NCT06720987 A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
| NCT ID | NCT06720987 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Kumquat Biosciences Inc. |
| Condition | KRAS G12C Mutation |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-02-04 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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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 140 participants in total. It began in 2025-02-04 with a primary completion date of 2029-06-30.
⚠ 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 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, in combination with cetuximab, or in combination with KQB198? * Does KQB365 alone, in combination with cetuximab, or in combination with KQB198 decrease the size of the tumor? * What happens to KQB365 in the body? Participants will: * Receive KQB365 infusion weekly alone, in combination with cetuximab, or in combination with oral KQB198. * Visit the clinic about 9 times in the first 6 weeks, and then once every week after that.
Eligibility Criteria
Inclusion Criteria: * PART 1 (monotherapy and combo therapy with KQB198): Histologically confirmed diagnosis of a solid tumor malignancy with either a KRAS G12C or KRAS G12S mutation. * PART 1 (combo therapy with Cetuximab) \& 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 Exclusion Criteria: * Active primary central nervous system tumors * Cardiac abnormalities * Active interstitial lung disease * Unable to swallow or GI condition that prevents absorption for patients in KQB198 combination cohorts
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06720987 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying KRAS G12C Mutation. 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 NCT06720987 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 NCT06720987 currently recruiting?
Yes, NCT06720987 is actively recruiting participants. Contact the research team at kumquatstudies@kumquatbio.com for enrollment information.
Where is the NCT06720987 trial being conducted?
This trial is being conducted at Phoenix, United States, Denver, United States, Jacksonville, United States, Boston, United States and 7 additional locations.
Who is sponsoring the NCT06720987 clinical trial?
NCT06720987 is sponsored by Kumquat Biosciences Inc.. The trial plans to enroll 140 participants.