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KB707

Phase 1

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

KB707 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Aug 2023

KB707 target and mechanism

Molecular targetIL-2
Target classCytokine
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials2
Total Enrollment490

FDA Designations

FAST_TRACK

KB707 clinical trials

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 CellUnlock trial analytics
PHASE1RECRUITING
A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors
CancerUnlock trial analytics

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 7 trials

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Frequently asked questions about KB707

What is KB707?

KB707 is an investigational monoclonal antibody developed by Krystal Biotech, Inc. for the treatment of advanced solid tumors, including non-small cell lung cancer. It is designed to target IL-2, a cytokine involved in immune system signaling, and is currently being evaluated in Phase 1 clinical trials.

What is KB707 used for in non-small cell lung cancer?

KB707 is being studied for the treatment of advanced solid tumor malignancies affecting the lungs, including non-small cell lung cancer and metastatic lung cancer. It is also being evaluated in locally advanced or metastatic solid tumors such as melanoma. KB707 is investigational and has not been approved for any indication.

What does KB707 target?

KB707 targets IL-2, a cytokine that plays a role in regulating immune responses. By binding to IL-2, KB707 is designed to modulate immune activity against tumor cells. This mechanism is being explored in Phase 1 trials for advanced solid tumors, including non-small cell lung cancer.

Who is developing KB707?

KB707 is being developed by Krystal Biotech, Inc., a biotechnology company traded on the Nasdaq under the ticker symbol KRYS. The company is sponsoring Phase 1 clinical trials to evaluate KB707 in patients with advanced solid tumors, including lung cancer and melanoma.

What phase is KB707 in?

KB707 is in Phase 1 clinical development. It is investigational and has not received FDA approval. The Phase 1 program includes trials evaluating the drug in advanced solid tumors, including non-small cell lung cancer and melanoma, with a combined planned enrollment of approximately 490 patients.

What clinical trials is KB707 in?

KB707 is being evaluated in two Phase 1 clinical trials. NCT06228326 is assessing KB707 in advanced solid tumor malignancies affecting the lungs, including non-small cell lung cancer, with a planned enrollment of 250 patients. NCT05970497 is studying KB707 in locally advanced or metastatic solid tumors, including melanoma, with a planned enrollment of 240 patients. Both trials are recruiting in the United States.