INV-8989 for Advanced Solid Tumors With a KRAS G12D Mutation
Tests INV-8989 in adults with advanced cancers carrying a KRAS G12D mutation.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced solid tumors that carry a KRAS G12D mutation and cannot be removed by surgery or have spread.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Locally advanced, unresectable, or metastatic solid tumors, confirmed by tissue or cell tests. Must have lesions that can be measured by RECIST 1.1.
- Earlier treatment
- Must not have had earlier treatment with specific KRAS G12D inhibitors or degraders, or pan-RAS inhibitors or degraders, for the KRAS G12D mutation. Must meet the protocol's washout period requirements.
- Biomarker or test result
- Tumor with a KRAS G12D mutation.
Main reasons for not taking part
- Second primary cancer
- Symptomatic brain or leptomeningeal metastases
- Known interstitial lung disease or active pulmonary tuberculosis
- Previous allogeneic solid organ or hematopoietic stem cell transplant
- Pregnancy or breastfeeding
Read by machine on 13 November 2026.
Where in China
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaContact: Ruihua XuTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Shenzhen Ionova Life Sciences Co., Ltd.
- Trial code
- NCT07610798
- Record updated
- 10 June 2026
- Original description
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.Read full original descriptionShow less
A Phase I/II, Open-Label, Multi-Center, Dose Escalation and Cohort Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of INV-8989 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutations
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.
Inclusion: 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; Have RECIST 1.1-defined measurable lesions; Has a life expectancy of > 3 months; ECOG performance status 0-1; Adequate marrow, liver and kidney function; Meet the study's specified contraceptive requirements; Meet protocol-specified washout period requirements.
Exclusion: Have protocol-defined toxicities within 28 days before the start of study treatment; Prior history of receiving targeted therapy with specific KRAS G12D inhibitors/degraders or pan-RAS inhibitors/degraders for KRAS G12D mutation; Has undergone major surgery within 28 days prior to the first dose of study drug; Have experienced a severe concurrent infection within 28 days prior to the first dose of study drug; Patients with concomitant diseases or conditions deemed by the Investigator likely to interfere with protocol compliance; Have a second primary malignancy; Patients with known hypersensitivity to the study drug or any of its components; Patients with other severe and persistent underlying medical conditions as assessed by the Investigator; Have protocol-defined clinically significant cardiovascular diseases; Patients with dyspnea at rest secondary to complications of advanced malignancy, or requiring continuous oxygen therapy due to other medical conditions; Patients with active pulmonary tuberculosis (TB); Patients with a known history of interstitial lung disease (ILD); Patients with a known history of allogeneic solid organ transplantation or allogeneic hematopoietic stem cell transplantation; Patients with symptomatic brain or leptomeningeal metastases; Prolonged QTcF interval; Patients with congenital or acquired immunodeficiency; Female patients in pregnancy or lactation period; Patients unwilling or unable to comply with protocol-specified procedures.