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Investigating KQB198 for treating advanced solid tumors

A Phase 1/1b, 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

Phase 1 Interventional Kumquat Biosciences Inc. · NCT06507306

This study is testing a new drug called KQB198 to see if it can safely help adults with advanced solid tumors when used alone or with other cancer treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment100 (estimated)
Ages18 Years and up
SexAll
SponsorKumquat Biosciences Inc. Industry-sponsored
Drugs / interventionsAmivantamab, Osimertinib
Locations35 sites (Denver, Colorado and 34 other locations)
Trial IDNCT06507306 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of KQB198, both as a standalone treatment and in combination with other anti-cancer drugs, for adults with advanced solid tumors. Participants will receive KQB198 daily and will undergo regular clinic visits to monitor their health and response to the treatment. The study will assess the safe dosage of KQB198, its effectiveness in reducing tumor size, and how the drug behaves in the body.

Who should consider this trial

Good fit: Ideal candidates include adults with advanced solid tumors harboring specific oncogenic mutations or those with non-small cell lung cancer (NSCLC) who have progressed on previous treatments.

Not a fit: Patients with prior therapy using a similar mechanism to KQB198 or those with certain gastrointestinal or cardiac conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.

How similar studies have performed: While this approach is novel, similar studies targeting specific mutations in solid tumors have shown promise in the past.

Eligibility criteria

Show full inclusion / exclusion 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 osimertinib
* Part 3 - Cohort A: Histologically confirmed diagnosis of NSCLC with exon 20 insertion EGFR mutation
* Unresectable or metastatic disease
* No available treatment with curative intent
* Adequate organ function
* Measurable 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

Where this trial is running

Denver, Colorado and 34 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Solid Tumor, Adult
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.