Clinical trial · Interventional
A Study to Investigate the Safety and Efficacy of KQB368 as Monotherapy in Participants With Advanced Solid Malignancies
A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB368 in Participants With Advanced Solid Malignancies With KRAS G12S or G12C Mutations
- 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 goal of this study is to learn if KQB368 works to treat advanced solid malignancies in adults. The study will also learn about the safety of KQB368. The main questions the study aims to answer are: * What is the safe dose of KQB368 as a monotherapy? * Does KQB368 decrease the size of the tumor? * What happens to KQB368 in the body? Participants will: * Take KQB368 orally daily in 21-day cycles * Return to the study site about 7 times in the first 5 weeks, and then once at the beginning of every 21-day cycle after that
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 |
| KRAS G12C Mutations | — | UNRESOLVED | — |
| KRAS G12S Mutations | — | UNRESOLVED | — |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Uterine Cancer | Malignant Uterine Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KQB368 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Monotherapy Dose Escalation
- interventionNames
- Drug: KQB368
Primary outcomes (1)
- measure
- Primary Objective
- timeFrame
- Up to 44 months
- description
- Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities. Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, SAEs, and DLTs, from first dose of study treatment to 30 days after last dose of study treatment.
Secondary outcomes (9)
- measure
- Objective response rate (ORR)
- timeFrame
- Up to 44 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* Histologically confirmed diagnosis of a solid tumor * Malignancy with either a KRAS G12C or KRAS G12S mutation * Unresectable or metastatic disease * No available treatment with curative intent * Adequate organ function * Measurable disease per RECIST v1.1 * Must be able to swallow with no GI condition that prevents absorption
References
Publications (0)
Data not yet available