Clinical Trials in China / NCT07610798
Recruiting
Phase 1/2
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
NCT07610798 · tracked via the Priya Life Science China tracker
Condition(s) studied
Advance Solid TumorsColon and Rectal CancerNon - Small Cell Lung Cancer NSCLCPancreatic Adenocarcinoma Advanced or MetastaticOvarian CancerEndometrial CancerBiliary Cancers
Investigational drug(s) / intervention(s)
INV-8989
INV-8989: INV-8989 is admistered once weekly
Study 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
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.
Primary outcome measure(s)
- Phase 1: Number of participants with treatment-emergent adverse events (TEAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 — 12 months
The number and percentage of participants with at least one TEAE will be summarized by severity grade and relationship to study drug. - Phase 1: Maximum tolerated dose (MTD) — Within first 21 days of treatment
The highest dose level at which at least 6 patients have been treated and less than 33% of patients experienced a DLT. - Phase 1: Recommended dose range (RDR) and/or Recommended Phase Ⅱ dose (RP2D) — 12 months
The RDR and/or RP2D will be determined based on the PK and PD data, the preliminary clinical activity of INV-8989, as well as the incidence rate and nature of the toxicities observed in subsequent cycles beyond Cycle 1. - Phase 2: Evaluate overall response rate (ORR) — 12 months
To evaluate ORR per RECIST v1.1
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07610798 on ClinicalTrials.gov ↗ ← All trials in China