๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-05-14

A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors (NCT05970497)

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

๐ŸŸข Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Krystal Biotech, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: UCLA Health โ€” Los Angeles, California

Age range: 18 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (15 Sites)

  • UCLA Health โ€” Los Angeles, California
  • Mission Dermatology Center โ€” Rancho Santa Margarita, California
  • BRCR Global โ€” Weston, Florida
  • IU Simon Comprehensive Cancer Center โ€” Indianapolis, Indiana
  • Henry Ford Cancer Institute โ€” Detroit, Michigan
  • University of Nebraska Medical Center โ€” Omaha, Nebraska
  • Morristown Medical Center / Atlantic Health System โ€” Morristown, New Jersey
  • Weill Cornell Medicine-New York-Presbyterian Hospital โ€” New York, New York
  • Gabrail Cancer Center Research โ€” Canton, Ohio
  • Cleveland Clinic โ€” Cleveland, Ohio
  • UPMC Hillman Cancer Center โ€” Pittsburgh, Pennsylvania
  • Sarah Cannon Research Institute โ€” Nashville, Tennessee
  • Renovatio Clinical - El Paso โ€” El Paso, Texas
  • MD Anderson Cancer Center โ€” Houston, Texas
  • Renovatio Clinical - The Woodlands โ€” The Woodlands, Texas

๐Ÿ“ž Contact the Study Coordinator

Phone: (412) 586-5830

Email: dchien@krystalbio.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—