Clinical trial · Interventional
Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors
A Phase 1/2 Open-Label, Multicenter Study of RAS(ON) Inhibitors in Combination With Ivonescimab With or Without Other Anti-Cancer Agents in Patients With Solid Tumors
NCT07397338CI-TRIAL-00120314recruitingPhase 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)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RAS(ON) inhibitors in combination with ivonescimab in adults with advanced or metastatic solid tumors with a RAS mutation.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Cancer (CRC) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| CRC | Colorectal Carcinoma | ALIAS | 0.90 |
| Metastatic Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Non-small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin/Cisplatin + Pemetrexed (Cohort B2 Only) | Drug | — | UNRESOLVED |
| Carboplatin/Cisplatin + Pemetrexed (Dose Expansion Only) | Drug | — | UNRESOLVED |
| cetuximab (Cohort C2 Only) | Drug | Cetuximab | ALIAS |
| Daraxonrasib | Drug | — | UNRESOLVED |
| Daraxonrasib (Cohort B1 only) | Drug | — | UNRESOLVED |
| Elironrasib | Drug | — | UNRESOLVED |
| Ivonescimab | Drug | — | UNRESOLVED |
| Zoldonrasib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A: Daraxonrasib + Ivonescimab Combination
- description
- Dose Exploration and Dose Expansion (+ Carboplatin/Cisplatin + Pemetrexed)
- interventionNames
- Drug: Daraxonrasib
- Drug: Ivonescimab
- Drug: Carboplatin/Cisplatin + Pemetrexed (Dose Expansion Only)
- type
- EXPERIMENTAL
- label
- Arm B: Elironrasib + Ivonescimab Combination
- description
- Dose Exploration and Dose Expansion. Dose Expansion will include two separate cohorts: Cohort B1 (+ daraxonrasib) and Cohort B2 (+ Carboplatin/Cisplatin + Pemetrexed).
- interventionNames
- Drug: Elironrasib
- Drug: Ivonescimab
- Drug: Carboplatin/Cisplatin + Pemetrexed (Cohort B2 Only)
- Drug: Daraxonrasib (Cohort B1 only)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * At least 18 years old and has provided informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Histologically confirmed, locally advanced or metastatic solid tumor malignancy with documented RAS mutation in KRAS, HRAS, or NRAS. * Received and progressed or been intolerant to prior standard therapy (Part 1 Dose Exploration). * Non-squamous NSCLC without a treatable driver mutation in other oncogenes that has not received prior systemic treatment (Arms A \& B for Part 2 Dose Expansion). * Solid tumor or CRC previously treated with no more than 2 prior lines of therapy for advanced disease and progressed or been intolerant to prior standard therapies (Arm C for Part 2 Dose Expansion). * Measurable disease per RECIST v1.1 * Adequate organ function (bone marrow, liver, kidney, coagulation, endocrine). * Able to take oral medications. Exclusion Criteria: * Head and neck squamous cell carcinoma. * Any conditions that may affect the ability to take or absorb study drug. * Major surgery within 4 weeks prior to receiving study drug(s). * Patient is unable or unwilling to comply with protocol-required study visits or procedures. * Other inclusion/exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.