Clinical trial · Interventional
a Study to Evaluate the Safety and Efficacy of D-1553 Combined With IN10018 in KRAS G12C Mutant Solid Tumors
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
NCT06166836CI-TRIAL-00116721active not recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| D1553 | Drug | — | UNRESOLVED |
| IN10018(Ifebemtinib) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Phase 1b-Dose Escalation Part
- description
- To evaluate the safety and Recommended Phase 2 dose (RP2D) of D-1553 in combination with IN10018 in previously-treated solid tumors.
- interventionNames
- Drug: D1553
- Drug: IN10018(Ifebemtinib)
- type
- EXPERIMENTAL
- label
- Phase II Cohort A-previously-treated CRC with KRAS G12C mutation(Treatmnt Group)
- description
- To evaluate the safety and antitumor efficacy of D-1553 in combination with IN10018 in previously-treated CRCs with KRAS G12C mutation.
- interventionNames
- Drug: D1553
- Drug: IN10018(Ifebemtinib)
- type
- ACTIVE_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDSong 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. PMID 42636835
- DERIVEDSong 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. PMID 42413526