Actively Recruiting
DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
Led by DualityBio Inc. · Updated on 2026-02-06
492
Participants Needed
37
Research Sites
258 weeks
Total Duration
On this page
Sponsors
D
DualityBio Inc.
Lead Sponsor
B
BioNTech SE
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors
CONDITIONS
Official Title
DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 2265 18 years or acceptable age according to local regulations at the time of voluntarily signing informed consent.
- At least one measurable lesion as assessed by the Investigator according to RECIST v1.1 criteria.
- Has a life expectancy of �b2265 3 months.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
- Has adequate organ function within 7 days prior to enrollment/randomization.
- Has adequate treatment washout period prior to the first dose of trial treatment.
- For hepatocellular carcinoma (HCC) patients: Histological/cytological confirmed diagnosis of HCC or clinically confirmed diagnosis of HCC; has a Child-Pugh class A liver score.
- For cervical cancer (CC) patients: Has persistent, recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology.
- For melanoma patients: Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic melanoma.
- For platinum-resistant ovarian cancer (PROC) patients (Cohort A): Participants must have a confirmed diagnosis of ovarian cancer, primary peritoneal cancer, or fallopian tube cancer with high-grade serous histology and platinum-resistant disease.
- For head and neck squamous cell carcinoma (HNSCC) patients: Histologically or cytologically confirmed recurrent or disseminated HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies.
- For non-small cell lung cancer (NSCLC) patients: Pathologically documented Stage IIIB or IIIC NSCLC not amenable for radical surgery or definitive chemoradiation or Stage IV NSCLC; must not have EGFR-sensitizing mutation, ALK gene rearrangements, or other oncogenic driver mutations.
You will not qualify if you...
- Prior treatment with B7H3 targeted therapy.
- Prior treatment with antibody-drug conjugate with topoisomerase inhibitor.
- Candidate for locoregional treatment with potential to induce complete or near complete response and prolonged tumor control, per investigator's assessment.
- Uncontrolled concomitant or intercurrent illness that contraindicates trial participation or limits compliance with trial procedures.
- Uncontrolled or significant cardiovascular disease.
- Clinically uncontrolled pleural effusion, ascites, or pericardial effusion requiring drainage or related therapies.
- History of non-infectious interstitial lung disease or pneumonitis.
- Any autoimmune, connective tissue, or inflammatory disorders.
- Spinal cord compression or clinically active central nervous system metastases.
- Unresolved toxicities from previous anticancer therapy, except alopecia, not resolved to Grade �b241 or baseline.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 37 locations
1
USA06-0
Los Angeles, California, United States, 90025
Actively Recruiting
2
USA16-0
Los Angeles, California, United States, 90025
Actively Recruiting
3
USA01-0
Wheat Ridge, Colorado, United States, 80033
Actively Recruiting
4
USA08-0
Florida City, Florida, United States, 99208
Actively Recruiting
5
USA10-0
Atlanta, Georgia, United States, 30318
Actively Recruiting
6
USA11-0
Bethesda, Maryland, United States, 20817
Actively Recruiting
7
USA14-0
Lincoln, Nebraska, United States, 68506
Actively Recruiting
8
USA04-0
New York, New York, United States, 10032
Actively Recruiting
9
USA15-0
Portland, Oregon, United States, 97239
Actively Recruiting
10
USA03-0
Charleston, South Carolina, United States, 29425
Actively Recruiting
11
USA13-0
Anderson, Texas, United States, 46011
Actively Recruiting
12
USA12-0
Houston, Texas, United States, 77030
Actively Recruiting
13
USA05-0
Virginia Beach, Virginia, United States, 22031
Actively Recruiting
14
USA09-0
Puyallup, Washington, United States, 98373
Actively Recruiting
15
USA07-0
Spokane, Washington, United States, 99208
Actively Recruiting
16
AUS07-0
North Sydney, New South Wales, Australia, 2060
Actively Recruiting
17
AUS06-0
Benowa, Queensland, Australia, 4217
Actively Recruiting
18
AUS04-0
Birtinya, Queensland, Australia, 4575
Actively Recruiting
19
AUS05-0
Adelaide, South Australia, Australia, 5000
Actively Recruiting
20
CHN02-0
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
21
CHN13-0
Beijing, Beijing Municipality, China, 100032
Actively Recruiting
22
CHN23-0
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
23
CHN17-0
Dongguan, Guangdong, China, 523000
Actively Recruiting
24
CHN06-0
Henan, Henan, China, 450008
Actively Recruiting
25
CHN12-0
Xinxiang, Henan, China, 453100
Actively Recruiting
26
CHN04-0
Hubei, Hubei, China, 430014
Actively Recruiting
27
CHN26-0
Wuhan, Hubei, China, 00000
Actively Recruiting
28
CHN34-0
Wuhan, Hubei, China, 430079
Actively Recruiting
29
CHN11-0
Changsha, Hunan, China, 410013
Actively Recruiting
30
CHN16-0
Xuzhou, Jiangsu, China, 221000
Actively Recruiting
31
CHN35-0
Shenyang, Liaoning, China, 110042
Actively Recruiting
32
CHN25-0
Xi'an, Shaanxi, China, 710061
Actively Recruiting
33
CHN04-0
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
34
CHN01-0
Shanghai, Shanghai Municipality, China, 200120
Actively Recruiting
35
CHN24-0
Chengdu, Sichuan, China, 610041
Actively Recruiting
36
TWN01-0
Taipei, Taipei, Taiwan, 0
Actively Recruiting
37
TWN02-0
Taipei, Taipei, Taiwan, 23561
Actively Recruiting
Research Team
J
Jay Ma
CONTACT
Q
Qiaoli Jiang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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