A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors
A Phase 1/2, Open-Label, Multi-Center, Dose Escalation and Expansion Study of KB707 in Subjects With Locally Advanced or Metastatic Solid Tumor Malignancies
1 other identifier
interventional
240
1 country
15
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 cancer
Started Oct 2023
Typical duration for phase_1 cancer
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2023
CompletedFirst Posted
Study publicly available on registry
August 1, 2023
CompletedStudy Start
First participant enrolled
October 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
May 18, 2025
May 1, 2025
3.7 years
July 24, 2023
May 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of adverse events (AEs)
Percentage of subjects with adverse events (AEs)
up to 36 months
Percentage of serious adverse events (SAEs)
Percentage of subjects with serious adverse events (SAEs)
up to 36 months
Secondary Outcomes (2)
Maximum tolerated dose (MTD)
up to 36 months
Percentage of overall response rate (ORR)
up to 36 months
Study Arms (3)
Cohorts 1 through 4
EXPERIMENTALDose escalation and expansion cohorts: KB707 monotherapy in subjects with solid tumors.
Cohort 5
EXPERIMENTALDose expansion cohort: KB707 administered in combination with Opdualag in approximately 100 subjects with advanced melanoma.
Cohort 6
EXPERIMENTALDose expansion cohort: KB707 administered in combination with Keytruda in approximately 100 subjects with advanced melanoma.
Interventions
Eligibility Criteria
You may qualify if:
- Life expectancy \>12 weeks
- ECOG performance status of 0 or 1
- Have measurable disease per RECIST v1.1 at Screening
- Cohorts 1-4 only: Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor and the individual has progressed on standard of care therapy, cannot tolerate standard of care therapy, refused standard of care therapy, or there is no standard of care therapy.
- Cohorts 5 and 6 only: Histologically confirmed stage III (unresectable) or stage IV melanoma, as per American Joint Committee on Cancer (AJCC) staging system (8th edition; AJCC 2017) and
- Subject has previously failed one prior anti-PD-1/PD-L1 treatment (as monotherapy or in combination with other checkpoint inhibitors such as anti-LAG-3 or anti-CTLA-4); and
- If proto-oncogene B-Raf (BRAF) V600 mutation-positive, subject previously failed a BRAF inhibitor or BRAF inhibitor in combination with mitogen-activated extracellular signal-regulated kinase (MEK) inhibitor
- Cohort 5 only: Age 12 years or older at the time of informed consent
- Cohort 6 only: Age 18 years or older at the time of informed consent
You may not qualify if:
- Prior surgery or radiation therapy must be fully recovered, including all radiation -related toxicities and subject does not require systemic corticosteroids
- The subject is pregnant, nursing, or plans to become pregnant during study treatment and through three months after the last dose of KB707
- Have known history of positive human immunodeficiency virus (HIV 1/2)
- Cohorts 5 and 6 only:
- Subject has a known additional malignancy that is progressing or requires active treatment.
- Subject has uveal/ocular melanoma.
- The subject has active brain metastases or leptomeningeal metastases
- Subject has received more than 2 lines of systemic therapy for unresectable or metastatic melanoma
- Prior anti-LAG-3 and/or anti-PD-1 therapy was intolerable and required discontinuation of treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
UCLA Health
Los Angeles, California, 90095, United States
Mission Dermatology Center
Rancho Santa Margarita, California, 92688, United States
BRCR Global
Weston, Florida, 33326, United States
IU Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202, United States
Henry Ford Cancer Institute
Detroit, Michigan, 48202, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Morristown Medical Center / Atlantic Health System
Morristown, New Jersey, 07960, United States
Weill Cornell Medicine-New York-Presbyterian Hospital
New York, New York, 10065, United States
Gabrail Cancer Center Research
Canton, Ohio, 44718, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Renovatio Clinical - El Paso
El Paso, Texas, 79915, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Renovatio Clinical - The Woodlands
The Woodlands, Texas, 77380, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
David Chien, MD
Senior Vice President of Clinical Development
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2023
First Posted
August 1, 2023
Study Start
October 31, 2023
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
May 18, 2025
Record last verified: 2025-05