A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors

NCT ID: NCT05914116

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 862 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-17
• Study Completion Date: 2028-05-31

Brief Summary

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1311/BNT324 in subjects with advanced solid tumors.

Detailed Description

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 (maximum tolerated dose) and/or RP2D(Recommended Phase 2 Dose). Phase 2a is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors treated with DB-1311/BNT324 as monotherapy or in combination with novel hormone therapy (NHT) in prostate cancer (PC). And the drug-drug-interaction (DDI) sub-study to evaluate the effect of lopinavir/ritonavir and itraconazole on the PK of DB-1311 and its payload.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DB-1311/BNT324 Dose Level 1

Enrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 1 on Day 1 of each cycle Q3W (every 3 weeks)

Group Type: EXPERIMENTAL

DB-1311

Intervention Type: DRUG

Administered I.V.(intravenous infusion)

DB-1311/BNT324 Dose Level 2

Enrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 2 on Day 1 of each cycle Q3W

Group Type: EXPERIMENTAL

DB-1311

Intervention Type: DRUG

Administered I.V.(intravenous infusion)

DB-1311/BNT324 Dose Level 3

Enrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 3 on Day 1 of each cycle Q3W

Group Type: EXPERIMENTAL

DB-1311

Intervention Type: DRUG

Administered I.V.(intravenous infusion)

DB-1311/BNT324 Dose Level 4

Enrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 4 on Day 1 of each cycle Q3W

Group Type: EXPERIMENTAL

DB-1311

Intervention Type: DRUG

Administered I.V.(intravenous infusion)

DB-1311/BNT324 Dose Level 5

Enrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 5 on Day 1 of each cycle Q3W

Group Type: EXPERIMENTAL

DB-1311

Intervention Type: DRUG

Administered I.V.(intravenous infusion)

DB-1311/BNT324 Dose Expansion 1

Subjects with advanced/unresectable, or metastatic SCLC who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324 randomized at dose level 1 or 2.

Group Type: EXPERIMENTAL

DB-1311

Intervention Type: DRUG

Administered I.V.(intravenous infusion)

DB-1311/BNT324 Dose Expansion 2

Subjects with advanced/unresectable, or metastatic NSCLC who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324 randomized at dose level 1 or 2.

Group Type: EXPERIMENTAL

DB-1311

Intervention Type: DRUG

Administered I.V.(intravenous infusion)

DB-1311/BNT324 Dose Expansion 3

Subjects with advanced/unresectable, or metastatic ESCC who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.

Group Type: EXPERIMENTAL

DB-1311

Intervention Type: DRUG

Administered I.V.(intravenous infusion)

DB-1311/BNT324 Dose Expansion 4

Subjects with advanced/unresectable, or metastatic CRPC who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324 randomized at dose level 1 or 2.

Group Type: EXPERIMENTAL

DB-1311

Intervention Type: DRUG

Administered I.V.(intravenous infusion)

DB-1311/BNT324 Dose Expansion 5

Subjects with advanced/unresectable, or metastatic melanoma who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.

Group Type: EXPERIMENTAL

DB-1311

Intervention Type: DRUG

Administered I.V.(intravenous infusion)

DB-1311/BNT324 Dose Expansion 6

Subjects with advanced/unresectable, or metastatic HCC who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.

Group Type: EXPERIMENTAL

DB-1311

Intervention Type: DRUG

Administered I.V.(intravenous infusion)

DB-1311/BNT324 Dose Expansion 7

Subjects with advanced/unresectable, or metastatic cervical cancer who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.

Group Type: EXPERIMENTAL

DB-1311

Intervention Type: DRUG

Administered I.V.(intravenous infusion)

DB-1311/BNT324 Dose Expansion 8

Subjects with other advanced or metastatic solid tumors who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.

Group Type: EXPERIMENTAL

DB-1311

Intervention Type: DRUG

Administered I.V.(intravenous infusion)

DB-1311/BNT324 Dose Expansion 9

Subjects with advanced/unresectable, or metastatic HNSCC (not including nasopharyngeal carcinoma \[NPC\]) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.

Group Type: EXPERIMENTAL

DB-1311

Intervention Type: DRUG

Administered I.V.(intravenous infusion)

DB-1311/BNT324 Dose Expansion 10

Subjects with advanced or metastatic rare tumor types who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.

Group Type: EXPERIMENTAL

DB-1311

Intervention Type: DRUG

Administered I.V.(intravenous infusion)

DB-1311/BNT324 Dose Expansion 11

Subjects with metastatic CRPC who have progressed on or after standard systemic treatments including no more than 2 lines of systemic chemotherapy, novel hormone therapy and lutetium-177 radioligand therapy, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.

Group Type: EXPERIMENTAL

DB-1311

Intervention Type: DRUG

Administered I.V.(intravenous infusion)

DB-1311/BNT324 Dose Expansion 12

Taxane-naive subjects with metastatic CRPC who have progressed on or after novel hormone therapy, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.

Group Type: EXPERIMENTAL

DB-1311

Intervention Type: DRUG

Administered I.V.(intravenous infusion)

DB-1311/BNT324 Dose Expansion 13

Subjects with advanced/unresectable, or metastatic HNSCC (not including NPC) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.

Group Type: EXPERIMENTAL

DB-1311

Intervention Type: DRUG

Administered I.V.(intravenous infusion)

DB-1311/BNT324 Dose Expansion 14

Subjects with epithelial OC who have had 1-3 prior lines of systemic treatment and are platinum-resistant, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324 randomized at dose level 1 or 2.

Group Type: EXPERIMENTAL

DB-1311

Intervention Type: DRUG

Administered I.V.(intravenous infusion)

DB-1311/BNT324 Dose Expansion 15

Subjects with Subjects with advanced/unresectable, or metastatic melanoma, ESCC, PROC and CC who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via IV will be used for DB-1311/BNT324.

Lopinavir and ritonavir/ Itraconazole will be administered orally twice a day/ once a day.

Group Type: EXPERIMENTAL

DB-1311

Intervention Type: DRUG

Administered I.V.(intravenous infusion)

Lopinavir and Ritonavir Tablets

Intervention Type: DRUG

Lopinavir and Ritonavir Tablets

itraconazole

Intervention Type: DRUG

itraconazole

DB-1311/BNT324 Dose Expansion 16

Taxane-naive subjects with metastatic CRPC who have progressed on or after NHT, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324, combined with enzalutamide 160mg QD orally.

Group Type: EXPERIMENTAL

DB-1311

Intervention Type: DRUG

Administered I.V.(intravenous infusion)

Enzalutamide

Intervention Type: DRUG

oral administration

DB-1311/BNT324 Dose Expansion 17

Taxane-naive subjects with metastatic CRPC who have progressed on or after NHT, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324, combined with abiraterone 1000mg QD orally.

Group Type: EXPERIMENTAL

DB-1311

Intervention Type: DRUG

Administered I.V.(intravenous infusion)

Abiraterone

Intervention Type: DRUG

oral administration

DB-1311/BNT324 Dose Expansion 18

CSPC subjects with suboptimal PSA response to ADT/NHT, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324, combined with enzalutamide 160mg or abiraterone 1000mg QD orally.

Group Type: EXPERIMENTAL

DB-1311

Intervention Type: DRUG

Administered I.V.(intravenous infusion)

Enzalutamide

Intervention Type: DRUG

oral administration

Abiraterone

Intervention Type: DRUG

oral administration

Interventions

DB-1311

Administered I.V.(intravenous infusion)

Intervention Type: DRUG

Lopinavir and Ritonavir Tablets

Lopinavir and Ritonavir Tablets

Intervention Type: DRUG

itraconazole

itraconazole

Intervention Type: DRUG

Enzalutamide

oral administration

Intervention Type: DRUG

Abiraterone

oral administration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent).

2. Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or is intolerable with standard treatment; or for which no standard treatment is available.

3. At least one measurable lesion as assessed by the investigator according to response evaluation criteria in solid tumors (RECIST) version 1.1 criteria (measurable disease as defined by RANO 2.0 criteria for GBM subjects). Castrate-resistant prostate cancer (CRPC) subjects with bone only disease may be eligible on a case-by- case basis after discussion with the Medical Monitor.

4. Has a life expectancy of ≥ 3 months.

5. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.

6. Has LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment.

7. Has adequate organ function within 7 days prior to Day 1 of Cycle 1

8. Has adequate treatment washout period prior to Day 1 of Cycle 1

9. Is willing to provide pre-existing resected tumor samples or undergo fresh tumor biopsy for the measurement of B7-H3 level and other biomarkers if no contraindication.

Note: there is no minimum B7-H3 expression level mandatory for entry into the study.

10. Is 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.

11. Male and female subjects of reproductive/childbearing potential must agree to use adequate contraceptive methods (e.g., double barrier or intrauterine contraceptive) during the study and for at least 4 months and 7 months after the last dose of study drug, respectively.

12. Male subjects must not freeze or donate sperm starting at screening and throughout the study period, and at least 4 months after the final study drug administration.

13. Female subjects must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study drug administration.

14. SCLC subjects (Phase 2a Cohort 1 ONLY):

• Pathologically documented locally advanced, or metastatic SCLC not amenable to curative surgery or radiation.
• Prior therapy with at least one platinum-based line as systemic therapy for extensive stage disease with at least two cycles of therapy (except in the case of early objective PD).
• Prior treatment regimens with irinotecan, topotecan or any other TOP I inhibitor including investigational TOP I inhibitors are not allowed.

15. NSCLC subjects (Phase 2a Cohort 2 ONLY):

• Pathologically documented locally advanced, or metastatic NSCLC and is not amenable to curative surgery or radiation.
• Has received prior treatment with platinum-based chemotherapy regimen and/or anti-PD-1/PD-L1 antibody-based regimen in the advanced/unresectable, or metastatic setting unless unable or unwilling. Subjects with NSCLC known to harbor a genomic alteration(s) other than EGFR mutation(s) (e.g., ALK rearrangement, ROS1 rearrangement, KRAS G12C mutation, BRAF V600E mutation, NTRK1/2/3 Gene fusion, MET Exon 14 skipping, RET rearrangement etc.) for which treatment is available must have also received prior treatment with at least 1 genotype-directed therapy.

16. ESCC subjects (Phase 2a Cohort 3 ONLY):

• Pathologically documented locally advanced, or metastatic ESCC and is not amenable to curative surgery or radiation.
• Having received at least one prior therapy for unresectable disease. Patients with recurrence within 6 months of completion of neoadjuvant or adjuvant therapy will be considered as having received one prior therapy for unresectable disease.

17. CRPC subjects (Phase 2a Cohort 4 ONLY):

• Pathologically documented metastatic adenocarcinoma of the prostate cancer.
• Progressive metastatic CRPC as defined: 1) castrate levels of serum testosterone < 50 ng/dL AND 2) progressive disease as defined by PCWG3 criteria.
• Having received prior docetaxel (before or after an AR-targeted therapy). Docetaxel rechallenge was allowed.
• Having received prior novel hormone therapy.

18. Melanoma subjects (Phase 2a Cohort 5 ONLY) • Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic melanoma not amenable to local therapy, must have had either:

> Previously treated with a PD-1 or PD-L1 inhibitor.

> If subjects with BRAF gene mutant melanoma, must have had a prior treatment regimen that included vemurafenib, dabrafenib, or another BRAF gene and/or mitogen-activated protein kinase (MEK) protein inhibitor.

19. HCC subjects (Phase 2a Cohort 6 ONLY)

• Histological/cytological confirmed diagnosis of HCC or clinically confirmed diagnosis of HCC as per American Association for the Study of Liver Diseases (AASLD) criteria (fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC are not eligible), and:
• Has received 1 or 2 prior systemic therapy regimens for recurrent or metastatic disease;
• Has experienced disease progression during or after treatment with an anti-PD-1/L1 agent administered either as monotherapy or in combination.

Note: Subjects basically should receive prior standard therapy.

• However, if the investigator judges the therapy is not appropriate for the subject, the prior standard therapy is not necessarily mandated for the eligibility.

• Has a Child-Pugh class A liver score within 7 days of first dose of study drug.

20. Cervical cancer subjects (Phase 2a Cohort 7 ONLY) • Has recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology, and:

• Has experienced disease progression during or after treatment with a standard of care systemic chemotherapy doublet, or platinum-based therapy (if eligible), defined as either: d. paclitaxel + cisplatin + bevacizumab + anti-PD-(L)1 agent, or e. paclitaxel + carboplatin + bevacizumab + anti-PD-(L)1 agent, or f. paclitaxel + topotecan + bevacizumab + anti-PD-(L)1 agent Note: In cases where bevacizumab and/or anti-PD-(L)1 agent is not a standard of care therapy or the subject was ineligible for such treatment according to local standards, prior treatment with bevacizumab and/or anti-PD-(L)1 agent is not required.

• Has received 1 or 2 prior systemic therapy regimens for recurrent or metastatic cervical cancer. Chemotherapy administered in the adjuvant or neoadjuvant setting, or in combination with radiation therapy, should not be counted as a systemic therapy regimen. Single agent therapy with an anti-PD(L)1 agent for recurrent or metastatic cervical cancer should be counted.

21. Subjects with other solid tumors (Phase 2a Cohort 8 ONLY) • Histologically or cytologically confirmed solid tumors. • Progressed or relapsed after at least one prior standard therapeutic regimen (Patients who have not received all approved or standard treatments for their cancer must be informed that these alternatives to receiving DB-1311/BNT324 are available prior to consenting to participate in this trial).

22. HNSCC subjects (Phase 2a Cohort 9 and Cohort 13)

• Histologically or cytologically confirmed refractory/metastatic (R/M) HNSCC (not including NPC) that is considered incurable by local therapies.

• Progressed on or after prior standard therapeutic regimen.

23. Subjects with rare tumors (Phase 2a Cohort 10 ONLY) Histologically or cytologically confirmed rare tumor types. Progressed or relapsed after at least one prior standard therapeutic regimen (Patients who have not received all approved or standard treatments for their cancer must be informed that these alternatives to receiving DB-1311/BNT324 are available prior to consenting to participate in this trial).

24. Post lutetium-177 CRPC subjects (Phase 2a Cohort 11 ONLY):

Pathologically documented metastatic adenocarcinoma of the prostate cancer. Progressive metastatic CRPC as defined: 1) castrate levels of serum testosterone < 50 ng/dL AND 2) progressive disease as defined by PCWG3 criteria.

25. Taxane-naive CRPC subjects (Phase 2a Cohort 12, 16, 17 ONLY)

• Pathologically documented metastatic adenocarcinoma of the prostate cancer. Progressive metastatic CRPC as defined: 1) castrate levels of serum testosterone < 50 ng/dL AND 2) progressive disease as defined by PCWG3 criteria.

26, PROC subjects (Phase 2a Cohort 14 ONLY)

• Subjects must have a confirmed diagnosis of OC, primary peritoneal cancer, or fallopian tube cancer, all of which with high-grade serous or endometrioid histology..
• Subjects must have platinum-resistant disease:
• Received at least 1 but ≤ 3 lines of prior systemic anticancer therapy and have radiographic progressed on or after their most recent line of therapy.

27. CSPC with suboptimal PSA response (Phase 2a Cohort 18 ONLY)

• Pathologically documented adenocarcinoma of the prostate cancer.
• Having advanced/unresectable, or metastatic disease and confirmed by imaging (e.g., CT and/or bone scan).
• Having received ADT and enzalutamide or abiraterone for ≥4 months, with suboptimal PSA response.

Exclusion Criteria

1. Prior treatment with B7-H3 targeted therapy.

2. Prior treatment with antibody drug conjugate with topoisomerase inhibitor (e.g., trastuzumab deruxtecan).

3. Has a medical history of symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] classes II-IV) or serious cardiac arrhythmia requiring treatment.

4. Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment.

5. Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to > 470 millisecond (ms) in males and females based on a 12-lead electrocardiogram (ECG) in triplicate.

6. Use of concomitant medications known to prolong the QT interval. If the use is deemed necessary, they should be administered with caution and closely monitoring the QT interval, after discussed with the Sponsor.

7. Has a medical history of interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening.

8. Has a history of underlying pulmonary disorder including, but not limited to, pulmonary emboli within 3 months of the start of study treatment, severe asthma, severe COPD, restrictive lung disease, and other clinically significant pulmonary compromise or requirement for supplemental oxygen.

9. Clinically significant gastrointestinal disorder including, but not limited to, history of gastrointestinal fistulation that need long-term intravenous nutrition; gastrointestinal dysfunction that need long-term enteral nutrition through the tube feeding; gastrointestinal obstruction/perforation that not recovered within 6 months prior to the enrollment.

10. Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk of bleeding; A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment (Only applicable to HCC patients).

11. Metastatic disease that involves major airways or blood vessels (e.g., patients with vascular invasion of the major portal vein and inferior vena cava).

12. Clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to the enrollment.

13. Any autoimmune, connective tissue or inflammatory disorders (e.g., rheumatoid arthritis, Sjögren's, sarcoidosis) where there is documented, or a suspicion of pulmonary involvement at the time of screening.

14. Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals.

15. Know human immunodeficiency virus (HIV) infection.

16. Subjects have active viral (any etiology) hepatitis are excluded. However, subjects with serologic evidence of chronic hepatitis B virus (HBV) infection (defined by a positive hepatitis B surface antigen [HBsAg] test or a positive hepatitis B core antibody test) who have a viral load below the limit quantification (e.g., HBV DNA titer < 1000 cps/mL or 200 IU/mL) and are willing to and maintain antiviral treatment if required, are eligible. However, subjects with a history of hepatitis C virus (HCV) infection who have completed curative antiviral treatment and have a viral load below the limit of quantification are eligible for study entry.

17. 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 enrollment.

18. Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Subjects with clinically inactive brain metastases may be included in the study. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study randomization.

19. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE version 5.0, grade ≤ 1 or baseline. Subjects with chronic Grade 2 toxicities (e.g., Grade 2 neuropathy) may be eligible based on the discussion and agreement between Investigator and Sponsor.

20. Has multiple primary malignancies within 3 years before enrollment, except adequately resected non-melanoma skin cancer (e.g., resected basal or squamous cell skin cancer), curatively treated in-situ disease (e.g., carcinoma in situ of the cervix or breast), other solid tumors curatively treated (e.g., superficial bladder cancer), or contralateral breast cancer.

21. Has substance abuse or any other medical conditions that would increase the safety risk to the subject or interfere with participation or evaluation of the clinical study in the opinion of the investigator.

22. Has known hypersensitivity to either the drug substances or inactive ingredients in the drug product.

23. Patients with other reasons that, in the opinion of the Investigator, make them unsuitable to participate in this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioNTech SE

INDUSTRY

Sponsor Role: collaborator

DualityBio Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lily Hu

Role: STUDY_DIRECTOR

DualityBio Inc.

Locations

Research Site 111

Tucson, Arizona, United States

Site Status: RECRUITING

Research Site 125

Los Angeles, California, United States

Site Status: RECRUITING

Research Site 133

Los Angeles, California, United States

Site Status: RECRUITING

Research Site 103

Los Angeles, California, United States

Site Status: RECRUITING

Research Site 128

Santa Monica, California, United States

Site Status: RECRUITING

Research Site 118

Celebration, Florida, United States

Site Status: RECRUITING

Research Site 127

Margate, Florida, United States

Site Status: RECRUITING

Research Site 137

Orlando, Florida, United States

Site Status: RECRUITING

Research Site 101

Plantation, Florida, United States

Site Status: RECRUITING

Research Site 109

Tamarac, Florida, United States

Site Status: RECRUITING

Research Site 114

Atlanta, Georgia, United States

Site Status: RECRUITING

Research Site 139

Atlanta, Georgia, United States

Site Status: RECRUITING

Research Site 115

Louisville, Kentucky, United States

Site Status: RECRUITING

Research Site 129

Detroit, Michigan, United States

Site Status: RECRUITING

Research Site 121

Saint Paul, Minnesota, United States

Site Status: RECRUITING

Research Site 110

Las Vegas, Nevada, United States

Site Status: RECRUITING

Research Site 107

New York, New York, United States

Site Status: RECRUITING

Research Site 138

Canton, Ohio, United States

Site Status: RECRUITING

Research Site 113

Cincinnati, Ohio, United States

Site Status: RECRUITING

Research Site 131

Dayton, Ohio, United States

Site Status: RECRUITING

Research Site 123

Charleston, South Carolina, United States

Site Status: RECRUITING

Research Site 108

Greenville, South Carolina, United States

Site Status: RECRUITING

Research Site 136

Nashville, Tennessee, United States

Site Status: RECRUITING

Research Site 135

Austin, Texas, United States

Site Status: RECRUITING

Research Site 120

Dallas, Texas, United States

Site Status: RECRUITING

Research Site 102

Fairfax, Virginia, United States

Site Status: RECRUITING

Research Site 112

Fairfax, Virginia, United States

Site Status: RECRUITING

Research Site 105

Spokane, Washington, United States

Site Status: RECRUITING

Research Site 208

Blacktown, New South Wales, Australia

Site Status: RECRUITING

Research Site 215

Camperdown, New South Wales, Australia

Site Status: RECRUITING

Research Site 212

Concord, New South Wales, Australia

Site Status: RECRUITING

Research Site 217

New Lambton Heights, New South Wales, Australia

Site Status: RECRUITING

Research Site 201

Sydney, New South Wales, Australia

Site Status: RECRUITING

Research Site 205

Sydney, New South Wales, Australia

Site Status: RECRUITING

Research Site 206

Sydney, New South Wales, Australia

Site Status: RECRUITING

Research Site 216

Waratah, New South Wales, Australia

Site Status: RECRUITING

Research Site 209

Birtinya, Queensland, Australia

Site Status: RECRUITING

Research Site 203

Brisbane, Queensland, Australia

Site Status: RECRUITING

Research Site 210

Gold Coast, Queensland, Australia

Site Status: RECRUITING

Research Site 202

Nedlands, Western Australia, Australia

Site Status: RECRUITING

Research Site 207

Nedlands, Western Australia, Australia

Site Status: RECRUITING

Research Site 319

Hefei, Anhui, China

Site Status: RECRUITING

Research Site 365

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Research Site 310

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Research Site 337

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Research Site 327

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Research Site 345

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Research Site 353

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Research Site 356

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Research Site 313

Fuzhou, Fujian, China

Site Status: RECRUITING

Research Site 314

Guangzhou, Guangdong, China

Site Status: RECRUITING

Research Site 322

Guangzhou, Guangdong, China

Site Status: RECRUITING

Research site 367

Guangzhou, Guangdong, China

Site Status: RECRUITING

Research Site 346

Guangzhou, Guangdong, China

Site Status: RECRUITING

Research Site 348

Guangzhou, Guangdong, China

Site Status: RECRUITING

Research Site 350

Guangzhou, Guangdong, China

Site Status: RECRUITING

Research Site 360

Nanning, Guangxi, China

Site Status: RECRUITING

Research Site 334

Baoding, Hebei, China

Site Status: RECRUITING

Research Site 315

Harbin, Heilongjiang, China

Site Status: RECRUITING

Research Site 316

Luoyang, Henan, China

Site Status: RECRUITING

Research Site 317

Xinxiang, Henan, China

Site Status: RECRUITING

Research Site 306

Zhengzhou, Henan, China

Site Status: RECRUITING

Research Site 304

Zhengzhou, Henan, China

Site Status: RECRUITING

Research Site 321

Wuhan, Hubei, China

Site Status: RECRUITING

Research Site 311

Wuhan, Hubei, China

Site Status: RECRUITING

Research Site 309

Changsha, Hunan, China

Site Status: RECRUITING

Research Site 323

Changsha, Hunan, China

Site Status: RECRUITING

Research Site 344

Nanjing, Jiangsu, China

Site Status: RECRUITING

Research Site 305

Nanjing, Jiangsu, China

Site Status: RECRUITING

Research Site 307

Ganzhou, Jiangxi, China

Site Status: RECRUITING

Research Site 349

Nanchang, Jiangxi, China

Site Status: RECRUITING

Research Site 361

Nanchang, Jiangxi, China

Site Status: RECRUITING

Research Site 328

Changchun, Jilin, China

Site Status: RECRUITING

Research Site 301

Changchun, Jilin, China

Site Status: RECRUITING

Research Site 320

Shenyang, Liaoning, China

Site Status: RECRUITING

Research Site 352

Shenyang, Liaoning, China

Site Status: RECRUITING

Research Site 363

Nanjing, Nanjing, China

Site Status: RECRUITING

Research Site 340

Jinan, Shandong, China

Site Status: RECRUITING

Research Site 308

Jinan, Shandong, China

Site Status: RECRUITING

Research Site 333

Linyi, Shandong, China

Site Status: RECRUITING

Research Site 302

Linyi, Shandong, China

Site Status: RECRUITING

Research Site 335

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Research Site 326

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Research Site 355

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Research Site 332

Xi’an, Shanxi, China

Site Status: RECRUITING

Research Site 312

Chengdu, Sichuan, China

Site Status: RECRUITING

Research Site 330

Chengdu, Sichuan, China

Site Status: RECRUITING

Research Site 366

Chengdu, Sichuan, China

Site Status: RECRUITING

Research Site 325

Chengdu, Sichuan, China

Site Status: RECRUITING

Research Site 347

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Research Site 318

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Research site 368

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Research Site 324

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Research Site 329

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Research Site 331

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Research Site 359

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Research site 369

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Research Site 303

Taizhou, Zhejiang, China

Site Status: RECRUITING

Research Site 408

Kaohsiung City, , Taiwan

Site Status: RECRUITING

Research Site 405

Kaohsiung City, , Taiwan

Site Status: RECRUITING

Research Site 406

New Taipei City, , Taiwan

Site Status: RECRUITING

Research Site 401

Taipei, , Taiwan

Site Status: RECRUITING

Research Site 402

Taipei, , Taiwan

Site Status: RECRUITING

Research Site 409

Taipei, , Taiwan

Site Status: RECRUITING

Research Site 403

Taipei, , Taiwan

Site Status: RECRUITING

Research Site 407

Taipei, , Taiwan

Site Status: RECRUITING

Research Site 404

Taoyuan District, , Taiwan

Site Status: RECRUITING

Countries

United States; Australia; China; Taiwan

Central Contacts

Ling Li

Role: CONTACT

ling.li@dualitybiologics.com

86-21-26018730

Tiana Zhao

Role: CONTACT

tiana.zhao@dualitybiologics.com

Other Identifiers

DB-1311-O-1001

Identifier Type: -

Identifier Source: org_study_id