INV-1120 / Ionova Life Sci - LARVOL DELTA

INV-1120-101: An Open-Label Study of INV-1120 As a Single Agent and in Combination with Pembrolizumab in Adult Patients with Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=78 | Active, not recruiting | Sponsor: Shenzhen Ionova Life Sciences Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Mar 2025 ➔ Mar 2026

Combination therapy • Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

INV-1120-101: An Open-Label Study of INV-1120 As a Single Agent and in Combination with Pembrolizumab in Adult Patients with Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=78 | Recruiting | Sponsor: Shenzhen Ionova Life Sciences Co., Ltd. | Trial primary completion date: Jul 2025 ➔ Mar 2025

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

INV-1120-101: An Open-Label Study of INV-1120 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=78 | Recruiting | Sponsor: Shenzhen Ionova Life Sciences Co., Ltd. | Phase classification: P1a/1b ➔ P1 | Trial completion date: Dec 2023 ➔ Dec 2025 | Trial primary completion date: Jul 2023 ➔ Jul 2025

Combination therapy • Metastases • Phase classification • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Preliminary safety, efficacy, and pharmacokinetics (PK) results of the EP4 antagonist INV-1120 from a phase I study in Chinese patients with advanced solid tumors. (ASCO 2023) - P1a/1b | "Single agent INV-1120 was generally well tolerated in the Chinese population and showed preliminary signs of antitumor activity in terms of stable disease. Data from this trial were in line with data in a Western population [NCT04443088, presented @ SITC 2022] and warrant further Global development. Due to the combined findings of this study and the above-mentioned sister study, the doses of 60, 100 and/or 150mg QD are proposed for further exploration in combination trials.Clinical trial information: ChiCTR20211872."

Clinical • Metastases • P1 data • PK/PD data • Oncology • Solid Tumor

INV-1120 Proves Tolerable in Advanced Solid Tumors, Moves to Expansion in Combination With Pembrolizumab (OncLive) - P1a/1b | N=78 | NCT04443088 | Sponsor: Shenzhen Ionova Life Sciences Co., Ltd.| "Twenty-one of 24 patients were evaluable for efficacy at the cutoff date of May 30, 2022. Nine (42.9%) of those had stable disease. Two patients (8.3%) had dose-limiting toxicities (DLTs), both low-grade adverse effects (AEs) leading to more than 7 days of treatment interruption: grade 2 duodenal ulcer at 60 mg and grade 2 duodenitis at 200 mg....'Single-agent INV-1120 was well tolerated in patients with advanced solid tumors. Five of 24 patients showed stable disease for at least 18 weeks and up to 64 weeks. With the support of preclinical data showing promising efficacy from combining an EP4 antagonist and anti–PD-1 [agent], a phase 1b [study] exploring the treatment of INV-1120 in combination with pembrolizumab is underway'"

P1 data • Trial status • Oncology • Solid Tumor

Preliminary safety, efficacy and pharmacokinetic results of the EP4 antagonist INV-1120 from a first-in-human study in subjects with advanced solid tumors (SITC 2022) - P1a/1b | "Trial Registration Clinical trial registry number: NCT04443088 . Ethics statement: This study was approved by IntegReview IRB."

Clinical • IO biomarker • P1 data • PK/PD data • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Oncology • Sarcoma • Solid Tumor

An Open-Label Study of INV-1120 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1a/1b | N=78 | Recruiting | Sponsor: Shenzhen Ionova Life Sciences Co., Ltd. | Phase classification: P1 ➔ P1a/1b | N=28 ➔ 78 | Trial completion date: Mar 2023 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ Jul 2023

Combination therapy • Enrollment change • Phase classification • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

IONOVA Announces Clinical Trial Collaboration with MSD to Evaluate INV-1120 in Combination with KEYTRUDA (pembrolizumab) in Patients with Advanced Solid Tumors (PRNewswire) - "Shenzhen IONOVA Life Science Co., Ltd. announces today it has entered into a clinical trial collaboration agreement with MSD (Merck & Co., Inc., Kenilworth, NJ., USA) to evaluate clinical benefits of INV-1120, IONOVA's EP4 antagonist, in combination with MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) for cancer treatment. Under this agreement, IONOVA will conduct a Phase 1b study in the US to evaluate the safety and efficacy of INV-1120 combined with KEYTRUDA® for the treatment of selected advanced solid tumors."

Licensing / partnership • Oncology • Solid Tumor

A Phase 1, Multi-Center, Safety, Dose Escalation, Pharmacokinetics of INV-1120 in Adult Patients Advanced Solid Tumors (clinicaltrials.gov) - P1; N=28; Recruiting; Sponsor: Shenzhen Ionova Life Sciences Co., Ltd.; Trial completion date: Mar 2022 ➔ Mar 2023; Trial primary completion date: Dec 2021 ➔ Dec 2022

Clinical • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • MRI

A Phase 1, Multi-Center, Safety, Dose Escalation, Pharmacokinetics of INV-1120 in Adult Patients Advanced Solid Tumors (clinicaltrials.gov) - P1; N=28; Recruiting; Sponsor: Shenzhen Ionova Life Sciences Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Oncology • Solid Tumor

A Phase 1, Multi-Center, Safety, Dose Escalation, Pharmacokinetics of INV-1120 in Adult Patients Advanced Solid Tumors (clinicaltrials.gov) - P1; N=28; Not yet recruiting; Sponsor: Shenzhen Ionova Life Sciences Co., Ltd.

Clinical • New P1 trial • Oncology • Solid Tumor