NCT05970497 A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors
| NCT ID | NCT05970497 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Krystal Biotech, Inc. |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2023-10-31 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 240 participants in total. It began in 2023-10-31 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Key Inclusion Criteria: * Life expectancy \>12 weeks * ECOG performance status of 0 or 1 * Have measurable disease per RECIST v1.1 at Screening * Cohorts 1-4 only: 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. * 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 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 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
Contact & Investigator
David Chien, MD
STUDY DIRECTOR
Senior Vice President of Clinical Development
Frequently Asked Questions
Who can join the NCT05970497 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05970497 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05970497 currently recruiting?
Yes, NCT05970497 is actively recruiting participants. Contact the research team at dchien@krystalbio.com for enrollment information.
Where is the NCT05970497 trial being conducted?
This trial is being conducted at Los Angeles, United States, Rancho Santa Margarita, United States, Weston, United States, Indianapolis, United States and 11 additional locations.
Who is sponsoring the NCT05970497 clinical trial?
NCT05970497 is sponsored by Krystal Biotech, Inc.. The principal investigator is David Chien, MD at Senior Vice President of Clinical Development. The trial plans to enroll 240 participants.
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