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NCT05833984
Safety and Efficacy of IMM01 Plus Tislelizumab in Patients With Advanced Solid Tumors and Lymphomas
Status unknown
Phase 1, PHASE2
Last updated 27 April 2023
What this trial tests
Phase 1, PHASE2 trial testing IMM01 in Solid Tumor in 309 participants. Status unknown.
Timeline
17 May 2022
Primary endpoint
7 February 2024
7 February 2024
20 November 2024
Quick facts
| Lead sponsor | ImmuneOnco Biopharmaceuticals (Shanghai) Inc. |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 309 |
| Start date | 17 May 2022 |
| Primary completion | 7 February 2024 |
| Estimated completion | 20 November 2024 |
| Sites | 5 locations across China |
Drugs / interventions tested
- IMM01 — full drug profile →
- Tislelizumab (TISLELIZUMAB) — full drug profile →
Conditions studied
- Solid Tumor — all drugs for Solid Tumor →
- Classic Hodgkin Lymphoma — all drugs for Classic Hodgkin Lymphoma →
Sponsor
ImmuneOnco Biopharmaceuticals (Shanghai) Inc. — full company profile →
Who can join
18 and older, any sex, with Solid Tumor or Classic Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an open-label, multicenter, phase 1b/2 trial of IMM01 (SIRPα Fc) plus tislelizumab in patients with advanced solid tumors and lymphomas.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting of TAMs: can we be more clever than cancer cells?
Kzhyshkowska J, Shen J, Larionova I. · · 2024 · cited 79× · PMID 39516356 · DOI 10.1038/s41423-024-01232-z -
Targeting the CD47/SIRPα pathway in malignancies: recent progress, difficulties and future perspectives.
Jiang C, Sun H, Jiang Z, Tian W, et al · · 2024 · cited 24× · PMID 39040441 · DOI 10.3389/fonc.2024.1378647 -
Opportunities and challenges for anti-CD47 antibodies in hematological malignancies.
Xu Y, Jiang P, Xu Z, Ye H. · · 2024 · cited 21× · PMID 38464520 · DOI 10.3389/fimmu.2024.1348852 -
Checkpoint inhibition in hematologic malignancies.
Tsumura A, Levis D, Tuscano JM. · · 2023 · cited 14× · PMID 37920162 · DOI 10.3389/fonc.2023.1288172 -
Understanding the complexity of tumor-associated macrophages: Druggable and therapeutic insights.
Li AQ, Huang F, Talaiti S, Yang X, et al · · 2025 · cited 7× · PMID 41049739 · DOI 10.1016/j.apsb.2025.07.021 -
Therapeutic strategies targeting CD47-SIRPα signaling pathway in gastrointestinal cancers treatment.
Che Z, Wang W, Zhang L, Lin Z. · · 2025 · cited 6× · PMID 39881799 · DOI 10.1016/j.jpha.2024.101099 -
Emerging therapeutics targeting tumor-associated macrophages for the treatment of solid organ cancers.
Li D, Rudloff U. · · 2025 · cited 5× · PMID 40353504 · DOI 10.1080/14728214.2025.2504376
Verify or expand the search:
- PubMed search for NCT05833984
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of IMM01
Trials testing the same drug.
- NCT06647862 — IMM01+Azacitidine VS Placebo +Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2) · Phase 3 · recruiting
- NCT05140811 — A Study of IMM01 Combined With Azacitidine in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome · Phase 1, PHASE2 · unknown
- NCT05860075 — Exploratory Study of IMM01 for Injection in the Treatment of Refractory or Recurrent Hematologic Malignancy · Phase 1 · terminated
Other recruiting trials for Solid Tumor
Currently open trials in the same condition.
- NCT07489378 — NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rar · recruiting
- NCT07487597 — Functionally Enhanced ALPP-Targeted Engineered T Cells in Advanced Solid Tumors · EARLY_PHASE1 · recruiting
- NCT07382544 — Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss · Phase 1 · recruiting
- NCT07466160 — A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07450560 — Research on Real-time Proton Therapy Guidance Through Monitoring Proton Range Using All-digital PET · active not recruiting
Other ImmuneOnco Biopharmaceuticals (Shanghai) Inc. trials
Trials by the same sponsor.
- NCT07118085 — A Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Phase I Clinical Trial to Evaluate t · Phase 1 · recruiting
- NCT06788431 — A Clinical Study of IMC-001 for Injection in Improving Atherosclerotic Plaque Stability in Patients With Acute Coronary · EARLY_PHASE1 · recruiting
- NCT06647862 — IMM01+Azacitidine VS Placebo +Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2) · Phase 3 · recruiting
- NCT06764836 — A Study of IMM2510 + IMM27M Combination Therapy in Patients With Advanced Solid Tumors · Phase 1 · recruiting
- NCT05985083 — A Study Of IMM47 In Subjects With Advanced Solid Tumors · Phase 1 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT05833984 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
- Last refreshed: 27 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05833984.
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