- |||||||||| Yidafan (ivonescimab) / Akesobio, Summit Therapeutics, ligufalimab (AK117) / Akesobio
Enrollment change, Trial completion date, Trial primary completion date: AK117-203: A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov) - Mar 12, 2025 P2, N=120, Recruiting, N=80 --> 120 | Trial completion date: Oct 2023 --> Dec 2026 | Trial primary completion date: Jan 2023 --> Jul 2025
- |||||||||| Yidafan (ivonescimab) / Akesobio, Summit Therapeutics, ligufalimab (AK117) / Akesobio
Enrollment change, Trial completion date, Trial primary completion date: AK112-206: A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer (clinicaltrials.gov) - Feb 27, 2025 P2, N=254, Recruiting, N=80 --> 120 | Trial completion date: Oct 2023 --> Dec 2026 | Trial primary completion date: Jan 2023 --> Jul 2025 N=104 --> 254 | Trial completion date: Dec 2026 --> Aug 2028 | Trial primary completion date: Dec 2024 --> May 2026
- |||||||||| ligufalimab (AK117) / Akesobio
Trial in Progress: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 2 Study of AK117/Placebo in Combination with Azacitidine in Patients with Newly Diagnosed Higher-Risk Myelodysplastic Syndromes (AK117-205) () - Dec 7, 2024 - Abstract #ASH2024ASH_8743; P2 Stratification factors will be based on IPSS-R scores : ?4.5, >4.5-6, and >6.The primary endpoint is complete remission rate (CRR) assessed by investigators based on 2023 International Working Group (IWG 2023) response criteria (Zeidan A et al, Blood, 2023), and to determine the optimal dose of AK117 for future confirmatory trials (can expand this Phase 2 trial to a Phase 3 trial). Key secondary endpoints include overall response rate (ORR), duration of response (DoR), event-free survival (EFS), overall survival (OS), rate and duration of transfusion independence (TI), time to transformation to acute myeloid leukemia (AML), safety assessed by incidence and severity of adverse events (AEs), pharmacokinetics (PK) and immunogenicity.
- |||||||||| Yidafan (ivonescimab) / Akesobio, Summit Therapeutics, ligufalimab (AK117) / Akesobio
Enrollment open, Metastases: AK117-302: A Phase 3 Study of AK112 Plus AK117 Versus Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (clinicaltrials.gov) - Nov 14, 2024 P3, N=510, Recruiting, Key secondary endpoints include overall response rate (ORR), duration of response (DoR), event-free survival (EFS), overall survival (OS), rate and duration of transfusion independence (TI), time to transformation to acute myeloid leukemia (AML), safety assessed by incidence and severity of adverse events (AEs), pharmacokinetics (PK) and immunogenicity. Not yet recruiting --> Recruiting
- |||||||||| ligufalimab (AK117) / Akesobio
AK132, a first-in-class asymmetric Claudin18.2/CD47 bispecific antibody for cancer immunotherapy (Exhibit Halls AB - George R. Brown Convention Center) - Oct 4, 2024 - Abstract #SITC2024SITC_505; Mice were treated with Isotype control antibody, AK117 (a bivalent CD47 antibody with IgG4 backbone; 20 mg/kg), anti-CLDN8.2 (a bivalent CLDN18.2 antibody with IgG1 backbone; 20 mg/kg) and AK132 (1.9 mg/kg; 5.7 mg/kg; 17 mg/kg) via i.p. injection...Conclusions AK132, an asymmetric CLDN18.2/CD47 bispecific antibody, has ADCC, ADCP and CDC effects on tumor cells but not on RBCs. It shows great anti-tumor efficacy with better safety, supporting its clinical development for the treatment of human cancers.
- |||||||||| ligufalimab (AK117) / Akesobio
Journal, IO biomarker: A novel anti-CD47 antibody with therapeutic potential for NK/T-cell lymphoma. (Pubmed Central) - Sep 30, 2024 In addition, in vivo experiments showed that the anti-CD47 mAb AK117 significantly inhibited the growth of subcutaneous xenograft tumors in SCID mice compared to the control antibody IgG. Our results indicate that targeting CD47 monoclonal antibodies is a potential therapeutic strategy for NKTCL.
- |||||||||| Yidafan (ivonescimab) / Akesobio, Summit Therapeutics, ligufalimab (AK117) / Akesobio
Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Metastases: AK117-202: A Study of AK112 in Advanced Malignant Tumors (clinicaltrials.gov) - Feb 21, 2024 P1/2, N=250, Recruiting, Not yet recruiting --> Recruiting N=160 --> 250 | Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2023 --> Aug 2024
- |||||||||| Yidafan (ivonescimab) / Akesobio, Summit Therapeutics, ligufalimab (AK117) / Akesobio
Trial completion date, Trial primary completion date: AK112-206: A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer (clinicaltrials.gov) - Feb 15, 2024 P2, N=104, Recruiting, N=160 --> 250 | Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2023 --> Aug 2024 Trial completion date: Jan 2025 --> Dec 2026 | Trial primary completion date: Oct 2022 --> Dec 2024
- |||||||||| ligufalimab (AK117) / Akesobio
Trial completion, Trial completion date, Metastases: A Phase 1 Dose Escalation and Expansion Study of AK117 (clinicaltrials.gov) - Nov 18, 2023 P1, N=49, Completed, Trial completion date: Jan 2025 --> Dec 2026 | Trial primary completion date: Oct 2022 --> Dec 2024 Active, not recruiting --> Completed | Trial completion date: Jan 2024 --> May 2023
- |||||||||| Kaitanni (cadonilimab) / Akesobio, ligufalimab (AK117) / Akesobio
Trial completion, Enrollment change, Trial completion date, Combination therapy, Monotherapy, Metastases: AK117-101: A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK117 as Monotherapy or in Combination With AK104 (clinicaltrials.gov) - Jan 9, 2023 P1, N=50, Completed, Clinical trial information: NCT05235542. Not yet recruiting --> Completed | N=159 --> 50 | Trial completion date: Sep 2023 --> Nov 2022
- |||||||||| ligufalimab (AK117) / Akesobio
Journal, Monotherapy, PD(L)-1 Biomarker, IO biomarker: Ligufalimab, a novel anti-CD47 antibody with no hemagglutination demonstrates both monotherapy and combo antitumor activity. (Pubmed Central) - Dec 1, 2022 AK117 eliminated hemagglutination and also enabled to maintain full effectiveness of CD47 blockade on tumor cells, which resulted in excellent antitumor efficacy and favorable safety profile of AK117. A series of clinical trials of AK117 as a therapeutic agent in combination with various agents such as AK112 are in progress for the treatment of multiple hematologic malignancies and solid tumors.
- |||||||||| ligufalimab (AK117) / Akesobio
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Metastases: A Phase 1 Dose Escalation and Expansion Study of AK117 (clinicaltrials.gov) - Oct 12, 2022 P1, N=49, Active, not recruiting, A series of clinical trials of AK117 as a therapeutic agent in combination with various agents such as AK112 are in progress for the treatment of multiple hematologic malignancies and solid tumors. Recruiting --> Active, not recruiting | N=162 --> 49 | Trial completion date: Jan 2023 --> Jan 2024 | Trial primary completion date: Jan 2022 --> Jan 2023
- |||||||||| Yidafan (ivonescimab) / Akesobio, Summit Therap, ligufalimab (AK117) / Akesobio
Enrollment open, Trial initiation date, Combination therapy, Metastases: A Phase Ib/II Study of AK112 in Combination With AK117 in Advanced Malignant Tumors (clinicaltrials.gov) - May 11, 2022 P1/2, N=114, Recruiting, Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | Initiation date: Feb 2022 --> May 2022
- |||||||||| Kaitanni (cadonilimab) / Akesobio, ligufalimab (AK117) / Akesobio
New P1 trial, Combination therapy, Monotherapy, Metastases: AK117-101: A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK117 as Monotherapy or in Combination With AK104 (clinicaltrials.gov) - Apr 15, 2020 P1, N=159, Not yet recruiting,
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