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Solid TumorPhase 1/2NCT06166836

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

A Phase 1/2 study testing D1553 and IN10018（Ifebemtinib） in people with Solid Tumor, run by InxMed (Shanghai) Co., Ltd. at 10 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
D1553 and IN10018（Ifebemtinib）
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
10 sitesChina
Study dates
12 Oct 2022to 31 Dec 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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

  • Men or women aged ≥ 18 years at the time of signing the informed consent form.
  • Subjects with pathologically confirmed locally advanced or metastatic solid tumors.
  • Confirmed positive KRAS G12C mutation in tumor tissue or other biospecimens (only for phase1b) containing cancer cells or DNA.
  • 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.
  • Has measurable lesions at baseline according to RECIST 1.1 criteria.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate bone marrow, liver, renal, and coagulation function within 7 days prior to the first dose.

Who cannot join

  • Prior KRAS G12C inhibitors treatment.
  • Have known symptoms of spinal cord compression, instable or symptomatic central nervous system (CNS) metastases, and/or carcinomatous meningitis.
  • Have a history of stroke or other serious cerebrovascular diseases within 12 months prior to the first dose.
  • Have had interstitial lung disease or any active infection requiring systemic treatment within 14 days prior to the first dose.
  • Has a history of severe cardiovascular disease such as acute myocardial infarction, severe/unstable angina, QTc prolongation, or poorly controlled hypertension.
  • Haven't recovered from toxicity due to prior antitumor therapy
  • Pregnant or lactating women.
  • Malignant neoplasms other than study disease within 5 years prior to enrollment.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

China10 sites

  • First Affiliated Hospital of Bengbu Medical College

    Bengbu

  • Hunan Cancer Hospital

    Changsha

  • Fujian Cancer Hospital

    Fuzhou

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310005

  • General Hospital Of Eastern Theater Command

    Nanjing

  • Renmin Hospital of Wuhan University

    Wuhan

  • Xuzhou Central Hospital

    Xuzhou

  • Henan Cancer Hospital

    Zhengzhou

  • The first Affiliated Hospital of Zhengzhou University

    Zhengzhou

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions
Solid Tumor
Being tested
D1553, IN10018（Ifebemtinib）

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • D1553Drug

    D1553 orally taken，600mg twice a day

  • IN10018（Ifebemtinib）Drug

    Also called BI 853520

    IN10018 orally taken once daily at approximately the same time each day

Study groups in NCT06166836
Study groupRoleWhat they receive
Phase 1b-Dose Escalation PartExperimentalTo evaluate the safety and Recommended Phase 2 dose (RP2D) of D-1553 in combination with IN10018 in previously-treated solid tumors.
Receives: Drug: D1553; Drug: IN10018（Ifebemtinib）
Phase II Cohort A-previously-treated CRC with KRAS G12C mutation（Treatmnt Group）ExperimentalTo evaluate the safety and antitumor efficacy of D-1553 in combination with IN10018 in previously-treated CRCs with KRAS G12C mutation.
Receives: Drug: D1553; Drug: IN10018（Ifebemtinib）
Phase II Cohort A-previously-treated CRC with KRAS G12C mutation (Control Group)Active comparatorTo evaluate the safety and antitumor efficacy of D-1553 in previously-treated CRCs with KRAS G12C mutation.
Receives: Drug: D1553
Phase II Cohort B-treatment-naïve or previously-treated NSCLC with KRAS G12C mutationExperimentalTo evaluate the safety and antitumor efficacy of D-1553 in combination with IN10018 in advanced NSCLCs with KRAS G12C mutation.
Receives: Drug: D1553; Drug: IN10018（Ifebemtinib）
Phase II Cohort C-other previously-treated solid tumors with KRAS G12C mutationExperimentalTo evaluate the safety and antitumor efficacy of D-1553 in combination with IN10018 in other solid tumors with KRAS G12C mutation
Receives: Drug: D1553; Drug: IN10018（Ifebemtinib）

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended phase II dose (RP2D) of D1553 in combination with IN10018 in solid tumors with KRAS G12C mutation

    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.

    Measured: Through study completion, approximately 3 years

  2. Objective Response Rate (ORR) of D1553 in combination with IN10018 in solid tumors with KRAS G12C mutation

    Defined as the proportion of subjects with complete response (CR) or partial response (PR).

    Measured: Through study completion, approximately 3 years

Secondary outcomes (12)

  1. Progression-free Survival (PFS) of D1553 in combination with IN10018 in solid tumors with KRAS G12C mutation

    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.

    Measured: Through study completion, approximately 3 years

  2. Duration of Response (DoR) of D1553 in combination with IN10018 in solid tumors with KRAS G12C mutation

    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.

    Measured: Through study completion, approximately 3 years

  3. Disease Control Rate (DCR) of D1553 in combination with IN10018 in solid tumors with KRAS G12C mutation

    Defined as the proportion of patients with CR, PR, or stable disease (SD).

    Measured: Through study completion, approximately 3 years

  4. Overall survival (OS) of D1553 in combination with IN10018 in solid tumors with KRAS G12C mutation

    Defined as the time from the first dose of study treatment to the date of death due to any cause.

    Measured: Through study completion, approximately 3 years

  5. Number of subjects with adverse event

    The number of subjects who experienced AEs is presented.

    Measured: Through study completion, approximately 3 years

  6. Plasma concentrations of D-1553 and IN10018 in solid tumors with KRAS G12C mutation

    Plasma concentrations of D-1553 and IN10018

    Measured: Through study completion, approximately 3 years

  7. PK: Cmax of D-1553 and IN10018

    Maximum concentration (Cmax)

    Measured: Through study completion, approximately 3 years

  8. PK: Cmin of D-1553 and IN10018

    Minimum concentration (Cmin)

    Measured: Through study completion, approximately 3 years

  9. PK:t1/2 of D-1553 and IN10018

    Elimination half-life (t1/2).

    Measured: Through study completion, approximately 3 years

  10. PK:CL/F of D-1553 and IN10018

    apparent clearance (CL/F)

    Measured: Through study completion, approximately 3 years

  11. PK:Vd/F of D-1553 and IN10018

    Apparent volume of distribution (Vd/F)

    Measured: Through study completion, approximately 3 years

  12. PK: AUC of D-1553 and IN10018

    Area under the concentration-time curve (AUC)

    Measured: Through study completion, approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2023
  2. Study start12 Oct 2022
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06166836
Sponsor's protocol ID
D1553-106/IN10018-602
Status last verified
Jun 2026
First submitted
4 Dec 2023
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Song Z, Zhu L, Liu Y, Lin R, Li X, Luo Y, Yuan Y, Shi H, Zhang Y, Zhang B, Zhu Y, Wang Z, Cheng X. Ifebemtinib plus garsorasib in previously treated metastatic colorectal cancer with KRASG12C mutation: a multicentre, randomised, phase 1b/2 trial. Lancet Oncol. 2026 Sep;27(9):1133-1145. doi: 10.1016/S1470-2045(26)00175-0.

    PubMed 42636835

  • Song Z, Li X, Lin R, Shi H, Yuan Y, Liu Y, Luo Y, Lv T, Zhang Y, Zhu L, Zhu Y, Zhang L, Wang Z. Ifebemtinib plus garsorasib as first-line treatment for KRASG12C-mutated non-small-cell lung cancer in China: a multicentre, single-arm expansion cohort from a phase 1b/2 trial. Lancet Respir Med. 2026 Jul 7:S2213-2600(26)00142-6. doi: 10.1016/S2213-2600(26)00142-6. Online ahead of print.

    PubMed 42413526

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing D1553 and IN10018（Ifebemtinib） in people with Solid Tumor, run by InxMed (Shanghai) Co., Ltd. at 10 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06166836, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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