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Unknown

DB-1305 for Solid Tumors

Phase 1 & 2
Recruiting
Research Sponsored by DualityBio Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 28 days
Treatment Varies
Follow Up up to follow-up period, approximately 1 year post-treatment
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it is safe and effective.

Who is the study for?
Adults with advanced solid tumors that have worsened after standard treatments or when no standard treatment exists. Participants must be willing to provide tumor samples, have a life expectancy of at least 3 months, be in good physical condition (ECOG 0-1), and have proper organ function.Check my eligibility
What is being tested?
DB-1305 is being tested for safety and effectiveness in treating advanced solid tumors. This early-phase trial gradually increases the dose to find the right balance between benefits and side effects before expanding to more patients.See study design
What are the potential side effects?
As this is a first-in-human study, specific side effects of DB-1305 are not yet known but may include typical reactions seen with cancer drugs such as nausea, fatigue, allergic reactions, or issues related to organ inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to provide previous tumor samples or undergo a biopsy for testing.
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I am 18 years old or older.
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My cancer is advanced, cannot be surgically removed, and has not responded to or is untreatable with standard therapies.
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I am fully active or can carry out light work.

Timeline

Screening ~ 28 days
Treatment ~ Varies
Follow Up ~up to follow-up period, approximately 1 year post-treatment
This trial's timeline: 28 days for screening, Varies for treatment, and up to follow-up period, approximately 1 year post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD) of DB-1305
Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0.
Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
+5 more
Secondary outcome measures
Phase 1 & Phase 2a: Pharmacokinetic-AUC
Phase 1 & Phase 2a: Pharmacokinetic-Cmax
Phase 1 & Phase 2a: Pharmacokinetic-T1/2
+1 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

16Treatment groups
Experimental Treatment
Group I: DB-1305 Dose Level 5Experimental Treatment1 Intervention
Enrolled subjects will receive a single-dose of DB-1305 at Dose Level 5 on Day 1 of each cycle Q3W
Group II: DB-1305 Dose Level 4Experimental Treatment1 Intervention
Enrolled subjects will receive a single-dose of DB-1305 at Dose Level 4 on Day 1 of each cycle Q3W
Group III: DB-1305 Dose Level 3Experimental Treatment1 Intervention
Enrolled subjects will receive a single-dose of DB-1305 at Dose Level 3 on Day 1 of each cycle Q3W
Group IV: DB-1305 Dose Level 2Experimental Treatment1 Intervention
Enrolled subjects will receive a single-dose of DB-1305 at Dose Level 2 on Day 1 of each cycle Q3W
Group V: DB-1305 Dose Level 1Experimental Treatment1 Intervention
Enrolled subjects will receive a single-dose of DB-1305 at Dose Level 1 on Day 1 of each cycle Q3W
Group VI: DB-1305 Dose Expansion 9Experimental Treatment1 Intervention
Enrolled subjects with CC who have progressed on or after standard systemic treatments who will receive a single-dose of DB-1305 on a selected dose level (RP2D) once every 3 weeks
Group VII: DB-1305 Dose Expansion 8Experimental Treatment1 Intervention
Enrolled subjects with malignant mesothelioma who have progressed on or after standard systemic treatments who will receive a single-dose of DB-1305 on a selected dose level (RP2D) once every 3 weeks
Group VIII: DB-1305 Dose Expansion 7Experimental Treatment1 Intervention
Enrolled subjects with EC with disease progression on or after treatment with at least one platinum-containing regimen for advanced or metastatic disease with or without immune checkpoint inhibitor (ICI) who will receive a single-dose of DB-1305 on a selected dose level (RP2D) once every 3 weeks
Group IX: DB-1305 Dose Expansion 6Experimental Treatment1 Intervention
Enrolled subjects with TNBC with treatment failure on sacituzumab govitecan who will receive a single-dose of DB-1305 on a selected dose level (RP2D) once every 3 weeks
Group X: DB-1305 Dose Expansion 5Experimental Treatment1 Intervention
Enrolled subjects with TNBC who have progressed on or after standard systemic treatments and without prior treatment of sacituzumab govitecan who will receive a single-dose of DB-1305 on a selected dose level (RP2D) once every 3 weeks
Group XI: DB-1305 Dose Expansion 4Experimental Treatment1 Intervention
Enrolled subjects with BC who will receive a single-dose of DB-1305 on a selected dose level (RP2D) once every 3 weeks
Group XII: DB-1305 Dose Expansion 3Experimental Treatment1 Intervention
Enrolled subjects with OC who will receive a single-dose of DB-1305 on a selected dose level once every 3 weeks
Group XIII: DB-1305 Dose Expansion 2Experimental Treatment1 Intervention
Enrolled subjects with NSCLC without AGAs who will receive a single-dose of DB-1305 on a selected dose level once every 3 weeks
Group XIV: DB-1305 Dose Expansion 11Experimental Treatment2 Interventions
Enrolled subjects with NSCLC without AGAs who has not received PD-1/PD-L1, PD-L2, CTLA-4 directed immunotherapy and previously received ≤1 line of platinum-based chemotherapy for advanced or metastatic NSCLC who will receive a single-dose of DB-1305 on a selected dose level in combination with pembrolizumab 200mg once every 3 weeks
Group XV: DB-1305 Dose Expansion 10Experimental Treatment1 Intervention
Enrolled subjects with other advanced or metastatic solid tumors who have progressed on or after standard systemic treatments who will receive a single-dose of DB-1305 on a selected dose level (RP2D) once every 3 weeks
Group XVI: DB-1305 Dose Expansion 1Experimental Treatment1 Intervention
Enrolled subjects with NSCLC with AGAs who will receive a single-dose of DB-1305 on a selected dose level once every 3 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

DualityBio Inc.Lead Sponsor
7 Previous Clinical Trials
2,572 Total Patients Enrolled
Raymond Zhao, MDStudy DirectorDualityBio Inc.
1 Previous Clinical Trials
287 Total Patients Enrolled

Media Library

DB-1305 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05438329 — Phase 1 & 2
Solid Tumors Research Study Groups: DB-1305 Dose Expansion 3, DB-1305 Dose Level 5, DB-1305 Dose Expansion 8, DB-1305 Dose Expansion 2, DB-1305 Dose Level 1, DB-1305 Dose Expansion 4, DB-1305 Dose Expansion 11, DB-1305 Dose Level 2, DB-1305 Dose Level 4, DB-1305 Dose Level 3, DB-1305 Dose Expansion 1, DB-1305 Dose Expansion 5, DB-1305 Dose Expansion 6, DB-1305 Dose Expansion 7, DB-1305 Dose Expansion 9, DB-1305 Dose Expansion 10
Solid Tumors Clinical Trial 2023: DB-1305 Highlights & Side Effects. Trial Name: NCT05438329 — Phase 1 & 2
DB-1305 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05438329 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the primary aims of this clinical trial?

"According to DualityBio Inc., the primary metric of this clinical study is determining a Recommended Phase 2 Dose (RP2D) for DB-1305 over an approximate 1 year post-treatment observation period. Additionally, researchers will be assessing secondary outcomes such as Area under the concentration-time curve from time 0 to infinity of DB-1305, Maximum observed plasma concentration (Cmax) of DB-1305, and Time to Cmax of DB-1305."

Answered by AI

Are participants currently being enrolled for this experiment?

"Affirmative. Information published on clinicaltrials.gov reports that this medical trial, which was made available to the public on July 19th 2022, is presently seeking participants. A total of 235 patients must be recruited from 7 different sites for the study's completion."

Answered by AI

How many individuals are enrolled to participate in this experiment?

"This clinical trial requires 235 eligible patients, and participants can join at Site 107 in Fairfax, Virginia or Site 104 in Houston, Texas."

Answered by AI

Are there a plethora of research centers conducting this experiment in Canada?

"Seven sites are currently available for enrollment, including Fairfax's Site 107, Houston's Site 104 and Nashville's Site 105. Moreover there are four additional locations that offer this trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
First-in-human Study of DB-1305 for Advanced/Metastatic Solid Tumors
2022. "First-in-human Study of DB-1305 for Advanced/Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05438329.
~138 spots leftby Jun 2025
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