Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors
NCT05970497 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2023-10-31 |
| Est. Completion | 2027-07 |
| Phase | Phase 1 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Krystal Biotech, which has 66 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05970497 reports 15 study locations spanning 11 distinct geographic areas — top geographies include Texas, California, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05970497?
The interventions under investigation include: KEYTRUDA ®( Pembrolizumab) (DRUG), KB707 (BIOLOGICAL), Opdualag (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05970497?
This trial is sponsored by Krystal Biotech, which has 66 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.