A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of INV-8989 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutations

Sponsor
Shenzhen Ionova Life Sciences Co., Ltd.
Study ID
NCT07610798
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advance Solid Tumors
  • Biliary Cancers
  • Colon and Rectal Cancer
  • Endometrial Cancer
  • Non - Small Cell Lung Cancer NSCLC
  • Ovarian Cancer
  • Pancreatic Adenocarcinoma Advanced or Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • INV-8989 — DRUG
    INV-8989 is admistered once weekly

Study Details

This is a Phase 1 and Phase 2 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of INV-8989 in patients with advanced solid tumors harboring KRAS G12D mutations.

Key Dates

Start date
Jun 1, 2026
Status verified
Jun 2026
Primary completion
May 31, 2029
Completion
May 31, 2029

Study Design

Enrollment
178 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 INV-8989 Dose escalation Dose level 1
  • Experimental: Phase 1 INV-8989 Dose escalation Dose level 2
  • Experimental: Phase 1 INV-8989 Dose escalation Dose level 3
  • Experimental: Phase 1 INV-8989 Dose escalation Dose level 4
  • Experimental: Phase 1 INV-8989 Dose escalation Dose level 5
  • Experimental: Phase 1 INV-8989 Dose escalation Dose level 6
  • Experimental: Phase 1 INV-8989 Dose escalation Dose level 7
  • Experimental: Phase 1 INV-8989 Dose escalation Dose level 8
  • Experimental: Phase 2a INV-8989 Dose level 1
  • Experimental: Phase 2a INV-8989 Dose level 2
  • Experimental: Phase 2b INV-8989 cohort A
  • Experimental: Phase 2b INV-8989 cohort B
  • Experimental: Phase 2b INV-8989 cohort C
  • Experimental: Phase 2b INV-8989 cohort D

Primary Outcome Measure

Phase 1: Number of participants with treatment-emergent adverse events (TEAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 [ Time Frame: 12 months ]

Central Contacts

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