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Last updated: July 17, 2026
B7-H3 (CD276) is a cell-surface protein in the B7 immune-checkpoint family. It is over-expressed on a broad range of solid tumors — small cell lung cancer, prostate, esophageal, nasopharyngeal, glioblastoma and pediatric brain tumors, ovarian, pancreatic, and more — as well as on tumor-associated blood vessels, while showing relatively limited expression on most normal tissues. This tumor-enriched pattern is what makes B7-H3 an attractive targeting antigen: therapies use it as a docking point to deliver a cytotoxic payload (ADCs), to direct engineered immune cells (CAR-T / CAR-NK), or to deliver targeted radiation (radioligands).
No validated companion diagnostic (as of July 2026). Unlike CLDN18.2 — which has an FDA-approved IHC companion test and a defined ≥75% cutoff — B7-H3 has no standardized, validated companion diagnostic. Because B7-H3 is expressed on a very high fraction of many tumor types, several B7-H3 ADC trials enroll based on tumor type and prior therapy without requiring a separate B7-H3 IHC test; some CAR-T trials do require documented B7-H3 expression. Read each trial's biomarker eligibility carefully.
Four modality classes target B7-H3 in current development: antibody-drug conjugates (ADCs) with cytotoxic payloads (ifinatamab deruxtecan, HS-20093, YL201, DB-1311) + monoclonal antibody (enoblituzumab) + radioligand (177Lu-omburtamab) + CAR-T / CAR-NK engineered cell therapies. ADCs are furthest along; cell therapy and radioligand approaches are earlier-phase but expanding, especially in pediatric CNS tumors and glioblastoma.
| Drug | Sponsor | Modality | Regulatory Status | Lead Recruiting Indications |
|---|---|---|---|---|
| Ifinatamab deruxtecan (I-DXd, DS-7300, MK-2400) | Daiichi Sankyo / Merck | ADC (DXd, topoisomerase-I payload) | FDA Priority Review — PDUFA Oct 10, 2026 (pretreated ES-SCLC). Breakthrough Therapy Designation (Aug 2025). Would be first-in-class if approved. No B7-H3 therapy approved yet. | SCLC (Ph3 IDeate-Lung02), prostate (Ph3), esophageal (Ph3), pan-tumor |
| HS-20093 / GSK5764227 | Hansoh Pharma / GSK | ADC | Investigational. Two Phase 3 trials in relapsed SCLC (ARTEMIS-008 vs topotecan; GSK5764227 program). GSK licensed ex-China rights from Hansoh. | SCLC (Ph3), prostate (Ph2), colorectal (Ph1 combos) |
| YL201 | MediLink Therapeutics | ADC | Investigational. Phase 3 in recurrent/metastatic nasopharyngeal carcinoma; Phase 3 in advanced esophageal squamous; Phase 1/2 pan-tumor. | Nasopharyngeal (Ph3), esophageal (Ph3), solid tumor |
| DB-1311 / BNT324 | DualityBio / BioNTech | ADC | Investigational. Phase 3 vs docetaxel in mCRPC; Phase 1/2a pan-tumor; Phase 2 combinations with BNT327 (PD-L1×VEGF bispecific). | Prostate/mCRPC (Ph3), lung, solid tumor |
| Enoblituzumab (MGA271) | MacroGenics | Monoclonal antibody (Fc-optimized) | Investigational. Phase 2 neoadjuvant vs standard of care in high-risk localized prostate cancer. | Prostate (Ph2 neoadjuvant) |
| 177Lu-DTPA-Omburtamab | (sponsor per trial) | Radioligand (lutetium-177) | Investigational. Phase 1 in children/adolescents with brain cancer or leptomeningeal (CNS-metastatic) disease. | Pediatric CNS / leptomeningeal (Ph1) |
| B7-H3 CAR-T / CAR-NK (multiple agents) | Academic + biotech | Engineered cell therapy | Investigational, Phase 1 / early. Numerous autologous, allogeneic, and dual-target (B7-H3 + IL13Rα2, EGFR, PD-L1, NKG2D) constructs. | Glioblastoma, DIPG, pediatric solid, ovarian, PDAC, TNBC, HCC |
The furthest-advanced B7-H3 therapy, from Daiichi Sankyo and Merck. It is an antibody-drug conjugate built on the same DXd (topoisomerase-I inhibitor) payload platform as trastuzumab deruxtecan and datopotamab deruxtecan. The FDA granted it Breakthrough Therapy Designation in August 2025 and has accepted its Biologics License Application under Priority Review, with a target decision date (PDUFA) of October 10, 2026, for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease progressed on or after platinum-based chemotherapy. The submission is supported by the IDeate-Lung01 and IDeate-PanTumor01 studies. The confirmatory Phase 3 IDeate-Lung02 (NCT06203210) tests ifinatamab deruxtecan versus physician's choice of chemotherapy in relapsed SCLC. Beyond SCLC, the program spans a Phase 3 in metastatic prostate cancer (NCT06925737), a Phase 3 in pretreated esophageal squamous carcinoma (NCT06644781), pan-tumor Phase 1/2 studies (NCT04145622, NCT06330064), a 1L ES-SCLC induction combination with atezolizumab (NCT06362252), and combinations with the DLL3-targeted T-cell engager gocatamig (MK-6070) in SCLC (NCT06780137, NCT07227597). If approved in October, it would become the first B7-H3-directed medicine for any cancer. As with other deruxtecan ADCs, interstitial lung disease / pneumonitis is a known class risk that requires monitoring; consult trial and (upon approval) prescribing information for the full safety profile.
A B7-H3 ADC developed by Hansoh Pharma, with ex-China rights licensed to GSK (as GSK5764227 / GSK'227). It has the deepest SCLC development after ifinatamab deruxtecan: the Phase 3 ARTEMIS-008 (NCT06498479) compares HS-20093 with topotecan in relapsed small cell lung cancer, and a parallel Phase 3 GSK5764227 study (NCT07099898) also enrolls relapsed SCLC. Beyond lung, ARTEMIS-003 (NCT06001255) is a Phase 2 in metastatic castration-resistant prostate cancer, and ARTEMIS-102 (NCT06825624) tests HS-20093 combinations in advanced colorectal cancer. This makes B7-H3 one of the few targets with multiple independent Phase 3 ADC programs in the same lead indication (relapsed SCLC).
A B7-H3 ADC from MediLink Therapeutics. YL201 is distinctive for advancing into nasopharyngeal carcinoma — the Phase 3 NCT06629597 studies YL201 in recurrent or metastatic nasopharyngeal carcinoma — and into esophageal squamous cell carcinoma (Phase 3 NCT07487896 versus investigator's choice of chemotherapy). The pan-tumor Phase 1/2 NCT05434234 established the dose across advanced solid tumors. The nasopharyngeal focus makes YL201 one of the more geographically distinctive B7-H3 programs, addressing a cancer with high incidence in Southern China and Southeast Asia.
A B7-H3 ADC jointly developed by DualityBio and BioNTech. Its lead registrational study is the Phase 3 NCT07365995 comparing BNT324 with docetaxel in metastatic castration-resistant prostate cancer — a head-to-head with the prostate-cancer chemotherapy standard. The pan-tumor Phase 1/2a NCT05914116 covers advanced/metastatic solid tumors, and Phase 2 NCT06953089 tests DB-1311 combined with BNT327 (a PD-L1×VEGF bispecific) or DB-1305, reflecting BioNTech's strategy of pairing its ADCs with its bispecific-antibody pipeline. A lung-cancer combination study (NCT06892548) is also recruiting.
An Fc-optimized anti-B7-H3 monoclonal antibody from MacroGenics. Rather than delivering a payload, it engages the immune system directly. The Phase 2 NCT06014255 tests neoadjuvant enoblituzumab versus standard of care in men with high-risk localized prostate cancer — a window-of-opportunity design in the pre-surgical setting, distinct from the metastatic focus of the ADC programs.
A B7-H3 antibody (omburtamab) labeled with the therapeutic radioisotope lutetium-177 to deliver targeted radiation. The Phase 1 NCT07698899 studies 177Lu-DTPA-omburtamab in children and adolescents with brain cancer or cancer that has spread to the central nervous system (leptomeningeal disease). It represents the radioligand approach to B7-H3 — a modality otherwise concentrated in prostate cancer (PSMA) and neuroendocrine tumors — applied to a devastating pediatric setting with few options.
B7-H3 is one of the most-pursued CAR-T / CAR-NK targets in solid tumors, especially in the brain, where B7-H3 is highly expressed and few other targets exist. Recruiting Phase 1 programs include loco-regional B7-H3 CAR-T in DIPG (diffuse intrinsic pontine glioma, NCT06221553), a B7-H3 / IL13Rα2 bispecific armored CAR-T in recurrent glioblastoma (NCT07193628), a dual-target CAR-NK in recurrent/progressive glioblastoma and high-grade glioma (NCT07480941), and CMD03 CAR-T in pediatric relapsed/refractory solid tumors (NCT06612645). Beyond the CNS, autologous B7-H3 CAR-T is in Phase 1 for ovarian cancer (iC9-CAR.B7-H3, NCT06305299), pancreatic cancer (NCT06158139), triple-negative breast cancer (NCT06347068), hepatocellular carcinoma (NCT05323201), and as an EGFR/B7-H3 dual CAR-T in lung and breast (NCT05341492). An allogeneic B7-H3 CAR-γδT program (NCT06825455) is not yet recruiting. These are early-phase, specialty-center therapies requiring apheresis and CRS / ICANS management.
Selected B7-H3-targeted trials are grouped by primary cancer type below. B7-H3 testing requirements vary by trial — some B7-H3 ADC trials enroll by tumor type without a separate B7-H3 IHC test, while some CAR-T trials require documented B7-H3 expression. Read each trial's biomarker eligibility carefully.
The most advanced B7-H3 setting, with multiple independent Phase 3 ADC programs in relapsed/pretreated disease and the ifinatamab deruxtecan FDA decision pending October 10, 2026.
B7-H3 is highly expressed in prostate cancer, driving two Phase 3 ADC programs plus a neoadjuvant antibody study.
Cross-cancer studies enrolling advanced solid tumors — useful for patients with less common B7-H3-expressing cancers.
Early-phase engineered cell therapies, concentrated in brain tumors (where B7-H3 is highly expressed) and pediatric / adult solid tumors. Require apheresis-capable specialty centers and CRS / ICANS management.
Showing selected trials from 86 RECRUITING + 12 not-yet-recruiting B7-H3 (CD276)-directed interventional trials in the ClinTrialFinder corpus as of July 17, 2026. Non-B7-H3 targets are out of scope. For the latest searches: ifinatamab deruxtecan, B7-H3, HS-20093, DB-1311.
B7-H3's appeal is its breadth of expression (many tumor types, plus tumor vasculature) combined with relatively limited normal-tissue expression, and the maturation of ADC and CAR-T platforms that can exploit a surface antigen without needing a fully-defined signaling receptor. The DXd payload platform behind ifinatamab deruxtecan has already produced multiple approved ADCs against other targets, which de-risks the chemistry.
What remains unproven: no B7-H3 therapy has yet cleared FDA review, so efficacy and the real-world safety/benefit balance in each indication are still being established. Cross-trial comparisons between the competing ADCs (ifinatamab deruxtecan, HS-20093, YL201, DB-1311) are unreliable without head-to-head randomized data. The lack of a standardized B7-H3 companion diagnostic also means the field has not yet defined which patients benefit most. The October 10, 2026 FDA decision on ifinatamab deruxtecan in ES-SCLC will be the first real regulatory read-out for the entire class.
Because B7-H3 therapies span several modalities, the side-effect profile depends heavily on the platform, not just the target:
Safety details for investigational agents are provisional and trial-specific. There is no approved B7-H3 prescribing information yet; consult each trial's protocol and your care team.
What is B7-H3 (CD276)?
B7-H3 (also called CD276) is a cell-surface protein in the B7 immune-checkpoint family. It is over-expressed on a broad range of solid tumors — including small cell lung cancer, prostate, esophageal, nasopharyngeal, glioblastoma and pediatric brain tumors, ovarian and pancreatic cancers — and on tumor-associated blood vessels, while showing relatively limited expression on most normal tissues. That tumor-enriched pattern makes it a useful targeting antigen: therapies use it to deliver a cytotoxic payload (ADCs), to direct engineered immune cells (CAR-T / CAR-NK), or to deliver targeted radiation (radioligands). B7-H3 also has an immunosuppressive role in the tumor microenvironment, but its exact receptor is not fully defined, and most B7-H3 drugs exploit it as a surface antigen for targeted delivery rather than as a checkpoint-blockade target.
Is there an FDA-approved B7-H3 therapy?
As of July 2026, no B7-H3-directed therapy is FDA-approved — all remain investigational. The furthest-advanced is ifinatamab deruxtecan (I-DXd), a B7-H3 ADC from Daiichi Sankyo and Merck. It holds FDA Breakthrough Therapy Designation (Aug 2025) and Priority Review, with a target FDA decision date (PDUFA) of October 10, 2026, for adults with extensive-stage small cell lung cancer whose disease progressed on or after platinum-based chemotherapy. If approved, it would be the first B7-H3 medicine. Regulatory status can change — check with the FDA and trial sponsor for current information.
Do I need a B7-H3 test to qualify for a B7-H3 trial?
It depends on the trial. Unlike CLDN18.2 (which has an FDA-approved companion IHC test and a ≥75% cutoff), B7-H3 has no standardized, validated companion diagnostic as of July 2026. Because B7-H3 is expressed on a very high fraction of many tumor types, several B7-H3 ADC trials — including much of the ifinatamab deruxtecan program — enroll by tumor type and prior therapy without a separate B7-H3 IHC test. Some CAR-T trials do require documented B7-H3 expression. Read each trial's biomarker eligibility, and if testing is required your oncologist can arrange IHC on a tumor block.
What cancers are B7-H3 therapies being tested in?
A wide range, because B7-H3 is broadly expressed. The most advanced programs are in extensive-stage small cell lung cancer (Phase 3 ifinatamab deruxtecan, HS-20093 / GSK5764227) and metastatic castration-resistant prostate cancer (Phase 3 ifinatamab deruxtecan and DB-1311 / BNT324). Other B7-H3 trials cover esophageal squamous cell carcinoma, nasopharyngeal carcinoma, pediatric CNS tumors (DIPG, medulloblastoma, leptomeningeal disease), glioblastoma and high-grade glioma, ovarian, pancreatic, triple-negative breast, hepatocellular, and colorectal cancers. ADCs dominate in SCLC and prostate; CAR-T / CAR-NK dominate in brain tumors.
What's the difference between a B7-H3 ADC, CAR-T, monoclonal antibody, and radioligand?
All target the same B7-H3 protein but kill the cancer cell differently. ADC (ifinatamab deruxtecan, HS-20093, YL201, DB-1311): an anti-B7-H3 antibody carries a cytotoxic payload — for ifinatamab deruxtecan, the DXd topoisomerase-I inhibitor — directly to B7-H3+ cells. Monoclonal antibody (enoblituzumab): binds B7-H3 and recruits natural immune mechanisms; tested neoadjuvantly in prostate cancer. Radioligand (177Lu-omburtamab): an anti-B7-H3 antibody labeled with lutetium-177 delivers targeted radiation, studied in pediatric CNS disease. CAR-T / CAR-NK: immune cells engineered to recognize B7-H3, re-infused to attack B7-H3+ tumors — concentrated in glioblastoma, DIPG, and other solid tumors. ADCs are furthest along; CAR-T and radioligand approaches are earlier-phase.
How do I find a B7-H3 trial that fits my situation?
Use ClinTrialFinder's AI-powered matching to surface B7-H3 trials based on your specifics — primary cancer type (SCLC, prostate, esophageal, nasopharyngeal, glioblastoma, pediatric CNS tumor, ovarian, pancreatic, or other), prior therapy and line of therapy (many B7-H3 ADC trials are for relapsed disease after platinum chemotherapy), performance status, age (pediatric CNS programs enroll children; CAR-T requires specialty centers), and country. Use the patient-match button below to enter the disease-specific wizard. Because B7-H3 testing requirements vary, ask your oncologist whether your tumor type expresses B7-H3 and whether IHC is needed. For disease context, see /trials/small-cell-lung-cancer, /trials/prostate-cancer, /trials/esophageal-cancer, and /trials/glioblastoma.
Find Matching B7-H3 Trials
Use ClinTrialFinder's AI-powered matching to find ifinatamab deruxtecan (I-DXd), HS-20093, YL201, DB-1311, enoblituzumab, B7-H3 CAR-T, and other B7-H3 trials based on your cancer type, prior therapy history, and country.
Find Matching B7-H3 TrialsThis page is for information only and is not medical advice. ClinTrialFinder helps you find clinical trials that may match your situation, but enrollment decisions and treatment choices should always be made with your medical oncologist (and for cell therapy, the CAR-T team). Trial eligibility, recruitment status, and treatment details can change — verify directly with the trial sponsor or on ClinicalTrials.gov before acting on any information here. Regulatory status is summarized for context only and can change; no B7-H3 therapy is FDA-approved as of July 2026, and the ifinatamab deruxtecan FDA decision date (October 10, 2026) is a target date, not an approval. Consult the FDA and current prescribing information for authoritative regulatory status.