Tests KB707 in adults with advanced solid tumors and melanoma
Tests KB707, given by injection into tumors, alone or with Opdualag in melanoma.
Key facts
- Who runs it
- Krystal Biotech, Inc.
- Where
- Canton, Cleveland, Detroit, El Paso, Houston, Indianapolis, Los Angeles, Morristown, Nashville, New York, Omaha, Pittsburgh, Rancho Santa Margarita, The Woodlands, and Weston, United StatesSee the 15 sites
- Trial code
- Registry title
- A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 240 people, planned
- Started
- 31 Oct 2023
- Expected to end
- Jul 2027
- Type of study
- Interventional, 3 groups
- Treatments tested
- KB707
- Opdualag
- KEYTRUDA ®( Pembrolizumab)
- Record updated
- 18 May 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or metastatic solid tumors, including melanoma, who have already tried other treatments. KB707 is given by injection into the tumor.
- Age
- 18 years or older. In Cohort 5 (melanoma), age 12 years or older. In Cohort 6 (melanoma), age 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Locally advanced or metastatic solid tumor (Cohorts 1-4, now closed to new enrollment). Stage III (unresectable) or stage IV melanoma (Cohorts 5 and 6). The disease must be measurable on scans, and life expectancy must be more than 12 weeks.
- Earlier treatment
- Cohorts 1-4: the cancer got worse on standard treatment, standard treatment was not tolerated or refused, or no standard treatment exists. Cohorts 5 and 6: one earlier anti-PD-1/PD-L1 treatment has failed. If the melanoma has a BRAF V600 mutation, a BRAF inhibitor (with or without a MEK inhibitor) must have failed. No more than 2 earlier lines of systemic treatment for melanoma.
- Biomarker or test result
- Melanoma with a BRAF V600 mutation needs an earlier BRAF inhibitor that failed. No other marker is required.
Main reasons for not taking part
- Pregnant or nursing, or planning pregnancy during treatment and for three months after the last dose of KB707
- Known history of positive HIV 1/2 test
- Not fully recovered from earlier surgery or radiation, or needing systemic corticosteroids
- Melanoma Cohorts 5 and 6: uveal/ocular melanoma, or active brain or leptomeningeal metastases
- Melanoma Cohorts 5 and 6: another cancer that is getting worse or needs active treatment
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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; 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; 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
Who cannot take part
- Prior surgery or radiation therapy must be fully recovered, including all radiation -related toxicities and subject does not require systemic corticosteroids
- Cohorts 5 and 6 only:; Subject has a known additional malignancy that is progressing or requires active treatment; Subject has uveal/ocular melanoma; The subject has active brain metastases or leptomeningeal metastases; Subject has received more than 2 lines of systemic therapy for unresectable or metastatic melanoma; Prior anti-LAG-3 and/or anti-PD-1 therapy was intolerable and required discontinuation of treatment
- Have known history of positive human immunodeficiency virus (HIV 1/2)
- The subject is pregnant, nursing, or plans to become pregnant during study treatment and through three months after the last dose of KB707
Where in United States
- Gabrail Cancer Center ResearchCanton, United StatesContact: Carrie Smith, RNTaking people
- Cleveland ClinicCleveland, United StatesContact: Cancer Answer LineTaking people
- Henry Ford Cancer InstituteDetroit, United StatesContact: Meghan Gauronskas, RNTaking people
- Renovatio Clinical - El PasoEl Paso, United StatesContact: Randa MaderoTaking people
- MD Anderson Cancer CenterHouston, United StatesContact: Li LiTaking people
- IU Simon Comprehensive Cancer CenterIndianapolis, United StatesContact: Anne Younger, RNTaking people
- UCLA HealthLos Angeles, United StatesContact: Youstina ZakiTaking people
- Morristown Medical Center, Atlantic Health SystemMorristown, United StatesContact: Salome Geene, RN, CRC, BSNTaking people
- Sarah Cannon Research InstituteNashville, United StatesContact: David Chien, MDTaking people
- Weill Cornell Medicine-New York Presbyterian HospitalNew York, United StatesContact: Anna C Pavlick, DOTaking people
- University of Nebraska Medical CenterOmaha, United StatesContact: Michaela SavineTaking people
- UPMC Hillman Cancer CenterPittsburgh, United StatesContact: Kelly SchroderTaking people
- Mission Dermatology CenterRancho Santa Margarita, United StatesContact: Shireen Guide, MD, FAADTaking people
- Renovatio Clinical - The WoodlandsThe Woodlands, United StatesContact: Randa MaderoTaking people
- BRCR GlobalWeston, United StatesContact: Vaneska ChacinTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 3 groups in the trial
- Cohorts 1 through 4Treatment being tested
Dose escalation and expansion cohorts: KB707 monotherapy in subjects with solid tumors.
Treatment: KB707
- Cohort 5Treatment being tested
Dose expansion cohort: KB707 administered in combination with Opdualag in approximately 100 subjects with advanced melanoma.
Treatment: KB707 and Opdualag
- Cohort 6Treatment being tested
Dose expansion cohort: KB707 administered in combination with Keytruda in approximately 100 subjects with advanced melanoma.
Treatment: KB707 and KEYTRUDA ®( Pembrolizumab)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Tests KB707 in adults with advanced solid tumors and melanomaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 18 May 2025