NCT07610798

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P75+ for phase_1

Timeline
36mo left

Started Jun 2026

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Jun 2026May 2029

First Submitted

Initial submission to the registry

May 14, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 28, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

2.9 years

First QC Date

May 14, 2026

Last Update Submit

June 7, 2026

Conditions

Advance Solid TumorsColon and Rectal CancerNon - Small Cell Lung Cancer NSCLCPancreatic Adenocarcinoma Advanced or MetastaticOvarian CancerEndometrial CancerBiliary Cancers

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    Within first 21 days of treatment

  • Phase 1: Recommended dose range (RDR) and/or Recommended Phase â…¡ 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.

    12 months

  • Phase 2: Evaluate overall response rate (ORR)

    To evaluate ORR per RECIST v1.1

    12 months

Secondary Outcomes (7)

  • Phase 1: Determine the pharmacokinetics (PK) using AUC of INV-8989

    12 months

  • Phase 1: Determine the PK using Cmax of INV-8989

    12 months

  • Phase 1: Evaluate overall response rate (ORR)

    12 months

  • Phase 1: Evaluate progression free survival (PFS)

    12 months

  • Phase 2: Evaluate progression free survival (PFS)

    12 months

  • +2 more secondary outcomes

Study Arms (14)

Phase 1 INV-8989 Dose escalation Dose level 1

EXPERIMENTAL
Drug: INV-8989

Phase 1 INV-8989 Dose escalation Dose level 2

EXPERIMENTAL
Drug: INV-8989

Phase 1 INV-8989 Dose escalation Dose level 3

EXPERIMENTAL
Drug: INV-8989

Phase 1 INV-8989 Dose escalation Dose level 4

EXPERIMENTAL
Drug: INV-8989

Phase 1 INV-8989 Dose escalation Dose level 5

EXPERIMENTAL
Drug: INV-8989

Phase 1 INV-8989 Dose escalation Dose level 6

EXPERIMENTAL
Drug: INV-8989

Phase 1 INV-8989 Dose escalation Dose level 7

EXPERIMENTAL
Drug: INV-8989

Phase 1 INV-8989 Dose escalation Dose level 8

EXPERIMENTAL
Drug: INV-8989

Phase 2a INV-8989 Dose level 1

EXPERIMENTAL
Drug: INV-8989

Phase 2a INV-8989 Dose level 2

EXPERIMENTAL
Drug: INV-8989

Phase 2b INV-8989 cohort A

EXPERIMENTAL
Drug: INV-8989

Phase 2b INV-8989 cohort B

EXPERIMENTAL
Drug: INV-8989

Phase 2b INV-8989 cohort C

EXPERIMENTAL
Drug: INV-8989

Phase 2b INV-8989 cohort D

EXPERIMENTAL
Drug: INV-8989

Interventions

INV-8989DRUG

INV-8989 is admistered once weekly

Phase 1 INV-8989 Dose escalation Dose level 1Phase 1 INV-8989 Dose escalation Dose level 2Phase 1 INV-8989 Dose escalation Dose level 3Phase 1 INV-8989 Dose escalation Dose level 4Phase 1 INV-8989 Dose escalation Dose level 5Phase 1 INV-8989 Dose escalation Dose level 6Phase 1 INV-8989 Dose escalation Dose level 7Phase 1 INV-8989 Dose escalation Dose level 8Phase 2a INV-8989 Dose level 1Phase 2a INV-8989 Dose level 2Phase 2b INV-8989 cohort APhase 2b INV-8989 cohort BPhase 2b INV-8989 cohort CPhase 2b INV-8989 cohort D

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Rectal NeoplasmsNeoplasm MetastasisOvarian NeoplasmsEndometrial NeoplasmsBiliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersUterine NeoplasmsUterine DiseasesBiliary Tract Diseases

Central Study Contacts

Yi Zhu, MD, MBA

CONTACT

1 908 240 7514yi.zhu@ionovabio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2026

First Posted

May 28, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2029

Last Updated

June 10, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)