Health TrialsbyHealthPanel

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

ConditionSolid Tumor, Adult
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorKumquat Biosciences Inc.

About this trial

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?

Participants will:

* Take KQB198 daily, alone or in combination with another anti-cancer drug * Visit the clinic about 8 times in the first 8 weeks, and then once every 4 weeks after that

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • KQB198

    Drug

    Oral KQB198

  • Osimertinib

    Drug

    Oral Osimertinib

  • Amivantamab

    Drug

    Subcutaneous administration

Treatment groups

100 Participants
are divided into 5 treatment groups
Group A: Monotherapy Dose EscalationExperimental treatment 1 intervention
Group B: Combo Therapy Dose EscalationExperimental treatment 3 interventions
Group C: Combo Therapy Dose Expansion - RP2DExperimental treatment 3 interventions
Group D: Combo Therapy Dose Expansion - RP2D-1Experimental treatment 3 interventions
Group E: Combo Therapy Dose Expansion OBDExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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

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.

Time frame
28 Days
2

Recommended Phase 2 Dose (RP2D) (Part 1)

Evaluate safety and assess number of patients with dose-limiting toxicity to determine the RP2D.

Time frame
up to 30 months
3

Efficacy and Optimal Biologic Dose of study treatment, as measured by Objective Response Rate (ORR) (Parts 2 and 3)

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.

Time frame
up to 30 months

Secondary outcomes

1

Concentration-time curve (AUC)

Time frame
up to 30 months
2

Maximum plasma concentration (Cmax)

Time frame
up to 30 months
3

Time to maximum plasma concentration (tmax)

Time frame
up to 30 months
4

Overall survival (OS)

Time frame
up to 30 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kumquat Biosciences Inc.

Lead sponsor

Source ClinicalTrials.gov
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