NCT06994806 A Study to Investigate the Safety and Efficacy of KQB168 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
| NCT ID | NCT06994806 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Kumquat Biosciences Inc. |
| Condition | Solid Tumor Malignancies |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2025-06-24 |
| Primary Completion | 2027-11-30 |
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 84 participants in total. It began in 2025-06-24 with a primary completion date of 2027-11-30.
⚠ 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 KQB168 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB168. The main questions it aims to answer are: * What is the safe dose of KQB168 by itself or in combination with pembrolizumab? * Does KQB168 alone or in combination with pembrolizumab decrease the size of the tumor? * What happens to KQB168 in the body? Participants will: * Take KQB168 daily, alone or in combination with pembrolizumab * Visit the clinic about 8 times in the first 8 weeks, and then once every 3 weeks after that
Eligibility Criteria
Inclusion Criteria: * Histologically confirmed diagnosis of solid tumor malignancy. * Unresectable or metastatic disease that has progressed on immunotherapy. * 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 * History of lung diseases * Any condition that may impair drug absorption or prevent oral dosing * Known history of immune-mediated colitis and uncontrolled autoimmune diseases
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06994806 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 NCT06994806 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 NCT06994806 currently recruiting?
Yes, NCT06994806 is actively recruiting participants. Contact the research team at kumquatstudies@kumquatbio.com for enrollment information.
Where is the NCT06994806 trial being conducted?
This trial is being conducted at Phoenix, United States, Los Angeles, United States, Denver, United States, New Haven, United States and 11 additional locations.
Who is sponsoring the NCT06994806 clinical trial?
NCT06994806 is sponsored by Kumquat Biosciences Inc.. The trial plans to enroll 84 participants.