A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

Description

The goal of this clinical trial is to learn if KQB365 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB365. The main questions it aims to answer are: * What is the safe dose of KQB365 by itself or in combination with cetuximab? * Does KQB365 alone or in combination with cetuximab decrease the size of the tumor? * What happens to KQB365 in the body? Participants will: * Receive KQB365 infusion weekly alone or in combination with cetuximab * Visit the clinic about 9 times in the first 6 weeks, and then once every week after that.

Conditions

KRAS G12C Mutation, KRAS G12S Mutation, Solid Tumor Malignancies, CRC (Colorectal Cancer)

Study Overview

Study Details

Study overview

The goal of this clinical trial is to learn if KQB365 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB365. The main questions it aims to answer are: * What is the safe dose of KQB365 by itself or in combination with cetuximab? * Does KQB365 alone or in combination with cetuximab decrease the size of the tumor? * What happens to KQB365 in the body? Participants will: * Receive KQB365 infusion weekly alone or in combination with cetuximab * Visit the clinic about 9 times in the first 6 weeks, and then once every week after that.

A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Optimization Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB365 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies With KRAS G12S or G12C Mutations

A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

Condition
KRAS G12C Mutation
Intervention / Treatment

-

Contacts and Locations

Grand Rapids

START Midwest, Grand Rapids, Michigan, United States, 49546

San Antonio

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

Fairfax

NEXT Virginia, LLC, 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 (monotherapy): Histologically confirmed diagnosis of a solid tumor malignancy with either a KRAS G12C or KRAS G12S mutation.
  • * PART 1 (combo therapy) \& PART 2: Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum with either a KRAS G12C or KRAS G12S mutation.
  • * Unresectable or metastatic disease
  • * No available treatment with curative intent
  • * Adequate organ function
  • * Measurable disease per RECIST v1.1
  • * Active primary central nervous system tumors
  • * Cardiac abnormalities
  • * Active interstitial lung disease

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

2030-06-30