A Phase I/Ib, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB198 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies

Study Identifier:
KQB198-101
CT.gov Identifier:
NCT06507306
EudraCT Identifier:
2.02451E+11
EU Trial (CTIS) Number:
2024-511453-22-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

The goal of this clinical trial is to learn if KQB198 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB198. The main questions it aims to answer are:

What is the safe dose of KQB198 by itself or in combination with other anti-cancer drugs?

Does KQB198 alone or in combination with other anti-cancer drugs decrease the size of the tumor?

What happens to KQB198 in the body?

Medical Condition
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.
Solid Tumor
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 I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: Participant Group/Arm:
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
Inclusion criteria
  • Inclusion Criteria:
  • PART 1 - Histologically confirmed diagnosis of a solid tumor malignancy with any of the following oncogenic mutations: EGFR, RAS, PTPN11, or SOS1 mutations, or inactivating mutations of NF1.PART 1 - (Osimertinib and Amivantamab arms) and Part 2 Cohort A and Cohort B: Histologically confirmed diagnosis of NSCLC with activating EGFR mutation and progression on osimertinibPart 3 - Cohort A: Histologically confirmed diagnosis of NSCLC with exon 20 insertion EGFR mutationUnresectable or metastatic diseaseNo available treatment with curative intentAdequate organ functionMeasurable disease per RECIST 1.1.
Exclusion criteria
  • Prior therapy with a similar mechanism of action to KQB198
  • History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow
  • History of interstitial lung disease
  • Cardiac abnormalities

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Carolinas
Myrtle Beach, SC, United States, 29572
Investigator
Status
Recruitment Complete
Condition(s) Treated at Site
Solid Tumor