cudarolimab (IBI101) / Innovent Biologics - LARVOL DELTA

First in Human Study of IBI101 in Chinese Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1a/1b | N=38 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting ➔ Completed

Combination therapy • Metastases • Monotherapy • Trial completion • Oncology • Solid Tumor

First in Human Study of IBI101 in Chinese Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1a/1b | N=38 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Trial completion date: Aug 2021 ➔ Mar 2023 | Trial primary completion date: Apr 2021 ➔ Dec 2022

Combination therapy • Monotherapy • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

First in Human Study of IBI101 in Chinese Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1a/1b; N=38; Active, not recruiting; Sponsor: Innovent Biologics (Suzhou) Co. Ltd.; Recruiting ➔ Active, not recruiting; N=80 ➔ 38; Trial primary completion date: Sep 2020 ➔ Apr 2021

Clinical • Combination therapy • Enrollment change • Enrollment closed • Monotherapy • Trial primary completion date • Oncology • Solid Tumor

First in Human Study of IBI101 in Chinese Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1a/1b; N=80; Recruiting; Sponsor: Innovent Biologics (Suzhou) Co. Ltd.; Trial completion date: Jan 2022 ➔ Aug 2021; Trial primary completion date: Jan 2022 ➔ Sep 2020

Clinical • Combination therapy • Monotherapy • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Development and characterization of a novel anti-OX40 antibody for potent immune activation. (PubMed, Cancer Immunol Immunother) - "Recently, several anti-OX40 agonistic monoclonal antibodies, pogalizumab as the most advanced, have entered early phase clinical trials. Preclinical studies of IBI101 in non-human primates demonstrate typical pharmacokinetic characteristics of an IgG antibody and no drug-related toxicity. Collectively, IBI101 has desirable preclinical attributes which support its clinical development for cancer treatment."

Journal • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Immune Modulation • Inflammation • Solid Tumor

Innovent announces financial results for full year ended December 31, 2019 and corporate progress (PRNewswire) - “IBI-376 (parsaclisib), a novel PI3Kδ inhibitor in-licensed from Incyte: Enroll first patient in a pivotal Phase 2 trial in China in third-line follicular lymphoma or marginal zone lymphoma in the first half of 2020; IBI-326, a novel fully-human anti-BCMA CAR-T therapy, co-developed with IASO BIO: Initiate a pivotal Phase 2 trial in r/r MM with first patient enrolled in 2020. Report the results of extended follow-up on IIT at ASH in 2020; IBI-318: Present preliminary clinical data in major medical conferences; IBI-101, a novel fully humanized anti-OX40 monoclonal antibody: Complete the patient enrollment of the Phase 1 trials in advanced solid tumors in the second half of 2020.”

Enrollment status • New P2 trial • P1 data • P2 data

Innovent announces first patient dosed in a phase I clinical trial of an anti-OX40 antibody (PRNewswire) - P1, N=80; NCT03758001; Sponsor: Innovent Biologics (Suzhou) Co. Ltd.; "Innovent Biologics...announced that the first patient has been dosed in a Phase I clinical trial of IBI101, a recombinant fully human anti-tumor necrosis factor receptor superfamily member 4 (anti-OX40) monoclonal antibody. In this Phase I clinical study, the tolerance, safety and primary efficacy of IBI101, either as monotherapy or in combination with Tyvyt® (sintilimab injection), an anti-programmed cell death protein 1 (PD-1) antibody, will be evaluated...Patients with advanced solid tumors who have failed standard treatments will be enrolled in the study."

Enrollment open

First in Human Study of IBI101 in Chinese Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1a/1b; N=80; Not yet recruiting; Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New P1 trial

First in Human Study of IBI101 in Chinese Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1a/1b; N=80; Recruiting; Sponsor: Innovent Biologics (Suzhou) Co. Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Monotherapy