Advance Solid TumorsPhase 1/2NCT07610798
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
A Phase 1/2 study testing INV-8989 in people with Advance Solid Tumors and Colon and Rectal Cancer, run by Shenzhen Ionova Life Sciences Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advance Solid Tumors, Colon and Rectal Cancer, Non - Small Cell Lung Cancer NSCLC
- What is being tested?
- INV-8989
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to May 2029
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- ECOG performance status 0-1.
- Adequate marrow, liver and kidney function.
- Meet the study's specified contraceptive requirements.
- Meet protocol-specified washout period requirements.
Who cannot join
- 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.
- Has undergone major surgery within 28 days prior to the first dose of study drug.
- Patients with symptomatic brain or leptomeningeal metastases.
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- Patients with other severe and persistent underlying medical conditions as assessed by the Investigator.
- Have protocol-defined clinically significant cardiovascular diseases.
- Prolonged QTcF interval.
- 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.
- Have experienced a severe concurrent infection within 28 days prior to the first dose of study drug.
- Patients with congenital or acquired immunodeficiency.
- Female patients in pregnancy or lactation period.
- Patients with concomitant diseases or conditions deemed by the Investigator likely to interfere with protocol compliance.
- Patients unwilling or unable to comply with protocol-specified procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Ruihua Xu, +86 181 2791 2755, Xurh@sysucc.org.cn
Ruihua Xu, MD, PhD
About this study
Official title: 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.
Read the detailed 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.
The entire study consists of two parts: Phase 1 for dose escalation and Phase 2 for dose expansion and indication exploration.
Phase 1 dose escalation of INV-8989 follows a real time monitored, PK/PD and safety guided scheme with an accelerated titration plus traditional 3+3 design for DLT assessment.
Phase 2 aims to reassure the safety profile and better define efficacy. Phase 2 consists of Phase 2a and Phase 2b.
Phase 2a study aims to further confirm the safety profile of INV-8989 through a larger number of patients, clarify its PK characteristics and preliminary efficacy, and optimize the recommended Phase 2 dose (RP2D).
The Phase 2b study aims to explore the anti-tumor efficacy of INV-8989 in the patients with different types of advanced solid tumors harboring the KRAS G12D mutation, and those who have failed previous standard treatments.
- Conditions
- Advance Solid Tumors, Colon and Rectal Cancer, Non - Small Cell Lung Cancer NSCLC, Pancreatic Adenocarcinoma Advanced or Metastatic, Ovarian Cancer, Endometrial Cancer
- Being tested
- INV-8989
- Medical subject headings
- Rectal Neoplasms, Neoplasm Metastasis, Ovarian Neoplasms, Endometrial Neoplasms, Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INV-8989Drug
INV-8989 is admistered once weekly
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 INV-8989 Dose escalation Dose level 1 | Experimental | Not described Receives: Drug: INV-8989 |
| Phase 1 INV-8989 Dose escalation Dose level 2 | Experimental | Not described Receives: Drug: INV-8989 |
| Phase 1 INV-8989 Dose escalation Dose level 3 | Experimental | Not described Receives: Drug: INV-8989 |
| Phase 1 INV-8989 Dose escalation Dose level 4 | Experimental | Not described Receives: Drug: INV-8989 |
| Phase 1 INV-8989 Dose escalation Dose level 5 | Experimental | Not described Receives: Drug: INV-8989 |
| Phase 1 INV-8989 Dose escalation Dose level 6 | Experimental | Not described Receives: Drug: INV-8989 |
| Phase 1 INV-8989 Dose escalation Dose level 7 | Experimental | Not described Receives: Drug: INV-8989 |
| Phase 1 INV-8989 Dose escalation Dose level 8 | Experimental | Not described Receives: Drug: INV-8989 |
| Phase 2a INV-8989 Dose level 1 | Experimental | Not described Receives: Drug: INV-8989 |
| Phase 2a INV-8989 Dose level 2 | Experimental | Not described Receives: Drug: INV-8989 |
| Phase 2b INV-8989 cohort A | Experimental | Not described Receives: Drug: INV-8989 |
| Phase 2b INV-8989 cohort B | Experimental | Not described Receives: Drug: INV-8989 |
| Phase 2b INV-8989 cohort C | Experimental | Not described Receives: Drug: INV-8989 |
| Phase 2b INV-8989 cohort D | Experimental | Not described Receives: Drug: INV-8989 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Number of participants with treatment-emergent adverse events (TEAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
The number and percentage of participants with at least one TEAE will be summarized by severity grade and relationship to study drug.
Measured: 12 months
Phase 1: Maximum tolerated dose (MTD)
The highest dose level at which at least 6 patients have been treated and less than 33% of patients experienced a DLT.
Measured: Within first 21 days of treatment
Phase 1: Recommended dose range (RDR) and/or Recommended Phase Ⅱ dose (RP2D)
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.
Measured: 12 months
Phase 2: Evaluate overall response rate (ORR)
To evaluate ORR per RECIST v1.1
Measured: 12 months
Secondary outcomes (7)
Phase 1: Determine the pharmacokinetics (PK) using AUC of INV-8989
To determine the (PK) using AUC of INV-8989 after a single dose and at steady state after multiple doses
Measured: 12 months
Phase 1: Determine the PK using Cmax of INV-8989
Determine the PK using Cmax of INV-8989 after a single dose and at steady state after multiple doses
Measured: 12 months
Phase 1: Evaluate overall response rate (ORR)
To evaluate ORR per RECIST v1.1
Measured: 12 months
Phase 1: Evaluate progression free survival (PFS)
To evaluate PFS per RECIST v1.1
Measured: 12 months
Phase 2: Evaluate progression free survival (PFS)
To evaluate PFS per RECIST v1.1
Measured: 12 months
Phase 2: Determine the PK using AUC of INV-8989
Determine the PK using AUC of INV-8989 after a single dose and at steady state after multiple doses
Measured: 12 months
Phase 2: Determine the PK using Cmax of INV-8989
To determine the PK using Cmax of INV-8989 after a single dose and at steady state after multiple doses
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start1 Jun 2026
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advance Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Ionova Life Sciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610798
- Sponsor's protocol ID
- INV-8989-101
- Other IDs
- INV-8989-101
- Status last verified
- Jun 2026
- First submitted
- 14 May 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No