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

Last updated: January 30, 2025
Sponsor: Krystal Biotech, Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Skin Cancer

Lung Cancer

Osteosarcoma

Treatment

Opdualag

KEYTRUDA ®( Pembrolizumab)

KB707

Clinical Study ID

NCT05970497
KB707-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Histologically confirmed diagnosis of a locally advanced or metastatic solid tumorand the individual has progressed on standard of care therapy, cannot toleratestandard of care therapy, refused standard of care therapy, or there is no standardof care therapy.

  • Age 12 years or older at the time of informed consent

  • Life expectancy >12 weeks

  • ECOG performance status of 0 or 1

  • Have measurable disease per RECIST v1.1 at Screening

  • Cohorts 5 and 6 only: Histologically confirmed stage III (unresectable) or stage IVmelanoma, as per American Joint Committee on Cancer (AJCC) staging system (8thedition; AJCC 2017) and

  1. Subject has previously failed one prior anti-PD-1/PD-L1 treatment (asmonotherapy or in combination with other checkpoint inhibitors such asanti-LAG-3 or anti-CTLA-4); and

  2. If proto-oncogene B-Raf (BRAF) V600 mutation-positive, subject previouslyfailed a BRAF inhibitor or BRAF inhibitor in combination with mitogen-activatedextracellular 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

Exclusion

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 treatmentand 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 requiresactive 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 ormetastatic melanoma

  5. Prior anti-LAG-3 and/or anti-PD-1 therapy was intolerable and requireddiscontinuation of treatment

Study Design

Total Participants: 240
Treatment Group(s): 3
Primary Treatment: Opdualag
Phase: 1/2
Study Start date:
October 31, 2023
Estimated Completion Date:
July 31, 2027

Study Description

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.

Connect with a study center

  • UCLA Health

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • Stanford Cancer Center

    Palo Alto, California 94305
    United States

    Active - Recruiting

  • Mission Dermatology Center

    Rancho Santa Margarita, California 92688
    United States

    Active - Recruiting

  • IU Simon Comprehensive Cancer Center

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Henry Ford Cancer Institute

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Morristown Medical Center / Atlantic Health System

    Morristown, New Jersey 07960
    United States

    Active - Recruiting

  • Weill Cornell Medicine-New York-Presbyterian Hospital

    New York, New York 10065
    United States

    Active - Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Renovatio Clinical - El Paso

    El Paso, Texas 79915
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Renovatio Clinical - The Woodlands

    The Woodlands, Texas 77380
    United States

    Active - Recruiting

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