NCT04912466

IBI322 Monotherapy or Combination Therapy in Subjects With Advanced Malignant Tumors.

Completed Phase 1 Last updated 6 September 2023

What this trial tests

Phase 1 trial testing Biological: IBI322 in Advanced Solid Tumor in 61 participants. Completed in 25 August 2023.

Timeline

21 July 2021

Primary endpoint
3 December 2022

25 August 2023

Quick facts

Lead sponsor	Innovent Biologics (Suzhou) Co. Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	61
Start date	21 July 2021
Primary completion	3 December 2022
Estimated completion	25 August 2023
Sites	1 location across China

Drugs / interventions tested

• Biological: IBI322 — full drug profile →

Conditions studied

• Advanced Solid Tumor — all drugs for Advanced Solid Tumor →

Sponsor

Innovent Biologics (Suzhou) Co. Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with Advanced Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The Phase Ia study was designed to evaluate the tolerability, safety, PK, PD, immunogenicity and primary resistance of single therapy tumor activity in subjects with advanced or metastatic solid tumors who have failed standard treatment. Phase Ib study was designed to evaluate the safety and initial efficacy of IBI322 in monotherapy or combination therapy in subjects with advanced or metastatic solid tumors. Investigators and sponsors determine the recommended dose of IBI322 for phase Ib based on PK, PD, safety and efficacy data obtained during phase Ia.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immunosuppressive cells in cancer: mechanisms and potential therapeutic targets.
   Tie Y, Tang F, Wei YQ, Wei XW. · · 2022 · cited 386× · PMID 35585567 · DOI 10.1186/s13045-022-01282-8
2. Targeting CD47 for cancer immunotherapy.
   Jiang Z, Sun H, Yu J, Tian W, et al · · 2021 · cited 254× · PMID 34717705 · DOI 10.1186/s13045-021-01197-w
3. Emerging phagocytosis checkpoints in cancer immunotherapy.
   Liu Y, Liu Y, Wang Y, Yang Y, et al · · 2023 · cited 186× · PMID 36882399 · DOI 10.1038/s41392-023-01365-z
4. Dual roles and therapeutic targeting of tumor-associated macrophages in tumor microenvironments.
   Xu J, Ding L, Mei J, Hu Y, et al · · 2025 · cited 89× · PMID 40850976 · DOI 10.1038/s41392-025-02325-5
5. CD47/SIRPα axis: bridging innate and adaptive immunity.
   van Duijn A, Van der Burg SH, Scheeren FA. · · 2022 · cited 89× · PMID 35831032 · DOI 10.1136/jitc-2022-004589
6. CD47-SIRPα blocking-based immunotherapy: Current and prospective therapeutic strategies.
   Bouwstra R, van Meerten T, Bremer E. · · 2022 · cited 82× · PMID 35908284 · DOI 10.1002/ctm2.943
7. Targeting macrophages: a novel treatment strategy in solid tumors.
   Liu M, Liu L, Song Y, Li W, et al · · 2022 · cited 52× · PMID 36510315 · DOI 10.1186/s12967-022-03813-w
8. Deciphering the role of CD47 in cancer immunotherapy.
   Liu Y, Liu Y, Weng L, Wang Y, et al · · 2024 · cited 41× · PMID 39167629 · DOI 10.1016/j.jare.2023.10.009