CancerPhase 1/2NCT05970497
A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing KB707, Opdualag and KEYTRUDA ®( Pembrolizumab) in people with Cancer and Melanoma Stage III, run by Krystal Biotech, Inc. at 15 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Melanoma Stage III, Melanoma Stage IV
- What is being tested?
- KB707, Opdualag and KEYTRUDA ®( Pembrolizumab)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 15 sitesUnited States
- Study dates
- 31 Oct 2023to Jul 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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 join
- 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:
- Subject has a known additional malignancy that is progressing or requires active treatment.
- Subject has uveal/ocular melanoma.
Show all 9Show fewer
- 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
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
United States15 sites, 15 recruiting
- Recruiting
Gabrail Cancer Center Research
Canton, Ohio, 44718
Carrie Smith, RN, 330-492-3345, csmith@gabrailcancercenter.com
Kim Roby, 330-492-3345, kroby@gabrailcancercenter.com
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Cancer Answer Line, 216-444-7923
- Recruiting
Henry Ford Cancer Institute
Detroit, Michigan, 48202
Meghan Gauronskas, RN, 313-693-5904, mgauron1@hfhs.org
Lisa Lange CCTRO Director, 313-556-8106, llange3@hfhs.org
- Recruiting
Renovatio Clinical - El Paso
El Paso, Texas, 79915
Randa Madero, 713-703-2398, Randa.madero@renovatioclinical.com
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Li Li, 713-792-3844, LLi8@mdanderson.org
- Recruiting
IU Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Anne Younger, RN, 317-274-0951, anefoste@iupui.edu
Yvonne LaFary, RN, (317) 278-5613, ylafary@iu.edu
- Recruiting
UCLA Health
Los Angeles, California, 90095
Youstina Zaki, 310-794-3102, YZaki@mednet.ucla.edu
Elizabeth Seja, 310-794-6892, ESeja@mednet.ucla.edu
- Recruiting
Morristown Medical Center / Atlantic Health System
Morristown, New Jersey, 07960
Salome Geene, RN, CRC, BSN, 973-971-6373, salome.geene@atlantichealth.org
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
844-482-4812, asksarah@sarahcannon.com
- Recruiting
Weill Cornell Medicine-New York-Presbyterian Hospital
New York, New York, 10065
Anna C Pavlick, DO, 646-962-6444
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Michaela Savine, 402-836-9488, misavine@unmc.edu
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Kelly Schroder, 412-623-3544, schroderka@upmc.edu
- Recruiting
Mission Dermatology Center
Rancho Santa Margarita, California, 92688
Shireen Guide, MD, FAAD, admin@missiondermatology.com
- Recruiting
Renovatio Clinical - The Woodlands
The Woodlands, Texas, 77380
Randa Madero, 713-703-2398, Randa.madero@renovatioclinical.com
- Recruiting
BRCR Global
Weston, Florida, 33326
Vaneska Chacin, 561-447-0614 ext. 109, vchacin@brcrglobal.com
Maria Abreu, 561-447-0614 ext. 106, mabreu@brcrglobal.com
About this study
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
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.
Read the detailed description
KB707 is a genetically modified herpes simplex type 1 virus that is designed to stimulate an anti-tumor immune response through the production of cytokines. This is a first-in-human (FIH) clinical study to evaluate the safety and tolerability and preliminary efficacy of KB707 in adult subjects with advanced and/or refractory solid tumors, including advanced melanoma. The study will include a dose escalation portion for single agent KB707 and an expansion portion to further evaluate single agent KB707 at a dose determined by preliminary data in the dose escalation phase as well as combination therapy of KB707 with immune checkpoint inhibitor therapy.
- Conditions
- Cancer, Melanoma Stage III, Melanoma Stage IV, Cutaneous Melanoma
- Being tested
- KB707, Opdualag, KEYTRUDA ®( Pembrolizumab)
- Keywords
- Krystal Biotech, cancer, melanoma
- Medical subject headings
- Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KB707Biological
Genetically modified herpes simplex type 1 virus
OpdualagDrug
Dual immunotherapy (PD-1 and LAG-3 immune checkpoint inhibitors)
KEYTRUDA ®( Pembrolizumab)Drug
Immunotherapy (PD-1 immune checkpoint inhibitor)
| Study group | Role | What they receive |
|---|---|---|
| Cohorts 1 through 4 | Experimental | Dose escalation and expansion cohorts: KB707 monotherapy in subjects with solid tumors. Receives: Biological: KB707 |
| Cohort 5 | Experimental | Dose expansion cohort: KB707 administered in combination with Opdualag in approximately 100 subjects with advanced melanoma. Receives: Biological: KB707; Drug: Opdualag |
| Cohort 6 | Experimental | Dose expansion cohort: KB707 administered in combination with Keytruda in approximately 100 subjects with advanced melanoma. Receives: Biological: KB707; Drug: KEYTRUDA ®( Pembrolizumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of adverse events (AEs)
Percentage of subjects with adverse events (AEs)
Measured: up to 36 months
Percentage of serious adverse events (SAEs)
Percentage of subjects with serious adverse events (SAEs)
Measured: up to 36 months
Secondary outcomes (2)
Maximum tolerated dose (MTD)
Assess whether the tested doses include the maximum tolerated dose (MTD) of KB707 based on the safety and response data collected during the dose escalation portion of the study
Measured: up to 36 months
Percentage of overall response rate (ORR)
Percentage of ORR
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start31 Oct 2023
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Krystal Biotech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krystal Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Chien, MD, Study director, Senior Vice President of Clinical Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970497
- Sponsor's protocol ID
- KB707-01
- Status last verified
- May 2025
- First submitted
- 24 Jul 2023
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05970497
- Acronym / sponsor ID
- KB707-01
- Conditions
- Cancer, Melanoma Stage III, Melanoma Stage IV, Cutaneous Melanoma
- Keywords
- Krystal Biotech, cancer, melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Krystal Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
KB707 is a genetically modified herpes simplex type 1 virus that is designed to stimulate an anti-tumor immune response through the production of cytokines. This is a first-in-human (FIH) clinical study to evaluate the safety and tolerability and preliminary efficacy of KB707 in adult subjects with advanced and/or refractory solid tumors, including advanced melanoma. The study will include a dose escalation portion for single agent KB707 and an expansion portion to further evaluate single agent KB707 at a dose determined by preliminary data in the dose escalation phase as well as combination therapy of KB707 with immune checkpoint inhibitor therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohorts 1 through 4 | Experimental | Biological: KB707Dose escalation and expansion cohorts: KB707 monotherapy in subjects with solid tumors. |
| Cohort 5 | Experimental | Biological: KB707, Drug: OpdualagDose expansion cohort: KB707 administered in combination with Opdualag in approximately 100 subjects with advanced melanoma. |
| Cohort 6 | Experimental | Biological: KB707, Drug: KEYTRUDA ®( Pembrolizumab)Dose expansion cohort: KB707 administered in combination with Keytruda in approximately 100 subjects with advanced melanoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KB707Genetically modified herpes simplex type 1 virus | Biological | Cohort 5, Cohort 6, Cohorts 1 through 4 |
| OpdualagDual immunotherapy (PD-1 and LAG-3 immune checkpoint inhibitors) | Drug | Cohort 5 |
| KEYTRUDA ®( Pembrolizumab)Immunotherapy (PD-1 immune checkpoint inhibitor) | Drug | Cohort 6 |
Primary outcome
Percentage of adverse events (AEs)
Time frame: up to 36 months
Percentage of subjects with adverse events (AEs)
Percentage of serious adverse events (SAEs)
Time frame: up to 36 months
Percentage of subjects with serious adverse events (SAEs)
2 secondary outcomes
Maximum tolerated dose (MTD)
Time frame: up to 36 months
Percentage of overall response rate (ORR)
Time frame: up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Chien, MD study director
Senior Vice President of Clinical Development
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing KB707, Opdualag and KEYTRUDA ®( Pembrolizumab) in people with Cancer and Melanoma Stage III, run by Krystal Biotech, Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Chien, MD (412-586-5830, dchien@krystalbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of adverse events (AEs) (time frame: up to 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.