IN10018 in Combination With RNK08954 for the Treatment of KRASG12D Mutation-Positive Locally Advanced or Metastatic Solid Tumors

NCT07441174 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2026-02-27

No results posted yet for this study

Summary

This is a multicenter, open-label, Phase Ib/II clinical study. The study includes Phase Ib-Dose Exploration Stage and Phase II - Efficacy Exploration and Determination Stage.

Conditions

  • Solid Tumor Cancer
  • PDAC

Interventions

DRUG

IN10018 in combination with RNK08954

Based on existing clinical data, the RP2D of IN10018 as monotherapy and in combination with chemotherapy, targeted therapy, and immunotherapy is 100 mg QD. For RNK08954 as monotherapy, the Maximum Tolerated Dose (MTD) was not reached during the dose escalation of the Phase I study, and effective doses with observed tumor responses were 800 mg QD, 1000 mg QD, and 1200 mg QD.

Sponsors & Collaborators

  • Ranok Therapuetics Co. Ltd.

    collaborator INDUSTRY
  • InxMed (Shenzhen) Co.,Ltd.

    collaborator UNKNOWN
  • InxMed (Shanghai) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Zhengbo Song, M.D · Zhejiang Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2031-02-28
Completion
2031-02-28
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07441174 on ClinicalTrials.gov