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- IBI-363 / Innovent Biologics
First-in-Class PD-1/IL-2 Bispecific Antibody IBI363 In Patients with Advanced Non-Small Cell Lung Cancer in a Phase I Study (20BC) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1024;
In pts with squamous NSCLC (n = 37, previously IO-treated: 36 pts, EGFR positive by immunohistochemistry: 1 pt), ORR and DCR were 35.1% (95%CI: 20.2-52.5) and 75.7% (95%CI: 58.8-88.2), respectively; median PFS was 5.5 months (95% CI: 4.0-NC) with 16 (43.2%) PFS events. Conclusions : IBI363 was well tolerated with encouraging efficacy observed in pts with advanced NSCLC including those previously IO-treated pts.
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New P1 trial, Combination therapy, Metastases: A Study of IBI363 in Subjects With Advanced Malignancies (clinicaltrials.gov) - Jun 21, 2024
P1, N=556, Recruiting, Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
- IBI-363 / Innovent Biologics
First-in-class PD-1/IL-2 bispecific antibody fusion protein IBI363 in patients with other solid tumors: Safety and efficacy results from a phase I study. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5607;
P1
Further clinical investigations on these tumors using IBI363 alone or in combination with other treatments are ongoing. Clinical trial information: NCT05460767.
- IBI-363 / Innovent Biologics
First-in-class PD-1/IL-2 bispecific antibody fusion protein IBI363 in patients with advanced colorectal cancer: Safety and efficacy results from a phase I study. (Hall A; Poster Bd #: 256) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2662;
P1
IBI363 showed acceptable tolerability and manageable safety profiles in pts with advanced CRC. Preliminary efficacy of IBI363 was observed, particularly in pts with PD-L1 CPS ?1.
- IBI-363 / Innovent Biologics
First-in-class PD-1/IL-2 bispecific antibody fusion protein IBI363 in patients with advanced melanoma: Safety and efficacy results from a phase I study. (Hall A; Poster Bd #: 346) - Apr 24, 2024 - Abstract #ASCO2024ASCO_870;
P1
The safety profiles were acceptable and manageable. Further clinical development of IBI363 in melanoma are ongoing both in China and overseas.
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Phase classification, Enrollment change, Metastases: A Study of IBI363 in Subjects With Advanced Melanoma (clinicaltrials.gov) - Apr 8, 2024
P2, N=120, Recruiting, Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Further clinical development of IBI363 in melanoma are ongoing both in China and overseas. Phase classification: P1/2 --> P2 | N=20 --> 120
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New P2 trial: A Study of IBI363 in Subjects With Advanced Solid Malignancies (clinicaltrials.gov) - Feb 28, 2024
P2, N=160, Not yet recruiting, Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
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Enrollment open, Phase classification, Trial primary completion date, Metastases: Safety, Tolerability and Preliminary Efficacy of IBI363 in Subjects With Advanced Solid Tumors or Lymphoma (clinicaltrials.gov) - Dec 29, 2023
P1, N=260, Recruiting, Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Phase classification: P1/2 --> P2 | N=20 --> 120 Not yet recruiting --> Recruiting | Phase classification: P1a/1b --> P1 | Trial primary completion date: Oct 2023 --> Mar 2024
- | IBI363 / Innovent Biologics
Enrollment open, Metastases: Promise: The Efficacy and Safety of IBI363 in Solid Tumors. (clinicaltrials.gov) - Dec 27, 2023
P1, N=430, Recruiting, Sponsor: Hunan Province Tumor Hospital
Not yet recruiting --> Recruiting | Phase classification: P1a/1b --> P1 | Trial primary completion date: Oct 2023 --> Mar 2024 Not yet recruiting --> Recruiting
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Enrollment open, Metastases: A Study of IBI363 in Subjects With Advanced Melanoma (clinicaltrials.gov) - Nov 18, 2023
P1/2, N=20, Recruiting, Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- || IBI-363 / Innovent Biologics
New P1/2 trial, Metastases: A Study of IBI363 in Subjects With Advanced Melanoma (clinicaltrials.gov) - Oct 13, 2023
P1/2, N=20, Not yet recruiting, Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
- | IBI363 / Innovent Biologics
New P1 trial, Metastases: Promise: The Efficacy and Safety of IBI363 in Solid Tumors. (clinicaltrials.gov) - Oct 13, 2023
P1, N=430, Not yet recruiting, Sponsor: Hunan Province Tumor Hospital
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Enrollment open, Trial initiation date, Metastases: A Phase 1, Open-label, Multicenter, Dose Escalation Study of IBI363 (PD1-IL2m) in Subjects With Advanced Solid Malignancies or Lymphomas (clinicaltrials.gov) - Sep 8, 2022
P1, N=84, Recruiting, Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | Initiation date: Apr 2022 --> Aug 2022
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New P1 trial, Metastases: Safety, Tolerability and Preliminary Efficacy of IBI363 in Subjects With Advanced Solid Tumors or Lymphoma (clinicaltrials.gov) - Jul 15, 2022
P1a/1b, N=260, Not yet recruiting, Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
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New P1 trial, Metastases: A Phase 1, Open-label, Multicenter, Dose Escalation Study of IBI363 (PD1-IL2m) in Subjects With Advanced Solid Malignancies or Lymphomas (clinicaltrials.gov) - Mar 21, 2022
P1, N=84, Not yet recruiting, Sponsor: Innovent Biologics (Suzhou) Co. Ltd.