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

Description

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

Conditions

Solid Tumor, Adult

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Solid Tumor, Adult
Intervention / Treatment

-

Contacts and Locations

Denver

Sarah Cannon Research Institute at HealthONE, Denver, Colorado, United States, 80218

Orlando

Sarah Cannon Research Institute at Florida Cancer Specialists, Orlando, Florida, United States, 32827

Sarasota

Florida Cancer Specialists, Sarasota, Florida, United States, 34232

Long Island City

Memorial Sloan Kettering Cancer Center, Long Island City, New York, United States, 11101

Cincinnati

The Lindner Center for Research and Education at The Christ Hospital, Cincinnati, Ohio, United States, 45219

Nashville

SCRI Oncology Partners, Nashville, Tennessee, United States, 37203

San Antonio

NEXT Oncology, San Antonio, Texas, United States, 78229

Fairfax

NEXT Oncology, Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 arm) and Part 2 Cohort A: 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kumquat Biosciences Inc.,

Study Record Dates

2027-01-31