a Study to Evaluate the Safety and Efficacy of D-1553 Combined With IN10018 in KRAS G12C Mutant Solid Tumors

Last updated: April 28, 2025
Sponsor: InxMed (Shanghai) Co., Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasms

Neuroblastoma

Treatment

D1553

IN10018(Ifebemtinib)

Clinical Study ID

NCT06166836
D1553-106/IN10018-602
  • Ages > 18
  • All Genders

Study Summary

This is a phase 1b/II, open-label study to evaluate the safety, tolerability, pharmacokinetics and antitumor activities of D-1553 in combination with IN10018 in subjects with locally advanced or metastatic solid tumor with KRAS G12C mutation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Men or women aged ≥ 18 years at the time of signing the informed consent form.

  2. Subjects with pathologically confirmed locally advanced or metastatic solid tumors.

  3. Confirmed positive KRAS G12C mutation in tumor tissue or other biospecimens (onlyfor phase1b) containing cancer cells or DNA.

  4. Tumor types in different phases and cohorts: 1) Phase 1b: subjects with locallyadvanced or metastatic solid tumors who have progressed on or failed in standardtherapy, and no standard treatment is available. 2) Phase II Cohort A: subjects withlocally advanced or metastatic CRC. 3) Phase II Cohort B: subjects with locallyadvanced or metastatic NSCLC. 4) Phase 2 Cohort C: subjects with other locallyadvanced or metastatic solid tumors.

  5. Has measurable lesions at baseline according to RECIST 1.1 criteria.

  6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

  7. Adequate bone marrow, liver, renal, and coagulation function within 7 days prior tothe first dose.

Exclusion

Exclusion Criteria:

  1. Prior KRAS G12C inhibitors treatment.

  2. Have known symptoms of spinal cord compression, instable or symptomatic centralnervous system (CNS) metastases, and/or carcinomatous meningitis.

  3. Have a history of stroke or other serious cerebrovascular diseases within 12 monthsprior to the first dose.

  4. Have had interstitial lung disease or any active infection requiring systemictreatment within 14 days prior to the first dose.

  5. Has a history of severe cardiovascular disease such as acute myocardial infarction,severe/unstable angina, QTc prolongation, or poorly controlled hypertension.

  6. Haven't recovered from toxicity due to prior antitumor therapy

  7. Pregnant or lactating women.

  8. Malignant neoplasms other than study disease within 5 years prior to enrollment.

Study Design

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: D1553
Phase: 1/2
Study Start date:
October 12, 2022
Estimated Completion Date:
December 31, 2026

Study Description

This study includes 2 phases: Phase Ib-Dose Escalation and Phase II-Dose Expansion. Phase Ib-Dose Escalation part will enroll at least 6 subjects to identify the safety and RP2D of D1553 in combination with IN10018 in KRAS G12C mutant solid tumors. Phase II-Dose Expansion part contains 3 cohorts with cohort A to enroll advanced colorectal cancer (CRC) with KRAS G12C mutation, cohort B to enroll advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation, and cohort C to enroll other advanced solid tumors with KRAS G12C mutation. Phase II study is to evaluate the safety and antitumor activities of D-1553 in combination with IN10018 in KRAS G12C mutant solid tumors. The sample size in each cohort is estimated per Simon's 2-stage design. In Cohort A, when Simon's 2-stage study achieved statistical hypothesis, an open-label, randomized study will be conducted for factorial analysis to evaluate the contribution of IN10018 in the combination regimen.

Connect with a study center

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 310005
    China

    Active - Recruiting

  • First Affiliated Hospital of Bengbu Medical College

    Bengbu,
    China

    Active - Recruiting

  • Hunan Cancer Hospital

    Changsha,
    China

    Active - Recruiting

  • Fujian Cancer Hospital

    Fuzhou,
    China

    Active - Recruiting

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou,
    China

    Active - Recruiting

  • General Hospital Of Eastern Theater Command

    Nanjing,
    China

    Active - Recruiting

  • Renmin Hospital of Wuhan University

    Wuhan,
    China

    Active - Recruiting

  • Xuzhou Central Hospital

    Xuzhou,
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou,
    China

    Active - Recruiting

  • The first Affiliated Hospital of Zhengzhou University

    Zhengzhou,
    China

    Active - Recruiting

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