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A Study of DB-1311 in Advanced/Metastatic Solid Tumors
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1311 in subjects with advanced solid tumors.
Study details:
This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a study. Phase 1 adopts an accelerated titration at first dose level followed with classic "3+3" design to identify the MTD and/or RP2D. Phase 2a is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors treated with DB-1311 as monotherapy.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-09-05
Primary completion: 2025-04-01
Study completion finish: 2025-04-01
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT05914116
Intervention or treatment
DRUG: DB-1311
Conditions
- • Advanced Solid Tumors
Find a site
Closest Location:
Site 201
Research sites nearby
Select from list below to view details:
Site 201
Sydney, New South Wales, Australia
Site 202
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: DB-1311 Dose Level 1
| DRUG: DB-1311
|
EXPERIMENTAL: DB-1311 Dose Level 2
| DRUG: DB-1311
|
EXPERIMENTAL: DB-1311 Dose Level 3
| DRUG: DB-1311
|
EXPERIMENTAL: DB-1311 Dose Level 4
| DRUG: DB-1311
|
EXPERIMENTAL: DB-1311 Dose Level 5
| DRUG: DB-1311
|
EXPERIMENTAL: DB-1311 Dose Expansion 1
| DRUG: DB-1311
|
EXPERIMENTAL: DB-1311 Dose Expansion 2
| DRUG: DB-1311
|
EXPERIMENTAL: DB-1311 Dose Expansion 3
| DRUG: DB-1311
|
EXPERIMENTAL: DB-1311 Dose Expansion 4
| DRUG: DB-1311
|
EXPERIMENTAL: DB-1311 Dose Expansion 5
| DRUG: DB-1311
|
EXPERIMENTAL: DB-1311 Dose Expansion 6
| DRUG: DB-1311
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0. Percentage of participants in Part 1 with DLTs | Percentage of participants in Part 1 with DLTs | 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. | Percentage of participants with AEs in Part 1 graded according to NCI CTCAE v5.0 | 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. | Percentage of Participants with SAEs in Part 1 graded according to NCI CTCAE v5.0 | Up to follow-up period, approximately 1 year post-treatment |
Maximum Tolerated Dose (MTD) of DB-1311 | MTD on the data collected during Part 1 | 12 months |
Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1311 | RP2D of DB-1311 based on the data collected during Part 1 | 12 months |
Phase 2a: Percentage of Participants with Treatment Emergent adverse events (TEAEs) as assessed by CTCAE v5.0. | Percentage of participants with AEs in Part 2 graded according to NCI CTCAE v5.0 | 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. | Percentage of participants with SAEs in Part 2 graded according to NCI CTCAE v5.0 | Up to follow-up period, approximately 1 year post-treatment |
Phase 2a: Percentage of Objective Response Rate (ORR) as assessed by RECIST 1.1. | The percentage of subjects who had a best response rating of CR and PR, for Part 2 only which was maintained ≥4 weeks | Up to follow-up period, approximately 1 year post-treatment |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Phase 1 & Phase 2a: Pharmacokinetic-AUC | Area under the concentration-time curve from time 0 to infinity of DB-1311 | within 8 cycles (each cycle is 21 days) |
Phase 1 & Phase 2a: Pharmacokinetic-Cmax | Maximum observed plasma concentration (Cmax) of DB-1311 | within 8 cycles (each cycle is 21 days) |
Phase 1 & Phase 2a: Pharmacokinetic-Tmax | Time to Cmax of DB-1311 | within 8 cycles (each cycle is 21 days) |
Phase 1 & Phase 2a: Pharmacokinetic-T1/2 | Terminal elimination half-life | within 8 cycles (each cycle is 21 days) |
Frequently Asked Questions
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