A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors
Recruiting now · Phase 1/Phase 2
Conditions studied: Cancer, Melanoma Stage III, Melanoma Stage IV, Cutaneous Melanoma
In brief
KB707-01 is a Phase 1/2, open-label, multicenter, dose escalation and expansion study. The study will evaluate the safety and tolerability of KB707 in adults with locally advanced or metastatic solid tumors who have progressed on standard of care therapy, cannot tolerate standard of care therapy, refused standard of care therapy, or for whom there is no standard of care therapy as well as the safety, tolerability, preliminary efficacy, and immunologic effect of KB707 administered in combination with Opdualag to subjects with unresectable or metastatic melanoma. Subjects in dose escalation (Cohorts 1 through 3) and dose expansion (Cohort 4) will receive intratumoral injections of KB707 approximately every three weeks. Cohorts 1 through 4 are closed to new enrollment. Dose expansion Cohort 5 and Cohort 6 will evaluate subjects with advanced melanoma. Subjects in Cohort 5 will receive intratumoral injections of KB707 biweekly (q2w), delivered in combination with Opdualag (dosed every q4w per prescribing information). Subjects in Cohort 6 will receive intratumoral injections of KB707 biweekly (q2w), delivered in combination with Keytruda (dosed every q6w per prescribing information). All subjects will be treated until disease progression, death, unacceptable toxicity, symptomatic deterioration, achievement of maximal response, subject choice, Investigator decision to discontinue treatment, or the Sponsor determines to terminate the study.
Key facts
- Study ID
- NCT05970497
- Run by
- Krystal Biotech, Inc.
- People needed
- 240
- Starts
- 2023-10-31
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2025-05-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- UCLA Health — Los Angeles, California, United States (enrolling)
- Mission Dermatology Center — Rancho Santa Margarita, California, United States (enrolling)
- BRCR Global — Weston, Florida, United States (enrolling)
- IU Simon Comprehensive Cancer Center — Indianapolis, Indiana, United States (enrolling)
- Henry Ford Cancer Institute — Detroit, Michigan, United States (enrolling)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
- Morristown Medical Center / Atlantic Health System — Morristown, New Jersey, United States (enrolling)
- Weill Cornell Medicine-New York-Presbyterian Hospital — New York, New York, United States (enrolling)
- Gabrail Cancer Center Research — Canton, Ohio, United States (enrolling)
- Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (enrolling)
- Sarah Cannon Research Institute — Nashville, Tennessee, United States (enrolling)
- Renovatio Clinical - El Paso — El Paso, Texas, United States (enrolling)
- MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- Renovatio Clinical - The Woodlands — The Woodlands, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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