A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

{ "KQB198 for Advanced Solid Tumors", "This study is testing a new drug called KQB198 for adults with advanced solid tumors. Researchers want to find out if KQB198 is safe and if it can shrink tumors, either when given alone or with other anti-cancer drugs like Osimertinib or Amivantamab. To join, you must have a solid tumor with specific genetic changes (mutations) in genes like EGFR, RAS, PTPN11, SOS1, or NF1. The study will measure side effects, find the best dose of KQB198, and see how many participants' tumors shrink. The study plans to enroll 92 participants.", "design": "This is an interventional study with an unclear phase, planning to enroll 92 participants. It will test KQB198 alone or in combination with other drugs.", "commitments": "You would take KQB198 daily, alone or with another anti-cancer drug. You would visit the clinic about 8 times in the first 8 weeks, then once every 4 weeks after that.", "compensation": "Not stated in the trial record.", "follow_up": "The study will measure outcomes for up to 30 months, including efficacy and optimal biologic dose.", }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

Active, Not Recruiting

PHASE1Ages 18+InterventionalTreatment

Kumquat Biosciences Inc.

~92 participants

Updated 2026-07-28 on ClinicalTrials.gov

What's tested:KQB198OsimertinibAmivantamab

At a glance

Recruiting sites

0 of 26 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1)

Measured over 28 Days

+2 more outcomes measured

Conditions

Solid Tumor, Adult

Where it's being run

26 sites across 17 states

Spain8

Florida2

Catalonia2

Colorado1

Michigan1

New York1

Ohio1

Tennessee1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1)28 Days
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 28 days after last dose of study treatment.
Recommended Phase 2 Dose (RP2D) (Part 1)up to 30 months
Evaluate safety and assess number of patients with dose-limiting toxicity to determine the RP2D.
Efficacy and Optimal Biologic Dose of study treatment, as measured by Objective Response Rate (ORR) (Parts 2 and 3)up to 30 months
Objective response is the proportion of subjects that experience confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 during the time period from 1st dose of study treatment until last dose.

Trialytics