Trial intelligence / Profile preview

INV-8989 in Advanced Solid Tumors Harboring KRAS G12D Mutations

NCT07610798Phase 2

Key facts

Status: Recruiting
Start: Jun 2026
Primary completion: May 2029
Countries: 1
Sponsor: Ionova Life Science

Drugs: INV-8989
Conditions: solid tumorcolorectal cancer (CRC)non-small cell lung cancer (NSCLC)pancreatic adenocarcinoma (PDAC)ovarian cancer

Overview

Phase 2, open-label trial of INV-8989 in solid tumor, colorectal cancer (CRC), non-small cell lung cancer (NSCLC) and 4 more (14 arms), sponsored by Ionova Life Science. Primary endpoints: Treatment-Emergent Adverse Events at 12 months, Maximum Tolerated Dose at 21 days and 2 more. Started Jun 2026; status: recruiting.

Design

14 arms

Study design: Non-randomizedOpen-label

Phase 1 INV-8989 Dose escalation Dose level 1
INV-8989 administered once weekly
Phase 1 INV-8989 Dose escalation Dose level 2
INV-8989 administered once weekly
Phase 1 INV-8989 Dose escalation Dose level 3
INV-8989 administered once weekly
Phase 1 INV-8989 Dose escalation Dose level 4
INV-8989 administered once weekly
Phase 1 INV-8989 Dose escalation Dose level 5
INV-8989 administered once weekly
Phase 1 INV-8989 Dose escalation Dose level 6
INV-8989 administered once weekly

8 more in the full profile.

Who it enrols

Adult patients with advanced solid tumors harboring KRAS G12D mutations, ECOG 0-1, life expectancy >3 months, who have not received prior KRAS G12D or pan-RAS targeted therapies.

Endpoints

Primary

Treatment-Emergent Adverse Events12 months
Maximum Tolerated Dose21 days
Recommended Phase 2 Dose12 months
Overall Response Rate12 months

Secondary

Area Under the Curve12 months
Maximum Plasma Concentration12 months
Progression-Free Survival12 months

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