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What’s the competitive landscape of Claudin 18.2?

Data pulled ·

Approved antibody and cell therapies now face ADCs with pivotal results, while bispecifics advance into Phase 3. The map below selects 20 programs across gastric/gastroesophageal junction (GEJ) cancer and other solid-tumor settings, including pancreatic cancer.

Claudin 18.2 competitive landscape185 asset records · 22 reviewed profiles · trials, licenses and sourcesDownload spreadsheet

Selected programs by modality and stage

Expand a program to see its reviewed status, development context and trial sources.

Twenty selected Claudin 18.2 therapeutic programs as of 9 September 2026. Expand a program for status, source links and trial identifiers.
ModalityEarlier clinical / Phase 3 pendingPhase 3 underwayFiling / positive Phase 3 readoutApproved in stated market
Antibodies
Osemitamab / TST001TranscentaPhase 3 not yet recruiting

Phase 3 registered, not yet recruiting; clinical evidence from earlier phases.

Enhanced-effector antibody; planned first-line pembrolizumab/chemotherapy study. Registration is not evidence that Phase 3 dosing began.

NCT06093425

ASKB589AskGenePhase 3 follow-up

Phase 3 active, not recruiting.

First-line CAPOX plus PD-1 inhibitor combination; estimated primary completion Dec 2026.

NCT06206733

FG-M108FutureGenGastric Phase 3 recruiting

Gastric Phase 3 recruiting; pancreatic Phase 3 not yet recruiting.

Gastric trial selects HER2-negative, PD-L1 CPS<5 disease and compares M108 plus CAPOX with placebo plus CAPOX. Gastric registry last updated Feb 2024.

NCT06177041 · NCT07383922

Zolbetuximab / VYLOYAstellasUS approved

FDA approved; first-line HER2-negative, CLDN18.2-positive advanced gastric/GEJ cancer with chemotherapy.

Commercial reference; Phase 3 program adding pembrolizumab.

NCT03504397 · NCT03653507 · NCT06901531

FDA approval

Antibody–drug conjugates
ATG-022AntengenePhase 3 not yet recruiting

Phase 3 registered, not yet recruiting.

MMAE ADC; Phase 3 listing updated 31 Aug 2026. Clinical Phase 1/2 program exists.

NCT07795346

ASP546C / XNW27011Astellas / EvopointPhase 1/2 recruiting

Phase 1/2 recruiting.

TOP1 ADC; ex-Greater-China rights licensed to Astellas.

NCT07488676 · NCT06792435

Astellas agreement

RC118RemeGenPhase 1/2 registry listing

Phase 1/2 recruiting in registry; updates dated Jan 2025.

MMAE ADC; earlier clinical watchlist, with aged registry timelines.

NCT05205850 · NCT06038396

SKB315KelunPhase 1; Phase 2 registered

Kelun Phase 1 recruiting; Phase 2 registered, not yet recruiting; Merck Phase 1/2 completed.

TOP1 ADC. Ownership/rights not inferred from a completed Merck trial; distinct regional trial statuses retained.

NCT05367635 · NCT06242691 · NCT07609667

SHR-A1904HengruiPhase 3 recruiting

Phase 3 recruiting.

TOP1 ADC; second-line gastric/GEJ trial versus chemotherapy; China sites in registry.

NCT06649292

JS107JunshiPhase 3 recruiting

Two Phase 3 trials recruiting.

MMAE ADC; later-line monotherapy and first-line toripalimab/chemotherapy regimens.

NCT07284134 · NCT07584135

BL-M05D1Baili / SystImmunePhase 3 recruiting

Phase 3 recruiting.

Later-line gastric/GEJ ADC program; trial sponsored by Sichuan Baili.

NCT07518147

IBI343 / TAK-921Innovent / TakedaChina NDA accepted

China NDA accepted; positive Phase 3 interim analysis announced 4 Jun 2026.

TOP1-payload ADC; later-line gastric filing and Phase 3 pancreatic expansion. Full comparative data remain important.

NCT06238843 · NCT07066098

Innovent filing announcement · Takeda agreement

LM-302LaNova / Sino BiopharmaceuticalChina NDA accepted

China NDA accepted; positive pivotal interim analysis announced 23 Jun 2026.

MMAE ADC; both pivotal endpoints reported met; detailed results planned early 2027. Current sponsor replaces historical BMS attribution.

NCT06351020 · NCT07385703

Sino filing announcement

AZD0901 / Sone-VeAstraZenecaOS endpoint met; PFS not met

Phase 3 positive OS topline; no approval established in reviewed sources.

MMAE ADC; 3L+ OS primary and 2L+ OS secondary endpoints met; 2L+ PFS primary not significant. First-line Phase 3 also recruiting.

NCT06346392 · NCT07431281

AstraZeneca results

Bispecifics
Givastomig / ABL111NovaBridge / ABL Bio · 4-1BBPhase 2 recruiting

Randomized Phase 2 recruiting; Phase 3 planned, not established as started.

CLDN18.2 x 4-1BB; first-line immunochemotherapy; low-expression eligibility. Sponsor aims for Phase 3 as early as year-end 2026.

NCT07432295 · NCT04900818

NovaBridge update

Spevatamig / PT886Phanes · CD47Phase 1/2 recruiting

Phase 1/2 recruiting.

CLDN18.2 x CD47; differentiates through macrophage checkpoint biology.

NCT05482893

ASP2138Astellas · CD3Phase 3 recruiting

Phase 3 recruiting; first patient dosed Aug 2026.

CLDN18.2 x CD3; subcutaneous administration; first-line pembrolizumab/chemotherapy combination.

NCT07673887

Astellas trial update

QLS31905Qilu · CD3Pancreatic Phase 3 recruiting

Pancreatic Phase 3 recruiting; gastric Phase 3 not yet recruiting.

CLDN18.2 x CD3; first-line pancreatic and gastric programs at different stages of trial initiation.

NCT07079228 · NCT07716449

Cell therapies
TAC01-CLDN18.2TriumviraPhase 1/2 follow-up

Phase 1/2 active, not recruiting; last update Feb 2025.

T-cell antigen coupler (TAC) product, a different engineered T-cell approach from conventional CAR-T.

NCT05862324

Satri-cel / CT041CARsgenChina approved

China approved 22 Jun 2026; HER2-negative, CLDN18.2-positive advanced gastric/GEJ cancer after at least two prior lines.

Later-line gastric/GEJ approval in China; pancreatic adjuvant expansion remains investigational.

NCT04581473 · NCT05911217

CARsgen approval announcement

Selected programs. Phase 3 underway includes active follow-up; registration alone is shown separately. Approval applies only to the market stated. Earlier trial listings can lag current activity.

Map as PDF · 22 reviewed profiles as CSV · 22 reviewed profiles as JSON

The commercial reference points

Zolbetuximab (VYLOY), Astellas, is FDA-approved with chemotherapy for first-line HER2-negative, CLDN18.2-positive advanced gastric/GEJ cancer. Satri-cel (CT041), CARsgen, was approved in China on 22 June 2026 after at least two prior lines of therapy in CLDN18.2-positive, HER2-negative advanced gastric/GEJ cancer. Their approved populations and treatment settings differ. FDA approval, CARsgen announcement.

Three ADCs closest to the next commercial wave

  • IBI343 / TAK-921 — Innovent / Takeda. China accepted the NDA after a positive interim analysis of G-HOPE-001. The program also has a Phase 3 pancreatic cancer study. Takeda holds rights outside Greater China. Innovent filing announcement, Takeda agreement.
  • LM-302 — LaNova / Sino Biopharmaceutical. China NDA acceptance was announced on 23 June 2026. The sponsor reported both pivotal endpoints met and guided detailed results to early 2027. The current developer differs from the historical BMS attribution in the raw export. Sino announcement.
  • Sonesitatug vedotin / AZD0901 — AstraZeneca. The Phase 3 trial met its third-line-or-later overall-survival primary endpoint and its second-line-or-later overall-survival secondary endpoint. The progression-free-survival primary endpoint was not statistically significant. This is pivotal survival evidence, not an approval. July 2026 results.

Where the next competition is forming

First-line combinations. Astellas dosed the first patient in ASP2138’s Phase 3 study in August 2026, combining the CLDN18.2 × CD3 bispecific with pembrolizumab and chemotherapy. Givastomig, a CLDN18.2 × 4-1BB bispecific from NovaBridge/ABL Bio, is in randomized Phase 2, with Phase 3 initiation planned as early as year-end 2026. A planned milestone is not a completed one. ASP2138, givastomig update.

Broader biomarker eligibility. SPOTLIGHT required moderate/strong CLDN18.2 staining in at least 75% of tumor cells. AstraZeneca’s pivotal ADC trial used at least 25% at any staining intensity; GIVA-2 allows at least 1% at intensity 1+ or higher. Different assays, thresholds and treatment lines make a simple cross-trial response-rate ranking misleading. SPOTLIGHT, CLARITY-Gastric01, GIVA-2.

Pancreatic cancer. IBI343 and QLS31905 have recruiting Phase 3 trials. FG-M108’s pancreatic Phase 3 is registered but not yet recruiting, while satri-cel is being studied in the adjuvant setting. These are investigational uses. IBI343, QLS31905, FG-M108, satri-cel.

Licensing puts the programs in context

AgreementAsset / rightsDisclosed economics
AstraZeneca / KYM · 2023CMG901 / AZD0901 · global$63m upfront; up to $1.1bn additional milestones, plus royalties
Astellas / Evopoint · 2025XNW27011 / ASP546C · outside Greater China$130m upfront; up to $70m near-term payments and $1.34bn additional milestones, plus royalties
Takeda / Innovent · 2025Portfolio including IBI343 · IBI343 rights outside Greater China$1.2bn portfolio upfront, including $100m equity; IBI343’s individual allocation was not disclosed

The strategic pattern is acquisition of access to differentiated clinical programs. The portfolio-level Takeda payment should not be treated as a valuation of IBI343 alone, and contingent milestones are not money already paid.

The full pipeline: preclinical to approval

The shortlist above highlights selected competitors. The full capture contains 185 asset records, including 105 preclinical and 38 Phase 1 records. This bullseye shows every captured ID, with separate Phase 2 and Phase 1 rings. Hover for a quick view, or click or tap a dot to keep its details open.

The chart uses recorded phase with two reviewed updates: satri-cel moves from Phase 2 to approved in China, and SOT102 moves from Phase 2 to discontinued. That produces 2 approved, 12 Phase 3/registered, 22 Phase 2, 38 Phase 1, 105 preclinical and 6 discontinued/historical records. The original export has 24 Phase 2 records; both versions remain available in each record’s details and the full-cohort downloads.

Phase 3 includes registered trials that have not begun recruiting. The cohort also retains overlapping aliases and four records flagged as diagnostic; 185 records does not mean 185 distinct active therapeutic programs. Single-record preclinical and historical developers share a sector to keep labels readable, while every asset retains its own dot and developer details.

All 185 records as CSV · All 185 records as JSON

Reading this snapshot

The selected program map and full-cohort bullseye serve different levels of detail; neither is a count of every active competitor. The raw cohort includes diagnostic assets, overlapping aliases and records marked Stale, a maintenance label that does not establish discontinuation. The 186-trial capture covers ClinicalTrials.gov; additional registries were not pulled for this example.

Two historical programs are retained in the downloads. SOT102 is discontinued despite its raw Active label; the sponsor-authored publication and registry confirm termination. Elevation’s EO-3021 program was discontinued in March 2025, which does not establish the status of every CSPC territory. SOT102 publication, EO-3021 announcement.

The workbook preserves source drug IDs, trial IDs, raw records and a correction log. Regulatory filings, clinical readouts and approvals are kept separate throughout.

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