NCT07207707 A Study to Investigate the Safety and Efficacy of KQB548 in Participants With Advanced Solid Malignancies
| NCT ID | NCT07207707 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Kumquat Biosciences Inc. |
| Condition | Solid Tumor Malignancies |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2025-09-16 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 78 participants in total. It began in 2025-09-16 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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?
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07207707 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor Malignancies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07207707 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07207707 currently recruiting?
Yes, NCT07207707 is actively recruiting participants. Contact the research team at kumquatstudies@kumquatbio.com for enrollment information.
Where is the NCT07207707 trial being conducted?
This trial is being conducted at La Jolla, United States, Los Angeles, United States, Denver, United States, Miami, United States and 9 additional locations.
Who is sponsoring the NCT07207707 clinical trial?
NCT07207707 is sponsored by Kumquat Biosciences Inc.. The trial plans to enroll 78 participants.