A Study to Investigate the Safety and Efficacy of KQB548 in Participants With Advanced Solid Malignancies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-16

Study Completion Date

2027-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this trial is to learn if KQB548 works to treat patients with advanced solid malignancies with a KRAS G12D mutation. It will also learn about the safety of KQB548. The main questions it aims to answer are:

* What is the safe dose of KQB548?
* Does KQB548 decrease the size of the tumor?
* What happens to KQB548 in the body?

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Investigate the Safety and Efficacy of KQB168 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

NCT06994806

Solid Tumor Malignancies

RECRUITING PHASE1

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

NCT06645886

Hematologic Malignancies Adult

RECRUITING PHASE1

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

NCT06507306

Solid Tumor, Adult

RECRUITING PHASE1

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

NCT06720987

KRAS G12C Mutation KRAS G12S Mutation Solid Tumor Malignancies +1 more

RECRUITING PHASE1

QTX3046 in Patients With KRAS G12D Mutations

NCT06428500

Advanced Solid Tumor

ACTIVE_NOT_RECRUITING PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Solid Tumor Malignancies

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Monotherapy Dose Escalation

Group Type EXPERIMENTAL

KQB548

Intervention Type DRUG

Oral KQB548

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

KQB548

Oral KQB548

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Pathologically confirmed, locally advanced or metastatic PDAC, CRC, or NSCLC with a KRAS G12D mutation
* Progressed on, or intolerant to at least one prior line of systemic standard of care therapy
* Measurable disease according to RECIST v1.1
* Adequate organ function

Exclusion Criteria

* Previous treatment with a KRAS G12D inhibitor or pan-RAS inhibitor
* History of intestinal disease, uncontrolled inflammatory bowel disease (e.g., Crohn's disease, Ulcerative Colitis), major esophageal or gastric surgery, or other gastrointestinal conditions (e.g., uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study intervention or result in inability to swallow oral medications
* Poorly controlled ascites and/or pleural effusion
* Requires treatment with a strong and/or moderate CYP3A inhibitor or inducer
* Requires treatment with a proton-pump inhibitor

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No