A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors

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A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

- 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.

1. 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. 2. 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.

Key

Exclusion Criteria:

- 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: 1.

Subject has a known additional malignancy that is progressing or requires active treatment. 2. Subject has uveal/ocular melanoma. 3. The subject has active brain metastases or leptomeningeal metastases. 4. Subject has received more than 2 lines of systemic therapy for unresectable or metastatic melanoma. 5. Prior anti-LAG-3 and/or anti-PD-1 therapy was intolerable and required discontinuation of treatment

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05970497
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Krystal Biotech, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	David Chien, MD
Principal Investigator Affiliation	Senior Vice President of Clinical Development
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cancer, Melanoma Stage III, Melanoma Stage IV, Cutaneous Melanoma

Additional Details

KB707 is a genetically modified herpes simplex type 1 virus that is designed to stimulate an anti-tumor immune response through the production of cytokines. This is a first-in-human (FIH) clinical study to evaluate the safety and tolerability and preliminary efficacy of KB707 in adult subjects with advanced and/or refractory solid tumors, including advanced melanoma. The study will include a dose escalation portion for single agent KB707 and an expansion portion to further evaluate single agent KB707 at a dose determined by preliminary data in the dose escalation phase as well as combination therapy of KB707 with immune checkpoint inhibitor therapy.

Arms & Interventions

Arms

Experimental: Cohorts 1 through 4

Dose escalation and expansion cohorts: KB707 monotherapy in subjects with solid tumors.

Experimental: Cohort 5

Dose expansion cohort: KB707 administered in combination with Opdualag in approximately 100 subjects with advanced melanoma.

Experimental: Cohort 6

Dose expansion cohort: KB707 administered in combination with Keytruda in approximately 100 subjects with advanced melanoma.

Interventions

Biological: - KB707

Genetically modified herpes simplex type 1 virus

Drug: - Opdualag

Dual immunotherapy (PD-1 and LAG-3 immune checkpoint inhibitors)

Drug: - KEYTRUDA ®( Pembrolizumab)

Immunotherapy (PD-1 immune checkpoint inhibitor)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UCLA Health, Los Angeles, California

Status

Recruiting

Address

UCLA Health

Los Angeles, California, 90095

Site Contact

Youstina Zaki

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