Oncology bispecific antibodies

• ClinicalTrials.gov lists 1,525 ¹ interventional oncology studies of bispecific antibodies; 1,109 ² are active and 160 ³ are Phase 3.
• 985 ⁴ started between January 2023 and September 2026: 489 ⁵ with a China site and 352 ⁶ with a US site.
• PD-(L)1 x VEGF bispecifics account for 204 ⁷ of the studies started since 2023, led by Akeso's ivonescimab (153 ⁸).
• Lung cancer (194 ⁹) and lymphoma (184 ¹⁰) are the largest indications among new studies.

Oncology bispecific trial starts rose from 61 ¹¹ in 2020 to 317 ¹² in 2025. Studies with a China site grew from 23 ¹³ to 153 ¹⁴; studies with a US site grew from 32 ¹⁵ to 117 ¹⁶. The two lines were level in 2022, and the China line has been above the US line every year since 2023.

Much of the growth is investigator-initiated. Chinese hospitals run many studies combining approved domestic bispecifics, such as ivonescimab and cadonilimab, with chemotherapy or other drugs. That gives developers cheap early evidence across many tumour types, but it also scatters effort. China approved 4 bispecific antibodies in 2025 ¹⁷.

Immune-modulating bispecifics. PD-(L)1 x VEGF drugs appear in 204 ⁷ studies started since 2023. Ivonescimab accounts for 153 ⁸ and pumitamig (BNT327, co-developed by BioNTech and Bristol Myers Squibb since June 2025, BioNTech) for 36 ³⁰. Pfizer's PF-08634404, licensed from 3SBio in May 2025 (Pfizer), is another. Akeso's PD-1 x CTLA-4 bispecific cadonilimab appears in 184 ³¹ studies. Ivonescimab was approved in China in May 2024. Summit Therapeutics holds the rights in the US, Canada, Europe, Japan, Latin America, the Middle East and Africa (Summit) and is testing it head-to-head against pembrolizumab.

T-cell engagers. CD20 x CD3 engagers (epcoritamab, glofitamab, mosunetuzumab, odronextamab) appear in 142 ³² new studies and BCMA x CD3 engagers in 99 ³³. Tarlatamab, the first DLL3 T-cell engager for small cell lung cancer, appears in 30 ³⁴. The EGFR x MET antibody amivantamab appears in 32 ³⁵.

The two families are starting to meet. New Phase 3 designs combine PD-(L)1 x VEGF drugs with ADCs, such as ivonescimab with enfortumab vedotin, or pair bispecific ADCs with them.

Lung cancer was listed in 194 ⁹ bispecific studies started since 2023, lymphoma in 184 ¹⁰ and multiple myeloma in 132 ³⁶. Gastrointestinal cancers (156 ³⁷), liver and biliary cancers (60 ³⁸) and breast cancer (51 ³⁹) follow.

T-cell engagers built the class in lymphoma and myeloma. The growth now comes from solid tumours, driven by PD-(L)1 x VEGF drugs in lung, gastrointestinal and liver cancer, and by DLL3 engagers in small cell lung cancer.

• Lynozyfic (linvoseltamab, BCMA x CD3), approved 2 July 2025 (BLA 761400)
• Ziihera (zanidatamab, HER2 biparatopic), 20 November 2024 (BLA 761416)
• Imdelltra (tarlatamab, DLL3 x CD3), 16 May 2024 (BLA 761344)
• Elrexfio (elranatamab) and Talvey (talquetamab), August 2023 (BLA 761345, BLA 761342)
• Columvi (glofitamab) and Epkinly (epcoritamab), mid-2023 (BLA 761309, BLA 761324)
• Tecvayli (teclistamab), 25 October 2022 (BLA 761291)

No PD-(L)1 x VEGF bispecific has FDA approval yet. The first US filings in that class will set the benchmark every follower is measured against.

• PD-(L)1 x VEGF is already a big-pharma race. At least four global companies hold assets in late development. A new entrant needs a different design, such as a trispecific, a masked or conditionally active format, or a clear safety advantage.
• T-cell engagers for solid tumours are the harder but less crowded path. The obstacles are finding tumour-selective targets and managing cytokine release. DLL3 showed it can work. Other neuroendocrine and prostate targets are next.
• Use investigator-initiated trials, but control the story. Many of the studies started since 2023 were run by hospitals rather than companies. They are cheap evidence, but scattered combinations can blur the registrational path.
• Licensing is the main exit. The largest recent bispecific deals went to Chinese-origin assets with human proof of concept, often before global Phase 3.

Every trial count is the totalCount of one ClinicalTrials.gov API v2 query, retrieved on 26 September 2026. Each numbered citation opens a record whose source link re-runs the query. The track includes interventional studies in cancer whose record mentions a bispecific antibody by class or by name.

The class term also captures some bispecific ADCs and occasional studies that only mention bispecifics in passing. Site-country counts overlap. China-only trials registered only in Chinese registries are missing. Asset bars count every indication for that asset and a study can count in several bars. Approval dates come from Drugs@FDA; the China approval count is cited to its publisher.