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Monoclonal Antibodies

KQB198 + Osimertinib for Advanced Cancer

Phase 1
Recruiting
Research Sponsored by Kumquat Biosciences Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No available treatment with curative intent
Histologically confirmed diagnosis of a solid tumor malignancy with specific oncogenic mutations (EGFR, RAS, PTPN11, or SOS1 mutations, or inactivating mutations of NF1)
Must not have
Prior therapy with a similar mechanism of action to KQB198
Cardiac abnormalities
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 months
Awards & highlights

Summary

"This trial aims to see if KQB198 is effective in treating advanced solid tumor cancer in adults and to understand its safety. It will determine the safe dosage of KQB198 alone or in combination with

Who is the study for?
Adults with advanced solid tumors are eligible for this trial. Participants must be able to take daily medication and commit to clinic visits approximately every four weeks after an initial eight-week period of more frequent visits.
What is being tested?
The study is testing the safety and effectiveness of a new cancer drug, KQB198, taken alone or alongside other anti-cancer drugs. It aims to determine the safe dosage, its impact on tumor size, and how it behaves in the body.
What are the potential side effects?
While specific side effects are not listed here, common ones associated with anti-cancer medications include nausea, fatigue, risk of infection, liver function changes, and reactions at the drug administration site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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There are no treatments that can cure my condition.
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My cancer has specific genetic changes (like EGFR or RAS mutations).
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My NSCLC has an EGFR mutation and has worsened despite osimertinib treatment.
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My cancer cannot be removed by surgery or has spread.
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My lung cancer has a specific genetic change (EGFR exon 20 insertion).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have previously been treated with a drug similar to KQB198.
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I have a heart condition.
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I have a history of serious gut issues that could affect medication absorption.
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I have a history of interstitial lung disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy and Optimal Biologic Dose of study treatment, as measured by Objective Response Rate (ORR) (Parts 2 and 3)
Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1)
Recommended Phase 2 Dose (RP2D) (Part 1)

Trial Design

5Treatment groups
Experimental Treatment
Group I: Monotherapy Dose EscalationExperimental Treatment1 Intervention
Group II: Combo Therapy Dose Expansion OBDExperimental Treatment2 Interventions
Group III: Combo Therapy Dose Expansion - RP2D-1Experimental Treatment2 Interventions
Group IV: Combo Therapy Dose Expansion - RP2DExperimental Treatment2 Interventions
Group V: Combo Therapy Dose EscalationExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
osimertinib
2023
Completed Phase 2
~160

Find a Location

Who is running the clinical trial?

Kumquat Biosciences Inc.Lead Sponsor
~67 spots leftby Jul 2026
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