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Trials
A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors

trialsTrialRecruiting

A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors

A phase 1/2 trial of Trastuzumab pamirtecan and Pertuzumab in advanced solid tumours, run by DualityBio Inc., now recruiting.

Overview Connected6

Overview

A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT05150691 by DualityBio Inc., with 796 participants planned, started 2022-01-31 and due to reach its primary completion in 2027-08. Interventions recorded: DB-1303/BNT323, Pertuzumab Injection, Ritonavir and Itraconazole.

Setting

A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1303/BNT323 in Patients With Advanced/Metastatic Solid Tumors

Phase

Phase 1/2

Sponsor

DualityBio Inc.

Registry

Started

2022-01-31

Enrolled

796 enrolled

Connected

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cancers

Metastatic cancer (cancer that has spread)

technologies

Antibody-drug conjugate (ADC)

drugs

ApprovedMonoclonal antibody (anti-HER2, dimerisation domain)

Pertuzumab · Perjeta; Phesgo (with trastuzumab, subcutaneous)

Phase 3Antibody-drug conjugate (anti-HER2 antibody, topoisomerase I inhibitor payload)

Trastuzumab pamirtecan

companies

BioNTech Duality Biotherapeutics

Evidence strength28/100 · Preliminary

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 1/2+8
796 enrolled+15
No structured primary endpoint0
Result: recruiting0
No independent replication recorded0
A linked product is approved+5

Formula disclosed on the evidence page.

ProvenanceLast edited 2026-09-22 · Jude Gomila · Wave 2 corpus-only joins applied · diff · file

Sources & links

ClinicalTrials.gov NCT05150691

Data

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Cancers

Metastatic cancer (cancer that has spread)

Technologies

Antibody-drug conjugate (ADC)

Products

Trastuzumab pamirtecan
Pertuzumab

Companies

Duality Biotherapeutics
BioNTech

Not yet reviewedNeeds expert (clinical) review. Review this page or see the review queue and roster.

Model panel commentary is coming to this page: machine commentary, not clinical review.

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