A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs

Conditions

• Advanced Cancer
• Lung Cancer (NSCLC)
• Lung Cancer Metastatic
• Lung Cancer, Non-small Cell
• Solid Tumor, Adult

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• KB707 — BIOLOGICAL
  Genetically modified herpes simplex type 1 virus
• Pembrolizumab (KEYTRUDA®) — DRUG
  PD-1 immune checkpoint inhibitor
• Chemotherapy — DRUG
  SOC chemotherapy
• Docetaxel — DRUG
  SOC chemotherapy

Study Details

The Sponsor is developing KB707, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector designed to stimulate an anti-tumor immune response through the production of cytokines within the local tumor microenvironment in the lungs. KB707 is administered via nebulization, delivering the therapy directly through the airways to the lungs of subjects with advanced solid tumor malignancies. This is a Phase 1/2, open-label, multicenter, dose escalation and expansion study designed to evaluate the safety, tolerability, preliminary efficacy, and immunologic effect of KB707. Monotherapy KB707 dose escalation and expansion cohorts enrolled adults with advanced solid tumor malignancies affecting the lungs who had progressed on standard of care therapy, cannot tolerate standard of care therapy, or refused standard of care therapy. The dose escalation phase (Cohorts 1 and 2) evaluated KB707 monotherapy using a standard 3+3 design, followed by a dose expansion phase (Cohort 4) to further evaluate the selected dose. Subjects received inhaled KB707 weekly for three weeks, then every three weeks. The dose escalation portion of the study is now complete, and the selected dose is being evaluated in the expansion phase. Combination regimens with a selected (fixed) dose of KB707 are being evaluated in subjects with advanced or metastatic non-small cell lung cancer (NSCLC). Subjects in Cohorts 5 and 6 are receiving inhaled KB707 once every 2 weeks (q2w), delivered in combination with Keytruda once every 6 weeks. Subjects in Cohort 7 are receiving inhaled KB707 in combination with docetaxel once every 3 weeks. All subjects will be treated until tumor 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.

Key Dates

Start date

Apr 17, 2024

Status verified

Oct 2025

Primary completion

Feb 28, 2027

Completion

Jul 31, 2028

Study Design

Enrollment

250 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Cohorts 1 through 4
  Dose escalation and expansion cohorts: KB707 monotherapy in subjects with solid tumor malignancies affecting the lungs.
• Experimental: Cohort 5
  Dose expansion cohort: KB707 administered in combination with Keytruda in approximately 60 subjects with NSCLC.
• Experimental: Cohort 6
  Dose expansion cohort: KB707 administered in combination with Keytruda and chemotherapy in approximately 60 subjects with NSCLC.
• Experimental: Experimental: Cohort 7
  Dose expansion cohort: KB707 administered in combination with docetaxel in approximately 50 subjects with NSCLC.

Primary Outcome Measure

To evaluate the safety and tolerability of inhaled KB707 based upon assessment of adverse events (AE) [ Time Frame: up to 36 months ]

Central Contacts

• David Chien, MD
  412-586-5830
  [email protected]
• Brittani Agostini, RN, CCRC
  412-586-5830
  [email protected]

Locations (14)

Find similar trials in Dothan, AL

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