DB-1311 in Combination with BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Dualitybio Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-05-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

DUALITYBIO INC.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Others, Pharmacokinetic

Part 1:
1. To determine the RP2D of DB-1311 in combination with BNT327 by assessing the safety and tolerability in targeted participant populations.
2. To determine the RP2D of DB-1311 in combination with DB-1305 by assessing the safety and tolerability in targeted participant populations.

Part 2:
3. Arms 1-4: To assess the efficacy of DB-1311 in combination with BNT327 in targeted participant populations.
4. Arm 4: To determine the optimal dose of DB-1311 in combination with BNT327 by assessing the safety profile and efficacy of the combination therapy in the randomized dose optimization arm.
5. Arm 5: To determine the optimal dose of DB-1311 in combination with DB-1305 by assessing the safety profile and efficacy of the combination therapy in the randomized dose optimization arm and to assess the efficacy of DB-1311 in combination with DB-1305 in targeted participant populations.

Secondary objectives 8

1. Part 1: To assess the preliminary antitumor activity of DB-1311 in combination with BNT327 in target participants.
2. Part 1: To assess the preliminary antitumor activity of DB-1311 in combination with DB-1305 in targeted participants.
3. Part 1: To characterize the Pharmacokinetics (PK) of DB-1311 in combination with BNT327 and in combination with DB-1305 (DB-1311 antibody-drug conjugate [ADC], total antibody, unconjugated payload P1021)
4. Part 1: To assess the immunogenicity of DB-1311 in combination with BNT327 or DB-1305 in targeted participants.
5. Part 2: To assess the efficacy (other than ORR) of DB-1311 in combination with BNT327 or DB-1305 in targeted participant populations.
6. Part 2: To assess the safety of DB-1311 in combination with BNT327 or DB-1305.
7. Part 2: To further assess the PK of DB-1311 (DB-1311 ADC, total anti-B7H3 antibody, unconjugated payload P1021) in combination with BNT327, and in combination with DB-1305.
8. Part 2: To evaluate the prevalence and incidence of ADA against DB-1311 in serum via a validated assay.

Conditions and MedDRA coding

Non-small cell lung cancer (NSCLC)

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 13

1. Adults aged ≥ 18 years or acceptable age according to local regulations at the time of voluntarily signing informed consent
2. At least one measurable lesion as assessed by the Investigator according to RECIST v1.1 criteria.
3. Has a life expectancy of ≥ 3 months.
4. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 (see Section 8.4.3 of the protocol for details).
5. Has adequate organ function within 7 days prior to enrollment/randomization, as defined in Section 5.3 of the protocol.
6. Has adequate treatment washout period prior to the first dose of trial treatment, as defined in Section 5.3 of the protocol. Previous effective treatment will not be discontinued due to study participation.
7. Is capable of comprehending trial procedures and risks outlined in the informed consent and able to provide written consent and agree to comply with the requirements of the trial and the schedule of assessments.
8. Are POCBP (participant of childbearing potential) who have a negative serum beta-hCG pregnancy test.
9. Are POCBP who agree to practice a highly effective form of contraception and to require their male partners to use condoms starting at the time of giving informed consent and continuously until 8 months after the last dose of DB-1311 or DB-1305, or until 6 months after the last dose of BNT327, whichever occurs last.
10. Are POCBP who agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the trial, starting at the time of giving informed consent and continuously until 8 months after the last dose of DB-1311 or DB-1305, or until 6 months after the last dose of BNT327, whichever occurs last.
11. Are males who are fertile or if they are potentially fertile (i.e., are not surgically [e.g., have had a vasectomy] or congenitally sterile) and sexually active with a partner of childbearing potential, who agree to use condoms and to ask their female sexual partners to practice a highly effective form of contraception during the trial, starting at the time of giving informed consent and continuously until 5 months after the last dose of DB-1311 or DB-1305, or until 6 months after the last dose of BNT327, whichever occurs last.
12. Are potentially fertile males who are willing to refrain from sperm donation, starting at the time of giving informed consent and continuously until 5 months after the last dose of DB-1311 or DB-1305, or until 6 months after the last dose of BNT327, whichever occurs last.
13. Please see Section 5.3 of the protocol for additional Cohort/Arm-specific inclusion criteria.

Exclusion criteria 12

1. Prior treatment with B7H3 targeted therapy.
2. Prior treatment with antibody-drug conjugate with topoisomerase inhibitor (e.g., trastuzumab deruxtecan).
3. Is a candidate to locoregional treatment (including surgical resection, stereotactic radiation therapy or tumor ablation) with potential to induce complete or near complete response and prolonged tumor control (sometimes described as “radical” intent), per investigator’s assessment.
4. Has an uncontrolled concomitant or intercurrent illness, that in the opinion of the investigator, contra-indicates trial participation, limits compliance with trial procedures or substantially increases the risk of incurring AEs, including conditions specified in Section 5.4 of the protocol.
5. Has uncontrolled or significant disease or disorder, or history of specific diseases and disorders, as detailed in Section 5.4 of the protocol.
6. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤1 or baseline. Toxicities that have resolved with sequelae (e.g., tracheostomy, chronic use of feeding tube, replacement hormones) are allowed, if not associated with increased risk of complications per investigator’s assessment.
7. Has a history of allergies, hypersensitivities, or intolerance to the trial treatments including any excipients thereof.
8. Has a history of another primary malignancy within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated or have a known additional malignancy that is progressing or requires treatment.
9. Use of any IMP within 28 days or five half-lives if known (whichever is longer) before administration of first dose of trial treatment or ongoing participation in the active treatment phase of another interventional clinical trial or prior randomization or treatment in a previous trial with the same IMPs as the current trial, regardless of treatment assignment.
10. Has a medical, psychological, or social condition or substance abuse which, in the opinion of the investigator, could compromise their wellbeing if they participate in the trial, or that could prevent, limit, or confound the protocol-specified assessments or procedures, or that could impact adherence to protocol-described requirements.
11. Is vulnerable individual as per ICH E6 definition, i.e., are individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. This includes all sponsor, trial site, or third party (e.g., CRO, vendor) personnel directly involved in the conduct of the trial and their family members or dependents, as well as all trial site personnel otherwise supervised by the investigator.
12. Please see Section 5.4 of the protocol for additional Cohort/Arm-specific exclusion criteria.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Part 1: Number of participants with Dose Limiting Toxicities (DLTs)
2. Part 1: Treatment emergent adverse events (TEAEs) and treatment emergent serious AE (TESAEs)
3. Part 2: ORR, defined as the proportion of participants in whom a confirmed CR or PR is observed as best overall response (per RECIST v1.1 based on the investigator’s assessment).
4. Part 2: Safety and tolerability: TEAEs and TESAEs

Secondary endpoints 11

1. Part 1: Efficacy evaluations: objective response rate (ORR), defined as the proportion of participants in whom a confirmed CR or PR is observed as best overall response (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1] based on the investigator’s assessment)
2. Part 1: Duration of response (DoR), disease-control rate (DCR), Time to Response (TTR), Progression Free Survival (PFS) will be determined from tumor assessments by Investigator per RECIST v1.1.
3. Part 1: Cancer antigen 125 (CA-125) response rate assessed per Gynecological Cancer Intergroup (GCIG) criteria in participants with platinumresistant ovarian cancer (PROC).
4. Part 1: Overall Survival (OS)
5. Part 1: PK parameters of DB-1311 antibody-drug conjugate (ADC), total antibody, and unconjugated P1021 in combination with BNT327 or in combination with DB-1305.
6. Part 1: Anti-drug antibody (ADA) prevalence: the proportion of participants who are ADA positive at any point in time (at baseline and post-baseline). ADA incidence: the proportion of participants having treatment-emergent ADA.
7. Part 2: DoR, DCR, TTR, and PFS determined by Investigator as per RECIST v1.1
8. Part 2: Safety and tolerability: TEAEs and TESAEs
9. Part 2: OS
10. Part 2: PK parameters of DB-1311 ADC, total anti-B7H3 antibody, and unconjugated P1021.
11. Part 2: ADA prevalence: the proportion of participants who are ADA positive at any point in time (at baseline and post-baseline). ADA incidence: the proportion of participants having treatment-emergent ADA.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Dualitybio Inc.

Sponsor organisation

Dualitybio Inc.

Address

3524 Silverside Road Suite 35b

City

Wilmington

Postcode

19810-4929

Country

United States

Scientific contact point

Organisation

Dualitybio Inc.

Contact name

Executive Medical Director

Public contact point

Organisation

Dualitybio Inc.

Contact name

Executive Medical Director

Third parties 12

Locations

5 EU/EEA countries · 23 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 56 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications