INV-8989 in KRAS G12D-mutant advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a combined Phase 1/Phase 2 trial evaluating INV-8989 in adults with KRAS G12D-mutant advanced solid tumors. Phase 1 uses dose escalation with PK/PD monitoring to establish tolerability and recommended dose. Phase 2 explores safety and preliminary efficacy, with Phase 2a confirming safety and PK and Phase 2b assessing anti-tumor activity across tumor types. The study includes planned expansion at the RP2D to assess efficacy signals in different KRAS G12D–mutant indications.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Written informed consent obtained.
2. Adult patients aged ≥ 18 years.
3. Patients with histologically or cytologically confirmed locally advanced, unresectable, or metastatic solid tumors harboring the KRAS G12D mutations.
4. Agree to provide available archived FFPE tumor tissue specimens or voluntarily accept pre-treatment tumor biopsy.
5. Have RECIST 1.1-defined measurable lesions.
6. Has a life expectancy of \> 3 months.
7. ECOG performance status 0-1.
8. Adequate marrow, liver and kidney function.
9. Meet the study's specified contraceptive requirements.
10. Meet protocol-specified washout period requirements.

Exclusion Criteria:

1. Have protocol-defined toxicities within 28 days before the start of study treatment.
2. Have a second primary malignancy.
3. Patients with known hypersensitivity to the study drug or any of its components.
4. Prior history of receiving targeted therapy with specific KRAS G12D inhibitors/degraders or pan-RAS inhibitors/degraders for KRAS G12D mutation.
5. Has undergone major surgery within 28 days prior to the first dose of study drug.
6. Patients with symptomatic brain or leptomeningeal metastases.
7. Patients with other severe and persistent underlying medical conditions as assessed by the Investigator.
8. Have protocol-defined clinically significant cardiovascular diseases.
9. Prolonged QTcF interval.
10. Patients with dyspnea at rest secondary to complications of advanced malignancy, or requiring continuous oxygen therapy due to other medical conditions.
11. Patients with active pulmonary tuberculosis (TB).
12. Patients with a known history of interstitial lung disease (ILD).
13. Patients with a known history of allogeneic solid organ transplantation or allogeneic hematopoietic stem cell transplantation.
14. Have experienced a severe concurrent infection within 28 days prior to the first dose of study drug.
15. Patients with congenital or acquired immunodeficiency.
16. Female patients in pregnancy or lactation period.
17. Patients with concomitant diseases or conditions deemed by the Investigator likely to interfere with protocol compliance.
18. Patients unwilling or unable to comply with protocol-specified procedures.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Yi Zhu, MD, MBA
• Email: yi.zhu@ionovabio.com
• Phone: 1 908 240 7514

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.