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

June 30, 2026 updated by: InxMed (Shanghai) Co., Ltd.

A Phase 1b/II, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 Combined With IN10018 in Subjects With Locally Advanced or Metastatic Solid Tumors With KRAS G12C Mutation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Bengbu, China
        • First Affiliated Hospital of Bengbu Medical College
      • Changsha, China
        • Hunan Cancer Hospital
      • Fuzhou, China
        • Fujian Cancer Hospital
      • Ganzhou, China
        • First Affiliated Hospital of Gannan Medical University
      • Nanjing, China
        • General Hospital of Eastern Theater Command
      • Wuhan, China
        • Renmin Hospital of Wuhan University
      • Xuzhou, China
        • Xuzhou Central Hospital
      • Zhengzhou, China
        • Henan Cancer Hospital
      • Zhengzhou, China
        • The First Affiliated Hospital of Zhengzhou University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310005
        • Zhejiang Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 (only for phase1b) containing cancer cells or DNA.
  4. Tumor types in different phases and cohorts: 1) Phase 1b: subjects with locally advanced or metastatic solid tumors who have progressed on or failed in standard therapy, and no standard treatment is available. 2) Phase II Cohort A: subjects with locally advanced or metastatic CRC. 3) Phase II Cohort B: subjects with locally advanced or metastatic NSCLC. 4) Phase 2 Cohort C: subjects with other locally advanced 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 to the first dose.

Exclusion Criteria:

  1. Prior KRAS G12C inhibitors treatment.
  2. Have known symptoms of spinal cord compression, instable or symptomatic central nervous system (CNS) metastases, and/or carcinomatous meningitis.
  3. Have a history of stroke or other serious cerebrovascular diseases within 12 months prior to the first dose.
  4. Have had interstitial lung disease or any active infection requiring systemic treatment 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Phase 1b-Dose Escalation Part
To evaluate the safety and Recommended Phase 2 dose (RP2D) of D-1553 in combination with IN10018 in previously-treated solid tumors.
Drug: D1553
D1553 orally taken，600mg twice a day
Drug: IN10018（Ifebemtinib）
IN10018 orally taken once daily at approximately the same time each day
Other Names:
  • BI 853520
Experimental: Phase II Cohort A-previously-treated CRC with KRAS G12C mutation（Treatmnt Group）
To evaluate the safety and antitumor efficacy of D-1553 in combination with IN10018 in previously-treated CRCs with KRAS G12C mutation.
Drug: D1553
D1553 orally taken，600mg twice a day
Drug: IN10018（Ifebemtinib）
IN10018 orally taken once daily at approximately the same time each day
Other Names:
  • BI 853520
Active Comparator: Phase II Cohort A-previously-treated CRC with KRAS G12C mutation (Control Group)
To evaluate the safety and antitumor efficacy of D-1553 in previously-treated CRCs with KRAS G12C mutation.
Drug: D1553
D1553 orally taken，600mg twice a day
Experimental: Phase II Cohort B-treatment-naïve or previously-treated NSCLC with KRAS G12C mutation
To evaluate the safety and antitumor efficacy of D-1553 in combination with IN10018 in advanced NSCLCs with KRAS G12C mutation.
Drug: D1553
D1553 orally taken，600mg twice a day
Drug: IN10018（Ifebemtinib）
IN10018 orally taken once daily at approximately the same time each day
Other Names:
  • BI 853520
Experimental: Phase II Cohort C-other previously-treated solid tumors with KRAS G12C mutation
To evaluate the safety and antitumor efficacy of D-1553 in combination with IN10018 in other solid tumors with KRAS G12C mutation
Drug: D1553
D1553 orally taken，600mg twice a day
Drug: IN10018（Ifebemtinib）
IN10018 orally taken once daily at approximately the same time each day
Other Names:
  • BI 853520

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recommended phase II dose (RP2D) of D1553 in combination with IN10018 in solid tumors with KRAS G12C mutation
Time Frame: Through study completion, approximately 3 years
Evaluate the number of patients with dose-limited toxicities (DLTs); Determine the RP2D of D1553 in combination with IN10018 in solid tumors with KRAS G12C mutation.
Through study completion, approximately 3 years
Objective Response Rate (ORR) of D1553 in combination with IN10018 in solid tumors with KRAS G12C mutation
Time Frame: Through study completion, approximately 3 years
Defined as the proportion of subjects with complete response (CR) or partial response (PR).
Through study completion, approximately 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS) of D1553 in combination with IN10018 in solid tumors with KRAS G12C mutation
Time Frame: Through study completion, approximately 3 years
Defined as the time from the first dose of study treatment to first documentation of disease progression or to death due to any cause, whichever comes first.
Through study completion, approximately 3 years
Duration of Response (DoR) of D1553 in combination with IN10018 in solid tumors with KRAS G12C mutation
Time Frame: Through study completion, approximately 3 years
Defined as the time from start of the first documentation of CR or PR to the first documentation of disease progression or to death due to any cause, whichever comes first.
Through study completion, approximately 3 years
Disease Control Rate (DCR) of D1553 in combination with IN10018 in solid tumors with KRAS G12C mutation
Time Frame: Through study completion, approximately 3 years
Defined as the proportion of patients with CR, PR, or stable disease (SD).
Through study completion, approximately 3 years
Overall survival (OS) of D1553 in combination with IN10018 in solid tumors with KRAS G12C mutation
Time Frame: Through study completion, approximately 3 years
Defined as the time from the first dose of study treatment to the date of death due to any cause.
Through study completion, approximately 3 years
Number of subjects with adverse event
Time Frame: Through study completion, approximately 3 years
The number of subjects who experienced AEs is presented.
Through study completion, approximately 3 years
Plasma concentrations of D-1553 and IN10018 in solid tumors with KRAS G12C mutation
Time Frame: Through study completion, approximately 3 years
Plasma concentrations of D-1553 and IN10018
Through study completion, approximately 3 years
PK: Cmax of D-1553 and IN10018
Time Frame: Through study completion, approximately 3 years
Maximum concentration (Cmax)
Through study completion, approximately 3 years
PK: Cmin of D-1553 and IN10018
Time Frame: Through study completion, approximately 3 years
Minimum concentration (Cmin)
Through study completion, approximately 3 years
PK:t1/2 of D-1553 and IN10018
Time Frame: Through study completion, approximately 3 years
Elimination half-life (t1/2).
Through study completion, approximately 3 years
PK:CL/F of D-1553 and IN10018
Time Frame: Through study completion, approximately 3 years
apparent clearance (CL/F)
Through study completion, approximately 3 years
PK:Vd/F of D-1553 and IN10018
Time Frame: Through study completion, approximately 3 years
Apparent volume of distribution (Vd/F)
Through study completion, approximately 3 years
PK: AUC of D-1553 and IN10018
Time Frame: Through study completion, approximately 3 years
Area under the concentration-time curve (AUC)
Through study completion, approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
InxMed (Shanghai) Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
InventisBio Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhengbo Song, study principal investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 12, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D1553-106/IN10018-602

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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