Advanced Solid TumorPhase 1NCT07667842
Study of D3L-002 in Subjects With Advanced Solid Tumors
A Phase 1 study testing D3L-002 in people with Advanced Solid Tumor, run by D3 Bio (Wuxi) Co., Ltd at 6 sites in 2 countries.
Trial summary
This is a first-in-human, multicenter, open-label, single-arm, dose-escalation Phase 1 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity of D3L-002 monotherapy 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?
- D3L-002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 14 Jul 2026to 12 Feb 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Ability to provide written informed consent and comply with study procedures
- Age ≥18 years
- Histologically confirmed metastatic or locally advanced incurable solid tumor that has progressed after ≥1 line of therapy or has no available standard treatment
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate organ function (hematologic, hepatic, renal)
- Life expectancy ≥12 weeks
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- Willingness to provide tumor tissue (if available) and blood samples
- Agreement to use effective contraception
- Negative pregnancy test for participants of childbearing potential
Who cannot join
- Prior anti-TIGIT or anti-PVRIG therapy
- Recent anticancer therapy without adequate washout
- Active or uncontrolled illness
- Interstitial lung disease/pneumonitis
- Active Central Nervous System (CNS) disease
- Uncontrolled effusions
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- Unresolved ≥Grade 2 toxicities
- Severe prior immunotherapy-related toxicity
- Active autoimmune disease
- Active infection
- Active hepatitis B/C or HIV
- Recent malignancy (exceptions apply)
- Significant cardiovascular disease
- Immunosuppressive therapy within 14 days
- Live vaccine within 30 days
- Pregnancy or breastfeeding
- Hypersensitivity to study drug
- Investigator-determined unsuitability
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
South Korea4 sites, 4 recruiting
- Recruiting
D3 Bio Investigative Site 1204
Cheongju-si, 28644
- Recruiting
D3 Bio Investigative Site 1202
Seoul, 03080
- Recruiting
D3 Bio Investigative Site 1203
Seoul, 03722
- Recruiting
D3 Bio Investigative Site 1201
Seoul, 06591
Australia2 sites, 2 recruiting
- Recruiting
D3 Bio Investigative Site 1101
Macquarie Park, 2109
- Recruiting
D3 Bio Investigative Site 1102
Nedlands, 6009
About this study
Official title: A Phase 1, Open-label, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3L-002 (an Anti-TIGIT/Anti-PVRIG Bispecific Antibody) Monotherapy in Subjects With Advanced Solid Tumors
This is a first-in-human, multicenter, open-label, single-arm, dose-escalation Phase 1 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity of D3L-002 monotherapy in subjects with advanced solid tumors. D3L-002 will be administered as an intravenous infusion every 3 weeks (Q3W) in 21-day cycles. Approximately 24 subjects will be enrolled. Dose escalation will follow a Bayesian Optimal Interval (BOIN) design to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D).
- Conditions
- Advanced Solid Tumor
- Being tested
- D3L-002
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D3L-002Drug
D3L-002 is an investigational anti-TIGIT/anti-PVRIG bispecific antibody administered as an intravenous infusion every 3 weeks (Q3W).
| Study group | Role | What they receive |
|---|---|---|
| D3L-002 | Experimental | Dose Escalation
* Cohort 1 (starting dose)
* Cohort 2
* Cohort 3
* Cohort 4 Receives: Drug: D3L-002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs)
Incidence, nature, and severity of TEAEs and TRAEs assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0
Measured: From first dose through 30 days after the last dose (Safety Follow-up Visit)
Change from Baseline in Hemoglobin
Change from baseline in hemoglobin (g/dL)
Measured: From baseline through 30 days after the last dose
Change from Baseline in White Blood Cell Count
Change from baseline in white blood cell count (×10^9/L)
Measured: From baseline through 30 days after the last dose
Change from Baseline in Platelet Count
Change from baseline in platelet count (×10^9/L)
Measured: From baseline through 30 days after the last dose
Change from Baseline in Alanine Aminotransferase (ALT)
Change from baseline in alanine aminotransferase (ALT, U/L)
Measured: From baseline through 30 days after the last dose
Change from Baseline in Aspartate Aminotransferase (AST)
Change from baseline in aspartate aminotransferase (AST, U/L)
Measured: From baseline through 30 days after the last dose
Change from Baseline in Creatinine
Change from baseline in creatinine (mg/dL)
Measured: From baseline through 30 days after the last dose
Change from Baseline in Urine Protein
Change from baseline in urine protein (semi-quantitative or mg/dL per local laboratory standard)
Measured: From baseline through 30 days after the last dose
Change from Baseline in Urine Glucose
Change from baseline in urine glucose (semi-quantitative per local laboratory standard)
Measured: From baseline through 30 days after the last dose
Change from Baseline in Urine Blood
Change from baseline in urine blood (semi-quantitative per local laboratory standard)
Measured: From baseline through 30 days after the last dose
Change from Baseline in Systolic Blood Pressure
Change from baseline in systolic blood pressure (mmHg)
Measured: From baseline through 30 days after the last dose
Change from Baseline in Diastolic Blood Pressure
Change from baseline in diastolic blood pressure (mmHg)
Measured: From baseline through 30 days after the last dose
Change from Baseline in Heart Rate
Change from baseline in heart rate (beats per minute)
Measured: From baseline through 30 days after the last dose
Change from Baseline in Respiratory Rate
Change from baseline in respiratory rate (breaths per minute)
Measured: From baseline through 30 days after the last dose
Change from Baseline in Body Temperature
Change from baseline in body temperature (°C or °F).
Measured: From baseline through 30 days after the last dose
Change from Baseline in Physical Examination Findings
Evaluation of clinically significant changes from baseline in physical examination findings across body systems (e.g., cardiovascular, respiratory, neurological), as assessed by the investigator and categorized as normal or abnormal.
Measured: From baseline through 30 days after the last dose
Change from Baseline in Electrocardiogram (ECG) Parameters (QT Interval, PR Interval, QRS Duration, Heart Rate)
Evaluation of clinically significant changes from baseline in 12 lead electrocardiogram (ECG) parameters, including QT interval (milliseconds), PR interval (milliseconds), QRS duration (milliseconds), and heart rate (beats per minute).
Measured: From baseline through 30 days after the last dose
Determination of Maximum Tolerated Dose (MTD)
Determination of MTD based on dose-limiting toxicities (DLTs) occurring during the first cycle (21 days); MTD defined as the dose with estimated DLT rate closest to 30% using a BOIN design
Measured: Cycle 1 (Day 1 through Day 21)
Determination of Recommended Phase 2 Dose (RP2D)
Determination of RP2D based on the totality of safety, tolerability, pharmacokinetic, pharmacodynamic, and preliminary efficacy data
Measured: Through end of dose-escalation phase (approximately up to 3 months following last subject's first dose)
Secondary outcomes (10)
Pharmacokinetics: Maximum Plasma Concentration (Cmax)
Maximum observed serum concentration of D3L-002 following intravenous administration
Measured: From Day 1 through End of Treatment (up to approximately 6 months)
Pharmacokinetics: Minimum (Trough) Concentration (Ctrough)
Predose serum concentration of D3L-002 at steady state
Measured: From Day 1 through End of Treatment (up to approximately 6 months)
Pharmacokinetics: Time to Maximum Concentration (Tmax)
Time from dosing to maximum observed serum concentration of D3L-002
Measured: From Day 1 through End of Treatment (up to approximately 6 months)
Pharmacokinetics: Terminal Half-Life (t½)
Terminal elimination half-life of D3L-002 calculated from serum concentration-time data
Measured: From Day 1 through End of Treatment (up to approximately 6 months)
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC)
Area under the serum concentration-time curve of D3L-002
Measured: From Day 1 through End of Treatment (up to approximately 6 months)
Immunogenicity: Incidence of Anti-Drug Antibodies (ADA)
Incidence of subjects with detectable anti-drug antibodies to D3L-002
Measured: From baseline through Safety Follow-up Visit (up to 30 days after last dose)
Objective Response Rate (ORR)
Proportion of subjects achieving confirmed complete response (CR) or partial response (PR) per RECIST version 1.1 as assessed by investigators
Measured: From first dose through disease progression or end of study (up to approximately 12 months)
Duration of Response (DOR)
Time from first documented objective response (CR or PR) to disease progression or death
Measured: From first documented response until disease progression or death (up to approximately 12 months)
Disease Control Rate (DCR)
Proportion of subjects achieving CR, PR, or stable disease (SD) lasting at least 6 weeks per RECIST v1.1
Measured: From first dose through disease assessment period (up to approximately 6 months)
Progression-Free Survival (PFS)
Time from first dose of D3L-002 to disease progression per RECIST v1.1 or death from any cause
Measured: From first dose until disease progression or death (up to approximately 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start14 Jul 2026
- Primary completion12 Nov 2027 (estimated)
- Study completion12 Feb 2028 (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.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- D3 Bio (Wuxi) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667842
- Sponsor's protocol ID
- D3L-002-100
- Status last verified
- Sep 2026
- First submitted
- 10 Jun 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3L-002 (an Anti-TIGIT/Anti-PVRIG Bispecific Antibody) Monotherapy in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07667842
- Acronym / sponsor ID
- D3L-002-100
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- D3 Bio (Wuxi) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2026 (actual)
- Primary completion
- 12 Nov 2027 (estimated)
- Study completion
- 12 Feb 2028 (estimated)
- First posted
- 25 Jun 2026 (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 first-in-human, multicenter, open-label, single-arm, dose-escalation Phase 1 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity of D3L-002 monotherapy in subjects with advanced solid tumors. D3L-002 will be administered as an intravenous infusion every 3 weeks (Q3W) in 21-day cycles. Approximately 24 subjects will be enrolled. Dose escalation will follow a Bayesian Optimal Interval (BOIN) design to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| D3L-002 | Experimental | Drug: D3L-002Dose Escalation * Cohort 1 (starting dose) * Cohort 2 * Cohort 3 * Cohort 4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ability to provide written informed consent and comply with study procedures
- Age ≥18 years
- Histologically confirmed metastatic or locally advanced incurable solid tumor that has progressed after ≥1 line of therapy or has no available standard treatment
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate organ function (hematologic, hepatic, renal)
Key exclusion criteria (18 listed)
- Prior anti-TIGIT or anti-PVRIG therapy
- Recent anticancer therapy without adequate washout
- Active or uncontrolled illness
- Interstitial lung disease/pneumonitis
- Active Central Nervous System (CNS) disease
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 |
|---|---|---|
| D3L-002D3L-002 is an investigational anti-TIGIT/anti-PVRIG bispecific antibody administered as an intravenous infusion every 3 weeks (Q3W). | Drug | D3L-002 |
Primary outcome
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs)
Time frame: From first dose through 30 days after the last dose (Safety Follow-up Visit)
Incidence, nature, and severity of TEAEs and TRAEs assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0
Change from Baseline in Hemoglobin
Time frame: From baseline through 30 days after the last dose
Change from baseline in hemoglobin (g/dL)
Change from Baseline in White Blood Cell Count
Time frame: From baseline through 30 days after the last dose
Change from baseline in white blood cell count (×10^9/L)
Change from Baseline in Platelet Count
Time frame: From baseline through 30 days after the last dose
Change from baseline in platelet count (×10^9/L)
Change from Baseline in Alanine Aminotransferase (ALT)
Time frame: From baseline through 30 days after the last dose
Change from baseline in alanine aminotransferase (ALT, U/L)
Change from Baseline in Aspartate Aminotransferase (AST)
Time frame: From baseline through 30 days after the last dose
Change from baseline in aspartate aminotransferase (AST, U/L)
Change from Baseline in Creatinine
Time frame: From baseline through 30 days after the last dose
Change from baseline in creatinine (mg/dL)
Change from Baseline in Urine Protein
Time frame: From baseline through 30 days after the last dose
Change from baseline in urine protein (semi-quantitative or mg/dL per local laboratory standard)
Change from Baseline in Urine Glucose
Time frame: From baseline through 30 days after the last dose
Change from baseline in urine glucose (semi-quantitative per local laboratory standard)
Change from Baseline in Urine Blood
Time frame: From baseline through 30 days after the last dose
Change from baseline in urine blood (semi-quantitative per local laboratory standard)
Change from Baseline in Systolic Blood Pressure
Time frame: From baseline through 30 days after the last dose
Change from baseline in systolic blood pressure (mmHg)
Change from Baseline in Diastolic Blood Pressure
Time frame: From baseline through 30 days after the last dose
Change from baseline in diastolic blood pressure (mmHg)
Change from Baseline in Heart Rate
Time frame: From baseline through 30 days after the last dose
Change from baseline in heart rate (beats per minute)
Change from Baseline in Respiratory Rate
Time frame: From baseline through 30 days after the last dose
Change from baseline in respiratory rate (breaths per minute)
Change from Baseline in Body Temperature
Time frame: From baseline through 30 days after the last dose
Change from baseline in body temperature (°C or °F).
Change from Baseline in Physical Examination Findings
Time frame: From baseline through 30 days after the last dose
Evaluation of clinically significant changes from baseline in physical examination findings across body systems (e.g., cardiovascular, respiratory, neurological), as assessed by the investigator and categorized as normal or abnormal.
Change from Baseline in Electrocardiogram (ECG) Parameters (QT Interval, PR Interval, QRS Duration, Heart Rate)
Time frame: From baseline through 30 days after the last dose
Evaluation of clinically significant changes from baseline in 12 lead electrocardiogram (ECG) parameters, including QT interval (milliseconds), PR interval (milliseconds), QRS duration (milliseconds), and heart rate (beats per minute).
Determination of Maximum Tolerated Dose (MTD)
Time frame: Cycle 1 (Day 1 through Day 21)
Determination of MTD based on dose-limiting toxicities (DLTs) occurring during the first cycle (21 days); MTD defined as the dose with estimated DLT rate closest to 30% using a BOIN design
Determination of Recommended Phase 2 Dose (RP2D)
Time frame: Through end of dose-escalation phase (approximately up to 3 months following last subject's first dose)
Determination of RP2D based on the totality of safety, tolerability, pharmacokinetic, pharmacodynamic, and preliminary efficacy data
10 secondary outcomes
Pharmacokinetics: Maximum Plasma Concentration (Cmax)
Time frame: From Day 1 through End of Treatment (up to approximately 6 months)
Pharmacokinetics: Minimum (Trough) Concentration (Ctrough)
Time frame: From Day 1 through End of Treatment (up to approximately 6 months)
Pharmacokinetics: Time to Maximum Concentration (Tmax)
Time frame: From Day 1 through End of Treatment (up to approximately 6 months)
Pharmacokinetics: Terminal Half-Life (t½)
Time frame: From Day 1 through End of Treatment (up to approximately 6 months)
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC)
Time frame: From Day 1 through End of Treatment (up to approximately 6 months)
Immunogenicity: Incidence of Anti-Drug Antibodies (ADA)
Time frame: From baseline through Safety Follow-up Visit (up to 30 days after last dose)
Objective Response Rate (ORR)
Time frame: From first dose through disease progression or end of study (up to approximately 12 months)
Duration of Response (DOR)
Time frame: From first documented response until disease progression or death (up to approximately 12 months)
Disease Control Rate (DCR)
Time frame: From first dose through disease assessment period (up to approximately 6 months)
Progression-Free Survival (PFS)
Time frame: From first dose until disease progression or death (up to approximately 12 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- 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.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing D3L-002 in people with Advanced Solid Tumor, run by D3 Bio (Wuxi) Co., Ltd at 6 sites in 2 countries.
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 9 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea, Australia. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical Director (+86 21 61635900, D3bio_CT@d3bio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) (time frame: From first dose through 30 days after the last dose (Safety Follow-up Visit)). The study lists 19 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 18 Sep 2026.