Table 1.
Ongoing and recruiting trials of anti-CD47 and anti-SIRPα agents (by estimated study completion date, grouped by agent)
| Agent | Company | Regimen | Population | Estimated enrollment, n | Estimated study completion | NCT identifier | Phase | Status |
|---|---|---|---|---|---|---|---|---|
| AO-176 (anti-CD47 IgG2 mAb) | Arch Oncology | AO-176 OR AO-176 + paclitaxel OR AO-176 + pembrolizumab | Advanced solid tumors | 183 | March 2023 | NCT03834948 | I/II | Recruiting |
| AO-176 OR AO-176 + either dexamethasone OR dexamethasone + bortezomib | R/R MM | 102 | March 2023 | NCT04445701 | I/II | Recruiting | ||
| HX009 (anti-CD47/PD-1 bifunctional antibody) | Waterstone Hanxbio Pty Ltd | HX009 monotherapy | R/R advanced malignant tumors | 21 | September 2021 | NCT04097769 | I | Active, not recruiting |
| HX009 monotherapy | Unresectable locally advanced/metastatic solid tumors | 210 | February 2023 | NCT04886271 | II | Recruiting | ||
| TTI-621 (SIRPaFc) | Trillium Therapeutics Inc. | TTI-621 OR TTI-621 + either rituximab OR nivolumab | R/R hematological malignancies and selected solid tumors (PTCL, CTCL) | 260 | December 2021 | NCT02663518 | I | Recruiting |
| TTI-622 (SIRPaFc) | TTI-622 OR TTI-622 + either azacitidine OR azactidine + venetoclax OR carfilzomib + dexamethasone | R/R lymphoma or MM | 150 | December 2022 | NCT03530683 | I | Recruiting | |
| IBI188 (anti-CD47 mAb) IBI188 (anti-CD47 mAb) |
Innovent Biologics (Suzhou) Co. Ltd. | IBI188 OR IBI188 + rituximab | Solid tumors and lymphomas | 49 | January 2022 | NCT03717103 | I | Active, not recruiting |
| IBI188 + azacitidine | Newly diagnosed high-risk MDS | 12 | February 2022 | NCT04485065 | I | Recruiting | ||
| IBI188 + azacitidine | AML | 126 | May 2022 | NCT04485052 | I/II | Recruiting | ||
| IBI188 monotherapy | Advanced malignant tumors and lymphomas | 42 | August 2022 | NCT03763149 | I | Active, not recruiting | ||
| IBI188 + GM-CSF + cisplatin/carboplatin + bevacizumab + sintilimab + pemetrexed | Advanced malignancies | 120 | October 2022 | NCT04861948 | I | Recruiting | ||
| BI-765063/OSE172 (anti-SIRPα Mab) | Boehringer Ingelheim | BI-765063 OR BI-765063 + BI-754091 (a PD-1 receptor antagonist) |
Japanese adults w/ advanced solid tumors | 36 | June 2022 | NCT04653142 | I | Recruiting |
| BI-765063 OR BI-765063 + BI-754091 (a PD-1 receptor antagonist) |
Advanced solid tumors (NSCLC, TNBC, pancreatic cancer, melanoma, HNSCC, RCC, UC, SCL, gastric cancer, CRC, and OC) | 116 | December 2022 | NCT03990233 | I | Recruiting | ||
| SL-172154 | Shattuck Labs, Inc. | SL-172154 monotherapy | Unresectable, locally advanced/metastatic ovarian, primary peritoneal, or fallopian tube cancer | 40 | July 2022 | NCT04406623 | I | Recruiting |
| SL-172154 monotherapy | Cutaneous SCC or HNSCC | 18 | July 2022 | NCT04502888 | I | Recruiting | ||
| ALX148 (CD47 antagonist) | ALX Oncology, Inc. | ALX148 OR ALX148 + either pembrolizumab OR trastuzumab OR rituximab OR pembrolizumab + 5-FU + cisplatin OR trastuzumab + ramucirumab + paclitaxel | Advanced/metastatic solid tumor malignancy; or R/R NHL | 174 | December 2022 | NCT03013218 | I | Active, not recruiting |
| ALX148 + azacitidine | Previously untreated or R/R higher-risk MDS | 173 | December 2023 | NCT04417517 | I/II | Recruiting | ||
| ALX148 + venetoclax and azacitidine | Newly diagnosed or R/R AML | 97 | December 2023 | NCT04755244 | I/II | Recruiting | ||
| ALX148 + pembrolizumab + cisplatin/carboplatin + 5-FU | Advanced HNSCC | 112 | October 2024 | NCT04675333 | II | Recruiting | ||
| ALX148 + pembrolizumab | Advanced HNSCC | 111 | October 2024 | NCT04675294 | II | Recruiting | ||
| IBI322 (recombinant anti-human CD47/PD-L1 bispecific antibody) | Innovent Biologics (Suzhou) Co. Ltd. | IBI322 monotherapy | Advanced malignant tumors | 45 | December 2022 | NCT04338659 | I | Not yet recruiting |
| IBI322 monotherapy | Hematologic malignancy that failed standard treatment | 230 | November 2023 | NCT04795128 | I | Recruiting | ||
| IBI322 monotherapy | Locally advanced, unresectable or metastatic tumors | 218 | December 2023 | NCT04328831 | Ia/Ib | Recruiting | ||
| IMC-002 (IgG4 CD47 mAb) | ImuneOncia Therapeutics Inc. | IMC-002 monotherapy | Metastatic or locally advanced solid tumors and R/R lymphomas | 24 | December 2022 | NCT04306224 | I | Recruiting |
| TQB2928 (blocks CD47 and SIRPa) | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | TQB2928 monotherapy | Locally advanced unresectable/metastatic solid tumors, hematological malignancies, or lymphoma | 20 | December 2022 | NCT04854681 | I | Not yet recruiting |
| TG-1801 (NI-1701) (CD47 and CD19 antibody) |
TG Therapeutics, Inc. | TG-1801 OR TG-1801 + ublituximab | B-cell lymphoma | 16 | December 2022 | NCT03804996 | I | Recruiting |
| TG-1801 OR TG-1801 + ublituximab | B-cell lymphoma or CLL | 60 | December 2023 | NCT04806035 | Ib | Recruiting | ||
| AK117 (anti-CD47 mAb) | Akeso | AK117 monotherapy | R/R advanced solid tumor, NHL (including R/R transformed lymphoma) | 162 | January 2023 | NCT04728334 | I | Recruiting |
| AK117 monotherapy | NHL | 159 | September 2023 | NCT04349969 | I | Not yet recruiting | ||
| GS-189 (FSI-189) (anti-SIRPα mAb) | Gilead Sciences/Forty Seven Inc. | FSI-189 OR FSI-189 + rituximab | R/R NHL | 75 | August 2023 | NCT04502706 | I | Recruiting |
| Magrolimab (anti-CD47 mAb) Magrolimab (anti-CD47 mAb) |
Gilead Sciences Gilead Sciences |
Magrolimab + daratumumab + pomalidomide + dexamethasone + bortezomib | R/R MM | 153 | September 2023 | NCT04892446 | II | Not yet recruiting |
| Magrolimab + azacitidine + venetoclax OR magrolimab + mitoxantrone + etoposide + cytarabine OR magrolimab + CC-486 | Myeloid malignancies | 164 | March 2024 | NCT04778410 | II | Not yet recruiting | ||
| Magrolimab OR magrolimab + azacitidine | R/R AML, MDS (monotherapy); untreated or R/R AML, MDS (with azacitidine) | 287 | February 2025 | NCT03248479 | I | Recruiting | ||
| Magrolimab + azacitidine OR venetoclax + azacididine OR 7+3 | TP53-mutant AML | 346 | November 2024 | NCT04778397 | III | Recruiting | ||
| Magrolimab + pembrolizumab + 5-FU + platinum OR magrolimab + docetaxel | HNSCC | 233 | December 2024 | NCT04854499 | II | Recruiting | ||
| Magrolimab + azacitidine | Treatment-naïve higher-risk MDS | 520 | February 2025 | NCT04313881 | III | Recruiting | ||
| Magrolimab + docetaxel | Solid tumors (mNSCLC, mSCLC) | 116 | March 2025 | NCT04827576 | II | Recruiting | ||
| Magrolimab + rituximab OR rituximab + gemcitabine + oxaliplatin | R/R B-cell NHL | 422 | August 2026 | NCT02953509 | I/II | Recruiting | ||
| Stanford University, Merck Sharp & Dohme Corp. | Magrolimab + pembrolizumab | Hodgkin’s lymphoma, or R/R Hodgkin’s lymphoma | 24 | May 2026 | NCT04788043 | II | Not yet recruiting | |
| ZL-1201 (anti-CD47 mAb) | Zai Lab (Shanghai) Co., Ltd. | ZL-1201 monotherapy | Locally advanced unresectable or metastatic solid tumors and lymphomas | 66 | January 2024 | NCT04257617 | I | Recruiting |
| PF-07257876 (CD47/PD-L1 bispecific antibody) | Pfizer | PF-07257876 monotherapy | NSCLC, HNSCC, ovarian cancer | 90 | July 2024 | NCT04881045 | I | Not yet recruiting |
| CPO107 (JMT601) (CD20-CD47 bispecific fusion protein) | Conjupro Biotherapeutics, Inc. | CPO107 monotherapy | CD20-positive NHL | 75 | December 2024 | NCT04853329 | I/II | Not yet recruiting |
| CC-95251 (anti-SIRPα mAb) | Celgene | CC-95251 OR CC-95251 + rituximab OR cetuximab | Advanced solid and hematologic cancers/neoplasms | 230 | November 2024 | NCT03783403 | I | Recruiting |
| TJC4 (TJ01133, lemzoparlimab) | AbbVie | TJ01133 + dexamethasone, carfilzomib, pomalidomide, daratumumab | R/R MM | 163 | July 2025 | NCT04895410 | I | Not yet recruiting |
5-FU, 5-fluorouracil; AML, acute myeloid leukemia; CLL, chronic lymphocytic leukemia; CRC, colorectal cancer; CTCL, cutaneous T-cell lymphoma; GM-CSF, granulocyte–macrophage colony-stimulating factor; HNSCC, head and neck squamous cell carcinoma; Ig, immunoglobulin; mAb, monoclonal antibody; MDS, myelodysplastic syndrome; MM, multiple myeloma; mNSCLC, metastatic non-small-cell lung cancer; mSCLC, metastatic small-cell lung cancer; NHL, non-Hodgkin’s lymphoma; NSCLC, non-small-cell lung cancer; OC, ovarian cancer; PD-1, programmed cell death protein 1; PD-L1, PD-1 ligand; PTCL, peripheral T-cell lymphoma; R/R, relapsed/refractory; RCC, renal cell carcinoma; SCC, squamous cell carcinoma; SCL, small-cell lung cancer; SIRPα, signal-regulating protein alpha; TNBC, triple-negative breast cancer; TTI, trillium; UC, urothelial carcinoma.
Source: ClinicalTrials.gov (updated as of 30 August 2021).