB-1305 · Intervention Types: Drug
DB-1305 Dose Level 5
Drug
Experimental Group · 1 Intervention: DB-1305 · Intervention Types: Drug
DB-1305 Dose Level 4
Drug
Experimental Group · 1 Intervention: DB-1305 · Intervention Types: Drug
DB-1305 Dose Expansion 2
Drug
Experimental Group · 1 Intervention: DB-1305 · Intervention Types: Drug
DB-1305 Dose Expansion 4
Drug
Experimental Group · 1 Intervention: DB-1305 · Intervention Types: Drug
DB-1305 Dose Expansion 3
Drug
Experimental Group · 1 Intervention: DB-1305 · Intervention Types: Drug
DB-1305 Dose Expansion 5
Drug
Experimental Group · 1 Intervention: DB-1305 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to follow-up period, approximately 1 year post-treatment
Closest Location: The Oncology Institute of Hope and Innovation · Downey, CA
Photo of california 1Photo of california 2Photo of california 3
2014First Recorded Clinical Trial
3 TrialsResearching Solid Tumors, Advanced Solid Tumors
26 CompletedClinical Trials

Who is running the clinical trial?

DualityBio Inc.Lead Sponsor
1 Previous Clinical Trials
180 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a left ventricular ejection fraction (LVEF) of 50% or greater.
You have advanced/ metastatic solid tumors that have relapsed or progressed on or after standard systemic treatments or for which no standard treatment is available.
You have measurable disease as assessed by the investigator according to RECIST version 1.1 criteria.
Has an ECOG PS of 0-1.
You have adequate organ functions within 7 days prior to Day 1 of Cycle 1.
You have received a full course of treatment and have had a complete treatment washout period prior to Day 1 of Cycle 1.
You are willing to undergo pre-existing resected tumor samples or fresh tumor biopsy for the measurement of Trop-2 level and other biomarkers if no contraindication.
You are 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.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.