NCT07610798 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
| NCT ID | NCT07610798 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shenzhen Ionova Life Sciences Co., Ltd. |
| Condition | Advance Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 178 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2029-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 178 participants in total. It began in 2026-06-01 with a primary completion date of 2029-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07610798 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advance Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07610798 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07610798 currently recruiting?
Yes, NCT07610798 is actively recruiting participants. Contact the research team at yi.zhu@ionovabio.com for enrollment information.
Where is the NCT07610798 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07610798 clinical trial?
NCT07610798 is sponsored by Shenzhen Ionova Life Sciences Co., Ltd.. The trial plans to enroll 178 participants.