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
Sponsor study identifier
interventional
862
4 countries
107
Study Start
August 17, 2023
Actual (reported)Primary Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 13, 2023
Actual (reported)June 22, 2023
Actual (reported)August 17, 2023
Actual (reported)December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Percentage of participants in Part 1 with DLTs
Percentage of participants in Part 1 with DLTs
up to 21 days after Cycle 1 Day 1
Phase 1& Phase 2a: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0.
Percentage of participants with TEAEs graded according to National Cancer Institute (NCI) CTCAE v5.0
Up to follow-up period, approximately 1 year post-treatment
Phase 1& Phase 2a: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Percentage of Participants with SAEs graded according to NCI CTCAE v5.0
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)
Enrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 2 on Day 1 of each cycle Q3W
Enrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 3 on Day 1 of each cycle Q3W
Administered I.V.(intravenous infusion)
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Lopinavir and Ritonavir Tablets
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordResearch Site 111
Tucson, Arizona, 85711, United States
Research Site 125
Los Angeles, California, 90033, United States
Research Site 133
Los Angeles, California, 90067, United States
Research Site 103
Los Angeles, California, 90095, United States
Lily Hu
DualityBio Inc.
First Submitted
June 13, 2023
First Posted
June 22, 2023
Study Start
August 17, 2023
Actual (reported)Primary Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
A Study for HSK39775 in Participants With Solid Tumors
A Study Explore WJB001 Capsules in Patients With Advanced Solid Tumors
Up to follow-up period, approximately 1 year post-treatment
Phase 1 & Phase 2a: vital sign measurements
Up to follow-up period, approximately 1 year post-treatment
Phase 1& Phase 2a: clinical safety laboratory parameters
Up to follow-up period, approximately 1 year post-treatment
Phase 1& Phase 2a: Electrocardiogram (ECG) parameters
Up to follow-up period, approximately 1 year post-treatment
Phase 1& Phase 2a: Eastern Cooperative Oncology Group (ECOG) performance status (PS)
Up to follow-up period, approximately 1 year post-treatment
Phase 1& Phase 2a: left ventricular ejection fraction (LEVF)
Up to follow-up period, approximately 1 year post-treatment
Phase 1: Maximum Tolerated Dose (MTD) of DB-1311/BNT324
MTD on the data collected during Part 1
Up to the completion of Part 1 (assessed up to 12 months)
Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1311/BNT324
RP2D of DB-1311/BNT324 based on the data collected during Part 1
Up to the completion of Part 1 (assessed up to 12 months)
Phase 2a: Objective Response Rate (ORR) as determined by investigator
Objective Response Rate (ORR) as determined by investigator per RECIST 1.1 in non-PC/non-GBM participants per RECIST v1.1 for soft tissue and Prostate Cancer Working Group 3 (PCWG3) criteria for bone metastases in PC participants, and ORR per neuro-oncology 2.0 (RANO 2.0) criteria in GBM participants.
Up to follow-up period, approximately 1 year post-treatment
Phase 1: Objective response rate (ORR)
Up to follow-up period, approximately 1 year post-treatment
Phase 1 & Phase 2a: duration of response (DoR)
Up to follow-up period, approximately 1 year post-treatment
Phase 1 & Phase 2a: disease-control rate (DCR)
Up to follow-up period, approximately 1 year post-treatment
Phase 1 & Phase 2a: Time to Response (TTR)
Up to follow-up period, approximately 1 year post-treatment
Phase 1 & Phase 2a: Progression Free Survival (PFS)
Up to follow-up period, approximately 1 year post-treatment
Enrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 4 on Day 1 of each cycle Q3W
Enrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 5 on Day 1 of each cycle Q3W
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Lopinavir and Ritonavir Tablets
itraconazole
oral administration
oral administration
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Research Site 128
Santa Monica, California, 90403, United States
Research Site 118
Celebration, Florida, 34747, United States
Research Site 127
Margate, Florida, 33063, United States
Research Site 137
Orlando, Florida, 32827, United States
Research Site 101
Plantation, Florida, 33322, United States
Research Site 109
Tamarac, Florida, 33321, United States
Research Site 114
Atlanta, Georgia, 30318, United States
Research Site 139
Atlanta, Georgia, 30322, United States
Research Site 115
Louisville, Kentucky, 40202, United States
Research Site 129
Detroit, Michigan, 48201, United States
Research Site 121
Saint Paul, Minnesota, 55101, United States
Research Site 110
Las Vegas, Nevada, 89169, United States
Research Site 107
New York, New York, 10032, United States
Research Site 138
Canton, Ohio, 44718, United States
Research Site 113
Cincinnati, Ohio, 45267, United States
Research Site 131
Dayton, Ohio, 45409, United States
Research Site 123
Charleston, South Carolina, 29425, United States
Research Site 108
Greenville, South Carolina, 29607, United States
Research Site 136
Nashville, Tennessee, 37203, United States
Research Site 135
Austin, Texas, 78731, United States
Research Site 120
Dallas, Texas, 75390, United States
Research Site 102
Fairfax, Virginia, 22031, United States
Research Site 112
Fairfax, Virginia, 22031, United States
Research Site 105
Spokane, Washington, 99208, United States
Research Site 208
Blacktown, New South Wales, 2148, Australia
Research Site 215
Camperdown, New South Wales, 2050, Australia
Research Site 212
Concord, New South Wales, 2139, Australia
Research Site 217
New Lambton Heights, New South Wales, 2305, Australia
Research Site 201
Sydney, New South Wales, 2031, Australia
Research Site 205
Sydney, New South Wales, 2109, Australia
Research Site 206
Sydney, New South Wales, 2228, Australia
Research Site 216
Waratah, New South Wales, 2298, Australia
Research Site 209
Birtinya, Queensland, 4575, Australia
Research Site 203
Brisbane, Queensland, 4102, Australia
Research Site 210
Gold Coast, Queensland, 4224, Australia
Research Site 202
Nedlands, Western Australia, 6009, Australia
Research Site 207
Nedlands, Western Australia, 6009, Australia
Research Site 319
Hefei, Anhui, 230031, China
Research Site 365
Beijing, Beijing Municipality, 100034, China
Research Site 310
Beijing, Beijing Municipality, 100142, China
Research Site 337
Beijing, Beijing Municipality, 100142, China
Research Site 327
Chongqing, Chongqing Municipality, 400030, China
Research Site 345
Chongqing, Chongqing Municipality, 400072, China
Research Site 353
Chongqing, Chongqing Municipality, 400072, China
Research Site 356
Chongqing, Chongqing Municipality, 400072, China
Research Site 313
Fuzhou, Fujian, 350001, China
Research Site 314
Guangzhou, Guangdong, 510060, China
Research Site 322
Guangzhou, Guangdong, 510060, China
Research site 367
Guangzhou, Guangdong, 510120, China
Research Site 346
Guangzhou, Guangdong, 510282, China
Research Site 348
Guangzhou, Guangdong, 510300, China
Research Site 350
Guangzhou, Guangdong, 510515, China
Research Site 360
Nanning, Guangxi, 530021, China
Research Site 334
Baoding, Hebei, 071030, China
Research Site 315
Harbin, Heilongjiang, 150081, China
Research Site 316
Luoyang, Henan, 450000, China
Research Site 317
Xinxiang, Henan, 453100, China
Research Site 306
Zhengzhou, Henan, 450000, China
Research Site 304
Zhengzhou, Henan, 450052, China
Research Site 321
Wuhan, Hubei, 430000, China
Research Site 311
Wuhan, Hubei, 430030, China
Research Site 309
Changsha, Hunan, 410031, China
Research Site 323
Changsha, Hunan, 410031, China
Research Site 344
Nanjing, Jiangsu, 210008, China
Research Site 305
Nanjing, Jiangsu, 21000, China
Research Site 307
Ganzhou, Jiangxi, 341000, China
Research Site 349
Nanchang, Jiangxi, 330006, China
Research Site 361
Nanchang, Jiangxi, 330029, China
Research Site 328
Changchun, Jilin, 130000, China
Research Site 301
Changchun, Jilin, 130012, China
Research Site 320
Shenyang, Liaoning, 110000, China
Research Site 352
Shenyang, Liaoning, 110042, China
Research Site 363
Nanjing, Nanjing, 210006, China
Research Site 340
Jinan, Shandong, 250013, China
Research Site 308
Jinan, Shandong, 250117, China
Research Site 333
Linyi, Shandong, 276000, China
Research Site 302
Linyi, Shandong, 276034, China
Research Site 335
Shanghai, Shanghai Municipality, 200030, China
Research Site 326
Shanghai, Shanghai Municipality, 200032, China
Research Site 355
Shanghai, Shanghai Municipality, 200120, China
Research Site 332
Xi’an, Shanxi, 710000, China
Research Site 312
Chengdu, Sichuan, 610041, China
Research Site 330
Chengdu, Sichuan, 610041, China
Research Site 366
Chengdu, Sichuan, 610041, China
Research Site 325
Chengdu, Sichuan, 610072, China
Research Site 347
Tianjin, Tianjin Municipality, 300052, China
Research Site 318
Tianjin, Tianjin Municipality, 300060, China
Research site 368
Tianjin, Tianjin Municipality, 300300, China
Research Site 324
Hangzhou, Zhejiang, 310014, China
Research Site 329
Hangzhou, Zhejiang, 310016, China
Research Site 331
Hangzhou, Zhejiang, 310022, China
Research Site 359
Hangzhou, Zhejiang, 310022, China
Research site 369
Hangzhou, Zhejiang, 310022, China
Research Site 303
Taizhou, Zhejiang, 317099, China
Research Site 408
Kaohsiung City, 807377, Taiwan
Research Site 405
Kaohsiung City, 824005, Taiwan
Research Site 406
New Taipei City, 235041, Taiwan
Research Site 401
Taipei, 100225, Taiwan
Research Site 402
Taipei, 100225, Taiwan
Research Site 409
Taipei, 104217, Taiwan
Research Site 403
Taipei, 110301, Taiwan
Research Site 407
Taipei, 112201, Taiwan
Research Site 404
Taoyuan, 333423, Taiwan
Study Completion
May 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 21, 2026
Record last verified: 2026-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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