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AzTrials

Advanced Solid TumorsPhase 1/2NCT05914116

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

A Phase 1/2 study testing DB-1311, Lopinavir and Ritonavir Tablets and itraconazole in people with Advanced Solid Tumors, run by DualityBio Inc. at 107 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
DB-1311, Lopinavir and Ritonavir Tablets and itraconazole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
862 participants
Where
107 sitesin 4 countries
Study dates
17 Aug 2023to May 2028
Phase
Phase 1/2
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

  • 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).
  • 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.
  • 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.
  • Has a life expectancy of ≥ 3 months.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
  • Has LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment.
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  • Has adequate organ function within 7 days prior to Day 1 of Cycle 1
  • Has adequate treatment washout period prior to Day 1 of Cycle 1
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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).
  • 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.
  • 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.
  • 28. Additional inclusion criteria for DDI cohort: has a study treatment expectancy of >= 2.5 months. Able to withhold CYP3A/P-gp/OATP1B inhibitors or substrates or CYP3A inducers as concomitant treatments for certain period.

Who cannot join

  • 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:
  • Prior treatment with B7-H3 targeted therapy.
  • Prior treatment with antibody drug conjugate with topoisomerase inhibitor (e.g., trastuzumab deruxtecan).
  • Has a medical history of symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] classes II-IV) or serious cardiac arrhythmia requiring treatment.
  • Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment.
  • 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.
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  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • Metastatic disease that involves major airways or blood vessels (e.g., patients with vascular invasion of the major portal vein and inferior vena cava).
  • 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.
  • 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.
  • Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals.
  • Know human immunodeficiency virus (HIV) infection.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Has known hypersensitivity to either the drug substances or inactive ingredients in the drug product.
  • Patients with other reasons that, in the opinion of the Investigator, make them unsuitable to participate in this study.
  • Additional exclusion criteria for DDI cohort: Has a contraindication for receiving lopinavir, ritonavir or itraconazole according to the prescribing information is not able to take lopinavir, ritonavir or itraconazole by oral intake.

Trial locations and contacts

107 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Nicole Huang contact

86-21-26018730

nicole.huang@dualitybiologics.com

Jay Ma contact

jay.ma@dualitybiologics.com

107 sites in 4 countries

China57 sites, 57 recruiting

  • Research Site 334

    Baoding, Hebei, 071030

    Recruiting

  • Research Site 365

    Beijing, Beijing Municipality, 100034

    Recruiting

  • Research Site 310

    Beijing, Beijing Municipality, 100142

    Recruiting

  • Research Site 337

    Beijing, Beijing Municipality, 100142

    Recruiting

  • Research Site 328

    Changchun, Jilin, 130000

    Recruiting

  • Research Site 301

    Changchun, Jilin, 130012

    Recruiting

  • Research Site 309

    Changsha, Hunan, 410031

    Recruiting

  • Research Site 323

    Changsha, Hunan, 410031

    Recruiting

  • Research Site 312

    Chengdu, Sichuan, 610041

    Recruiting

  • Research Site 330

    Chengdu, Sichuan, 610041

    Recruiting

  • Research Site 366

    Chengdu, Sichuan, 610041

    Recruiting

  • Research Site 325

    Chengdu, Sichuan, 610072

    Recruiting

  • Research Site 327

    Chongqing, Chongqing Municipality, 400030

    Recruiting

  • Research Site 345

    Chongqing, Chongqing Municipality, 400072

    Recruiting

  • Research Site 353

    Chongqing, Chongqing Municipality, 400072

    Recruiting

  • Research Site 356

    Chongqing, Chongqing Municipality, 400072

    Recruiting

  • Research Site 313

    Fuzhou, Fujian, 350001

    Recruiting

  • Research Site 307

    Ganzhou, Jiangxi, 341000

    Recruiting

  • Research Site 314

    Guangzhou, Guangdong, 510060

    Recruiting

  • Research Site 322

    Guangzhou, Guangdong, 510060

    Recruiting

  • Research site 367

    Guangzhou, Guangdong, 510120

    Recruiting

  • Research Site 346

    Guangzhou, Guangdong, 510282

    Recruiting

  • Research Site 348

    Guangzhou, Guangdong, 510300

    Recruiting

  • Research Site 350

    Guangzhou, Guangdong, 510515

    Recruiting

  • Research Site 324

    Hangzhou, Zhejiang, 310014

    Recruiting

  • Research Site 329

    Hangzhou, Zhejiang, 310016

    Recruiting

  • Research Site 331

    Hangzhou, Zhejiang, 310022

    Recruiting

  • Research Site 359

    Hangzhou, Zhejiang, 310022

    Recruiting

  • Research site 369

    Hangzhou, Zhejiang, 310022

    Recruiting

  • Research Site 315

    Harbin, Heilongjiang, 150081

    Recruiting

  • Research Site 319

    Hefei, Anhui, 230031

    Recruiting

  • Research Site 340

    Jinan, Shandong, 250013

    Recruiting

  • Research Site 308

    Jinan, Shandong, 250117

    Recruiting

  • Research Site 333

    Linyi, Shandong, 276000

    Recruiting

  • Research Site 302

    Linyi, Shandong, 276034

    Recruiting

  • Research Site 316

    Luoyang, Henan, 450000

    Recruiting

  • Research Site 349

    Nanchang, Jiangxi, 330006

    Recruiting

  • Research Site 361

    Nanchang, Jiangxi, 330029

    Recruiting

  • Research Site 344

    Nanjing, Jiangsu, 210008

    Recruiting

  • Research Site 305

    Nanjing, Jiangsu, 21000

    Recruiting

  • Research Site 363

    Nanjing, Nanjing, 210006

    Recruiting

  • Research Site 360

    Nanning, Guangxi, 530021

    Recruiting

  • Research Site 335

    Shanghai, Shanghai Municipality, 200030

    Recruiting

  • Research Site 326

    Shanghai, Shanghai Municipality, 200032

    Recruiting

  • Research Site 355

    Shanghai, Shanghai Municipality, 200120

    Recruiting

  • Research Site 320

    Shenyang, Liaoning, 110000

    Recruiting

  • Research Site 352

    Shenyang, Liaoning, 110042

    Recruiting

  • Research Site 303

    Taizhou, Zhejiang, 317099

    Recruiting

  • Research Site 347

    Tianjin, Tianjin Municipality, 300052

    Recruiting

  • Research Site 318

    Tianjin, Tianjin Municipality, 300060

    Recruiting

  • Research site 368

    Tianjin, Tianjin Municipality, 300300

    Recruiting

  • Research Site 321

    Wuhan, Hubei, 430000

    Recruiting

  • Research Site 311

    Wuhan, Hubei, 430030

    Recruiting

  • Research Site 332

    Xi’an, Shanxi, 710000

    Recruiting

  • Research Site 317

    Xinxiang, Henan, 453100

    Recruiting

  • Research Site 306

    Zhengzhou, Henan, 450000

    Recruiting

  • Research Site 304

    Zhengzhou, Henan, 450052

    Recruiting

Other trials in China

United States28 sites, 28 recruiting

  • Research Site 114

    Atlanta, Georgia, 30318

    Recruiting

  • Research Site 139

    Atlanta, Georgia, 30322

    Recruiting

  • Research Site 135

    Austin, Texas, 78731

    Recruiting

  • Research Site 138

    Canton, Ohio, 44718

    Recruiting

  • Research Site 118

    Celebration, Florida, 34747

    Recruiting

  • Research Site 123

    Charleston, South Carolina, 29425

    Recruiting

  • Research Site 113

    Cincinnati, Ohio, 45267

    Recruiting

  • Research Site 120

    Dallas, Texas, 75390

    Recruiting

  • Research Site 131

    Dayton, Ohio, 45409

    Recruiting

  • Research Site 129

    Detroit, Michigan, 48201

    Recruiting

  • Research Site 102

    Fairfax, Virginia, 22031

    Recruiting

  • Research Site 112

    Fairfax, Virginia, 22031

    Recruiting

  • Research Site 108

    Greenville, South Carolina, 29607

    Recruiting

  • Research Site 110

    Las Vegas, Nevada, 89169

    Recruiting

  • Research Site 125

    Los Angeles, California, 90033

    Recruiting

  • Research Site 133

    Los Angeles, California, 90067

    Recruiting

  • Research Site 103

    Los Angeles, California, 90095

    Recruiting

  • Research Site 115

    Louisville, Kentucky, 40202

    Recruiting

  • Research Site 127

    Margate, Florida, 33063

    Recruiting

  • Research Site 136

    Nashville, Tennessee, 37203

    Recruiting

  • Research Site 107

    New York, New York, 10032

    Recruiting

  • Research Site 137

    Orlando, Florida, 32827

    Recruiting

  • Research Site 101

    Plantation, Florida, 33322

    Recruiting

  • Research Site 121

    Saint Paul, Minnesota, 55101

    Recruiting

  • Research Site 128

    Santa Monica, California, 90403

    Recruiting

  • Research Site 105

    Spokane, Washington, 99208

    Recruiting

  • Research Site 109

    Tamarac, Florida, 33321

    Recruiting

  • Research Site 111

    Tucson, Arizona, 85711

    Recruiting

Other trials in United States

Australia13 sites, 13 recruiting

  • Research Site 209

    Birtinya, Queensland, 4575

    Recruiting

  • Research Site 208

    Blacktown, New South Wales, 2148

    Recruiting

  • Research Site 203

    Brisbane, Queensland, 4102

    Recruiting

  • Research Site 215

    Camperdown, New South Wales, 2050

    Recruiting

  • Research Site 212

    Concord, New South Wales, 2139

    Recruiting

  • Research Site 210

    Gold Coast, Queensland, 4224

    Recruiting

  • Research Site 202

    Nedlands, Western Australia, 6009

    Recruiting

  • Research Site 207

    Nedlands, Western Australia, 6009

    Recruiting

  • Research Site 217

    New Lambton Heights, New South Wales, 2305

    Recruiting

  • Research Site 201

    Sydney, New South Wales, 2031

    Recruiting

  • Research Site 205

    Sydney, New South Wales, 2109

    Recruiting

  • Research Site 206

    Sydney, New South Wales, 2228

    Recruiting

  • Research Site 216

    Waratah, New South Wales, 2298

    Recruiting

Other trials in Australia

Taiwan9 sites, 9 recruiting

  • Research Site 408

    Kaohsiung City, 807377

    Recruiting

  • Research Site 405

    Kaohsiung City, 824005

    Recruiting

  • Research Site 406

    New Taipei City, 235041

    Recruiting

  • Research Site 401

    Taipei, 100225

    Recruiting

  • Research Site 402

    Taipei, 100225

    Recruiting

  • Research Site 409

    Taipei, 104217

    Recruiting

  • Research Site 403

    Taipei, 110301

    Recruiting

  • Research Site 407

    Taipei, 112201

    Recruiting

  • Research Site 404

    Taoyuan, 333423

    Recruiting

Other trials in Taiwan

About this study

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

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.

Read the 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.

Being tested
DB-1311, Lopinavir and Ritonavir Tablets, itraconazole, Enzalutamide, Abiraterone
Keywords
B7-H3, SCLC (small cell lung cancer), NSCLC (non-small cell lung cancer), ESCC (esophageal squamous cell carcinoma), CRPC (castration-resistant prostate cancer), Melanoma, HCC (Hepatocellular Carcinoma), HNSCC (Head and neck squamous cell carcinomas), CC (Cervical Cancer), PROC (platinum-resistant ovarian cancer), PC (prostate cancer), CSPC (castration-sensitive prostate cancer)
Medical subject headings
Small Cell Lung Carcinoma, Carcinoma, Non-Small-Cell Lung, Esophageal Squamous Cell Carcinoma, Melanoma, Carcinoma, Hepatocellular, Squamous Cell Carcinoma of Head and Neck, Uterine Cervical Neoplasms, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DB-1311Drug

    Administered I.V.(intravenous infusion)

  • Lopinavir and Ritonavir TabletsDrug

    Lopinavir and Ritonavir Tablets

  • itraconazoleDrug

    itraconazole

  • EnzalutamideDrug

    oral administration

  • AbirateroneDrug

    oral administration

Study groups in NCT05914116
Study groupRoleWhat they receive
DB-1311/BNT324 Dose Level 1ExperimentalEnrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 1 on Day 1 of each cycle Q3W (every 3 weeks)
Receives: Drug: DB-1311
DB-1311/BNT324 Dose Level 2ExperimentalEnrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 2 on Day 1 of each cycle Q3W
Receives: Drug: DB-1311
DB-1311/BNT324 Dose Level 3ExperimentalEnrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 3 on Day 1 of each cycle Q3W
Receives: Drug: DB-1311
DB-1311/BNT324 Dose Level 4ExperimentalEnrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 4 on Day 1 of each cycle Q3W
Receives: Drug: DB-1311
DB-1311/BNT324 Dose Level 5ExperimentalEnrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 5 on Day 1 of each cycle Q3W
Receives: Drug: DB-1311
DB-1311/BNT324 Dose Expansion 1ExperimentalSubjects 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.
Receives: Drug: DB-1311
DB-1311/BNT324 Dose Expansion 2ExperimentalSubjects 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.
Receives: Drug: DB-1311
DB-1311/BNT324 Dose Expansion 3ExperimentalSubjects 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.
Receives: Drug: DB-1311
DB-1311/BNT324 Dose Expansion 4ExperimentalSubjects 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.
Receives: Drug: DB-1311
DB-1311/BNT324 Dose Expansion 5ExperimentalSubjects 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.
Receives: Drug: DB-1311
DB-1311/BNT324 Dose Expansion 6ExperimentalSubjects 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.
Receives: Drug: DB-1311
DB-1311/BNT324 Dose Expansion 7ExperimentalSubjects 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.
Receives: Drug: DB-1311
DB-1311/BNT324 Dose Expansion 8ExperimentalSubjects 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.
Receives: Drug: DB-1311
DB-1311/BNT324 Dose Expansion 9ExperimentalSubjects 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.
Receives: Drug: DB-1311
DB-1311/BNT324 Dose Expansion 10ExperimentalSubjects 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.
Receives: Drug: DB-1311
DB-1311/BNT324 Dose Expansion 11ExperimentalSubjects 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.
Receives: Drug: DB-1311
DB-1311/BNT324 Dose Expansion 12ExperimentalTaxane-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.
Receives: Drug: DB-1311
DB-1311/BNT324 Dose Expansion 13ExperimentalSubjects 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.
Receives: Drug: DB-1311
DB-1311/BNT324 Dose Expansion 14ExperimentalSubjects 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.
Receives: Drug: DB-1311
DB-1311/BNT324 Dose Expansion 15ExperimentalSubjects 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.
Receives: Drug: DB-1311; Drug: Lopinavir and Ritonavir Tablets; Drug: itraconazole
DB-1311/BNT324 Dose Expansion 16ExperimentalTaxane-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.
Receives: Drug: DB-1311; Drug: Enzalutamide
DB-1311/BNT324 Dose Expansion 17ExperimentalTaxane-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.
Receives: Drug: DB-1311; Drug: Abiraterone
DB-1311/BNT324 Dose Expansion 18ExperimentalCSPC 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.
Receives: Drug: DB-1311; Drug: Enzalutamide; Drug: Abiraterone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: up to 21 days after Cycle 1 Day 1

  2. 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

    Measured: Up to follow-up period, approximately 1 year post-treatment

  3. 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

    Measured: Up to follow-up period, approximately 1 year post-treatment

  4. Phase 1 & Phase 2a: vital sign measurements

    Measured: Up to follow-up period, approximately 1 year post-treatment

  5. Phase 1& Phase 2a: clinical safety laboratory parameters

    Measured: Up to follow-up period, approximately 1 year post-treatment

  6. Phase 1& Phase 2a: Electrocardiogram (ECG) parameters

    Measured: Up to follow-up period, approximately 1 year post-treatment

  7. Phase 1& Phase 2a: Eastern Cooperative Oncology Group (ECOG) performance status (PS)

    Measured: Up to follow-up period, approximately 1 year post-treatment

  8. Phase 1& Phase 2a: left ventricular ejection fraction (LEVF)

    Measured: Up to follow-up period, approximately 1 year post-treatment

  9. Phase 1: Maximum Tolerated Dose (MTD) of DB-1311/BNT324

    MTD on the data collected during Part 1

    Measured: Up to the completion of Part 1 (assessed up to 12 months)

  10. Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1311/BNT324

    RP2D of DB-1311/BNT324 based on the data collected during Part 1

    Measured: Up to the completion of Part 1 (assessed up to 12 months)

  11. 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.

    Measured: Up to follow-up period, approximately 1 year post-treatment

Secondary outcomes (15)

  1. Phase 1: Objective response rate (ORR)

    ORR will be determined by investigator per RECIST v1.1 in non-CRPC participants, and per RECIST v1.1 for soft tissue and PCWG3 criteria for bone metastases in CRPC participants

    Measured: Up to follow-up period, approximately 1 year post-treatment

  2. Phase 1 & Phase 2a: duration of response (DoR)

    DoR will be determined by investigator per RECIST v1.1 in non-PC/non-GBM participants, per RECIST v1.1 for soft tissue and PCWG3 criteria for bone metastases in PC participants, and per RANO 2.0 criteria in GBM participants

    Measured: Up to follow-up period, approximately 1 year post-treatment

  3. Phase 1 & Phase 2a: disease-control rate (DCR)

    DCR will be determined by investigator per RECIST v1.1 in non-PC/non-GBM participants, per RECIST v1.1 for soft tissue and PCWG3 criteria for bone metastases in PC participants, and per RANO 2.0 criteria in GBM participants

    Measured: Up to follow-up period, approximately 1 year post-treatment

  4. Phase 1 & Phase 2a: Time to Response (TTR)

    TTR will be determined by investigator per RECIST v1.1 in non-PC/non-GBM participants, per RECIST v1.1 for soft tissue and PCWG3 criteria for bone metastases in PC participants, and per RANO 2.0 criteria in GBM participants

    Measured: Up to follow-up period, approximately 1 year post-treatment

  5. Phase 1 & Phase 2a: Progression Free Survival (PFS)

    PFS will be determined by investigator per RECIST v1.1 in non-PC/non-GBM participants, and per RANO 2.0 criteria in GBM participants

    Measured: Up to follow-up period, approximately 1 year post-treatment

  6. Phase 1 & Phase 2a: Radiographic Progression Free Survival (rPFS)

    rPFS will be determined by investigator per RECIST v1.1 for soft tissue and PCWG3 criteria for bone metastases in PC participants

    Measured: Up to follow-up period, approximately 1 year post-treatment

  7. Phase 1 & Phase 2a: Overall Survival (OS)

    OS is defined as the time from date of first dose to the date of death.

    Measured: From date of first dose until the date of death or lost to follow up, approximately 1 year post-treatment

  8. Phase 2a: Prostate-specific antigen (PSA)

    Time to PSA progression, PSA50 response rate and PSA90 response rate, duration of PSA response in PC participants and the rate of PSA conversion to <0.2 in CSPC.

    Measured: From date of first dose until the date of first PSA progression, approximately 1 year post-treatment

  9. Phase 2a: CA-125 response rate

    CA-125 response assessed per GCIG criteria for ovarian cancer subjects

    Measured: Up to follow-up period, approximately 1 year post-treatment

  10. Phase 1 & Phase 2a: Pharmacokinetic-AUC

    Area under the concentration-time curve from time 0 to infinity of DB-1311/BNT324 ADC, total anti-B7-H3 antibody, and unconjugated P1021

    Measured: within 8 cycles (each cycle is 21 days)

  11. Phase 1 & Phase 2a: Pharmacokinetic-Cmax

    Maximum observed plasma concentration (Cmax) of DB-1311/BNT324 ADC, total anti-B7-H3 antibody, and unconjugated P1021

    Measured: within 8 cycles (each cycle is 21 days)

  12. Phase 1 & Phase 2a: Pharmacokinetic-Tmax

    Time to Cmax of DB-1311/BNT324 ADC, total anti-B7-H3 antibody, and unconjugated P1021

    Measured: within 8 cycles (each cycle is 21 days)

  13. Phase 1 & Phase 2a: Pharmacokinetic-Cthrough

    Trough concentration

    Measured: within 8 cycles (each cycle is 21 days)

  14. Phase 1 & 2a: Anti-drug antibody (ADA) prevalence

    Percentage of participants who are ADA positive at any point

    Measured: Up to follow-up period, approximately 1 year post-treatment

  15. Phase 1 & 2a: ADA incidence

    Percentage of participants having treatment-emergent ADA

    Measured: Up to follow-up period, approximately 1 year post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2023
  2. Study start17 Aug 2023
  3. Primary completionDec 2027 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
862 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05914116
Sponsor's protocol ID
DB-1311-O-1001
Status last verified
Oct 2026
First submitted
13 Jun 2023
Last updated
21 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing DB-1311, Lopinavir and Ritonavir Tablets and itraconazole in people with Advanced Solid Tumors, run by DualityBio Inc. at 107 sites in 4 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 60 inclusion and 25 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 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 107 sites in China, United States, Australia, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

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 Nicole Huang (86-21-26018730, nicole.huang@dualitybiologics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Percentage of participants in Part 1 with DLTs (time frame: up to 21 days after Cycle 1 Day 1). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05914116.

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 21 Oct 2026.

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