A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors

Conditions

• Cancer
• Cutaneous Melanoma
• Melanoma Stage III
• Melanoma Stage IV

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• KB707 — BIOLOGICAL
  Genetically modified herpes simplex type 1 virus
• Opdualag — DRUG
  Dual immunotherapy (PD-1 and LAG-3 immune checkpoint inhibitors)
• KEYTRUDA ®( Pembrolizumab) — DRUG
  Immunotherapy (PD-1 immune checkpoint inhibitor)

Study Details

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.

Key Dates

Start date

Oct 31, 2023

Status verified

May 2025

Primary completion

Jul 31, 2027

Completion

Jul 31, 2027

Study Design

Enrollment

240 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 tumors.
• Experimental: Cohort 5
  Dose expansion cohort: KB707 administered in combination with Opdualag in approximately 100 subjects with advanced melanoma.
• Experimental: Cohort 6
  Dose expansion cohort: KB707 administered in combination with Keytruda in approximately 100 subjects with advanced melanoma.

Primary Outcome Measure

Percentage of adverse events (AEs) [ 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 (15)

Find similar trials in Los Angeles, CA

Related Studies

• Effects of Oncological Treatment During Pregnancy on Mother and Child
  Recruiting · University Hospital, Gasthuisberg · Camden, New Jersey
• Establishment of a Lifetime of Cohort of Adults Surviving Childhood Cancer
  Recruiting · St. Jude Children's Research Hospital · Memphis, Tennessee
• Childhood Cancer Survivor Study
  Recruiting · St. Jude Children's Research Hospital · Birmingham, Alabama
• Long-Term Follow-Up of Recipient of Gene Transfer Research
  Recruiting · M.D. Anderson Cancer Center · Houston, Texas