Skip to content

Cancers & treatments

News & evidence

Living with cancer

Learn & contribute

Loading

A public, cited, editable map of oncology: technologies, targets, products, companies, institutions, pathways, trials, pairings, roadmaps, and ideas. One page per object, with a plain-language TL;DR on every page.

Work in progress. Every fact on this site is being built and checked in the open and may be incomplete, out of date, or wrong. You must do your own research and verify anything here at its primary source before relying on it. Nothing on this site is medical advice; decisions belong with you and your clinicians.

OnCo is an information resource, not medical advice. Nothing here replaces a conversation with a qualified clinician. Never delay care because of something you read here; in an emergency, call your local emergency services. Terms of use

Browse by cancer
Tags
Search
Connections
For me
Navigator
Biomarker matrix
Calculators
Interactions
Decision aids
Checkpoint side effects
Tumour board
Compare
Counts by category
Rankings
Timeline
Year by year
Query builder
Graph explorer
Saved
Body map

Cancers & treatments

News & evidence

Institutions & people

Institutions
Universities
Trial leadership
People
Heroes and heroines
Companies
Startups
Requests for startups
Investors
Company scorecards
Trial sponsors
Manufacturing map
Countries
United States deep dive
India deep dive
China deep dive
Germany deep dive
Israel deep dive
United Kingdom deep dive
Cases by country
Funding flows

Living with cancer

For me
The first 60 days
Appointment prep pack
Side effects
Symptom to test
Report reader
Survivorship planner
Second opinion
Financial help
Free in oncology
Paying for care in the US
NHS coverage
Paying for care in India
Coverage rankings
Cutting cancer care costs
Diet, exercise and lifestyle
Supportive care
Recovery and rejuvenation
Complementary and supportive approaches
Hair loss and regrowth
What comes back after treatment
Heroes and heroines

Learn & contribute

Reading paths
About & methodology
Roadmap
Gaps to fill
Coverage of the field
Review queue
Reviewer roster
Contributors
Idea votes
Teaching packs
Weekly issue
Suggest an edit
Answer quality
Data dictionary
Build on OnCo
Open API
Open data
Open tools
Open source in oncology
The software of oncology
GitHub

© 2026 OnCo. Code MIT. The data are free for individual and educational use with the attribution “Data from OnCo (onco.cc)”, under CC BY-NC 4.0. Commercial use must contact us to pay for the data. Commercial licences. Made with heart and soul by Jude Gomila .

About and methodology Corrections Open API Tags Terms of use Privacy policy GitHub

Loading

Home
Trials
First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors

trialsTrialActive

First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors

A phase 1/2 trial of Pembrolizumab and PM8002 in advanced solid tumours, run by DualityBio Inc., active and no longer recruiting.

Overview Connected5

Overview

First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT05438329 by DualityBio Inc., with 1123 participants enrolled, started 2022-07-19 and due to reach its primary completion in 2027-08-13. Interventions recorded: DB-1305/BNT325, Pembrolizumab and BNT327.

Setting

A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1305 in Subjects With Advanced/Metastatic Solid Tumors

Phase

Phase 1/2

Sponsor

DualityBio Inc.

Registry

Started

2022-07-19

Enrolled

1,123 enrolled

Connected

Similar pages

Trial
A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer
Shares Duality Biotherapeutics, PM8002, BioNTech, Metastatic cancer (cancer that has spread) and the tag pipeline.
Trial
DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
Shares Duality Biotherapeutics, PM8002, BioNTech, Metastatic cancer (cancer that has spread) and the tag pipeline.
Trial
A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer
Shares Duality Biotherapeutics, PM8002, BioNTech, Metastatic cancer (cancer that has spread) and the tag pipeline.
Trial
PM8002 in the Treatment of Patients With Advanced Solid Tumors
Shares PM8002, BioNTech, Metastatic cancer (cancer that has spread) and the tag pipeline.
Trial
A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors
Shares PM8002, BioNTech, Metastatic cancer (cancer that has spread) and the tag pipeline.
Trial
A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors
Shares PM8002, BioNTech, Metastatic cancer (cancer that has spread) and the tag pipeline.
Trial
First-in-human Study of DB-1419 for Advanced/Metastatic Solid Tumors
Shares Duality Biotherapeutics, Metastatic cancer (cancer that has spread) and the tag pipeline.
Trial
A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors
Shares Duality Biotherapeutics, BioNTech, Metastatic cancer (cancer that has spread) and the tag pipeline.

cancers

Metastatic cancer (cancer that has spread)

drugs

ApprovedMonoclonal antibody (anti-PD-1)

Pembrolizumab · Keytruda / Keytruda Qlex (SC)

Phase 3bispecific antibody

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
1,123 enrolled+15
No structured primary endpoint0
Result: active0
No independent replication recorded0
A linked product is approved+5

Formula disclosed on the evidence page.

ProvenanceLast edited 2026-09-16 · Jude Gomila · Registry trials wave 6 and products wave 7 · diff · file

Sources & links

ClinicalTrials.gov NCT05438329

Data

JSON ·

Follow this page

Wrong or missing?

Propose a change with a source. Organisations can update their own records. Every suggestion is reviewed, safety-checked and validated before it goes live; nothing is edited directly.

Suggest an editDiscuss start a thread

Out of date?
Report a readout
How review works

Cancers

Metastatic cancer (cancer that has spread)

Products

Pembrolizumab
PM8002

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.

Machine-readable versions of First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors

JSON record with neighbours
Markdown context for language models
RDF Turtle for this record (its triples, relations and owl:sameAs; the IRI of this record is https://onco.cc/trials/nct05438329/)
All trials as JSON
RDF N-Triples for the whole corpus
Search index: id, kind, name, TL;DR and route for every record
OpenAPI 3.1 description
API root and meta.json
llms.txt

MCP server: npx -y onco-mcp, tools search, get_entity, list_kind, ask, context, compare. This record is get_entity or context with id nct05438329.

WebMCP tools registered on this page: onco_search, onco_get_entity.