Clinical trial NCT05914116: A Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors
Official title: A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1311 in Subjects With Advanced/Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumors
Keywords: B7-H3
SCLC
NSCLC
ESCC
CRPC
Melanoma
small cell lung cancer
non-small cell lung cancer
esophageal squamous cell carcinoma
castration-resistant prostate cancer
HCC
HNSCC
Cervical Cancer
Lead sponsor: DualityBio Inc.
Sponsor class: INDUSTRY
Collaborators: name: BioNTech SE
First posted: 2023-06-22
Enrollment: 610
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 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/BNT324 as monotherapy.

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 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.

Exclusion Criteria:

Unless otherwise specified, the exclusion criteria are common to both Phase 1 and Phase 2a. Subjects who meet any of the following criteria will be excluded from the study:

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. Unable or unwilling to discontinue concomitant drugs that are known to prolong the QT interval.
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 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.

Primary outcomes:
measure: Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0. Percentage of participants in Part 1 with DLTs
timeFrame: up to 21 days after Cycle 1 Day 1
measure: Phase 1: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0.
timeFrame: Up to follow-up period, approximately 1 year post-treatment
measure: Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
timeFrame: Up to follow-up period, approximately 1 year post-treatment
measure: Maximum Tolerated Dose (MTD) of DB-1311/BNT324
timeFrame: Up to the completion of Part 1 (assessed up to 12 months)
measure: Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1311/BNT324
timeFrame: Up to the completion of Part 1 (assessed up to 12 months)
measure: Phase 2a: Percentage of Participants with Treatment Emergent adverse events (TEAEs) as assessed by CTCAE v5.0.
timeFrame: Up to follow-up period, approximately 1 year post-treatment
measure: Phase 2a: Percentage of participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
timeFrame: Up to follow-up period, approximately 1 year post-treatment
measure: Phase 2a: Objective Response Rate (ORR) as determined by investigator
timeFrame: Up to follow-up period, approximately 1 year post-treatment
Secondary outcomes:
measure: Phase 1: Objective response rate (ORR)
timeFrame: Up to follow-up period, approximately 1 year post-treatment
measure: Phase 1 & Phase 2a: duration of response (DoR)
timeFrame: Up to follow-up period, approximately 1 year post-treatment
measure: Phase 1 & Phase 2a: disease-control rate (DCR)
timeFrame: Up to follow-up period, approximately 1 year post-treatment
measure: Phase 1 & Phase 2a: Time to Response (TTR)
timeFrame: Up to follow-up period, approximately 1 year post-treatment
measure: Phase 1 & Phase 2a: Progression Free Survival (PFS)
timeFrame: Up to follow-up period, approximately 1 year post-treatment
measure: Phase 1 & Phase 2a: Overall Survival (OS)
timeFrame: From date of first dose until the date of death or lost to follow up, approximately 1 year post-treatment
measure: Prostate-specific antigen (PSA)
timeFrame: From date of first dose until the date of first PSA progression, approximately 1 year post-treatment
measure: Phase 1 & Phase 2a: Pharmacokinetic-AUC
timeFrame: within 8 cycles (each cycle is 21 days)
measure: Phase 1 & Phase 2a: Pharmacokinetic-Cmax
timeFrame: within 8 cycles (each cycle is 21 days)
measure: Phase 1 & Phase 2a: Pharmacokinetic-Tmax
timeFrame: within 8 cycles (each cycle is 21 days)
measure: Phase 1 & Phase 2a: Pharmacokinetic-Cthrough
timeFrame: within 8 cycles (each cycle is 21 days)
measure: Phase 1 & 2a: Anti-drug antibody (ADA) prevalence
timeFrame: Up to follow-up period, approximately 1 year post-treatment
measure: Phase 1 & 2a: ADA incidence
timeFrame: Up to follow-up period, approximately 1 year post-treatment
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Research Site 111
state: Arizona
city: Los Angeles
country: United States
facility: Research Site 125
state: California
city: Los Angeles
country: United States
facility: Research Site 133
state: California
city: Los Angeles
country: United States
facility: Research Site 103
state: California
city: Santa Monica
country: United States
facility: Research Site 128
state: California
city: Celebration
country: United States
facility: Research Site 118
state: Florida
city: Margate
country: United States
facility: Research Site 127
state: Florida
city: Plantation
country: United States
facility: Research Site 101
state: Florida
city: Tamarac
country: United States
facility: Research Site 109
state: Florida
city: Atlanta
country: United States
facility: Research Site 114
state: Georgia
city: Louisville
country: United States
facility: Research Site 115
state: Kentucky
city: Detroit
country: United States
facility: Research Site 129
state: Michigan
city: Saint Paul
country: United States
facility: Research Site 121
state: Minnesota
city: Las Vegas
country: United States
facility: Research Site 110
state: Nevada
city: New York
country: United States
facility: Research Site 107
state: New York
city: Cincinnati
country: United States
facility: Research Site 113
state: Ohio
city: Dayton
country: United States
facility: Research Site 131
state: Ohio
city: Charleston
country: United States
facility: Research Site 123
state: South Carolina
city: Greenville
country: United States
facility: Research Site 108
state: South Carolina
city: Dallas
country: United States
facility: Research Site 120
state: Texas
city: Fairfax
country: United States
facility: Research Site 102
state: Virginia
city: Fairfax
country: United States
facility: Research Site 112
state: Virginia
city: Spokane
country: United States
facility: Research Site 105
state: Washington
city: Blacktown
country: Australia
facility: Research Site 208
state: New South Wales
city: Camperdown
country: Australia
facility: Research Site 215
state: New South Wales
city: Concord
country: Australia
facility: Research Site 212
state: New South Wales
city: New Lambton Heights
country: Australia
facility: Research Site 217
state: New South Wales
city: Sydney
country: Australia
facility: Research Site 201
state: New South Wales
city: Sydney
country: Australia
facility: Research Site 205
state: New South Wales
city: Sydney
country: Australia
facility: Research Site 206
state: New South Wales
city: Waratah
country: Australia
facility: Research Site 216
state: New South Wales
city: Birtinya
country: Australia
facility: Research Site 209
state: Queensland
city: Brisbane
country: Australia
facility: Research Site 203
state: Queensland
city: Gold Coast
country: Australia
facility: Research Site 210
state: Queensland
city: Nedlands
country: Australia
facility: Research Site 202
state: Western Australia
city: Nedlands
country: Australia
facility: Research Site 207
state: Western Australia
city: Hefei
country: China
facility: Research Site 319
state: Anhui
city: Beijing
country: China
facility: Research Site 365
state: Beijing
city: Beijing
country: China
facility: Research Site 310
state: Beijing
city: Beijing
country: China
facility: Research Site 337
state: Beijing
city: Chongqing
country: China
facility: Research Site 327
state: Chongqing
city: Chongqing
country: China
facility: Research Site 345
state: Chongqing
city: Chongqing
country: China
facility: Research Site 353
state: Chongqing
city: Chongqing
country: China
facility: Research Site 356
state: Chongqing
city: Fuzhou
country: China
facility: Research Site 313
state: Fujian
city: Guangzhou
country: China
facility: Research Site 314
state: Guangdong
city: Guangzhou
country: China
facility: Research Site 322
state: Guangdong
city: Guangzhou
country: China
facility: Research Site 346
state: Guangdong
city: Guangzhou
country: China
facility: Research Site 348
state: Guangdong
city: Guangzhou
country: China
facility: Research Site 350
state: Guangdong
city: Nanning
country: China
facility: Research Site 360
state: Guangxi
city: Baoding
country: China
facility: Research Site 334
state: Hebei
city: Harbin
country: China
facility: Research Site 315
state: Heilongjiang
city: Luoyang
country: China
facility: Research Site 316
state: Henan
city: Xinxiang
country: China
facility: Research Site 317
state: Henan
city: Zhengzhou
country: China
facility: Research Site 306
state: Henan
city: Zhengzhou
country: China
facility: Research Site 304
state: Henan
city: Wuhan
country: China
facility: Research Site 321
state: Hubei
city: Wuhan
country: China
facility: Research Site 311
state: Hubei
city: Changsha
country: China
facility: Research Site 309
state: Hunan
city: Changsha
country: China
facility: Research Site 323
state: Hunan
city: Nanjing
country: China
facility: Research Site 344
state: Jiangsu
city: Nanjing
country: China
facility: Research Site 305
state: Jiangsu
city: Ganzhou
country: China
facility: Research Site 307
state: Jiangxi
city: Nanchang
country: China
facility: Research Site 349
state: Jiangxi
city: Nanchang
country: China
facility: Research Site 361
state: Jiangxi
city: Changchun
country: China
facility: Research Site 328
state: Jilin
city: Changchun
country: China
facility: Research Site 301
state: Jilin
city: Shenyang
country: China
facility: Research Site 320
state: Liaoning
city: Shenyang
country: China
facility: Research Site 352
state: Liaoning
city: Nanjing
country: China
facility: Research Site 363
state: Nanjing
city: Jinan
country: China
facility: Research Site 340
state: Shandong
city: Jinan
country: China
facility: Research Site 308
state: Shandong
city: Linyi
country: China
facility: Research Site 333
state: Shandong
city: Linyi
country: China
facility: Research Site 302
state: Shandong
city: Shanghai
country: China
facility: Research Site 335
state: Shanghai
city: Shanghai
country: China
facility: Research Site 326
state: Shanghai
city: Shanghai
country: China
facility: Research Site 355
state: Shanghai
city: Xi'an
country: China
facility: Research Site 332
state: Shanxi
city: Chengdu
country: China
facility: Research Site 312
state: Sichuan
city: Chengdu
country: China
facility: Research Site 330
state: Sichuan
city: Chengdu
country: China
facility: Research Site 325
state: Sichuan
city: Tianjin
country: China
facility: Research Site 347
state: Tianjin
city: Tianjin
country: China
facility: Research Site 318
state: Tianjin
city: Hangzhou
country: China
facility: Research Site 324
state: Zhejiang
city: Hangzhou
country: China
facility: Research Site 329
state: Zhejiang
city: Hangzhou
country: China
facility: Research Site 331
state: Zhejiang
city: Hangzhou
country: China
facility: Research Site 359
state: Zhejiang
city: Taizhou
country: China
facility: Research Site 303
state: Zhejiang
city: Kaohsiung
country: Taiwan
facility: Research Site 408
city: Kaohsiung
country: Taiwan
facility: Research Site 405
city: New Taipei City
country: Taiwan
facility: Research Site 406
city: Taipei
country: Taiwan
facility: Research Site 401
city: Taipei
country: Taiwan
facility: Research Site 402
city: Taipei
country: Taiwan
facility: Research Site 409
city: Taipei
country: Taiwan
facility: Research Site 403
city: Taipei
country: Taiwan
facility: Research Site 407
city: Taoyuan
country: Taiwan
facility: Research Site 404
Study officials:
affiliation: DualityBio Inc.
name: Lily Hu
role: STUDY_DIRECTOR
References: