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NCT05970497 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Cancer and Cutaneous Melanoma, sponsored by Krystal Biotech.

Recruiting
Registry status
Phase 1
Development phase
240
Enrollment target
15
Study locations

NCT05970497 is a Phase 1 study of Cancer and Cutaneous Melanoma that is actively recruiting participants, run by Krystal Biotech. The registered enrollment target is 240 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (93% lower). The trial reports 15 study locations across 11 states.

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The verdict

NCT05970497, a Phase 1 study of Cancer and Cutaneous Melanoma, is actively recruiting participants, sponsored by Krystal Biotech.

RECRUITING
Registry status
Phase 1
Development phase
240 participants
Enrollment target
15
Study locations

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.

Conditions Studied

Cancer Cutaneous Melanoma Melanoma Stage IV Melanoma Stage III

Interventions

  • DRUG KEYTRUDA ®( Pembrolizumab)
  • BIOLOGICAL KB707
  • DRUG Opdualag

Study Locations (15)

Texas

  • Renovatio Clinical - El Paso - El Paso
  • MD Anderson Cancer Center - Houston
  • Renovatio Clinical - The Woodlands - The Woodlands

California

  • UCLA Health - Los Angeles
  • Mission Dermatology Center - Rancho Santa Margarita

Ohio

  • Gabrail Cancer Center Research - Canton
  • Cleveland Clinic - Cleveland

Florida

  • BRCR Global - Weston

Indiana

  • IU Simon Comprehensive Cancer Center - Indianapolis

Michigan

  • Henry Ford Cancer Institute - Detroit

Nebraska

  • University of Nebraska Medical Center - Omaha

New Jersey

  • Morristown Medical Center / Atlantic Health System - Morristown

Trial Details

FieldValue
Enrollment Target 240 participants
Start Date 2023-10-31
Est. Completion 2027-07
Phase Phase 1

Sponsor

Krystal Biotech

13 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05970497

The ClinicalTrials.gov registry entry for NCT05970497 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (93% lower). The listed sponsor is Krystal Biotech, which has 13 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Cancer appearing as the primary indexed condition, and to 3 interventions - of which KEYTRUDA ®( Pembrolizumab) is the first listed.

NCT05970497 reports 15 study locations spanning 11 distinct geographic areas - top geographies include Texas, California, Ohio.

Frequently Asked Questions

What is clinical trial NCT05970497 about?

NCT05970497 is a clinical study titled "A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors". 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, re...

What is the current status of trial NCT05970497?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 240 participants. The study started on 2023-10-31. Estimated completion is 2027-07.

What conditions does trial NCT05970497 study?

This clinical trial studies the following conditions: Cancer, Cutaneous Melanoma, Melanoma Stage IV, Melanoma Stage III.

What interventions are being tested in trial NCT05970497?

The interventions under investigation include: KEYTRUDA ®( Pembrolizumab) (DRUG), KB707 (BIOLOGICAL), Opdualag (DRUG).

Who is sponsoring clinical trial NCT05970497?

This trial is sponsored by Krystal Biotech, which has 13 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05970497 being conducted?

This trial has 15 study locations across California, Florida, Indiana, Michigan, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.