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KB707

Phase 1

Cancer | Monoclonal antibody | Oncology |Krystal Biotech, Inc.|Last Updated: Oct 24, 2025

Success Probability
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Market & Valuation
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Trial Design
CONTROLLED
Total Trials1
Total Enrollment240
FDA Designations
FAST_TRACKRMAT
Clinical trial landscape

KB707 · 2 trials · 9 indications

Phase 1 2
NCT06228326A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the LungsLung Cancer, Non-small Cell
RECRUITING250 Analytics
NCT05970497A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid TumorsCancer
RECRUITING240 Analytics
PHASE1RECRUITING
A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs
Lung Cancer, Non-small Cell
NCT06228326250
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PHASE1RECRUITING
A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors
Cancer
NCT05970497240
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Study Endpoints
Primary Endpoints
To evaluate the safety and tolerability of inhaled KB707 based upon assessment of adverse events (AE)
up to 36 months

Percentage of subjects with treatment-related AEs as assessed by NCI-CTCAE v5

Percentage of adverse events (AEs)
up to 36 months

Percentage of subjects with adverse events (AEs)

Percentage of serious adverse events (SAEs)
up to 36 months

Percentage of subjects with serious adverse events (SAEs)

Secondary Endpoints
To evaluate whether the proposed dose ranges include the maximum tolerated dose of KB707 as determined by incidence of dose limiting toxicities (DLTs)
up to 36 months
To evaluate the preliminary efficacy of inhaled KB707 as determined by overall response rate (ORR)
up to 36 months
Maximum tolerated dose (MTD)
up to 36 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohorts 1 through 4EXPERIMENTALDose escalation and expansion cohorts: KB707 monotherapy in subjects with solid tumor malignancies affecting the lungs.
Cohort 5EXPERIMENTALDose expansion cohort: KB707 administered in combination with Keytruda in approximately 60 subjects with NSCLC.
Cohort 6EXPERIMENTALDose expansion cohort: KB707 administered in combination with Keytruda and chemotherapy in approximately 60 subjects with NSCLC.
Experimental: Cohort 7EXPERIMENTALDose expansion cohort: KB707 administered in combination with docetaxel in approximately 50 subjects with NSCLC.
Interventions
NameTypeDescription
KB707BIOLOGICALGenetically modified herpes simplex type 1 virus
Pembrolizumab (KEYTRUDA®)DRUGPD-1 immune checkpoint inhibitor
ChemotherapyDRUGSOC chemotherapy
DocetaxelDRUGSOC chemotherapy
OpdualagDRUGDual immunotherapy (PD-1 and LAG-3 immune checkpoint inhibitors)
KEYTRUDA ®( Pembrolizumab)DRUGImmunotherapy (PD-1 immune checkpoint inhibitor)
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites14

Key Inclusion Criteria: * Age 18 years or older at the time of informed consent * Life expectancy \>12 weeks * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Have at least one measurable lung lesion per RECIST v1.1 at Screening * Cohorts 1 through 4 only: Histologically co...

Countries:United States
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Competitive Landscape -Cancer 5 trials
CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520 / GEH200521 - Part A
Zimmer Biomet Holdings, Inc.ZBH1 - Undisclosed
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06228326primaryCompletionDate: changed
LOWMay 26, 2026NCT05970497primaryCompletionDate: changed
LOWMay 24, 2026NCT06228326studyFirstPostDate: changed
LOWMay 24, 2026NCT05970497studyFirstPostDate: changed