Table 3.
Ongoing or discontinued (terminated) clinical trials evaluating CD226 axis-related antibody-based therapies in cancer patients.
| Target | Agent | Isotype | Phase | Indication | Study | Details |
|---|---|---|---|---|---|---|
| TIGIT | Tiragolumab (Roche) | hIgG1 | 3 | NSCLC | NCT04294810 (SKYSCRAPER-01) | • PD-L1-selected • + atezolizumab |
| … | … | … | 3 | ES-SCLC |
NCT04256421 NCT04665856 (SKYSCRAPER-02/C) |
• + atezolizumab and chemo |
| … | … | … | 3 | NSCLC |
NCT04513925 (SKYSCRAPER-03) |
• + atezolizumab • + durvalumab • No progression on CRT |
| … | … | … | 3 | LA Esophageal | NCT04543617 (SKYSCRAPER-07) | • + atezolizumab |
| … | … | … | 3 | 1L LA Esophageal | NCT04540211 (SKYSCRAPER-08) | • + atezolizumab and chemo |
| … | … | … | 2 | Cervical | NCT04300647 (SKYSCRAPER-04) | • PD-L1+ patients • + atezolizumab |
| … | … | … | 2 | NSCLC | NCT03563716 (CITYSCAPE) | • Chemo-naïve • + atezolizumab |
| … | … | … | 2 | NSCLC |
NCT05034055 (SKYROCKET) |
• SBRT • + atezolizumab |
| … | … | … | 2 | HNSCC |
NCT04665843 (SKYSCRAPER-09) |
• 1L PD-L1+ • + atezolizumab |
| … | … | … | 2 | Non-squam. NSCLC | NCT04958811 | • + bevacizumab • + atezolizumab |
| … | … | … | 2 | SCLC | NCT04308785 | • + atezolizumab • No progression on CRT |
| … | … | … | 2 | Melanoma | NCT05060003 | • ctDNA+ following resection • + atezolizumab |
| … | … | … | 2 | Non-squam. NSCLC |
NCT04619797 (SKYSCRAPER-06) |
• + atezolizumab and chemo |
| … | … | … | 2 | Rectal | NCT05009069 | • + atezolizumab following neoadjuvant chemo |
| … | … | … | 2 | HER2-G/GEJ | NCT04933227 | • + atezolizumab and chemo |
| … | … | … | 2 | NSCLC | NCT04832854 | • + atezolizumab • +/- neoadjuvant chemo |
| … | … | … | 2 | Melanoma (stage III) |
NCT03554083 (NeoACTIVE) |
• + atezolizumab and chemo |
| … | … | … | 2 | HNSCC | NCT03708224 | • + neoadjuvant atezolizumab • + tocilizumab |
| … | … | … | 2 | Mixed |
NCT04632992 (MyTACTIC) |
• Platform study |
| … | … | … | 1b/2 | GEJC | NCT05251948 (Morpheus-C-Gastric) | • Platform study |
| … | … | … | 1b/2 | HCC |
NCT04524871 (Morpheus-Liver) |
• Platform study |
| … | … | … | 1b/2 | mUC | NCT03869190 (Morpheus-UC) | • Platform study • Post-platinum fail |
| … | … | … | 1b/2 | mPDAC | NCT03193190 (Morpheus-Pancreatic) | • Platform study • 1L/2L cohorts |
| … | … | … | 1b/2 | G/GEJ |
NCT03281369 (Morpheus) |
• Platform study • 1L/2L cohorts |
| … | … | … | 1b | TNBC | NCT04584112 | • + atezolizumab and chemo |
| … | … | … | 1 | MM/NHL | NCT04045028 | • R/R setting • + daratumumab and rituximab |
| … | … | … | 1 | Mixed | NCT02794571 | • Dose-escalation • + atezolizumab and chemo |
| TIGIT | Vibostolimab (Merck US) | hIgG1 | 3 | NSCLC | NCT04738487 | • PD-L1+ • + pembrolizumab and chemo |
| … | … | … | 2 | NSCLC |
NCT04165070 (Keynote-01A) |
• Treatment-naïve • + pembrolizumab and chemo |
| … | … | … | 2 | R/R heme malignancies | NCT05005442 | • pembrolizumab co-formulation |
| … | … | … | 2 | NSCLC | NCT04725188 | • Progression post-chemo/PD-1 • pembrolizumab co-formulation + chemo |
| … | … | … | 2 | Mixed | NCT05007106 | • pembrolizumab co-formulation +/chemo |
| … | … | … | 2 | NSCLC |
NCT04165070 (KEYMAKER-U01) |
• + pembrolizumab and chemo |
| … | … | … | 1/2 | Melanoma |
NCT04305041 (KEYMAKER-U02A) |
• Platform study • PD-1 refractory • + pembrolizumab |
| … | … | … | 1/2 | Castration-resistant prostate |
NCT02861573 (KEYNOTE-365) |
• pembrolizumab co-formulation |
| … | … | … | 1/2 | Melanoma |
NCT04305054 (KEYMAKER-U02B) |
• Platform study • 1L patients • + pembrolizumab |
| … | … | … | 1/2 | Melanoma |
NCT04303169 (KEYMAKER-U02C) |
• Platform study • Neoadjuvant Tx • + pembrolizumab |
| … | … | … | 1 | Mixed |
NCT02964013 (KEYNOTE-01A) |
• Dose-escalation • + pembrolizumab and chemo |
| TIGIT | Ociperlimab (Beigene) |
hIgG1 | 3 | NSCLC | NCT04746924 | • + tislelizumab |
| … | … | … | 3 | LA NSCLC | NCT04866017 | • + tislelizumab vs durvalumab • + CRT |
| … | … | … | 2 | HCC | NCT04948697 | • + tislelizumab and BAT1706 |
| … | … | … | 2 | NSCLC | NCT05014815 | • + tislelizumab and chemo |
| … | … | … | 2 | NSCLC | NCT04952597 | • + tislelizumab and CRT |
| … | … | … | 2 | Esophageal | NCT04732494 | • + tislelizumab |
| … | … | … | 2 | BTC | NCT05019677 | • 1L • + tislelizumab and chemo |
| … | … | … | 2 | Cervical | NCT04693234 | • + tislelizumab |
| … | … | … | 2 | BTC | NCT05023109 | • Unresectable • + tislelizumab and chemo |
| … | … | … | 1 | Mixed | NCT04047862 | • + tislelizumab |
| TIGIT | Domvanalimab AB154 (Arcus) |
hgG1, FcγR-null* |
3 | NSCLC | NCT04736173 | • PD-L1+ patients • 1L setting • + zimberelimab and etrumadenant |
| … | … | … | 2 | NSCLC | NCT04791839 | • Prior checkpoint blockade • + zimberelimab and AB928 |
| … | … | … | 2 | NSCLC |
NCT04262856 (ARC-7) |
• PD-L1+ patients • 1L setting • + zimberelimab and AB928 |
| … | … | … | 2 | R/R melanoma | NCT05130177 | • + zimberelimab |
| … | … | … | 1 | Mixed | NCT03628677 | • Dose-escalation • + zimberelimab |
| TIGIT | BMS-986207 (BMS) | hgG1, FcγR-null* |
2 | NSCLC (stage IV) | NCT05005273 | • + nivolumab and ipilimumab |
| … | … | … | 1/2 | Mixed | NCT04570839 | • Dose-escalation • + nivolumab and COM701 |
| … | … | … | 1/2 | Mixed | NCT02913313 | • Dose-escalation • + nivolumab • + nivolumab and ipilimumab |
| … | … | … | 1/2 | MM | NCT04150965 | • R/R setting • + chemotherapy |
| TIGIT | IBI939 (Innovent) |
hIgG1* | 1 | Advanced lung cancer | NCT04672356 | • Dose-escalation • + sintilimab |
| … | … | … | 1 | NSCLC | NCT04672369 | • Dose-escalation • + sintilimab |
| … | … | … | 1 | Mixed | NCT04353830 | • Dose-escalation • + sintilimab |
| TIGIT | Etigilimab (Oncomed) |
hIgG1 | 2 | Ovarian/ fallopian |
NCT05026606 | • + nivolumab |
| … | … | … | 1/2 | Mixed | NCT04761198 | • + nivolumab |
| … | … | … | Term. | Mixed |
NCT03119428 (terminated) |
• Dose-escalation • + nivolumab |
| TIGIT | ASP8374& (Astellas) | hIgG4 | 1b | Mixed | NCT03260322 | • Dose-escalation • + pembrolizumab |
| … | … | … | 1 | Mixed | NCT03945253 | • Japanese patients |
| … | … | … | 1 | Glioma | NCT04826393 | • + cemiplimab |
| TIGIT | EOS884448 (GSK/iTeos) |
hIgG1 | 1/2 | Mixed |
NCT04335253 (IO-002) |
• Dose-escalation |
| … | … | … | 1/2 | Mixed |
NCT05060432 (TIG-006) |
• + pembrolizumab • + inupadenant |
| TIGIT | SGN-TGT (Seattle Genetics) |
hIgG1 FcγR-enhanced | 1 | Mixed | NCT04254107 | • Dose-escalation • Solid tumors and lymphomas + sasanlimab |
| TIGIT | COM902 (Compugen) |
hIgG4* | 1 | Mixed | NCT04354246 | • Dose-escalation |
| TIGIT | M6223 (Merck KGaA) |
hIgG1* | 1 | Mixed | NCT04457778 | • Dose-escalation • + bintrafusp alfa |
| TIGIT | AB308 (Arcus) |
hIgG1 | 1 | Mixed | NCT04772989 | • Dose-escalation • + zimberelimab |
| TIGIT | BAT6021 (Bio-Thera) |
hIgG1 FcγR-enhanced* | 1 | Mixed | NCT05073484 | • Dose-escalation • + BAT1308 |
| TIGIT | JS006 (Junshi Bio) |
hIgG4 | 1 | Mixed | NCT05061628 | • Dose-escalation • + toripalimab |
| TIGIT | AK127 (Akesobio) |
? | 1 | Mixed | NCT05021120 | • Dose-escalation • + AK104 |
| TIGIT x PD-1 | AZD2936 (AstraZeneca) |
? | 1/2 | NSCLC |
NCT04995523 (ARTEMIDE-01) |
• Bi-specific based on COM902 |
| TIGIT x ? |
AGEN1777 (Agenus/BMS) |
? | 1 | Mixed | NCT05025085 | • Bi-specific • Dose-escalation • + PD-1 |
| PVRIG | COM701 (Compugen) | hIgG4 | 1/2 | Mixed | NCT04570839 | • + nivolumab and BMS-986207 |
| … | … | … | 1 | Mixed | NCT03667716 | • Dose-escalation • + nivolumab |
| … | … | … | 1 | Mixed | NCT04354246 | • Dose-escalation • + COM902 |
| PVRIG | GSK4381562 (Compugen) | hIgG1 | 1 | Mixed | NCT05277051 | • + Dose-escalation • + dostarlimab |
| CD226 | LY-3435151 (Eli Lilly) |
Unknown | Term. | Mixed |
NCT04099277 (terminated) |
• Dose-escalation • + pembrolizumab |
| CD96 | GSK6097608 (GSK/23andMe) | hIgG1 | 1 | Mixed | NCT04446351 | • Dose-escalation • + dostarlimab |
*to be confirmed; &discontinued; LA, locally advanced; ES-SCLC, extensive-stage small cell lung cancer; mUC, metastatic urothelial carcinoma; mPDAC, metastatic pancreatic ductal adenocarcinoma; G/GEJ, gastric or gastroesophageal junction adenocarcinoma; GEJC, gastroesophageal junction carcinoma, TNBC, triple-negative breast cancer; R/R, relapsed/refractory; MM/NHL, multiple myeloma/non-Hodgkin lymphoma; BTC, biliary tract carcinoma; FTIH, first time in human study; CRT, chemoradiotherapy. The “?” symbol in Table 3 symbolizes “undetermined”.