Health Trials

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

ConditionsAdvance Solid TumorsColon and Rectal CancerNon - Small Cell Lung Cancer NSCLCPancreatic Adenocarcinoma Advanced or MetastaticOvarian CancerEndometrial CancerBiliary Cancers
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShenzhen Ionova Life Sciences Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

Written informed consent obtained.

Adult patients aged ≥ 18 years.

Patients with histologically or cytologically confirmed locally advanced, unresectable, or metastatic solid tumors harboring the KRAS G12D mutations.

Agree to provide available archived FFPE tumor tissue specimens or voluntarily accept pre-treatment tumor biopsy.

Disqualifiers

Have protocol-defined toxicities within 28 days before the start of study treatment.

Have a second primary malignancy.

Patients with known hypersensitivity to the study drug or any of its components.

Prior history of receiving targeted therapy with specific KRAS G12D inhibitors/degraders or pan-RAS inhibitors/degraders for KRAS G12D mutation.

Trial design

Treatments tested in this trial

  • INV-8989

Treatment groups

178 Participants
are divided into 14 treatment groups

14

Treatment groups

See each treatment group below.

Sponsors and collaborators

Shenzhen Ionova Life Sciences Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov