Advanced Solid TumorPhase 1/2NCT05785728
A Study of DB-1202 Monotherapy in Advanced Solid Tumors
A Phase 1/2 study testing DB-1202 in people with Advanced Solid Tumor, run by DualityBio Inc. at 1 site in China.
Trial summary
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1201 in subjects with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- DB-1202
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2023to 28 Feb 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female at least 18 years old.
- Has histologically or cytologically confirmed metastatic or locally advanced solid tumors for which no effective standard therapy existed or standard of care has failed or is not considered as an option.
- Is capable of comprehending study procedures and risks outlined in the informed consent and is willing to provide written consent.
- Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1.
- At least one measurable lesion as assessed by the investigator according to response evaluation criteria in solid tumors (RECIST) version 1.1 criteria.
- Has adequate organ function within 7 days prior to initiation of the first Treatment Cycle
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- Platelet count ≥ 100 000/mm3
- Hemoglobin (Hb) ≥ 8.5 g/dL
- Absolute neutrophil count (ANC) ≥ 1500/mm3
- Creatinine ≤ 1.5 × upper limit of normal (ULN), or
- Creatinine clearance ≥ 60 mL/min (modification Cockcroft-Gault equation)
Who cannot join
- Has a medical history of symptomatic chronic 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 within 6 months before Day 1.
- Has a QTc prolongation to > 470 millisecond (ms) based on a 12-lead electrocardiogram (ECG) in triplicate.
- Active or prior documented autoimmune disease within the past 2 years. NOTE: Subjects with a history of autoimmune thyroid disease are not excluded. Subjects with vitiligo or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
- Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
- History of primary immunodeficiency.
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- History of allogeneic organ transplant.
- Has an uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals.
- Known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection.
- Is a lactating mother (women who are willing to temporarily interrupt breastfeeding will also be excluded), or pregnant as confirmed by pregnancy tests performed within 7 days prior to initiation of the first Treatment Cycle.
- Male and female subjects who are unwilling to use adequate contraceptive methods (double barrier or intrauterine contraceptive) during the study and for at least 7 months after the last dose of study drug.
Trial locations and contacts
1 site in 1 country.
Ren Y Yue contact
China1 site
Fudan University Shanghai Cancer Center
Shanghai, 200120
Jian Zhang, PhD, Syner2000@163.com
About this study
Official title: Phase 1/2, Multicenter, Open-label, First-in-human Study of DB-1202 Monotherapy in Patients With Advanced Solid Malignant Tumors to Evaluate the Tolerability, Safety, Pharmacokinetics and Antitumor Activity
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1201 in subjects with advanced solid tumors.
Read the detailed description
This is a multicenter, non-randomized, open-label, multiple-dose, FIH study. The study consists of two parts: Part 1 adopts a rule based "3 + 3" design to identify MTD/RP2D; Part 2 is a dose expansion phase to confirm the safety, tolerability and efficacy in selected solid malignant tumors.
- Conditions
- Advanced Solid Tumor
- Being tested
- DB-1202
- Keywords
- TGF-β, thyroid cancer
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DB-1202Drug
Administered I.V.
| Study group | Role | What they receive |
|---|---|---|
| DB-1202 Dose Level 1 | Experimental | Enrolled Subjects will receive a single-dose of DB-1202 at Dose Level 1 on Day 1 of each cycle Q3W Receives: Drug: DB-1202 |
| DB-1202 Dose Level 2 | Experimental | Enrolled Subjects will receive a single-dose of DB-1202 at Dose Level 2 on Day 1 of each cycle Q3W Receives: Drug: DB-1202 |
| DB-1202 Dose Level 3 | Experimental | Enrolled Subjects will receive a single-dose of DB-1202 at Dose Level 3 on Day 1 of each cycle Q3W Receives: Drug: DB-1202 |
| DB-1202 Dose Level 4 | Experimental | Enrolled Subjects will receive a single-dose of DB-1202 at Dose Level 4 on Day 1 of each cycle Q3W Receives: Drug: DB-1202 |
| DB-1202 Dose Level 5 | Experimental | Enrolled Subjects will receive a single-dose of DB-1202 at Dose Level 5 on Day 1 of each cycle Q3W Receives: Drug: DB-1202 |
| DB-1202 Dose Level 6 | Experimental | Enrolled Subjects will receive a single-dose of DB-1202 at Dose Level 6 on Day 1 of each cycle Q3W Receives: Drug: DB-1202 |
| DB-1202 Dose Expansion 1 | Experimental | Enrolled Subjects with locally advanced or metastatic primary thyroid cancers with pathology of epithelial tumors that originated from thyroid follicular cells will be enrolled regardless of PD-L1 expression will receive initial dose of DB-1202 Q3W under a 21-day Treatment Cycle with RP2D. Receives: Drug: DB-1202 |
| DB-1202 Dose Expansion 2 | Experimental | Enrolled Subjects in selected solid malignant tumors can be added will receive initial dose of DB-1202 Q3W under a 21-day Treatment Cycle with RP2D. Receives: Drug: DB-1202 |
| DB-1202 Dose Expansion 3 | Experimental | Enrolled Subjects in selected solid malignant tumors can be added will receive initial dose of DB-1202 Q3W under a 21-day Treatment Cycle with RP2D. Receives: Drug: DB-1202 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0
Percentage of participants in Part 1 with DLTs
Measured: 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
Measured: 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
Measured: Up to follow-up period, approximately 1 year post-treatment
Maximum Tolerated Dose (MTD) of DB-1202
MTD on the data collected during Part 1
Measured: 12 months
Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1202
RP2D of DB-1202 based on the data collected during Part 1
Measured: 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
Measured: 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
Measured: Up to follow-up period, approximately 1 year post-treatment
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
Measured: Up to follow-up period, approximately 1 year post-treatment
Secondary outcomes (4)
Phase 1 & Phase 2a: Pharmacokinetic-AUC
Area under the concentration-time curve from time 0 to infinity of DB-1202
Measured: within 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: Pharmacokinetic-Cmax
Maximum observed plasma concentration (Cmax) of DB-1202
Measured: within 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: Pharmacokinetic-Tmax
Time to Cmax of DB-1202
Measured: within 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: Pharmacokinetic-T1/2
Terminal elimination half-life
Measured: within 8 cycles (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start28 Jun 2023 (estimated)
- Primary completion28 Feb 2024 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by DualityBio Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DualityBio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raymond Zhao, Study director, DualityBio Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785728
- Sponsor's protocol ID
- DB-1202-O-1001
- Status last verified
- Mar 2023
- First submitted
- 14 Mar 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2, Multicenter, Open-label, First-in-human Study of DB-1202 Monotherapy in Patients With Advanced Solid Malignant Tumors to Evaluate the Tolerability, Safety, Pharmacokinetics and Antitumor Activity
- ClinicalTrials.gov ID
- NCT05785728
- Acronym / sponsor ID
- DB-1202-O-1001
- Conditions
- Advanced Solid Tumor
- Keywords
- TGF-β, thyroid cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- DualityBio Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2023 (estimated)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1201 in subjects with advanced solid tumors.
Detailed description
This is a multicenter, non-randomized, open-label, multiple-dose, FIH study. The study consists of two parts: Part 1 adopts a rule based "3 + 3" design to identify MTD/RP2D; Part 2 is a dose expansion phase to confirm the safety, tolerability and efficacy in selected solid malignant tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| DB-1202 Dose Level 1 | Experimental | Drug: DB-1202Enrolled Subjects will receive a single-dose of DB-1202 at Dose Level 1 on Day 1 of each cycle Q3W |
| DB-1202 Dose Level 2 | Experimental | Drug: DB-1202Enrolled Subjects will receive a single-dose of DB-1202 at Dose Level 2 on Day 1 of each cycle Q3W |
| DB-1202 Dose Level 3 | Experimental | Drug: DB-1202Enrolled Subjects will receive a single-dose of DB-1202 at Dose Level 3 on Day 1 of each cycle Q3W |
| DB-1202 Dose Level 4 | Experimental | Drug: DB-1202Enrolled Subjects will receive a single-dose of DB-1202 at Dose Level 4 on Day 1 of each cycle Q3W |
| DB-1202 Dose Level 5 | Experimental | Drug: DB-1202Enrolled Subjects will receive a single-dose of DB-1202 at Dose Level 5 on Day 1 of each cycle Q3W |
| DB-1202 Dose Level 6 | Experimental | Drug: DB-1202Enrolled Subjects will receive a single-dose of DB-1202 at Dose Level 6 on Day 1 of each cycle Q3W |
| DB-1202 Dose Expansion 1 | Experimental | Drug: DB-1202Enrolled Subjects with locally advanced or metastatic primary thyroid cancers with pathology of epithelial tumors that originated from thyroid follicular cells will be enrolled regardless of PD-L1 expression will receive initial dose of DB-1202 Q3W under a 21-day Treatment Cycle with RP2D. |
| DB-1202 Dose Expansion 2 | Experimental | Drug: DB-1202Enrolled Subjects in selected solid malignant tumors can be added will receive initial dose of DB-1202 Q3W under a 21-day Treatment Cycle with RP2D. |
| DB-1202 Dose Expansion 3 | Experimental | Drug: DB-1202Enrolled Subjects in selected solid malignant tumors can be added will receive initial dose of DB-1202 Q3W under a 21-day Treatment Cycle with RP2D. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female at least 18 years old.
- Has histologically or cytologically confirmed metastatic or locally advanced solid tumors for which no effective standard therapy existed or standard of care has failed or is not considered as an option.
- Is capable of comprehending study procedures and risks outlined in the informed consent and is willing to provide written consent.
- Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1.
- At least one measurable lesion as assessed by the investigator according to response evaluation criteria in solid tumors (RECIST) version 1.1 criteria.
Key exclusion criteria (11 listed)
- Has a medical history of symptomatic chronic 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 within 6 months before Day 1.
- Has a QTc prolongation to > 470 millisecond (ms) based on a 12-lead electrocardiogram (ECG) in triplicate.
- Active or prior documented autoimmune disease within the past 2 years. NOTE: Subjects with a history of autoimmune thyroid disease are not excluded. Subjects with vitiligo or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
- Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DB-1202Administered I.V. | Drug | DB-1202 Dose Expansion 1, DB-1202 Dose Expansion 2, DB-1202 Dose Expansion 3, DB-1202 Dose Level 1, DB-1202 Dose Level 2, DB-1202 Dose Level 3, DB-1202 Dose Level 4, DB-1202 Dose Level 5, DB-1202 Dose Level 6 |
Primary outcome
Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0
Time frame: up to 21 days after Cycle 1 Day 1
Percentage of participants in Part 1 with DLTs
Phase 1: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0
Time frame: Up to follow-up period, approximately 1 year post-treatment
Percentage of participants with AEs in Part 1 graded according to NCI CTCAE v5.0
Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Time frame: Up to follow-up period, approximately 1 year post-treatment
Percentage of Participants with SAEs in Part 1 graded according to NCI CTCAE v5.0
Maximum Tolerated Dose (MTD) of DB-1202
Time frame: 12 months
MTD on the data collected during Part 1
Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1202
Time frame: 12 months
RP2D of DB-1202 based on the data collected during Part 1
Phase 2a: Percentage of Participants with Treatment Emergent adverse events (TEAEs) as assessed by CTCAE v5.0.
Time frame: Up to follow-up period, approximately 1 year post-treatment
Percentage of participants with AEs in Part 2 graded according to NCI CTCAE v5.0
Phase 2a: Percentage participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Time frame: Up to follow-up period, approximately 1 year post-treatment
Percentage of participants with SAEs in Part 2 graded according to NCI CTCAE v5.0
Percentage of Objective Response Rate (ORR) as assessed by RECIST 1.1.
Time frame: Up to follow-up period, approximately 1 year post-treatment
The percentage of subjects who had a best response rating of CR and PR, for Part 2 only which was maintained ≥4 weeks
4 secondary outcomes
Phase 1 & Phase 2a: Pharmacokinetic-AUC
Time frame: within 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: Pharmacokinetic-Cmax
Time frame: within 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: Pharmacokinetic-Tmax
Time frame: within 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: Pharmacokinetic-T1/2
Time frame: within 8 cycles (each cycle is 21 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ren Y Yue contact
Raymond Zhao study director
DualityBio Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DB-1202 in people with Advanced Solid Tumor, run by DualityBio Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jenny Y Li (16502379339, jenny.li@dualitybiologics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0 (time frame: up to 21 days after Cycle 1 Day 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.