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

Description

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.

Conditions

Cancer, Melanoma Stage III, Melanoma Stage IV, Cutaneous Melanoma

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Cancer
Intervention / Treatment

-

Contacts and Locations

Los Angeles

UCLA Health, Los Angeles, California, United States, 90095

Palo Alto

Stanford Cancer Center, Palo Alto, California, United States, 94305

Rancho Santa Margarita

Mission Dermatology Center, Rancho Santa Margarita, California, United States, 92688

Indianapolis

IU Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States, 46202

Detroit

Henry Ford Cancer Institute, Detroit, Michigan, United States, 48202

Morristown

Morristown Medical Center / Atlantic Health System, Morristown, New Jersey, United States, 07960

New York

Weill Cornell Medicine-New York-Presbyterian Hospital, New York, New York, United States, 10065

Cincinnati

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States, 45229

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Pittsburgh

UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States, 15232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Krystal Biotech, Inc.,

David Chien, MD, STUDY_DIRECTOR, Senior Vice President of Clinical Development

Study Record Dates

2027-07